Intervet International B.V. v E. I. du Pont de Nemours and Company
[2017] APO 31
•29 June 2017
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Intervet International B.V. v E. I. du Pont de Nemours and Company [2017] APO 31
Patent Application: 2008268321
Title:Animal pest control method
Patent Applicant: E. I. du Pont de Nemours and Company
Opponent: Intervet International B.V.
Delegate: Dr M-A. Fam
Decision Date: 29 June 2017
Hearing Date: 10 May 2017, in Canberra
Catchwords: PATENTS – section 59 – opposition to the grant of a patent – grounds of novelty, inventive step, manner of manufacture, clarity, full description and fair basis considered – novelty – one citation does not disclose all the features of the claims – one citation does not form part of the prior art base – inventive step – claims 1 – 28 lack an inventive step in view of US 2007/0066617 and the common general knowledge – claims define a manner of manufacture – claims are clear – invention fully described – lack of fair basis not established – opposition succeeds – costs awarded – variation of costs in view of documents provided under regulation 5.23
Representation: Counsel for the applicant: Mr Christian Dimitriadis SC and Ms Claire Cunliffe
Patent attorneys for the applicant: Dr Elizabeth Houlihan and Dr Jim Onishi of Houlihan2
Counsel for the opponent: Ms Katrina Howard SC
Patent attorney for the opponent: Dr David Myers of Spruson & Ferguson
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2008268321
Title:Animal pest control method
Patent Applicant: E. I. du Pont de Nemours and Company
Date of Decision: 29 June 2017
DECISION
Claims 1 – 28 lack an inventive step in view of US 2007/0066617 and the common general knowledge.
I allow E. I. du Pont de Nemours and Company a period of two months from the date of this decision to file amendments.
Costs according to Schedule 8 are awarded against E. I. du Pont de Nemours and Company, varied as follows: Intervet International B.V. is entitled to claim double the cost of preparing evidence in reply (item 9 of Schedule 8).
REASONS FOR DECISION
1. Background
The present application was filed by E. I. du Pont de Nemours and Company (DuPont) on 26 June 2008 and claims priority from US 60/937, 389 which was filed on 27 June 2007. Following examination, the application was advertised accepted on 7 August 2014. A notice of opposition was filed by Intervet International B.V. (Intervet) on 7 November 2014. A hearing was held in Canberra on 10 May 2017.
The request for examination in relation to the application was filed on 28 May 2012. Consequently, substantive amendments of the Patents Act 1990 brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (Raising the Bar) do not apply to the present application. This includes the amendment to subsection 60 (3A) that allows the Commissioner to refuse a patent application if satisfied on the balance of probabilities that a ground of opposition exists. Any subsequent references to sections of the Patents Act relate to the Patents Act 1990 prior to amendment by the Raising the Bar Act. A similar qualification applies to references to the Patents Regulations 1991.
2. Grounds of opposition
The statement of grounds and particulars (SG&P) was filed on 9 February 2015. Intervet’s submissions filed on 26 April 2017 raised the ground of utility, however this ground was not listed in the SG&P. DuPont objected to the inclusion of the ground at this late stage.
Under subregulation 5.16(1)(a), an opponent may request the Commissioner to amend the SG&P to correct an error or omission in the grounds of opposition. Requests to amend under regulation 5.16 were recently considered by a Deputy Commissioner of Patents.[1] In that decision, it was stated that there is an expectation that amendments to the SG&P are made at the earliest reasonable opportunity.[2]
[1] CSL Limited v Isconova AB et al. [2016] APO 82.
[2] ibid. at [15].
At the hearing, Intervet did not indicate that an error or omission had been made in the SG&P, or provide reasons for the late inclusion of the ground of utility. Instead, Intervet suggested that utility could be introduced under subsection 60(3), which states that the Commissioner may take into account any ground on which the grant of a patent may be opposed, whether relied upon by the opponent or not.
The provisions of subsection 60(3) are discretionary and require consideration of whether it is in the public interest to take into account a ground not previously raised by the opponent. In this case I consider that the likelihood of success on the ground of utility is insufficient to warrant the inclusion of this ground in the public interest. Therefore at the hearing I refused to take into account the ground of utility.
The grounds pressed at the hearing were novelty, inventive step, manner of manufacture, sufficiency, fair basis and clarity.
3. Standard of proof
The onus of proof in this opposition proceeding rests with the opponent, who must demonstrate that it is clear that a valid patent cannot be granted.[3]
[3] F.Hoffman-La Roche AG v New England Biolabs Inc [2000] FCA 283; 50 IPR 305 at [67]; Commissioner of Patents v Sherman [2008] FCAFC 182; 79 IPR 426 at [18].
4. Evidence
The evidence is summarised in the table below.
Evidence Declarant Exhibits Date Reference Bryce Alan Peters
BAP-1 to BAP-15 11 May 2015 Peters-1 In Support Penelope-Jane Linnett
PJL-1 to PJL-15 11 May 2015 Linnett-1 Petr Fisara
PF-1 to PF-4 11 May 2015 Fisara-1 Peter Alexander Taylor
PAT-1 to PAT-13 11 August 2011 Taylor In Answer Steven Rodney Kopp SRK-1 to SRK-13 12 August 2011
Kopp-1 Petr Fisara
25 September 2015 Fisara-2 In Reply Ronald Kaminsky
RK-1 to RK-5 13 October 2015 Kaminsky-1 Bryce Alan Peters
BAP-16 to BAP-19 14 October 2015 Peters-2 Penelope-Jane Linnett
14 October 2015 Linnett-2 Steven Rodney Kopp
SRK-14 to SRK-18 28 April 2016 Kopp-2 Ronald Kaminsky RK-6 to RK-7
13 June 2016 Kaminsky-2 Regulation 5.23
Appendices I – XI filed 23 April 2016 DuPont Appendices Appendices I – XI filed 22 June 2016 Intervet Appendices 5. The subject matter of the specification
5.1 Background of the invention
The invention relates to methods for protecting animals from parasitic pests. The specification states that existing methods for the treatment and control of parasites are being compromised due to growing resistance to many commercial parasiticides.[4] Thus, it is imperative to find more effective ways to control animal parasites.[5] In addition, there are advantages in finding ways to apply pesticides to animals orally or parenterally, in order to prevent the possible contamination of humans or the surrounding environment.[6]
[4] Specification at page 1, lines 8 – 9.
[5] ibid., line 10.
[6] ibid., lines 10 – 13.
The specification states that certain insecticidal isoxazoline derivatives are disclosed in WO 05/085216 (Australian family member AU 2005219788, D4).[7]
[7] ibid., lines 14 – 18.
5.2 Nature of the invention
The specification indicates that the invention relates to a method for protecting animals from parasitic invertebrate pests by orally or parenterally administering to the animal a pesticidally effective amount of an isoxazoline compound. In particular, the invention is directed to a compound of Formula 1 (Compound 3) when used for protecting a mammal from a flea, wherein the compound is administered orally or parenterally to the mammal.[8]
[8] ibid., page 3, lines 17 – 25.
The specification states that Compound 3 can be prepared as described in D4[9] and certain properties of the compound are provided in Tables A and B.[10] The activity of Compound 3 against fleas is tested by orally or subcutaneously administering the compound to mice and by a flea ingestion test.[11]
[9] ibid., page 16, lines 3 – 4 and lines 30 – 31.
[10] ibid., pages 65 – 66.
[11] ibid., pages 67 – 68.
5.3 The claims of the specification
The specification contains 28 claims and these are reproduced in Annex A. Claim 1 is directed to Compound 3 when used for protecting a mammal from a flea and claim 8 is a Swiss style claim that refers to the use of the compound of claim 1. The remaining claims are dependent.
6. The person skilled in the art
The person skilled in the art is the hypothetical addressee:
“He is the person to whom the patent is addressed and who must construe it. He is the person whose knowledge will determine whether a patent is novel. He is the person who will judge whether a patent is obvious. …
In Catnic Lord Diplock said (at 242) that skilled addressees are ‘those likely to have a practical interest in the subject matter of [the] invention’. A variety of people may have that interest. There are those who might wish to make or construct the invention, those who may wish to compound the invention and those who may wish to use the invention. The skilled addressee seems to me to be a relative expression which does not identify any specific person.”[12]
[12] Root Quality Pty Ltd v Root Control Technologies Pty Ltd [2000] FCA 980; 49 IPR 225 at [70] – [71].
Intervet submitted that the person skilled in the art would be involved in developing methods for protecting mammals from ectoparasites, in particular fleas, and be a team of people including an entomologist, an animal health scientist and a research and development director, especially those with experience in testing, evaluating and developing chemicals for this purpose. DuPont submitted that the team would be in the field of developing new ectoparasiticides and include a veterinarian, an entomologist and a chemist.
Whilst the skilled teams identified by the parties differ slightly, I do not consider these differences to be significant. However, given that the invention relates to methods for protecting animals from parasitic pests, I consider the skilled person would have knowledge of parasites. Further, I consider the chemist would require knowledge and experience in formulating parasitic compositions. I therefore conclude that the person skilled in the art is a team including an animal health scientist/veterinarian, a parasitologist, a formulation chemist and a research and development manager.
In this opposition evidence was filed by the following declarants:[13]
·Mr Peters is an entomologist and has experience as a pest control operator and in the testing and evaluation of products for flea control.
·Dr Linnett is a veterinarian with experience in controlling ectoparasite infestations in mammals.
·Mr Fisara is a Senior Development Scientist with experience in evaluating products and methods for controlling pests including fleas.
·Dr Kaminsky, as a Head of Parasitology, has experience in testing and evaluating products for controlling parasites including fleas.
·Dr Kopp is veterinarian and has research experience in the canine hookworm, an endoparasite.
·Dr Taylor is a research entomologist, has lectured in parasitology and as a Senior Plant Pathologist and Research Manager has experience in the research and development of fungicides, pesticides and insecticides.
[13] The statements below provide a brief summary of knowledge and experience up until 27 June 2007 (the claimed priority date of the present application).
Intervet submitted that before June 2007, Dr Kopp had no experience in the relevant field and that his PhD research relates to endoparasites, not ectoparasites.[14] However, I note that Dr Kopp has been a qualified veterinarian since 2004 and I am satisfied that I can have regard to his evidence.
[14] Ectoparasites include fleas; specification at page 58, lines 29 – 33.
Intervet further submitted that Dr Taylor’s work in the areas of crop protection, entomology, pesticides and herbicides has been in relation to plant protection and that he does not describe any experience he has had with protecting mammals from pests. I acknowledge Dr Taylor’s experience primarily involves plant protection. However, notwithstanding this, he has skills in the application of research results to practice, and research and development experience in evaluating crop protection fungicides and insecticides. Noting that the skilled team includes a research and development manager, I consider that Dr Taylor’s evidence is useful in this regard.
I am therefore satisfied that I can give regard to the evidence of all of the declarants. Where there is conflicting evidence, I will use the normal practice of evaluating and weighing that evidence in order to resolve any conflict.
7. Claims construction
The principles of construction have been considered by the courts. These were summarised by the Full Court of the Federal Court:
“When determining the nature and extent of the monopoly claimed, the specification must be read as a whole. But as a whole it is made up of several parts which have different functions. The claims mark out the legal limits of the monopoly granted. The specification describes how to carry out the process claimed and the best method known to the patentee of doing that. Although the claims are construed in the context of the specification as a whole, it is not legitimate to narrow or expand the boundaries of monopoly as fixed by the words of a claim, by adding to those words glosses drawn from other parts of the specification. If a claim is clear and unambiguous, it is not to be varied, qualified or made obscure by statements found in other parts of the document. It is legitimate, however, to refer to the rest of the specification to explain the background of the claims, to ascertain the meaning of technical terms and resolve ambiguities in the construction of the claims. See Flexible Steel Lacing Co v Beltreco Ltd (2000) 49 IPR 331 at [73] – [75] (Hely J).
Other more specific principles of construction collected in Flexible Steel at [81] are:
·a specification should be given a purposive construction rather than a purely literal one;
·the hypothetical addressee of the specification is the non-inventive person skilled in the art before the priority date;
·the words used in a specification are to be given the meaning the hypothetical addressee would attach to them, both in the light of the addressee’s own general knowledge and in the light of what is disclosed in the body of the specification;
·as a general rule, the terms of the specification should be according their ordinary English meaning;
·evidence can be given by experts on the meaning those skilled in the art would give to technical or scientific terms and phrases, and on unusual or special meanings given by such persons to words which might otherwise bear their ordinary meaning;
·however, the construction of the specification is for the court, not for the expert. In so far as a view expressed by an expert depends upon a reading of the patent, it cannot carry the day unless the court reads the patent in the same way.”[15]
[15] Kinabalu Investments Pty Ltd v Barron Rawson Pty Ltd [2008] FCAFC 178 at [44] – [45].
As stated by Middleton J:
“It is well settled that the court should, from the outset, approach the task of patent construction with a generous measure of common sense. The court must place itself in the position of a person skilled in the relevant art, being the subject matter of the patent. From this perspective, the patent is to be read as a whole, in the context of the specification and in light of the prevailing common general knowledge and state of the relevant art at the priority date.”[16]
[16] Eli Lilly & Co Ltd v Apotex Pty Ltd [2013] FCA 214; 100 IPR 451 at [139].
7.1 Construction of claim 1
Claim 1 is as follows:
A compound of Formula 1, an N-oxide or a salt thereof when used for protecting a mammal from a flea, wherein the compound is administered orally or parenterally to the mammal
1
(a)When used
A “when used” claim is normally construed as a process claim.[17] In the present case, I agree that this is the correct construction. Thus, claim 1 is construed to define a process for protecting a mammal from a flea by the oral or parenteral administration of a compound of Formula 1 (Compound 3).
[17] Wellcome Foundation Ltd v Commissioner of Patents [1980] HCA 21; 1A IPR 261 at 266. Note that the Court did not use the phrase “when used”, and instead stated “that there is no distinction between the claim to the process and the claim to the substance when the substance claim is limited to its use in the process.”
(b)Parenteral
Intervet submitted that parenteral administration encompasses administration by all routes other than via the gastrointestinal tract and includes topical administration.
DuPont submitted that parenteral administration is limited to administration via injection or implant and does not encompass topical administration. Reference was made to the fact that the specification indicates it is desirable to apply pesticides to animals orally or parenterally, so as to prevent the possible contamination of humans or the surrounding environment[18] (that would otherwise occur with topical administration). DuPont further submitted that this interpretation was consistent with other parts of the specification:
“Treatments of the invention are by conventional means such as by enteral administration in the form of, for example, tablets, capsules, drinks, drenching preparations, granulates, pastes, boli, feed-through procedures, or suppositories; or by parenteral administration, such as, for example, by injection (including intramuscular, subcutaneous, intravenous, intraperitoneal) or implants; or nasal administration.”[19] (emphasis added)
…
“For parenteral administration including intravenous, intramuscular and subcutaneous injection …”.[20] (emphasis added)
[18] Specification at page 1, lines 10 – 13.
[19] ibid., page 62, lines 13 – 17.
[20] ibid., lines 30 – 31.
However, I note that the specification states that “including” is intended to cover a non-exhaustive inclusion,[21] i.e. parenteral administration is not limited to those modes specifically listed. Similarly, the plain meaning of the phrase “for example” is “as an instance” (Macquarie Dictionary), i.e. non-exhaustive rather than exhaustive.
[21] ibid, page 3, line 36 – page 3a, line 4.
The plain meaning of the word “parenteral” is “taken into the body or administered in a manner other than through the digestive canal” (Macquarie Dictionary). Clearly, this encompasses administration via topical means. I also note that the specification does not have a dictionary definition for the term “parenteral”. Furthermore, the specification states that pour-on formulations may be used in the method of the invention[22] and such formulations are applied topically.
[22] ibid, page 64, lines 26 – 27.
I therefore conclude that the plain meaning of “parenteral” applies and the term encompasses all modes of administration other than through the digestive canal.
7.2 Construction of claim 8
Claim 8 is as follows:
Use of a compound of Claim 1 in the manufacture of a medicament for protecting a mammal from a flea, wherein the medicament comprises a pesticidally effective amount of the compound for administration to a mammal orally or parenterally.
Claim 8 is a “Swiss” type claim, the construction of which was considered by Yates J.[23] It was held that a Swiss claim defines a method or process for making a medicament, wherein the intended therapeutic use of the medicament qualifies the scope of the claim.
[23] Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4) [2015] FCA 634; 113 IPR 191.
(a)Use of a compound of Claim 1
As discussed above, claim 1 is construed as a process claim. Therefore a further consideration is whether claim 8 imports the “when used” aspect of claim 1, or only the compound per se. The use of a different preamble in claim 8 (use of a compound) when compared with claim 1 (a compound) suggests only a partial dependency. The alternative construction, i.e. importing the “when used” aspect, would result in the inclusion of process steps already defined in claim 8. Such a construction would not be purposive. Claim 8 is therefore considered to import only the compound per se of claim 1.
(b)Medicament comprises a pesticidally effective amount of the compound
Claim 8 further states that the medicament comprises a pesticidally effective amount of the compound. The specification states that:
“The terms ‘pesticidal’ and ‘pesticidally’ refer to observable effects on a pest to provide protection of an animal from the pest. Pesticidal effects typically relate to diminishing the occurrence or activity of the target parasitic invertebrate pest. Such effects on the pest include necrosis, death, retarded growth, diminished mobility or lessened ability to remain on or in the host animal, reduced feeding and inhibition of reproduction. These effects on parasitic invertebrate pests provide control (including prevention, reduction or elimination) of parasitic infestation or infection of the animal.”[24]
[24] Specification at page 4, lines 3 – 10.
The medicament is therefore considered to contain an amount of Compound 3 that will control (including preventing, reducing or eliminating) flea infestation or infection in a mammal.
(c)For administration to a mammal orally or parenterally
The term “for” is construed to indicate that the medicament must merely be suitable for administration to a mammal by oral or parenteral means. Parenteral, as discussed previously, defines all modes of administration other than through the digestive canal.
(d)Conclusion on claim 8
Claim 8 is construed to define a method for making a medicament containing the compound of Formula 1 (Compound 3), wherein the intended use of the medicament is to protect a mammal from a flea. The medicament contains an amount of the compound that that will control (including preventing, reducing or eliminating) flea infestation or infection in a mammal and must be suitable for administration by oral or parenteral means.
I note that claims 9 – 28 are ultimately dependent on claim 8. The conclusions that I have drawn on the construction of claim 8 necessarily extend to claims 9 – 28. Thus, dependent claims 9 – 11 are considered to further qualify that the medicament is suitable for a particular mode of administration and claims 12 – 14 further qualify the mammal to be protected.
Claims 15 – 22 further qualify that the medicament is suitable for a particular mode of administration, and additionally specify the length of protection or dosage interval. The latter two parameters are considered to further qualify the effective amount of the compound present in the medicament. Thus, where the length of protection is specified, the effective amount of the compound in the medicament must be such as to achieve this. Where a dosage interval is specified, I consider that the medicament contains an amount of the compound that will be effective for that interval, i.e. effective for a day, week, month etc., as the case may be.
Claims 23 – 26 further qualify that the medicament is suitable for a particular mode of administration, and that the medicament is administered in an amount such as to achieve protection for a specific length of time. Claims 27 – 28 further qualify the amount of the compound present in the medicament.
8. Clarity
Subsection 40(3) requires that the claims must be clear. A claim will lack clarity if a third party could not ascertain whether a proposed action would fall within the ambit of the claim.[25]
[25] Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59.
Intervet submitted that claim 8 and its dependent claims 9 – 28 lack clarity for several reasons. Reference was made to comments made by Mr Peters:
“Claim 8 appears to cover the same ground as claim 1, but using slightly different words, which I find confusing. Particularly confusing is the wording ‘Use of a compound of claim 1 in the manufacture of a medicament …’. A compound of claim 1 is a compound of Formula 1 when used for protecting a mammal. A strict reading of claim 8 would therefore be the use of a compound of Formula 1, when used for protecting a mammal …, for the manufacture of a medicament. This is rather tortuous and unclear to me.”[26]
[26] Peters-1 [66].
As discussed above, I have determined that the “when used” aspect of claim 1 is not imported into claim 8 and therefore claim 8 is clear in this regard.
Intervet further submitted that the claims are to processes for the manufacture of a medicament, but they purport to be characterised by features applicable to a method of treatment, in particular the medicament must contain a pesticidally effective amount for particular modes of administration. Intervet additionally stated that claim 8 is compounded by the fact that there are two “for” features. Furthermore, claims 15 – 26 include features relating to dosing interval and these cannot possibly be limiting in relation to a process for making a medicament.
I have construed claim 8 and its dependent claims and, for reasons stated above, found their meaning to be clear. Consequently, it has not been established that the claims lack clarity.
9. Novelty
Under subsection 7(1), an invention is taken to be novel unless it is not novel in the light of the prior art base. Information in a document forms part of the prior art base for the purposes of novelty if it was published before the priority date of a claim.
It is well established that the general test for anticipation is the reverse infringement test. The classic formulation of this test is that given by Aicken J:
“The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement”.[27]
[27] Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19; 137 CLR 228 at 235.
This test is satisfied if the alleged anticipation discloses all the essential features of the invention claimed.[28] In order to meet this requirement, the prior art “must contain clear and unmistakeable directions to do what the patentee claims to have invented”.[29]
[28] Nicaro Holdings Pty Limited v Martin Engineering Company [1990] FCA 40; 16 IPR 545 at 549.
[29] The General Tire & Rubber Company v The Firestone Tyre and Rubber Company Limited [1972] RPC 457 at 486.
Intervet submitted that claims 1 – 26 are not novel in view of US 2007/0066617 (D3) and claims 1 – 28 lack novelty in light of WO 2009/024541 (D5). Intervet acknowledged that D5 is only relevant for novelty if the present application is not entitled to claim priority from US 60/937, 389 (D2). I will first consider the priority issue.
9.1 Priority date
Under regulation 3.12, where a claim is fairly based on matter disclosed in 1 or more priority documents, the priority date of the claim is the date of filing of the priority document in which the matter was first disclosed.
The test for fair basis [in the context of subsection 40(3)] was stated by the High Court as:
“Rather, the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification.”[30]
[30] Lockwood Security v Doric Products [2004] HCA 58 at [69]; 217 CLR 274.
Intervet submitted that in view of the differences between the disclosures of D2 and the present application, the present claims are not entitled to rely on D2 for priority.
(a)Disclosure of D2
D2 discloses methods for protecting animals from invertebrate pests by the oral or parenteral administration of certain isoxazoline derivatives.[31] Compound 3 of the present claims is specifically named and depicted in Table 1.[32] Mammals to be protected include livestock, felines and canines and pests that the isoxazoline compounds are effective against include fleas.[33] Oral and parenteral administration is discussed,[34] as are dosage intervals and amounts.[35]
[31] D2 at page 1, line 20 – page 3, line 5.
[32] ibid., page 12, 2nd named compound; page 25, left hand column, 22nd compound; claim 12, 2nd named compound.
[33] ibid., page 34, lines 18 – 36; page 36, lines 28 – 32; page 37, lines 14 – 16.
[34] ibid., page 41, line 34 – page 45, line 2.
[35] ibid., page 45, lines 25 – 30; claims 37 – 40.
Index Table A on page 46 depicts certain isoxazoline derivatives. Variable R6 is not defined and there was some discussion by Mr Peters, Dr Linnett, Dr Kopp and Dr Taylor as to whether compound 3 in D2 corresponds to Compound 3 of the present invention. However, it is not necessary for me to decide this point. I am satisfied that D2 provides a real and reasonably clear disclosure of Compound 3, and its use to protect mammals against fleas by oral or parenteral administration, in the parts of this document that I have referred to above.
At the hearing Intervet submitted that Dr Kopp views the present invention as residing in the feeding of Compound 3 to fleas by ingestion. In support of this argument, Intervet made reference to certain paragraphs of Dr Kopp’s evidence, including his discussion of Test D of the present specification (a flea ingestion test). From these paragraphs I have selected what I consider to be the relevant parts and reproduced them below:
“In my opinion, the fundamental assertion in the Opposed Application is that the compound of Formula 1 has activity via ingestion against ectoparasites, or ‘external parasitic pests’, which is the term used on page 55 at line 17 of the Opposed Application as accepted, and that the flea is used as a model ectoparasite.”[36]
“The practical application of the results of Test D would indicate to me that Compound 3 gave a high degree of promise, because not only was it tested for its direct effect through Tests A to C, but in addition, it was tested for the degree of uptake. This confirmation is particularly important, in my opinion, having read Exhibit SRK-4, where selamectin when administered orally is known to be effective on endoparasites and yet was found to be ineffective against cat fleas in artificial membrane studies. Therefore, the results obtained in Test D are conclusive evidence of the systemic efficacy of these isoxazoline compounds on ectoparasites.”[37]
“… whereas the claims laid out in the Opposed Application are based upon the proof of concept that [sic] compound has demonstrated oral activity against fleas via the artificial membrane feeding test [demonstration of activity via ingestion]”.[38]
[36] Kopp-1 [129].
[37] ibid., [141].
[38] ibid., [182].
Intervet submitted that Dr Kopp views Test D in the present specification as being important, however there is no corresponding flea ingestion test in D2.
Whilst the only biological tests in D2 relate to the oral or subcutaneous administration of isoxazoline compounds to mice,[39] I note that the document states in relation to the isoxazoline derivatives:
“Compounds of Formula 1 have been discovered to have surprisingly favorable pharmacokinetic and pharmacodynamic properties providing systemic availability from oral administration and ingestion. Therefore after ingestion by the animal to be protected, parasiticidally effective concentrations of compounds of Formula 1 in the bloodstream protect the treated animal from blood-sucking pests such as fleas, ticks and lice.”[40]
[39] D2 at pages 46 – 47.
[40] ibid., page 42, line 36 – page 43, line 2.
I therefore consider that D2 provides a real and reasonably clear disclosure of the feeding of the isoxazoline derivatives, including Compound 3, to fleas via ingestion.
(b)Conclusion on priority date
I am satisfied that the priority date of the present claims is the filing date of D2, i.e. 27 June 2007.
9.2 WO 2009/024541 (D5)
D5 was filed on 15 August 2008, published on 26 February 2009 and claims priority from four documents, the earliest of which were filed on 17 August 2007. As I have found that the priority date of the present claims is 27 June 2007, D5 does not form part of the prior art base and is therefore not relevant for novelty.
9.3 US 2007/0066617 (D3)
D3 was published on 22 March 2007 and therefore forms part of the prior art base. This document describes isoxazoline derivatives and their use as pesticides.[41] The compounds may be used to control ectoparasites in mammals and can be administered via oral or parenteral means.[42] Fleas are mentioned as one of a large number of pests that may be controlled.[43]
[41] D3 Abstract, [007].
[42] ibid., [0192].
[43] ibid., [0172], [0177].
The compound designated as 5-151 corresponds to the present Compound 3[44] and is prepared in Synthetic Example 21.[45] The key example is Test Example 19 where a number of compounds, including Compound 5-151, are tested in vitro against fleas.[46] The dosage for Compound 5-151, and the other compounds marked with an asterisk, is stated to be 0.11g/cm2, compared with 1 mg/cm2 for the unmarked compounds. This dosage is discussed in further detail below under inventive step.
[44] Throughout this decision the terms “Compound 3” and “Compound 5-151” are used interchangeably, depending upon the context.
[45] ibid., [0372] – [0374].
[46] ibid., [0526] – [0529].
There are no tests involving the administration of any compound to a mammal for the purpose of providing protection against fleas.
Intervet submitted that the fact that D3 does not disclose any data relating to in vivo activity is of no consequence. Intervet stated that the fact that the prior art teaches a new method of treatment reliant on in vitro data does not prevent it from depriving a later claim to such a method of novelty. In support of this, reference was made to Merck and Co Inc v Arrow Pharmaceuticals Ltd[47] (Merck), which I have briefly summarised below.
[47] [2006] FCAFC 91; 68 IPR 511 at [104] – [112].
In the Merck case, the claims were directed to methods for treating or preventing osteoporosis in a human comprising orally administering a particular amount of alendronate (a bisphosphonate), at a dosage interval which was once weekly. Alendronate was already used to treat osteoporosis before the claimed priority date. The claims were found to lack novelty in view of certain news articles which discussed the use of bisphosphonates in the treatment of osteoporosis. One article indicated that an intermittent treatment program with alendronate, for example a dosage interval which was once weekly, “needs to be tested”. The Full Court of the Federal Court found that “the contemplation of further experiment or testing is not necessarily fatal to a finding of anticipation”.[48]
[48] ibid., [104].
In considering “further experiments”, the Full Court referred to a statement made by Aiken J in
Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd:
“It will always be necessary to distinguish between experiments leading to an invention and subsequent experiments for checking and testing the product or process the subject of the invention. The latter would not be material to obviousness but might be material to the question of utility.”[49]
[49] ibid., [107].
In the Merck case, as stated above, alendronate was a known drug already known for its use to treat osteoporosis in humans. Thus, the prior art was well down the path towards the claimed invention and I consider that the testing of alendronate at once weekly intervals falls into the category of “experiments for checking and testing the product or process of the invention”.
In the present case, D3 discloses in vitro tests wherein Compound 5-151 is administered to fleas. It has not been established that Compound 5-151, or indeed any of the compounds described in D3, demonstrates in vivo activity when administered to mammals, let alone provides protection from fleas when administered orally or parenterally. I consider that such experiments fall into the category of those “leading to an invention” and are not just merely checking and testing a product or process.
I am therefore satisfied that D3 does not provide clear and unmistakeable directions for a process for protecting a mammal from a flea by the oral or parenteral administration of Compound 3 as defined by claim 1.
9.4 Conclusion on novelty
It has not been established that the claims lack novelty in view of the prior art.
10. Inventive step
Under subsections 7(2) and 7(3), an invention is taken to involve an inventive step unless it would have been obvious to the person skilled in the art in the light of the common general knowledge, either considered alone or together with the prior art. The prior art is information that the skilled person could, before the priority date of the relevant claim, be reasonably expected to have ascertained, understood and regarded as relevant.
The test for whether an invention is obvious is whether it would have been a matter of routine to proceed to the claimed invention.
“The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not.”[50]
[50] Wellcome Foundation Ltd v VR Laboratories (Aust) Pty Ltd [1981] HCA 12; 148 CLR 262 at 286.
In Aktiebolaget Hassle v Alphapharm Pty Ltd (Alphapharm)[51], the High Court accepted the approach taken in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd[52] where Graham J posed the reformulated Cripp’s question:
“Would the notional research group at the relevant date, in all the circumstances, …. directly be led as a matter of course to try [the claimed combination] in the expectation that it might well produce a [useful or better result]?” (emphasis in original)
[51] [2002] HCA 59; 212 CLR 411 at [53].
[52] [1970] RPC 157 at [187].
In AstraZeneca AB v Apotex Pty Ltd (AstraZeneca)[53], the court held that in formulating the problem it is not permissible to incorporate information that is not available to the person skilled in the art either as common general knowledge or information available under subsection 7(3).
[53] [2014] FCAFC 99; 107 IPR 177.
10.1 Determining the problem
At the hearing DuPont submitted that the problem to be addressed is one of parasite control in general. However, I note that DuPont’s written submissions, when discussing whether prior art documents would have been ascertained, understood and regarded as relevant, state:
“Even if it is accepted that the skilled addressee would have undertaken a literature search, there is no evidence which supports the proposition that a person seeking to identify new agents for the treatment of fleas would have found [the prior art] in that search … .
There is some reason on the face of the documents to think that they would not have found the documents, given that fleas are not mentioned in either the title or the abstract.”[54] (emphasis added)
[54] DuPont submissions [155] – [156].
Intervet’s written submissions state that “The problem to be solved by the alleged invention was the need to identify new methods for protecting animals from pests because of growing resistance to existing pesticides”.[55] At the hearing, when questioned in relation to D3 (which describes in vitro tests against both fleas and ticks) whether the skilled addressee would focus on a particular parasite, Intervet indicated that the problem related to pest control in animals in general, but fleas were known to be a bigger problem.
[55] Intervet submissions [136].
Thus, whilst both parties refer to pest control in general, they also acknowledge the need to identify new agents for the control of fleas.
Turning to the specification, it states:
“Existing methods of treatment and parasite control are being compromised due to growing resistance to many current commercial parasiticides. The discovery of more effective ways to control animal parasites is therefore imperative.”[56]
[56] Specification at page 1, lines 8 – 10.
Within this context, it is clear that the control of fleas is the main focus of the specification, as this is the only parasite on which compounds are tested.[57]
[57] ibid., pages 67 – 68.
I therefore consider that the problem to be addressed is the provision of a method for the control of fleas in animals.
This is consistent with statements made by Mr Peters regarding the known resistance of fleas to certain pest control products[58] and statements made in the prior art that cat fleas are the most common ectoparasites of cats and dogs.[59]
[58] Peters-1 [27] – [28].
[59] D10 at page 232; this document is equivalent to Exhibit BAP-2, Exhibit SRK-4 and Exhibit PAT-5 and referred to by the declarants in the context of background knowledge in the field of ectoparasite control. D11 at page 257; this document is equivalent to Exhibit BAP-5 and Exhibit PJL-6 and referred to by the declarants in the context of background knowledge in the field of ectoparasite control.
10.2 Common general knowledge
The common general knowledge was considered by Emmett J:
“The common general knowledge is the technical background to the hypothetical skilled worker in the relevant art. It is not limited to material which might be memorised and retained at the front of the skilled workers mind but also includes material in the field in which he is working which he knows exists and to which he would refer as a matter of course. It might, for example, include:
·standard texts and handbooks;
·standard English dictionaries;
·technical dictionaries relevant to the field;
·magazines and other publications specific to the field.”[60]
[60] ICI Chemicals & Polymers Ltd v Lubrizol Corporation Inc [1999] FCA 345; 45 IPR 577 at [112].
The parties agreed that it was commonly known that there was a need to identify new methods for protecting animals from pests because of growing resistance to existing pesticides.
The evidence indicates that the following matters are part of the common general knowledge:
·Modes of administration of pesticides to animals include topical, oral and injectable.[61]
·The various modes of administration each have their associated problems as well as benefits.[62]
[61] Peters-1 [17] – [19]; Linnett-1 [17]; Kopp-1 [37] – [39]; Taylor [49].
[62] Peters-1 [21] – [25]; Linnett-1 [25] – [27].
10.3 Matters of routine
The parties agreed that it would be routine for the skilled addressee to determine dose and dosing intervals for a particular pesticide.
In discussing the evaluation of a compound or compounds for their suitability as an active agent for the control of ectoparasites in mammals, Mr Peters outlines what he considers to be steps that are standard in the industry.[63] I have summarised these steps below:
·The first step, especially if large numbers of compounds are involved, is a screening test for activity against a range of pests to select the most active compound(s). Such tests include contact tests or membrane feeding tests (in vitro tests).
·Those compounds found to have good activity in the screening tests are tested for in vivo efficacy and toxicity on a model animal such as mice or guinea pigs.
·All relevant administration routes, including oral, topical and injection, would be tested.
·Compounds that pass the model animal tests (desired activity, low toxicity) proceed to tests on target animals (such as cats, dogs and livestock) for efficacy against the target pest.
[63] Peters-1 [36] – [45].
Mr Peters states that in his opinion, such steps are routine in the testing of active agents and formulations for animal health purposes.[64]
[64] ibid., [46].
Dr Linnett describes a similar procedure and states that the methods used are well established in the field of developing animal health products and are generally straightforward.[65] Mr Fisara outlines a similar approach and indicates that such procedures are routine,[66] as does Dr Kaminsky.[67]
[65] Linnett-1 [32] – [35].
[66] Fisara-1 [18] – [24].
[67] Kaminsky-1 [19] – [26]; Kaminsky-2 [12], [17].
Dr Kopp, when commenting on the declaration of Mr Fisara, agrees in principle that in vitro screening assays are the first step,[68] and considers that determining whether a compound might be more active via ingestion, or via a contact effect, is a very important part of the screening process.[69] Dr Kopp agrees that the mouse is an ideal preliminary in vivo screening model[70] and that testing on target animals is typically the next step in the process following successful in vitro and preliminary in vivo mouse studies.[71]
[68] Kopp-1 [80].
[69] ibid., [80] – [85].
[70] ibid., [86].
[71] ibid., [91].
I therefore consider that the person skilled in the art, in evaluating compounds for their suitability for controlling ectoparasites in animals, would as a matter of routine, undertake a procedure involving in vitro screening tests, followed by in vivo testing in a model animal of those compounds found to have good activity in the screening process, and then proceeding to tests in target animals using those compounds that pass the model animal tests. The skilled addressee would, as a matter of routine, test all relevant modes of administration, including oral, topical and injectable.
10.4 Consideration of inventive step and prior art
Intervet submitted that claims 1 – 28 are not inventive in light of US 2007/0066617 (D3), or D3/WO 2005/085216 (D4) when combined with WO 2007/070606 (D9).
The first question to consider is whether D3, D4 and D9 would have been ascertained, understood and regarded as relevant.
Dr Linnett,[72] Mr Peters[73] and Mr Fisara[74] indicate that they would search the patent literature. Dr Kaminsky states that he had patent searches carried out for him and monitored the patent literature.[75] Dr Kopp indicates that he searches literature databases to find articles related to his research,[76] but does not specify whether these include patent literature. Dr Taylor does not comment on whether he undertakes literature searches.
[72] Linnett-1 [31].
[73] Peters-1 [35].
[74] Fisara-1 [16].
[75] Kaminsky-1 [7], [17].
[76] Kopp-1 [19].
I consider it reasonable to conclude that the skilled addressee would have searched the patent literature and therefore D3, D4 and D9 would be ascertained.
In determining the relevance of a document, it was stated in Beecham Group Limited’s (Amoxycillin) Application:
“The test in my judgment is whether it can be expected that the skilled man will be likely to recognise the document in question as being particularly pertinent to, though it may not specifically solve the problem before him.”[77]
[77] [1980] RPC 261 at 282.
D3 relates to pesticidal isoxazoline derivatives as discussed above and would therefore be regarded as relevant. D3 is a continuation in part of D4 and hence the latter document would also be regarded as relevant. D9 discloses the use of isoxazoline derivatives for controlling invertebrate pests and would be regarded as relevant.
10.4.1 US 2007/0066617 (D3)
Intervet submitted that claims 1 – 28 are not inventive in view of D3 and the common general knowledge.
(a)Test Example 19
As discussed previously in part 9.3, Test Example 19 of this document is the most relevant.
Test Example 19 describes the testing of a number of compounds, including Compound 5-151, in vitro against fleas (contact test). The dosage for Compound 5-151, and the other compounds marked with an asterisk, is stated to be 0.11g/cm2, compared with 1 mg/cm2 for the unmarked compounds. Intervet submitted that the dosage of 0.11g/cm2 is an error and that the correct dosage is 0.1 mg/cm2. DuPont stated that the dosage for the asterisked compounds should be taken at face value, i.e. 0.11g/cm2.
In order to determine whether the asterisk represents a dosage of 0.11g/cm2 or a dosage lower than 1 mg/cm2 (the dosage for the unmarked compounds), there are a number of factors to consider. I note that in making such a determination, it is not necessary for me to decide that the lower dosage (if applicable) is 0.1 mg/cm2, as stated by Intervet. The relevant consideration is simply whether an asterisk is indicative of a dosage less than 1 mg/cm2, and therefore higher activity.
Factors that support an assertion that an asterisk in Test Example 19 equates to a dosage of 0.11g/cm2 include:
·Document D3 should be read on its face.
·There is no indication that there is an error in D3, for example an accompanying certificate of correction stating that the dosage in Test Example 19 should be a different value.
·Dr Kopp takes the stated dosage at face value.[78]
[78] Kopp-1 [176].
Factors that support an assertion that an asterisk in Test Example 19 equates to a dosage of less than 1 mg/cm2 include:
·D3 has 24 examples that relate to pesticidal activity. Of these, 9 use an asterisk to indicate a lower value. Thus, Test Examples 1, 2, 7, 11 – 13, 15 and 16 use an asterisk to indicate a concentration of 100 ppm compared with 500 ppm for unmarked compounds. Similarly, Test Example 20 uses an asterisk to indicate a dosage of 0.1 mg/cm2 compared with 1 mg/cm2 for unmarked compounds. Therefore the use of an asterisk in Test Example 19 to indicate a lower dosage would be consistent with its use throughout D3.
·Mr Peters,[79] Mr Fisara[80] and Dr Kaminsky[81] consider the asterisk in Test Example 19 to indicate good or significantly better activity.
·Dr Linnett considers the value 0.11g/cm2 is likely to be a typographical error and should be 0.1 mg/cm2.[82]
·It would be unusual to highlight those compounds having poorer pesticidal activity.
·A dosage of 0.11g/cm2 is extremely high and represents a 110, 000 fold increase on the dosage for unmarked compounds.
[79] Peters-1 [117]; Peters-2 [60].
[80] Fisara-2 [36].
[81] Kaminsky-1 [29]; Kaminsky-2 [18].
[82] Linnett-1 [109]; Linnett-2 [57] – [58].
The use of an asterisk to indicate a higher dosage is not implausible and Dr Kopp takes the dosage of 0.11g/cm2 at face value. However, taking all factors into consideration, I believe that the asterisk in Test Example 19 is indicative of a dosage lower than 1 mg/cm2, consistent with the manner in which an asterisk is used throughout D3.
(b)Is it a matter of routine to use the compounds of Test Example 19 in a method for flea control?
I have determined that Test Example 19 discloses that certain compounds, including Compound 5-151, have better activity in vitro against fleas when compared with the unmarked compounds. The question to consider is whether it would be a matter of routine for the person skilled in the art, in seeking to provide a method for the control of fleas in animals, to use Compound 5-151 in such a method and thereby arrive at the invention defined by the present claims.
Mr Peters, in discussing Test Example 19, states:
“A moderate number of compounds was [sic] allocated asterisks. In my opinion, all compounds found to have good specific activity should be tested further in either further in vitro tests, or in in vivo tests, such as in a mouse model, by all relevant administration routes.
I understand that one of the compounds that was allocated an asterisk in this Test Example was compound 5-151, which I understand to be the same compound as the compound of Formula 1 according to the opposed application. I notice that compound 5-151 features in most of the other Test Examples, often being allocated an asterisk where these were allocated, indicating good specific activity, making it in my opinion, an obvious target for further investigations.
…
As mentioned above, in my opinion, compound 5-151, amongst others, is clearly a candidate for further studies based on its activity in the Test Examples of exhibit BAP-10 [D3].”[83]
[83] Peters-1 [116] – [118].
Dr Linnett states:
“Given the good results achieved with compound 5-151, in my view this compound would be targeted, amongst a number of the other compounds tested, as a candidate for further studies, especially in vivo and toxicity studies”.[84]
[84] Linnett-1 [110].
Dr Kaminsky comments:
“… based on what is shown in Test Example 19 of the US Nissan patent publication [D3], I am confident that, if one or more of the compounds marked with an asterisk had the desired properties (good activity against fleas, and safe to the animal to which it is to be administered), be they oral, topical or by injection, such compound(s) would have been identified by the routine steps that would have been taken by my previous company or other companies, as I have described above, and at least the best compounds further developed with the aim to become animal healthcare products.”[85]
[85] Kaminsky-1 [30].
DuPont submitted that efficacy during topical administration (which is demonstrated through in vitro contact assays) provides no assurance that a drug will have any efficacy when administered orally. In discussing basic contact assay activity, Dr Kopp states:
“… I refer to the second paragraph in the right-hand column on page 1702 of Exhibit SRK-10, which clearly outlines a situation where basic contact assay activity did not translate into in vivo topical or oral activity. Hence, activity in preliminary contact assays does not provide any guarantee about downstream parasiticidal activity under in vivo conditions.”[86]
[86] Kopp-1 [169]. Dr Taylor also refers to this Exhibit (identified as Exhibit PAT-12) as an illustration of how compounds that show in vitro efficacy can be ineffective in vivo; see Taylor [114].
In relation to Test Example 19, Dr Kopp comments that 139 compounds were tested for in vitro efficacy and of those 68 are reported to have shown an efficacy of 80% or more at a treatment dosage of 0.11g/cm2.[87] He states that “To have located Compound 5-151 is to me like looking for a needle in a haystack.”[88]
[87] ibid., [176]. As discussed previously, I have found the dosage in Test Example 19 to be less than 0.11g/cm2.
[88] ibid.
Dr Kopp further submits:
“There is nothing in this document that makes any mention or suggestion of in vivo testing in mammals or use. Simply because something shows in vitro activity is no assurance at all that it will exhibit in vivo activity and I refer to my numerous comments above in this respect.”[89]
…
“There is simply no proof that because a compound displays efficacy in vitro that it will similarly display efficacy in vivo, as I have stated previously. There would also be no certainty of success such that it would be worthwhile to try every single compound in Exhibit PJL-10 [D3].”[90]
[89] ibid., [178].
[90] ibid., [182].
Dr Taylor indicates that whilst he agrees that high in vitro activity might provide good results in in vivo experiments, such results are certainly not guaranteed.[91]
[91] Taylor [108].
DuPont also referred to material provided under regulation 5.23 (DuPont Appendices) in support of its submissions that there is no expectation of success that systemic parasitic activity could be achieved should any isoxazoline compound be administered orally or parenterally. I note that the DuPont Appendices relate to the prosecution by Intervet of two of its Australian patent applications, or their overseas equivalents. DuPont also submitted that based on the DuPont Appendices, there were inconsistencies in Intervet’s submissions with respect to the present proceedings.
I will briefly consider the DuPont Appendices. These relate to the prosecution of Intervet’s related applications 2013207639 (Divisional) and 2008290581 (Parent).
The claims of the Divisional are directed to a method for controlling an ectoparasite infestation in an environment that is occupied periodically or continuously by an animal, comprising administering Compound 3 to the animal. In contrast, the present claims define a method for protecting a mammal from a flea by administering Compound 3 to the mammal. Clearly, the two sets of claims relate to different inventions. I am therefore satisfied that the DuPont Appendices, in so far as they relate to the Divisional, are not relevant to the present opposition.
The claims of the Parent relate to the use of isoxazoline derivatives, including Compound 3, to treat ectoparasite infestations in animals through topical administration at bi-monthly or longer frequency. DuPont argued that Intervet’s submissions in the present opposition are inconsistent with its submissions in relation to the Parent, and its US and EP equivalents. Intervet’s submissions in the Parent may be summarised as follows: the person skilled in the art, in view of D3, would not expect that topical administration of an isoxazoline compound, at bi-monthly or longer frequency, would result in effective pest control. In support of this, Intervet filed evidence (Williams Declaration)[92] comparing the activity of Compound 3 and Fipronil[93] against fleas. Compound 3 demonstrated excellent persistent efficacy for at least 15 weeks. Fipronil demonstrated excellent persistent efficacy for 7 weeks, borderline efficacy in week 9 and insufficient efficacy thereafter.
[92] DuPont Appendix V, declaration of Dr H. Williams.
[93] Fipronil is the active ingredient in the commercially available ectoparasiticide Frontline®; see Linnett-1 [16].
I consider that Intervet’s submissions in relation to the Parent carry less weight than the Williams Declaration. The Williams Declaration is dated 14 September 2012 and there is no evidence before me to suggest that the fact that Compound 3 demonstrates excellent persistent efficacy when compared with Fipronil was published before the priority date of the present claims (June 2007), or formed part of the common general knowledge at that date. It therefore follows that the data in the Williams Declaration does not impact upon what the skilled addressee would do as a matter of routine in the present opposition.
The main concerns raised by Dr Kopp and Dr Taylor as to why it would not be a matter of routine to arrive at the claimed invention relate to firstly, the number of compounds that would need to be tested, and whether these would include Compound 5-151, and secondly, that in vitro activity does not guarantee in vivo activity.
In responding to the first point, Mr Peters states that he would have tested as a matter of routine all 68 compounds in Test Example 19 that are marked with an asterisk.[94] Dr Linnett indicates that she would further test at least about 61 compounds, including Compound 5-151, and it would not be onerous to do so.[95]
[94] Peters-2 [60].
[95] Linnett-2 [58], [61]. Dr Linnett appears to have included only compounds of formulae (1) to (5) in D3, and excluded any asterisked compound in Test Example 19 where the prefix number is greater than 5. There are six asterisked compounds with a prefix greater than 5, giving a total of 62 compounds.
On the second point, Mr Fisara states that Dr Taylor:
“… appears to argue that in vitro tests do not guarantee in vivo activity. I agree. However, this does not mean that you wouldn’t carry out the tests. As I have mentioned above and in my declaration of 11 May 2015, if a compound shows promising in vitro activity, you would, as an animal health product developer, as a matter of routine, carry out further tests to determine whether the candidate compound has the desired activity(ies), being oral, topical or other.”[96]
…
“In paragraph 114, TAYLOR exhibits a document that shows that in vitro activity did not translate to in vivo activity. Such a result is not unexpected. However, this does not mean that the tests would not be carried out, or that the search for new active compounds would not continue.”[97]
[96] Fisara-2 [32].
[97] ibid., [37].
Mr Fisara further states:
“Good in vitro contact activity can translate to good in vivo activity, and therefore promising in vitro should and, in my experience, will be further investigated by all relevant means, as I have already described in my first declaration. What remains to be determined is whether the in vitro results translate into good in vivo activity, and whether the compound is not toxic to the target animal, and still has the desired activity in the target animal – such testing is routine and straightforward in my opinion.”[98]
[98] ibid., [47].
I have already determined that the person skilled in the art, in evaluating compounds for their suitability for controlling ectoparasites in animals would, as a matter of routine, undertake a procedure involving in vitro screening tests, followed by in vivo testing in a model animal of those compounds found to have good activity in the screening process, and then proceeding to tests in target animals using those compounds that pass the model animal tests. The skilled addressee would, as a matter of routine, test all relevant modes of administration, including oral, topical and injectable.
If proceeding to in vivo testing in model and target animals is a matter of routine for all compounds found to have good activity in the in vitro screening process, it follows that such a process would be routine for Compound 5-151, as for the other asterisked compounds in Test Example 19. Thus, it is of no consequence whether Compound 5-151 forms part of larger group of compounds, as further testing of Compound 5-151, based on its good in vitro activity, would routinely occur as part of the normal course of events.
Dr Kopp and Dr Taylor indicate that in vitro activity does not provide any guarantee of in vivo activity or certainty of success. However, guarantee of success or certainty of success is not the approach followed by the courts. As stated in Alphapharm, the correct consideration is whether there would have been an expectation that something “might well” solve the problem. Based on the evidence before me, I am satisfied that the skilled addressee would further test Compound 5‑151 with a reasonable expectation of success.
The evidence demonstrates that the skilled addressee would, as a matter of routine, test Compound 5-151 for in vivo activity against fleas by all relevant modes of administration, including oral and parenteral. It therefore follows that based on the disclosure of D3, the person skilled in the art would, as a matter of routine, arrive at a process for protecting a mammal from a flea as defined by claim 1.
I note that claim 1 also defines the use of a salt of a compound of Formula 1 (Compound 3). D3 refers to salts of the isoxazoline compounds, including acid addition salts and metal salts.[99] I therefore consider that the skilled addressee would as a matter of routine arrive at a method for protecting a mammal from a flea, wherein a salt of Compound 3 is administered to the mammal.
[99] D3 at [0008], [0012], [0013].
Claim 1 additionally defines the use of an N-oxide of a compound of Formula 1 (Compound 3). Turning to the specification, it describes pyridine heterocycles which can form N-oxides.[100] Given that there is no other disclosure relating to N-oxides, I consider it reasonable to infer that in the context of the invention, the term “N-oxides” refers to N-oxides of heterocyclic rings. I therefore construe claim 1 to define an N-oxide of the isoxazoline ring of Compound 3. D9 indicates that methods for the preparation of N-oxides of heterocyclic rings are very well known by one skilled in the art.[101] I therefore consider that the skilled addressee would as a matter of routine arrive a method for protecting a mammal from a flea, wherein an N-oxide of Compound 3 is administered to the mammal.
[100] Specification at page 16, lines 5 – 20.
[101] D9 at page 12, lines 3 – 21.
Consequently claim 1 lacks an inventive step.
(c)Consideration of claims 2 to 28
I will now consider the remaining claims.
Claims 2 – 4
Claims 2 and 3 are appended to claim 1, with the additional qualification that the compound is administered orally or parenterally respectively. Claim 4 is appended to claim 3, with the additional qualification that the compound is administered by injection. As previously discussed for claim 1, administration of the compound via oral or parenteral (including injection) means would be arrived at as a matter of routine. Consequently claims 2 – 4 lack an inventive step.
Claims 5 – 7
Claims 5 – 7 are appended to claim 1, with the additional qualification that the mammal to be protected is livestock, a canine and a feline respectively. I have previously found that it is a matter of routine for compounds with good in vitro pest control activity to be tested on target animals including dogs, cats and livestock. Consequently claims 5 – 7 lack an inventive step.
Claim 8
Claim 8 is a “Swiss” type claim which, as discussed previously, is construed to define a method for making a medicament containing Compound 3, wherein the intended use of the medicament is to protect a mammal from a flea. The medicament contains an amount of the compound that will control (including preventing, reducing or eliminating) flea infestation or infection in a mammal and must be suitable for administration by oral or parenteral means.
D3 describes various dosage forms of the isoxazoline derivatives that are suitable for oral and parenteral use and means for their preparation.[102] It follows that the method of claim 8 would be arrived at as a matter of routine. Consequently claim 8 lacks an inventive step.
[102] D3 at [0192] – [0218].
Claims 9 – 11
Claims 9 and 10 are appended to claim 8, with the additional qualification that the medicament is administered orally or parenterally respectively. Claim 11 is appended to claim 10, with the additional qualification that the medicament is administered by injection. As discussed previously, such means of administration would be arrived at as a matter of routine. Consequently claims 9 – 11 lack an inventive step.
Claims 12 – 14
Claims 12 – 14 are appended to claim 8, with the additional qualification that the mammal to be protected is livestock, a canine and a feline respectively. As discussed previously, it is a matter of routine for compounds with good in vitro pest control activity to be tested on target animals including dogs, cats and livestock. Consequently claims 12 – 14 lack an inventive step.
Claims 15 – 28
Claims 15 – 28 are appended to claim 8, with the additional qualification that the medicament is administered at a particular interval, the mammal is protected for a certain period or the medicament comprises a specified amount of Compound 3. The parties agreed that it is a matter of routine for the skilled addressee to determine dose and dosing intervals and this is confirmed by the evidence.[103] Consequently claims 15 – 28 lack an inventive step.
[103] See, for example, Peters-1 [52]; Linnett-1 [116] – [117]; Kopp-1 [183].
(d)Conclusion on D3
Claims 1 – 28 lack an inventive step in view of D3 and the common general knowledge.
10.4.2 US 2007/0066617 (D3)/WO 2005/085216 (D4) when combined with WO 2007/070606 (D9)
Intervet submitted that claims 1 – 28 are not inventive in light of D3/D4 when combined with WO 2007/070606 (D9) and the common general knowledge.
At the hearing Intervet indicated that its primary argument for lack of inventive step relied on the disclosure of D3. Having already determined that claims 1 – 28 are not inventive in view of D3, the consideration of D3/D4 when combined with D9 would appear to be a moot point. Nevertheless, I will give regard to this combination of documents.
D9 discloses isoxazoline derivatives for controlling invertebrate pests. The compounds contain a pyrimidine or triazine ring attached to the double bond of the isoxazoline ring, compared with a phenyl ring in Compound 3. D9 indicates that the isoxazoline derivatives may be used to protect animals from pests including fleas.[104] However, the focus of the document is on crop protection. In particular, all of the biological test examples are directed to testing the effectiveness of compounds against plant pests.[105]
[104] D9 at page 53, lines 30 – 37 and page 74, line 21 – page 77, line 8.
[105] ibid., pages 80 – 81.
D9 states that D4 discloses certain isoxazoline derivatives.[106] However, this is only mention of D4 and D9 does not incorporate D4 by reference. I note that Synthetic Example 21 of D4 describes the preparation of Compound 5-151. Test Example 19 of D4 discloses the in vitro testing of a number of compounds against fleas. However, Compound 5-151 is not one of the compounds tested.
[106] ibid., page 1, lines 17 – 18.
Mr Peters states that D9 is a very agriculturally-oriented document, however understands that most products for animal health of companion animals have come from the agricultural industry.[107] He comments that due to the cross-reference in D9 to D4, and D3 being highly related to D4, he would have combined the information in D9 with that in either of D3 or D4.[108] In view of this combination, he considers that an animal health product developer would understand that not only the compounds described in D3, but also Compound 5-151 (and other compounds) described in D3 or D4, could be used for the control of fleas in mammals.[109]
[107] Peters-1 [131].
[108] ibid., [136]. Note that Exhibits BAP-15, BAP-11 and BAP-10 correspond to D9, D4 and D3 respectively.
[109] ibid.
Dr Linnett similarly states that the emphasis in D9 is on agricultural applications, but comments that reference is made to nonagronomic applications including protection of mammals from invertebrate pests.[110] She notes the reference in D9 to D4[111] and states that on reading D9, would have considered Compound 5-151 (amongst others), as disclosed in D4, to be suitable for further investigation as a systemically active agent by standard tests.[112] These would have been carried out as a matter of course by a team seeking to develop a new product for the control of fleas.[113]
[110] Linnett-1 [131].
[111] ibid., [130]. Note that Exhibits PJL-10, PJL-11 and PJL-15 correspond to D3, D4 and D9 respectively.
[112] ibid., [136].
[113] ibid.
As I have stated previously, the emphasis in D9 is on plant pest control and this document does not disclose Compound 5-151. Although D9 refers to D4, the contents of D4 are not explicitly incorporated by reference. Mr Peters and Dr Linnett discuss combining the information in D9 with that in D4. However, I consider such statements are made with the benefit of hindsight. Notwithstanding this, even if D9 and D4 were combined, D4 does not test Compound 5-151 for in vitro activity against fleas. Therefore I consider that the person skilled in the art, in seeking to provide a method for flea control, would further test in vivo those compounds that had shown in vitro activity against fleas. Such compounds do not include Compound 5-151.
In terms of the combination of D9 and D3, as previously indicated, D9 makes reference to D4. Although D3 is a continuation in part of D4, as stated on the front page of D3, D4 itself does not allude to this fact. I am not satisfied that the skilled addressee would have reason to look at D3, when D9 refers only to D4 and there is no link on the face of D4 to D3.
It has not been established that there is a lack of inventive step in view of D3/D4 when combined with D9.
10.5 Conclusion on inventive step
Claims 1 – 28 lack an inventive step in view of D3 and the common general knowledge.
11. Manner of manufacture
Paragraph 18(1)(a) requires that an invention must be a manner of manufacture within the meaning of section 6 of the Statute of Monopolies. In D’Arcy v Myriad Genetics Inc[114], it was stated:
“The legislative history of the requirement for patentability imposed by s 18(1)(a) of the Act has been set out in previous decisions of this Court [40]. The question posed by the application of s 18(1)(a) may be framed as in NRDC [41]:
‘Is this a proper subject of letters patent according to the principles which have been developed for the application of s 6 of the Statute of Monopolies?’
That question is to be answered according to a common law methodology under the rubric of ‘manner of manufacture’ as developed through the cases, but consistently with ‘a widening conception of the notion [which] has been a characteristic of the growth of patent law.’ [42] That widening conception is a necessary feature of the development of patent law in the 20th and 21st centuries as scientific discoveries inspire new technologies which may fall on or outside the boundaries of patentability set by the case law which predated their emergence.”
[114] [2015] HCA 35; 115 IPR 1 at [18].
As indicated in NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd[115], the manner of manufacture requirement will not be met if, on the face of the specification, the claimed subject matter is not new, or lacks the necessary quality of inventiveness.
[115] [1995] HCA 15; (1995) 183 CLR 655 at 663 – 664.
Intervet submitted that there is no invention on the face of the specification. Intervet stated that the face of the specification includes the contents of D4, which is referred to at page 1 of the specification. By virtue of the statement at page 16, lines 30 – 31 of the specification, the contents of D4 should be incorporated by reference.
Intervet submitted that D4 discloses compounds in the class of the general Formula 1, including Compound 5-151, and the high insecticidal activity of Compound 5-151 against a range of pests. It was further stated that present claim 1 is to nothing but a known method of administering a known insecticide via known routes to protect a mammal from a flea. Thus, D4 teaches that the compound of Formula 1 can be administered orally or parenterally to control parasites including fleas in animals.
The specification states that the isoxazoline derivatives can be prepared as described in WO 2005/085216 (D4).[116] In relation to the compounds listed in Index Table A, which include Compound 3, the specification indicates that:
“Methods for preparing the compounds listed in Index Table A are disclosed in PCT Patent Publication WO 2005/085216 [D4]. To the extent necessary to teach the methods of preparing the compounds Formula 1, (and only to the extent that they are not inconsistent with the disclosure herein) this patent publication is herein incorporated by reference.”[117] (emphasis added)
[116] Specification at page 16, lines 3 – 4 and lines 30 – 31.
[117] ibid., page 67, lines 1 – 4.
I therefore consider that, in the context of the claimed invention, D4 is only incorporated by reference for the purposes of providing a means for preparing Compound 3. Turning to D4, Synthetic Example 21 describes the preparation of Compound 5-151 and it is this information that the present specification incorporates by reference. I do not consider that the biological tests in D4 are incorporated by reference. Notwithstanding this, as I have previously noted, D4 does not test Compound 5-151 for in vitro activity against fleas.
It therefore follows that the specification on its face does not disclose the claimed method for protecting a mammal against fleas.
It has not been established that the claimed invention is not a manner of manufacture.
12. Fair basis
Subsection 40(3) requires that the claims must be fairly based on the matter described in the specification. The test for fair basis was stated by the High Court as:
“Rather, the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification.”[118]
[118] Lockwood Security v Doric Products [2004] HCA 58 at [69]; 217 CLR 274.
Intervet submitted that claims 17 – 26 are not fairly based as there is no real and reasonably clear disclosure of the claimed doses and dosing intervals.
The specification indicates that the isoxazoline derivatives may be administered at suitable intervals ranging from about daily to about yearly, and in particular from about weekly to about once every 6 months, and monthly intervals.[119] The amounts of compound to be administered are also described.[120] Thus, the specification provides a real and reasonably clear disclosure of the claimed doses and dosing intervals.
[119] Specification at page 65, lines 18 – 21.
[120] ibid., lines 15 – 17.
It has not been demonstrated that there is a lack of fair basis.
13. Sufficiency and best method
Paragraph 40(2)(a) requires that a complete specification must describe the invention fully, including the best method of performing the invention. The High Court stated that the question to consider is:
“will the disclosure enable the addressee of the specification to produce something within each claim without new inventions or additions or prolonged study of matters presenting initial difficulty?”[121]
[121] Kimberly Clark Australia Pty Ltd v Arico Trading International Pty Ltd [2001] HCA 8; 207 CLR 1 at [25].
Intervet submitted that the specification does not describe what combination of doses and intervals of dosing are to be used to protect mammals from fleas. In particular, the examples only measure a single dose in a mouse and measure activity after 24 hours. Intervet submitted that this gives no indication as to what combination of doses and dosing intervals is required to protect a mammal from a flea for the dosing intervals claimed in claims 17 – 26 and to work out the relevant doses and intervals of dosing up to yearly would require undue experimentation.
I have previously found that it is a matter of routine for the person skilled in the art to determine dose and dosing intervals for a particular pesticide. Consistent with this, the specification acknowledges that dose and dosing interval can be determined through simple experimentation.[122] I am satisfied that the skilled addressee could produce something that falls within the scope of claims 17 – 26 without difficulty.
[122] Specification at page 65, lines 5 – 14.
It has not been demonstrated that the specification fails to describe the invention fully.
14. Conclusion
Claims 1 – 28 lack an inventive step in light of D3 (US 2007/0066617) and the common general knowledge. This deficiency could be addressed by amendment. It is therefore appropriate to allow DuPont a period of two months from the date of this decision to file amendments.
15. Costs
Under subregulation 22.8(1), the Commissioner must not award costs in proceedings, other than costs specified in Schedule 8 of the Patents Regulations, unless each party to the proceedings has had a reasonable opportunity to make submissions on the matter of the award of those costs.
At the hearing both parties submitted that costs should follow the event. However, the parties also sought a variation in costs in accordance with Schedule 8.
In determining whether there should be any variation in the costs awarded, “the basic question is whether the justice of the case requires variation of the schedule.”[123] As stated by a Delegate of the Commissioner:
“… I believe the Commissioner should not lightly depart from the scheduled costs and needs to be satisfied that a variation is justified in the circumstances. I believe relevant factors to consider when deciding to vary the scale of costs include whether the matter involved unusual complexity, the importance of the matter, whether additional work was needed and done, the conduct and interest of the parties, and the nature of the schedule of costs in the legislation.”[124]
[123] E. I. Du Pont De Nemours and Company v ICI Chemicals & Polymers Limited and Atofina S.A. [2007] APO 12 at [9].
[124] G S Technology Pty Ltd v Davies Shephard Pty Ltd and GSA Industries (Aust.) Pty Ltd [2000] APO 49.
DuPont submitted that costs should be varied to include the costs that it incurred in lodging additional evidence under regulation 5.23 (Kopp-2), as a result of Kaminsky-1 being filed as evidence in reply, when it should have been evidence in support and included two new exhibits (Exhibits RK-4 and RK-5). However, I note that a Delegate of the Commissioner considered Kaminsky-1 and the accompanying exhibits and concluded that they are properly evidence in reply. Therefore I do not consider a variation of costs as requested by DuPont is justified in the circumstances.
Intervet submitted that costs should be varied to include the costs it incurred as a result of the three requests made by DuPont to provide additional documents under regulation 5.23. I note that regulation 5.23 was not invoked for the third request,[125] and therefore I need only have regard to the first and second requests.
[125] Intervet International B.V. v E.I. du Pont de Nemours and Company [2017] APO 11.
Kopp-2 and the DuPont Appendices were provided with the first and second requests respectively. In response, Intervet filed Kaminsky-2 and the Intervet Appendices respectively. I note that appropriate management of the filing of evidence by parties will obviate the need to rely on documents provided under regulation 5.23. I consider there was an inconvenience to Intervet in having to undertake additional work in responding to material that did not change the outcome of the opposition.
Schedule 8 does not contain an item relating to documents provided under regulation 5.23. However, in the circumstances I consider a variation from Schedule 8 is justified. I consider it appropriate to allow double the cost of preparing evidence in reply (item 9) to cover all of Intervet’s responses to the regulation 5.23 requests.
The opposition has been successful on the ground of inventive step. As a consequence, I award costs according to Schedule 8 against DuPont, varied as follows: Intervet is entitled to claim double the cost of preparing evidence in reply (item 9 of Schedule 8).
Dr M-A. Fam
Delegate of the Commissioner of PatentsAnnex A – Claims of the specification
- A compound of Formula 1, an N-oxide or a salt thereof when used for protecting a mammal from a flea, wherein the compound is administered orally or parenterally to the mammal
1
- The compound of Claim 1, wherein the compound is administered orally.
- The compound of Claim 1, wherein the compound is administered parenterally.
- The compound of Claim 3, wherein the compound is administered by injection.
- The compound of Claim 1, wherein the mammal to be protected is livestock.
- The compound of Claim 1, wherein the mammal to be protected is a canine.
- The compound of Claim 1, wherein the mammal to be protected is a feline.
- Use of a compound of Claim 1 in the manufacture of a medicament for protecting a mammal from a flea, wherein the medicament comprises a pesticidally effective amount of the compound for administration to a mammal orally or parenterally.
- The use of Claim 8, wherein the medicament is administered orally.
- The use of Claim 8, wherein the medicament is administered parenterally.
- The use of Claim 8, wherein the medicament is administered by injection.
- The use of Claim 8, wherein the mammal to be protected is livestock.
- The use of Claim 8, wherein the mammal to be protected is a canine.
- The use of Claim 8, wherein the mammal to be protected is a feline.
- The use of Claim 8, wherein the medicament is administered orally or parenterally and the mammal is protected for 24 hours after oral or parenteral administration.
- The use of Claim 8, wherein the medicament is administered orally and the mammal is protected for 24 hours after oral administration.
- The use of Claim 8, wherein the medicament is administered orally or parenterally about daily to yearly.
- The use of Claim 8, wherein the medicament is administered orally about daily to yearly.
- The use of Claim 8, wherein the medicament is administered orally or parenterally about weekly to about once every six months.
- The use of Claim 8, wherein the medicament is administered orally about weekly to about once every six months.
- The use of Claim 8, wherein the medicament is administered orally or parenterally monthly.
- The use of Claim 8, wherein the medicament is administered orally monthly.
- The use of Claim 8, wherein the medicament is administered orally or parenterally in an amount effective to protect the mammal against a flea for one month.
- The use of Claim 8, wherein the medicament is administered orally in an amount effective to protect the mammal against a flea for one month.
- The use of Claim 8, wherein the medicament is administered orally or parenterally in an amount effective to protect the mammal against a flea for six months.
- The use of Claim 8, wherein the medicament is administered orally in an amount effective to protect the mammal against a flea for six months.
- The use of Claim 8 wherein the medicament comprises 10 mg of the compound of Formula 1 per kg weight of the mammal.
- The use of Claim 8 wherein the medicament comprises 0.3 mg of the compound of Formula 1.
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