Merck, Sharpe & Dohme (Australia) Pty Ltd. v Genentech, Inc - [2015] APO 19

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Merck, Sharpe & Dohme (Australia) Pty Ltd. v Genentech, Inc. [2015] APO 19

Patent Application: 2003287257

Title:Inhibition of IL-17 production

Patent Applicant:                   Genentech, Inc.
Opponent:  Merck, Sharpe & Dohme (Australia) Pty Ltd.
Delegate:  Dr B. Akhurst
Decision Date:  12 May 2015
Hearing Date:  23 February 2015, in Canberra
Catchwords:  PATENTS – Final determination of an opposition under section 59 – the earlier hearing was conducted, and the decision made, on the basis of the independent claims with no detailed submissions or consideration with respect to the dependent claims ‑ the specific deficiencies to be overcome for all claims found invalid are those explicitly identified in the earlier decision – if a ground of opposition could have been pursued at the earlier hearing with respect to a feature in a dependent claim then introduction of this feature into an independent claim does not introduce a new deficiency – the amendments overcome the deficiencies identified in the earlier decision and do not introduce new deficiencies

Representation: Patent applicant: Andrew Fox of Counsel, instructed by Dr Stuart Boyer patent attorney of Griffith Hack, Perth.
Opponent: Matthew Darke of Counsel, instructed by Andrew Blattmann and Simon Potter patent attorneys of Spruson & Ferguson, Sydney.

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2003287257

Title:Inhibition of IL-17 production

Patent Applicant: Genentech, Inc.
Date of Decision: 12 May 2015
DECISION
The amendments to the specification overcome the deficiencies identified in the earlier decision and do not introduce new deficiencies. Therefore, subject to an appeal of this decision, I direct the application proceed to grant.
Costs according to Schedule 8 are awarded against Merck, Sharpe & Dohme (Australia) Pty Ltd.
REASONS FOR DECISION
Background

Patent application 2003287257 in the name of Genentech, Inc. (Genentech) was advertised as accepted on 10 December 2009. Merck, Sharpe & Dohme (Australia) Pty Ltd. (MSDA) opposed the grant of a patent under s. 59 and the matter was heard on 12 November 2013 (the earlier hearing). On 6 February 2014, my decision that the opposition succeeded on the grounds of novelty and fair basis was reported as [2014] APO 6 (the earlier decision). Although the opposition was successful, I believed it was possible to overcome the deficiencies in the claims and I provided Genentech with 2 months in which to propose suitable amendments under s. 104. Genentech’s amendments on 4 April 2014 (the amendments) were allowed unopposed on 13 November 2014.
After receiving advice that the opposition was due for final determination, MSDA requested a hearing and the date was set. MSDA’s summary of submissions was filed on 13 February 2015 and Genentech’s on 20 February 2015. It was apparent from MSDA’s summary that it intended to pursue the grounds of novelty and inventive step on the basis of a particularised document not raised in the earlier hearing. Thus, on 16 February 2015, the delegate reminded the parties of the nature of a final determination hearing as follows:
“It is well established that the decision of the Delegate in the opposition proceedings is final, and determines all issues that were capable of determination at that time. (R v Smith; Ex parte Mole Engineering Pty Ltd [1981] HCA 25; (1981) 147 CLR 340 at 348-9).
Thus, in a final determination the only questions are whether the amendments to the specification overcome the deficiencies identified in the earlier decision, and whether the amendments introduce any new deficiencies. New deficiencies are grounds of opposition that arise solely from the amendment of the specification (and exclude pre-existing deficiencies, whether or not these were argued at the original hearing). For example, a novelty citation that could have been argued against the original claims is not a new deficiency and cannot be raised in a final determination.”
The matter was heard in Canberra on 23 February 2015. Although included in its summary of submissions, at the hearing MSDA advised that it did not pursue the ground of inventive step with respect to the amended claims.
The Law
At the final determination hearing, it was not in dispute that the decision of the High Court in R v Smith (Commissioner of Patents); Ex parte Mole Engineering Pty Ltd [1981] HCA 25; (1981) 147 CLR 340 (Ex parte Mole) supports the Commissioner deciding an opposition with more than one decision, providing that each decision is final and decides all the issues arising on the notice of opposition so far as they were capable of determination at the time. The parties did not dispute that the issues to be considered in the final determination are whether the amendments to the specification overcome the deficiencies identified in the earlier decision and whether the amendments introduce any new deficiencies.
The earlier decision
Page 1 of the earlier decision records my findings on the grounds of opposition, as follows:
“The invention of claims 1-5, 11-12 and 14-33 lacks novelty. Claim 15 and all its dependent claims lack fair basis, insofar as these claims require each individual subject to be tested to determine an elevated level of IL-17 expression prior to treatment with the IL-23 antagonist.”
The amendments
The amended claims, a ‘marked-up’ copy showing the nature of the amendments and the accepted claims (the subject of the earlier decision) are attached to this decision as Annexes A, B and C, respectively. What must be determined is whether the amendments overcome the novelty and fair basing deficiencies identified in the earlier decision and whether they introduce new deficiencies.
In this regard, MSDA advised it had no issue with the claims found valid in the earlier decision – as amended these are claims 15-22 and omnibus claim 36. Accepted claims 1-3 have been deleted overcoming the deficiencies in those claims. The balance of the accepted claims have been amended and renumbered. Most relevantly for the final determination, amended independent claims 1, 2, 23 and 14 correspond to accepted claims 4, 5, 14 and 15, respectively.
Fair basis
In the earlier decision, I found that accepted claim 15 and dependent claims lacked fair basis insofar as they require each individual subject to be tested to determine an elevated level of IL-17 expression prior to treatment with the IL-23 antagonist. MSDA made no submissions regarding the fair basing of corresponding amended claim 14.
Claim 14 has no dependent claims and it no longer refers to “a subject determined to have an elevated level of expression of IL-17 compared with a healthy subject”. Instead, consistent with other accepted claims, claim 14 now requires that the inflammatory disease “is characterized by elevated expression of interleukin-17 (IL-17)”.
I am satisfied that this amendment overcomes the fair basis deficiency identified in the earlier decision.
Novelty
For novelty purposes, MSDA addressed the amended claims in two groups and it is convenient to do so in this decision.
Amended claims 1, 2 and 14
MSDA’s primary submission with respect to amended claims 1, 2 and 14 is essentially that Genentech cannot overcome the novelty deficiencies identified in the earlier decision by the addition of features from an invalid dependent claim. In the alternative, MSDA submitted that amended claims 1-14 lack novelty and/or an inventive step in light of a particularised prior art document that was not raised at the earlier hearing.
After hearing submissions from both parties on whether it is open to me to consider MSDA’s alternative submission, I refused to do so. My reasons for that refusal follow.
MSDA’s alternative submission – the new prior art document
To provide context to the parties’ submissions, in the earlier hearing Genentech had conceded that where an independent claim was found invalid under a ground of opposition then that finding would apply to the associated dependent claims. MSDA accepted Genentech’s concession and conducted its opposition accordingly. I decided the matter on the same basis as is apparent from paras [17], [82] and [117] of the earlier decision. For completeness, the parties conducted this final determination in the same manner.
MSDA asserted that if Genentech were allowed to retract its concession in the earlier hearing, either explicitly or by default (in the event of a finding that the amendments overcome the deficiencies), then the opponent should be allowed to raise a new citation. MSDA submitted that the addition of features from a dependent claim results in a new deficiency because there was no detailed consideration of the validity of the dependent claims in the earlier hearing and decision. Furthermore, that as I had not considered the features of the dependent claims in the earlier decision, a final determination taking account of the new document would not be inconsistent with the previous decision.
I cannot accept MSDA’s submission as a correct interpretation of the law. The earlier decision in opposition proceedings is a final decision on the accepted application, which determines all issues capable of determination at the time and decides them once and for all (see Ex parte Mole at 349). In this regard, the earlier decision is to be taken as dealing with and deciding the grounds of opposition generally, rather than only the specific grounds particularised, argued or pressed by the opponent in the earlier opposition hearing (Merkel J in Iluka Midwest Ltd v Technological Resources Pty Limited [2002] FCA 49 at [50] and [2002] FCA 1233 at [17], [37]).
The features now present in amended claims 1, 2 and 14 were present in the claims at acceptance and MSDA did not suggest otherwise. For reasons provided later in this decision, the earlier decision contains no adverse finding with respect to the subset of inflammatory diseases now listed in these claims. If there are valid grounds of opposition to claims 1, 2 and 4 on the basis of that subset of inflammatory diseases, those grounds could have been pursued in the earlier hearing with respect to dependent claim 28. It follows that the amendments do not introduce a new deficiency. In the absence of any new deficiency in the claims, it is not open to me to consider a new citation at this stage of the opposition. To do so would constitute a re-hearing of the opposition and an adverse decision on the basis of the new document would be in conflict with the earlier decision. Both circumstances were expressly prohibited by the High Court in Ex‑parte Mole.
MSDA’s primary submission - Genentech’s concession
MSDA submitted that Genentech, by way of its unqualified concession, had acknowledged that where an independent claim lacked novelty under a ground of opposition, the whole subject matter of the associated dependent claims lacked novelty. On this basis, MSDA argued that the introduction of subject matter from a dependent claim found wholly invalid in the earlier decision could not confer novelty on the independent claims, and to find otherwise would be inconsistent with the earlier decision.
While Genentech did not resile from the process in the earlier hearing, it did not accept the consequences suggested by MSDA. It submitted that the amendments have narrowed the scope of the claims to avoid the prior art and overcome the deficiencies identified in the earlier decision.
It is clear from the earlier decision that my novelty findings were based on the prior disclosure of particular subject matter that anticipates embodiments of the accepted independent claims. On the basis of that same disclosure, and in accordance with the parties’ agreed conduct of the hearing, I found the associated dependent claims also lacked novelty. Regardless of the level of detail involved in considering the validity of each claim in the specification, or the merits of my earlier decision, that decision is final insofar as it determines all issues capable of determination at the time (Ex parte Mole at 349 applied). For the purposes of this final determination, where it identifies the relevant prior disclosure, the earlier decision must be understood as identifying the specific novelty deficiencies to be overcome for all claims found invalid under this ground.
MSDA submitted that amended claims 1, 2 and 14 lack novelty over two documents relied on in the earlier decision. These are Benson, J. et al. (2002) FASEB Journal 16(5): A1045 Abstract 759.12 (Benson et al.) and WO 2001/085790 A2 (Schering Corporation) 15 November 2001 (WO’790).
Benson et al.
In the earlier decision at [52]-[56], I found accepted claims 4, 5 and 15 were anticipated by Benson et al. which discloses the in vivo use of an IL-23 antagonist to treat relapsing experimental autoimmune encephalomyelitis (EAE) in mice. Corresponding amended claims 1, 2 and 14 explicitly require that the subject is human and the inflammatory disease to be treated is selected from a subset of those originally encompassed by dependent claim 28.
I accept Genentech’s submission that the inflammatory diseases now listed in these claims are not the inflammatory demyelinating diseases of the central nervous system for which EAE serves as a model, since it was not disputed by MSDA and is consistent with the evidence (Exhibit H to the Ouyang declaration). This renders moot MSDA’s submission that while Benson et al. exemplifies the treatment of EAE in mice it is nevertheless relevant to the treatment of mammals generally, including humans.
I am satisfied that Benson et al. does not disclose the treatment in humans of the inflammatory diseases now listed in claims 1, 2 and 14.
WO’790
In the earlier decision at [73]-[77], I found that WO’790 anticipates accepted claims 4, 5 and 15, by providing clear and unmistakable directions to the therapeutic in vivo administration of an IL‑23 antagonist to a mammalian host exhibiting signs or symptoms of multiple sclerosis (MS), rheumatoid arthritis (RA) or psoriasis.
Most relevant to overcoming this deficiency, corresponding amended claims 1, 2 and 14 and dependent claims do not encompass the treatment of these three conditions. Although the inflammatory diseases now listed in claims 1, 2 and 14 include psoriatic arthritis, I have no submissions or evidence before me that establishes that in following the directions in WO’790 for the treatment of psoriasis, the person skilled in the art would inevitably, in every case, treat psoriatic arthritis.
MSDA did not suggest that WO’790 provides clear and unmistakeable directions to the treatment of the specific conditions now listed in claims 1, 2 and 14, and on review of my earlier decision I made no such finding.
I am satisfied that WO’790 does not disclose the treatment in humans of the inflammatory diseases now listed in claims 1, 2 and 14.
Amended claim 23 and dependent claims
At paras [70] and [78] of the earlier decision, I found accepted claim 14 to a “method for inducing IL-17 production in a mammalian subject comprising administering to said subject an IL-23 agonist” lacked novelty in light of two documents: WO 2001/018051 A2 (Schering Corporation) 15 March 2001 (WO’051) and WO’790.
Corresponding claim 23 is substantially amended and now recites:
“An in vivo method for inducing a cell-mediated immune response in a human subject comprising administering to said subject an IL-23 agonist; wherein said subject is suffering from an infection and said immune response is triggered by an increase of IL-17 production by T cells.”
MSDA submitted that the features of the amended claim are disclosed by both WO’051 and WO’790 - in effect, that the amendments to this claim do not overcome the deficiencies identified in the earlier decision.
WO’051
In the earlier decision at [68], based on the inherent activity of the agonist, I found that insofar as WO’051 discloses the use of therapeutic amount of IL-23 agonist to modulate the inflammatory response in an animal, it anticipated accepted claim 14. My conclusion that this method would inherently involve induction of IL-17 was based on data in the opposed specification and the expert evidence. I made no findings regarding the downstream effects of IL-17.
MSDA submitted that a cell-mediated immune response would be an inherent result of the method taught by WO’051. Responding, Genentech submitted that WO’051 contains no suggestion that a relevant agonist could be administered to a human subject such that a cell-mediated immune response is triggered via an increase in IL-17 production by T cells.
MSDA did not identify any expert evidence to support its submission that in following the directions in WO’051 to modulate the inflammatory response in an animal by contacting cells of the animal with a therapeutic amount of a relevant agonist, the person skilled in the art would inevitably induce a cell-mediated immune response. I have reviewed the expert evidence and can find no clear statements in this regard.
In the absence of expert evidence on this point, MSDA has not established that WO’051 is relevant to the novelty of claim 23.
WO’790
In the earlier decision at [78], I found that accepted claim 14 and dependent claims were anticipated by WO’790 which discloses a method of modulating the physiology and development of a cell comprising contacting the cell with an IL-23 agonist. As for WO’051, this finding was based on the inherent activity of an IL-23 agonist to induce IL-17 production in a mammalian subject.
MSDA submitted that corresponding amended claim 23 is anticipated by WO’790, which broadly discloses the therapeutic use of a relevant agonist to modulate the physiology or development of a cell including, relevantly, where the cell is from a host which suffers from a viral or fungal growth (infection) (pages 5-6 and claim 23). MSDA relied on the increase in IL‑17 and a consequential cell-mediated immune response being an inherent feature of the WO’790 method. However, as for WO’051, in the absence of evidence that a cell-mediated immune response would be an inevitable outcome of the method taught by WO’079, MSDA has not established that WO’079 is relevant to the novelty of amended claim 23.
Summary
I am satisfied that the amendments in independent claims 1, 2, 14 and 23 overcome the novelty deficiencies identified in the earlier decision. MSDA has not established that the amendments introduce new deficiencies.
MSDA submitted that the fate of the dependent claims follows that of the independent claims and Genentech’s submissions were consistent with this approach. Since dependent claims 3-13 and 24-35 are all narrower in scope than independent claims 1, 2 and 23, it is reasonable to conclude that the subject matter of these claims is also novel.
Conclusion
Genentech’s amendments overcome the deficiencies identified in the earlier decision and do not introduce new deficiencies. Subject to an appeal of this decision, I direct the application to proceed to grant.
Costs
It is normal in actions before the Commissioner that costs should follow the event and the parties’ submissions were consistent with this. Genentech has been successful in this final determination of the opposition and I see no reason to vary the normal practice.
I award costs according to Schedule 8 against Merck, Sharpe & Dohme (Australia) Pty Ltd.
Dr Barbara Akhurst
Delegate of the Commissioner of Patents
Annex A: The amended claims the subject of the final determination
Annex B: A ‘marked-up’ copy of the amended claims showing the nature of the amendments
Annex C: The accepted claims the subject of the earlier decision