Idenix Pharmaceuticals, Inc., L'Universite Montpellier II and Centre National De La Recherche Scientifique
[2012] APO 113
•24 October 2012
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Idenix Pharmaceuticals, Inc., L'Universite Montpellier II and Centre National De La Recherche Scientifique [2012] APO 113
Patent Application: 2007216721
Title:Beta-L-2'-Deoxy Nucleosides for the Treatment of Hepatitis B
Patent Applicant: Idenix Pharmaceuticals, Inc., L'Universite Montpellier II and Centre National De La Recherche Scientifique
Delegate: Dr S.D.Barker
Decision Date: 24 October 2012
Hearing Date: 15 October 2012 by telephone
Catchwords: PATENTS – application for extension of term of a patent relating to a pharmaceutical substance – whether a pharmaceutical substance per se falls within the scope of the claims – claims to a substance "when used" – claims directed to a process – does not comply with section 70(2) – application refused
Representation: Patentee: Lisa Taliadoros of Jones Day
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Application: 2007216712
Title:Beta-L-2'-Deoxy Nucleosides for the Treatment of Hepatitis B
Patent Applicant: Idenix Pharmaceuticals, Inc., L'Universite Montpellier II and Centre National De La Recherche Scientifique
Date of Decision: 24 October 2012
DECISION
I refuse the application for extension of term.
REASONS FOR DECISION
The patentee of patent number 2007216712 is Idenix Pharmaceuticals, Inc., L'Universite Montpellier II and Centre National De La Recherche Scientifique. On 29 February 2012 the patentee applied for an extension of the term of the patent. The extension was based upon the inclusion in the Australian Register of Therapeutic Goods (ARTG) of the product SEBIVO®. The relevant ARTG registration is AUST R 126089, which commenced on 5 March 2007. The product covered by the registration is described as "SEBIVO telbivudine 600mg tablet blister pack".
The application for extension of term was made within 6 months of the date the patent was granted, as required by section 71(2). However, an examiner has objected that a pharmaceutical substance per se does not in substance fall within the scope of any claim of the specification (and consequently the application does not comply with section 70(2)). The patentee requested an oral hearing, which was held in Canberra on 15 October 2012 by telephone. The patentee was represented by Lisa Taliadoros of Jones Day.
The relevant law
The provisions governing the extension of term of patents relating to pharmaceutical substances are found in Part 3 of Chapter 6 of the Patents Act. The present case turns on the proper construction of section 70(2). The patentee urged me to construe this provision according to the teaching of Hayne and Heydon JJ in Shi v Migration Agents Registration Authority (2008) 235 CLR 286 at 311-312:
"As this Court has so often emphasised in recent years, questions presented by the application of legislation can be answered only by first giving close attention to the relevant provisions. Reference to decided cases or other secondary material must not be permitted to distract attention from the language of the applicable statute or statutes. Expressions used in decided cases to explain the operation of commonly encountered statutory provisions and their application to the facts and circumstances of a particular case may serve only to mask the nature of the task that is presented when those provisions must be applied in another case. That masking effect occurs because attention is focused upon the expression used in the decided cases, not upon the relevant statutory provisions."
Section 70(2) states:
Either or both of the following conditions must be satisfied:
(a)one or more pharmaceutical substances per se must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification;
(b)one or more pharmaceutical substances when produced by a process that involves the use of recombinant DNA technology, must in substance be disclosed in the complete specification of the patent and in substance fall within the scope of the claim or claims of that specification.
For the purposes of this decision it is paragraph (a) that is relevant. The term "pharmaceutical substance" is defined in the Schedule as follows:
pharmaceutical substance means a substance (including a mixture or compound of substances) for therapeutic use whose application (or one of whose applications) involves:
(a)a chemical interaction, or physio-chemical interaction, with a human physiological system; or
(b)action on an infectious agent, or on a toxin or other poison, in a human body;
but does not include a substance that is solely for use in in vitro diagnosis or in vitro testing.
It is clear that what section 70(2)(a) requires is:
i) there must be a substance that fits the description of a pharmaceutical substance;
ii) that substance "per se" must in substance be disclosed in the specification; and
iii)that substance "per se" must in substance fall within the scope of one or more claims of the specification.
The patent
The patent relates to the use of the substance β-L-thymidine, commonly known as telbivudine. Telbivudine was previously known, and the specification states that it has been discovered that it can be used for the treatment of hepatitis B infection in humans and other host animals. The specification has 13 claims, of which only one is independent. Claim 1 reads as follows:
An oral pharmaceutical unit dosage form of β-L-thymidine when used in the treatment of HBV infection in a subject, wherein the dosage form comprises (i) 50-1000 mg β-L-thymidine; and (ii) a pharmaceutically acceptable carrier for oral delivery.
The patentee identified telbivudine as the pharmaceutical substance. Undoubtedly telbivudine is a substance, and it is also a pharmaceutical substance. It is also clear that the specification discloses telbivudine. The sole question to be answered is whether telbivudine "per se" falls within the scope of the claims of the specification.
The patentee submitted that claim 1 is directed to a dosage form, wherein the way in which it interacts with the human body is described by the words "in the treatment of HBV infection". The response filed on 13 September 2012 put the argument this way:
"It is clear on its face that claim 1 of the Patent is directed to a pharmaceutical dosage form which contains an amount of the active ingredient telbivudine together with a pharmaceutically acceptable carrier for the treatment of HBV infection. That is, claim 1 is directed to a substance which chemically interacts with a human physiological system for the purpose of preventing, curing or alleviating a disease state, namely HBV infection. Further, the claim is limited to doses of the active ingredient (50 to 1000mg) which the specification discloses is a therapeutic dose range for the treatment of HBV infection. The claim is therefore directed to a 'pharmaceutical substance' in accordance with the definition of that term in Schedule 1 to the Patents Act."
The patentee's view, which was repeated at the hearing, is essentially that the "when used" part of the claim explains the way that the dosage form interacts with the body, but does not necessarily limit the claim to a process of treatment.
The High Court considered the scope of a "when used" claim (without using that term) in Wellcome Foundation Ltd v Commissioner of Patents [1980] HCA 21, (1980) 145 CLR 520, which came before the Court as a special case stated by the Chief Justice. The Court stated at 529:
"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"
In the case of the present claims, the patentee essentially asks me to read the term "when used" as meaning "for use in the treatment of HBV infection in a subject". I can see no reason adopt the construction of the patentee, other than that it would be convenient for the patentee. The term "when used" in the context of claim 1 limits the substance to environments where the specified use is taking place. For the treatment of HBV to be taking place, the substance must have been administered to a patient. The acts that would fall within the scope of a claim to telbivudine when used to treat HBV infection are the same as the acts that fall within a claim to a process of treating HBV infection by using telbivudine. The patentee's construction would amount to a rewriting of the words of the claim rather than the construction of the existing words. I consider that claim 1 (and all of the appended claims) define a process of treatment of HBV by the administration of a unit dosage form of telbivudine.
Can a pharmaceutical substance per se in substance fall within the scope of a process claim?
The Explanatory Memorandum to the Intellectual Property Laws Amendment Bill 1997 (Cth) (which inserted the relevant sections into the Act) makes it clear that it was not intended to extend the term of patents directed solely to pharmaceutical substances "when used" in a method of treatment:
"The extension of term provisions will be available for patents that include claims to pharmaceutical substances per se (provided that the other criteria are met). These claims to pharmaceutical substances per se would usually be restricted to new and inventive substances. Patents that claim pharmaceutical substances when produced by a particular process (product by process claims) will not be eligible unless that process involves the use of recombinant DNA technology. Claims which limit the use of a known substance to a particular environment, for example claims to pharmaceutical substances when used in a new and inventive method of treatment, are not considered to be claims to pharmaceutical substances per se."
In Boehringer Ingelheim International GmbH v Commissioner of Patents [2001] FCA 647, 52 IPR 529 the Federal Court considered a patent that claimed an active agent in a container for nasal administration. At first instance, Heerey J held that section 70(2)(a) was not satisfied because the expression per se showed that an extension of term is to be available only where the claim is for a pharmaceutical substance as such, not a substance forming part of a new delivery method or process. The Full Court agreed (at [37]), stating that the expression "fall within the scope of the claim or claims of that specification" in s 70(2)(a) means that it must be "included amongst the things claimed" (at [42]).
Even more relevant for present purposes, in Prejay Holdings Ltd v Commissioner of Patents [2003] FCAFC 77 at [24], 57 IPR 424 at 429, all of the claims were method claims, not product claims. Wilcox and Cooper JJ (Allsop J concurring) held that a substance that is mentioned in the context of a method claim does not per se fall within the scope of a method claim (at [24]):
"for a substance to fall within s 70(2)(a) it must itself be the subject of a claim in the relevant patent. It is not enough that the substance appears in a claim in combination with other integers or as part of the description of a method (or process) that is the subject of a claim."
I conclude that a pharmaceutical substance per se will not in substance fall within the scope of a claim that is directed to a method.
Conclusion
While the Federal Court has not considered whether an extension of term is available for a "when used" claim, the principles to be applied are clear. The claims of the present patent are process claims. Telbivudine per se does not in substance fall within the scope of any of the claims of the specification. It follows that the application does not comply with section 70(2), and must be refused under section 74(3). This decision represents notification under section 74(4).
Dr S.D.Barker
Delegate of the Commissioner of Patents
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