European Biotech Patent Law Update

Transcription

1 Welcome. The Webinar will start shortly No audio is being output at this time. European Biotech Patent Law Update 23 October 2013 Presented by Robert Dempster & Simon O Brien

2 Welcome. The Webinar has started. Audio is now being transmitted. European Biotech Patent Law Update 23 October 2013 Presented by Robert Dempster & Simon O Brien

3 Webinar agenda T 1836/10 (Würfel) patentability of methods relating to human embryonic stem cells EPO repeals 2-year time limit for divisional applications T 0734/12 (Genentech) novelty and inventive step of second medical use claims relating to patient subgroups T 1599/09 (Covidien AG) methods of treatment by therapy Questions (please use the panel to the right of the screen)

4 T 1836/10 (Würfel) Application related to a method of obtaining pluripotent stem cells from an embryo A canal is opened through the zona pelucida, an instrument inserted and stem cells in the inner cell mass are mobilised Stem cells are then aspirated out from the inner cell mass without impairing the vitality of the blastocyst Examining Division refused application for being contrary to morality (Article 53(a) EPC) in combination with Rule 28(c) EPC, in so far as method related to human embryos Applicant appealed and tried to avoid prohibition by use of disclaimers

5 Human embryonic stem cells and morality Rule 28(c) EPC (derived from EU Biotech Directive) excludes from patentability on morality grounds: uses of human embryos for industrial or commercial purposes Scope of Article 6(2)(c) of the Directive (corresponding to Rule 28(c) EPC) considered by CJEU in Brüstle v Greenpeace, especially second question (does exclusion cover the use of human embryos for purposes of scientific research?)

6 CJEU in Brüstle v Greenpeace The answer to the second question is therefore that the exclusion from patentability concerning the use of human embryos for industrial or commercial purposes in Article 6(2)(c) of the Directive also covers use for purposes of scientific research, only use for therapeutic or diagnostic purposes which is applied to the human embryo and is useful to it being patentable.

7 Is a non-destructive use of human embryos patentable? Both Brüstle and earlier WARF case from EPO Enlarged Board (G 2/06) only considered exclusion in context of methods which required the destruction of human embryos. In Brüstle, method related to production of neural precursors, which presupposed earlier removal of stem cells from an embryo at blastocyst stage: It is apparent from the observations presented to the Court that the removal of a stem cell from a human embryo at the blastocyst stage entails the destruction of that embryo. In present method, stem cells removed from embryo without destroying embryo is a non-destructive use of a human embryo within exclusion of Rule 28(c) EPC?

8 Non-destructive uses still excluded Examining Division considered non-destructive use still excluded and Board agreed Application mentioned that human embryos could be used as starting material for process and that was enough to fall within exclusion of commercial use of a human embryo The process provided no benefit for the embryo itself It was considered to be irrelevant that in contrast to known methods, the claimed method did not destroy the embryo Suggests absence of detriment to embryo not enough claimed method must relate to diagnosis/therapy useful to the embryo itself (based on wording of Brüstle decision)

9 First disclaimer Applicant introduced disclaimer into claim directed to: with the proviso that if the blastocyst is a human blastocyst, the obtained cells are not brought to industrial or commercial use 1 Disclaimer had no basis in application as filed Board had to consider whether disclaimer was allowable under Art. 123(2) EPC (added matter) 1....mit der Maßgabe, dass die gewonnenen Zellen keiner industriellen oder kommerziellen Nutzung zugeführt werden, falls die Blastocyste eine menschliche Blastocyste ist

10 Disclaimers at EPO Allowability of undisclosed disclaimers (having no basis in application as filed) governed by Enlarged Board decisions in G1/03 and G2/03 Undisclosed disclaimers permitted (i.e. not considered as added matter contrary to Art. 123(2) EPC) if they disclaim subject matter which is excluded from patentability according to Articles 52 to 57 EPC for non-technical reasons But such disclaimers must not remove more than is necessary to disclaim the excluded subject matter

11 Arguments in support of disclaimer Applicant argued essentially that the claim only referred to the isolation process but whether method was commercial or not decided by subsequent use of obtained cells. Disclaimer removed only industrial or commercial uses excluded by Rule 28(c) EPC, leaving (undefined) non-commercial uses such as in diagnostic or therapeutic methods (which would benefit embryo itself). For instance, the obtained stem cells could function as a source for its own personalised organ replacement part store for the embryo or the human which developed therefrom, or be used for pre-implantation diagnostics

12 Does disclaimer limit scope of claim? Board pointed out that a disclaimer can only exclude subject matter which would otherwise be within scope of the claim! Board considered scope of claim with and without disclaimer Without disclaimer: claim related to steps in which stem cells are obtained from embryo, end product is pluripotent embryonic stem cells. Says nothing about subsequent uses of obtained cells although description mentioned therapeutic and medicinal uses, these were seen as subjective intentions and not relevant for determining the subject matter of the claim

13 Future uses excluded With disclaimer: disclaimer excluded future uses of the obtained stem cells for industrial or commercial purposes, which were not otherwise within the scope of the claim. CLAIM FUTURE USES Therapy for embryo Commercial Disclaimed! use Because disclaimer tried to exclude something from claim which was not otherwise included, not allowable according to Article 123(2) EPC (and Art 84 EPC, clarity)

14 Second disclaimer Applicant tried alternative disclaimer: with the proviso that if the blastocyst is a human blastocyst, the obtained cells are brought to no use other than a use for therapeutic or diagnostic purposes useful to the human embryo embodied in the blastocyst 2 Tries to conform disclaimer to wording of Brüstle decision ( only use for therapeutic or diagnostic purposes which is applied to the human embryo and is useful to it being patentable ) Failed for same reasons as main request attempts to exclude subject matter not otherwise within scope of claim Further late attempt to rewrite as a positive feature ( with the proviso that in the case of a human blastocyst the method is carried out only for therapeutic or diagnostic purposes useful to the human embryo embodied in the blastocyst ) failed undisclosed disclaimers must be negative features

15 Third disclaimer Applicant tried adding an additional feature to the method: d) after their extraction the stem cells are cultured and propagated in a culture medium for embryonic stem cells Does this now provide a basis for a positive subsequent step from which industrial and commercial uses could be excluded? Board said no - claim is still directed to a method of obtaining embryonic stem cells and doesn t cover downstream commercial uses of the obtained cells Applicant requested referral of questions to Enlarged Board, on basis that WARF and Brüstle cases had only considered cases where method required destruction of embryos. Board rejected referral, because it was deciding case only on basis of Art. 123(2) EPC (added matter) If at first you don't succeed, try, try again. Then quit. There's no point in being a damn fool about it. (W. C. Fields)

16 Lessons from T 1836/10 (Würfel) A non-destructive use of a human embryo may still be a use for commercial or industrial purposes and therefore excluded from patentability In order to be patentable, subject matter of claim must be useful to the human embryo, not merely not detrimental A future potential commercial use of obtained cells excludes claim from patentability (even though not within actual scope of claim!) But these commercial uses cannot be disclaimed unless they are covered by an active step of the claim! Include basis in application for additional uses of cells in general terms, so that industrial and commercial uses can be disclaimed Include explicit basis for disclaimers based on wording of Rule 28(c) and Brüstle decision (excluding use for industrial/commercial purposes or positively use for therapeutic or diagnostic purposes useful to the embryo ) but reciting medical uses may lead to objection under Art. 53(c)

17 EPO repeals 2-year time limit for divisional applications Current Rule 36 EPC (introduced in 2009) limits deadline for filing divisional applications to 2 years from first examination report (or 2 years from later examination report raising new lack of unity objection) EPO has now decided to revert back to old (pre-2009) practice divisional application can be filed at any time provided that parent application is still pending (i.e. not granted, refused or withdrawn) Second and subsequent generation divisional applications will incur additional fees (to deter cascading divisionals) New rule will enter into force on 1 April 2014 and apply to any divisional applications filed from that date. Means that for many cases, divisional filing window will re-open if divisional applications are required, delay prosecution of parent application in order to ensure still pending on 1 April 2014

18 This complimentary event will focus on the major differences between European and US approaches to biotech patenting - including antibodies, diagnostics, stem cells, personalised medicine and more. Plus the impact of the unitary patent on filing strategies. To register registrations@dyoung.com

19 T 0734/12 - Genentech Claim to patient sub-group Use of rituximab in the manufacture of a medicament for treating rheumatoid arthritis by intravenous administration of two doses of antibody of 1000mg to a human who experiences an inadequate response to a TNFα-inhibitor, wherein the first dose is administered on day 1 of treatment and the second dose on day 15.

20 T 0734/12 - Genentech Sufficiency Clinical trial protocol but no data in application as filed which does not go beyond the mere statement that the patients treated will show a beneficial clinical response A prior art document (D10) which discloses the successful treatment of all 31 methotrexate refractory RA patients by the administration of the claimed rituximab dosage regimen Was common general knowledge before the priority date that 30 to 40% of the total group of RA patients are inherently TNFα-inhibitor refractory. Being aware of this high percentage and looking at a patient group size of 31 individuals as disclosed in D10 makes it statistically plausible that at least some of these patients are inherently TNFαinhibitor refractory. Therefore claim 1 plausible meets requirements of Article 83 EPC

21 T 0734/12 - Genentech Novelty T 233/96 set out conditions for a claim that is directed to a new patient group. The treatment or diagnosis of the same disease with the same compound must be carried out on a new group of subjects which is distinguished from the former by its physiological or pathological status Chosen subjects group must not be arbitrary i.e., where no functional exists between the particular physiological or pathological status of the group of subjects and the therapeutic or pharmacological effect achieved.

22 T 0734/12 - Genentech Novelty Held that patients that had an inadequate response to TNFα-inhibitor have physiological differences from the remaining group of RA patients The board did not deem it necessary to further examine the statistical data provided by the parties which either support or deny the presence of a particular beneficial therapeutic effect for the RA sub-group as claimed. The argument that the prior art (D10) inherently encompassed this patient group was not persuasive. This was despite the fact that it was undisputed by all the parties that it belonged to the common general knowledge before the priority date that 30 to 40% of the total group of RA patients are inherently TNFα-inhibitor Appears disclosure requirement to establish plausibility under sufficiency is far lower than disclosure requirement to establish lack of novelty!!

23 T 0734/12 - Genentech This case is consistent with G2/88 (Mobil) "Under the EPC, a hidden or secret use, because it has not been made available to the public, is not a ground of objection to [the] validity of a European patent. Thus, the question of inherency does not arise as such under Article 54. Any vested right derived from prior use of an invention is a matter for national law..."

24 T 0734/12 - Genentech Inventive step The closest prior art is generally a prior art document disclosing subject-matter conceived for the same purpose or aiming at the same objective as the claimed invention and having the most technical features in common. Choice of closest prior art: Treatment of RA using same dosage as recited in claim but not directed at specifically treating patients with inadequate response to TNFα-inhibitor OR Treatment of RA using different dosage as recited in claim directed at treating patients with inadequate response to TNFα-inhibitor

25 T 0734/12 - Genentech Inventive step The closest prior art is generally a prior art document disclosing subject-matter conceived for the same purpose or aiming at the same objective as the claimed invention and having the most technical features in common. Choice of closest prior art: Treatment of RA using same dosage as recited in claim but not directed at specifically treating patients with inadequate response to TNFα-inhibitor OR Treatment of RA using different dosage as recited in claim directed at treating patients with inadequate response to TNFα-inhibitor Claim held to lack inventive step as choice of particular dosage is obvious.

26 Article 53 (c) Exceptions European patents shall not be granted in respect of: Methods for treatment of the human or animal body by therapy Methods for treatment of the human or animal body by surgery and diagnostic methods practised on the human or animal body; This provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

27 Article 53 (c) Exceptions Diagnostic methods G 1/04 Narrow construction of prohibition to diagnostic methods practiced on human/animal If any technical step of claimed method is carried out in the absence of body then the method is not excluded Surgical and Therapeutic methods Excluded if method comprises at least one feature that constitutes a method step for treatment of a human or animal body by surgery or therapy (G1/07)

28 Article 53 (c) Exceptions Treatment by therapy - claim language when a drug is involved If a method of treatment by therapy: EPC 1973: Claim: Use of X in the preparation of a medicament for treating e.g. cancer EPC 2000: Claim: X for use in treating e.g. cancer If not a method of treatment by therapy: Claim: Use of X for e.g., a contraceptive

29 Article 53 (c) Exceptions But what if method comprises an apparatus? Claim apparatus per se? Claim apparatus for use in treating... (i.e. Second medical use claim). Method of using apparatus comprising. Need to asses whether functional relationship between operations effected using apparatus and a therapeutic effect produced by the apparatus.

30 T 1599/09 (Covidien AG) The invention provided a method for ensuring that the enteral pump could operate only when the interlock device was correctly positioned. If the interlock device was not correctly positioned, it was not possible to operate the pump.

31 T 1599/09 (Covidien AG) Claim 1: A method of controlling the enabling of an enteral feeding pump comprising: inserting the interlock device of the feeding set into the recess of the feeding pump; detecting electromagnetic radiation striking the interlock device when it is properly inserted in the pump recess; such that operation of the pump to pump nutrient liquid in the feeding set in response to the detected electromagnetic radiation is enabled.

32 T 1599/09 (Covidien AG) Applicant argued claims do not relate to feeding (provision of nutrition) via pump: The claims are not directed to controlling the actual pumping action of the pump Once the operation of the pump was enabled in accordance with the claim, there was no direct consequence that the pumping action did take place only that it may take place As such, the method of the invention had no direct effect on the treatment of a patient undergoing enteral feeding. None of the steps recited in the method provided a functional link to the therapeutic treatment of a patient.

33 T 1599/09 (Covidien AG) The Board used description to interpret the claims: "[d]uring operation of the pump,... the safety interlock status is continuously monitored and if the status changes from "SET LOADED" TO "FAULT", the controller will stop operating the pump Disabling operation of the pump is also part of dependent claims 10 and 12. Accordingly, held that claim 1 encompasses embodiments where the enteral feeding pump is actually operating to pump nutrient liquid.

34 T 1599/09 (Covidien AG) Is nutritional feeding a method of therapy? Enteral feeding did not provide a method of treatment by therapy as it did not relate to the treatment of a disease. If this were the case term "therapy would have to be considered to have a meaning going beyond the everyday meaning of the term. Applicant argued even if claim was directed to controlling feeding, the operation of the pump did not require the involvement of a medical doctor Board held Enteral feeding is used to provide nutrition to patients who cannot obtain nutrition by mouth or are unable to swallow safely. These patients suffered from incapacity or disease. Enteral feeding does not cure the underlying cause of disease but alleviates and lessens the symptoms thereof According to established EPO case law, this is treatment by therapy

35 T 1599/09 (Covidien AG) Board held G 1/04 states "whether or not a method is a diagnostic method within the meaning of Article 52(4) EPC [1973] should neither depend on the participation of a medical or veterinary practitioner, by being present or by bearing the responsibility, nor on the fact that all method steps can also, or only, be practised by medicinal or non-medicinal support staff, the patient himself or herself or an automated system". This finding is also applicable to therapeutic methods. It is noted that many forms of medicaments, e.g. in the form of tablets or pills, can be administered by the patient himself. Conclusion Claim 1 not allowed since it encompasses embodiments falling under the exception clause of Article 53(c) EPC.

36 T 1599/09 (Covidien AG) Can we use disclaimers to overcome Article 53 (c) objections? Yes - The clause: "wherein the method does not include the step of controlling the operation of the enteral feeding pump to pump nutrient liquid was used to limit claim 1 to embodiments in which the pump is merely set into a state where it is permitted to operate.

37 Previous decisions T 0329/94 The object of the claimed invention was principally to facilitate sustained venous blood flow to a blood extraction point by alerting the blood donor to help in maintaining the desired blood flow (e.g., by clenching fist) through a selective automated tactile stimulus. Claim drafted to relate to method of operating an apparatus that alerts user, but does not explicitly recite that sustained blood flow achieved in method Even if claim construed to require user to respond to alert by increasing blood flow, this does not result in a therapeutic or prophylactic effect on the donor himself.

38 Previous decisions T 245/87 Claim 1 related to a method for measuring the volume of the drug solution flowing into the body per unit of time. The claimed steps even when applied to an implanted device for controlled drug administration, only involve measuring the volume of the drug solution flowing into the body per unit of time and the flow itself is not affected. Therefore not a method of treatment by therapy

39 Lessons Method of using an apparatus that results in method of treatment by therapy excluded under Article 53 (c) EPC Where possible claim the apparatus Draft method claims that clearly restrict method of using apparatus to non-therapeutic steps Is there a functional link or physical causality between the method and any therapeutic effect produced on the body to which the method is applied? The claims will be interpreted with reference to the description so make sure no reference in the description to the claimed method including therapeutic steps Use disclaimers during examination if necessary

40 Any Questions? Seminar slides and a link to a recording of this webinar will be ed to you later this week To register free for our California seminars on Nov 19/20: registrations@dyoung.com Next Webinar: 22 January 2014 An invitation will be sent to you soon!