Pharma Session 1: The endgame: patent term extensions and SPCs

Transcription

1 Pharma Session 1: The endgame: patent term extensions and SPCs Tuesday, September 25 09:00-10:30

2 Alexa von Uexkuell, Vossius & Partner (Moderator) MaryAnne Armstrong, BSKB LLP Makoto Ono, Anderson Mori & Tomotsune John Todaro, Merck & Co, Inc., Kenilworth, New Jersey (USA) 2

3 Topics to be discussed 1. One Patent one patent term extension? 2. Patent term extensions for combination products 3. The level of disclosure required to what extent must a patent disclose or claim the active ingredient(s)? 4. Best practices for complying with Patent Term Extension/SPC Filing Deadlines 3

4 (1) U.S. - One Patent One patent term extension? Patent Term Extension is provided under 35 U.S.C. 154 (a) The term of a patent which claims a product, a method of using a product, or a method of manufacturing a product shall be extended in accordance with this section from the original expiration date of the patent, which shall include any patent term adjustment granted under section 154(b) 35 U.S.C. 154(a) Under 35 U.S.C. 154 (f) (1) The term product means: (A) A drug product. (B) Any medical device, food additive, or color additive subject to regulation under the Federal Food, Drug, and Cosmetic Act. 4

5 (1) U.S. - One Patent One patent term extension? Under 35 U.S.C. 154(d)(5)(F) (F) The rights derived from any patent the term of which is extended under this paragraph shall, during the period of interim extension (i) in the case of a patent which claims a product, be limited to any use then under regulatory review; (ii) in the case of a patent which claims a method of using a product, be limited to any use claimed by the patent then under regulatory review; and (iii) in the case of a patent which claims a method of manufacturing a product, be limited to the method of manufacturing as used to make the product then under regulatory review. However, under 37 C.F.R The term of a patent may be extended if: (b) The term of the patent has never been previously extended, except for extensions issued pursuant to 1.701, 1.760, or

6 (1) U.S. - One Patent One patent term extension? Thus, under U.S. rules there can only be one extension per patent If there is more than one potential API in a patent, it may be desirable to file a continuation application and split the compounds into separate patent applications. Other limitations: Only for first commercial marketing of the product - Fisons PLC v Quigg, (Fed. Cir. 1989) new formulations of cromolyn sodium not eligible for PTE because it was not the first commercial marketing of the active cromolyn sodium. One patent for a single regulatory period (37 C.F.R (h)) 6

7 (1) U.S. - One Patent One patent term extension? US Prohibition on Double Patenting: a judicially created doctrine that prohibits an inventor from obtaining a second patent for claims that are not patentably distinct from the claims of the first patent (UCB,. Inc. v. Accord Health Care, Inc. (Fed. Cir. 2018) Quote from Gilead Sciences, Inc. v. Natco Pharma Ltd. (Fed. Cir. 2014): [I]t is a bedrock principle of our patent system that when a patent expires, the public is free to use not only the same invention claimed in the expired patent but also obvious or patentably indistinct modifications of that invention.... And that principle is violated when a patent expires and the pubic is nevertheless barred from practicing obvious modifications of the invention claimed in that patent because the inventor holds another later-expiring patent with claims for obvious modifications of the invention. Double Patenting can be overcome by filing a terminal disclaimer up until expiration of the later-expiring patent Boehringer Ingelhim Int l GmBH v. Barr Labs, Inc. (Fed. Cir. 2010) 7

8 (1) U.S. - One Patent One patent term extension? Double Patenting Scenarios: Two patents, with different filing dates, claiming subject matter that is not patentably distinct But does Double Patenting apply to patents from the same family, with the same filing date? Patent Term Adjustment: extension of patent term due to patent office delay during prosecution Quote from Gilead Sciences, Inc. v. Natco Pharma Ltd. (Fed. Cir. 2014): Patents claiming overlapping subject matter that were filed at the same time can still have different patent terms due to examination delays at the PTO. 8

9 (1) U.S. - One Patent One patent term extension? Why is this important for PTE? What if the patent which is to be extended is subject to a Double Patenting scenario? Potential Double Patenting Scenarios Species Claims/Genus Claims Compound Claims/Composition of Matter Claims First Species Claims/Second Species Claim Some PTE applicants file terminal disclaimers during the PTE process to avoid potential double patenting issues 9

10 (1) JP One Patent One PTE? Conditions for obtaining a PTE Examination Guidelines in JPO A PTE application may be granted: 1. if all the claimed elements are found in a newly approved drug product; and 2. when there is another drug already on the market, if the newly approved drug is different from the previously approved drug in any of components (ingredients and quantities thereof), dosage and administration (dosing amount, dosing schedule and administration route), or indication (effect and efficacy). Condition 1: The patent claims can be read on the approved drug. Condition 2: This is the first approval for any of the components, dosage and administration, or indication. 10

11 (1) JP One Patent One PTE? How many patents? How many times? Accordingly, if the above conditions are met: Multiple PTEs may be granted for a single patent based on multiple regulatory approvals; and Multiple patents may be extended based on a single regulatory approval for a product. 11

12 (1) JP One Patent One PTE? Hypothetical Examples Conditions 1. The patent claims can be read on the approved drug. 2. This is the first approval for any of the components, dosage and administration, or indication. Patent Approvals Extendable? Remarks (Basic Patent) A pharmaceutical composition comprising compound A. 1 st API: compound A Admin.: 5 mg/kg daily Indication: psoriasis 2 nd API: compound A Admin.: 25 mg/kg weekly Indication: psoriasis Yes Yes Conditions 1 and 2 are met. 3 rd API: compound A Admin.: 5 mg/kg daily Indication: IBD Yes 12

13 (1) JP One Patent One PTE? Hypothetical Examples (continued) Patent Approvals Extendable? Remarks (Dosage Patent) A pharmaceutical composition comprising compound A wherein said composition is administered to patients at a dose of 25 mg/kg weekly. 1 st API: compound A Admin.: 5 mg/kg daily Indication: psoriasis 2 nd API: compound A Admin.: 25 mg/kg weekly Indication: psoriasis 3 rd API: compound A Admin.: 5 mg/kg daily Indication: IBD 4 th API: compound A Admin.: 25 mg/kg weekly Indication: IBD No Yes No Yes Condition 1 is not met. Conditions 1 and 2 are met. Condition 1 is not met. Conditions 1 and 2 are met. 13

14 (1) EU One Patent One SPC? REGULATION (EC) No 469/2009 (the SPC Regulation for Medicinal Products) Regulation (EC) No 1610/96 (the SPC Regulation for Plant Protection Products) no statutory provision in the SPC Regulations that one patent may give rise to only one SPC the only statutory limitation is that only one SPC should issue per product per patentee CJEU C-181/95 (Biogen) of 23 Jan 1997, para. 28: Under Article 3 (c) of the regulation, however, only one certificate may be granted for each basic patent Article 3 (c): the product has not already been the subject of a certificate only one certificate per product, rather than only one SPC per patent Standing Practice of the national patent offices to grant multiple SPC on the basis of a single patent, if different products are involved PDL EP Humanized Immunoglobulins 7SPCs 14

15 (1) EU One Patent One SPC? CJEU C-322/10 (Medeva) of 24 November 2011, para. 41 Second, where a patent protects a product, in accordance with Article 3(c) of Regulation No 469/2009, only one certificate may be granted for that basic patent Medeva and its Progeny (see also CJEU Georgetown (C-422/10), as well as the reasoned orders Yeda (C-518/10), Queensland (C-630/10) and Daiichi (C-6/11)). Some patent offices adopted the interpretation of Medeva to the effect that it prohibits the grant of more than one SPC per patent. This controversy has triggered multiple further referrals to the CJEU for clarification. 15

16 (1) EU One Patent One SPC? CJEU C-443/12 (Actavis v Sanofi) of 12 December 2013 CJEU C-577/13 (Actavis v Boehringer Ingelheim) of 12 March 2015) Facts: Basic Patent: Ibersartan and Irbesartan + a diuretic / Telmisartan and Telmisartan + HCTZ First SPC: Ibersartan / Telmisartan Second SPC: Irbesartan +HCTZ / Telmisartan + HCTZ It is possible, on the basis of a patent which protects several different products, to obtain several SPCs in relation to each of those different products, provided, that each of those products is protected as such by that basic patent within the meaning of Article 3(a). No second SPC available for combination of the API protected as such by the basic patent and which constitutes the core inventive advance (CJEU C-443/12) the sole subject-matter of the invention (CJEU C-577/13) and another API which is not protected by the basic patent 16

17 (1) EU One Patent One PTE? CJEU C-484/12 (Georgetown II) of 12 December 2013 Basic patent: a vaccine for the prevention of papillomavirus infection, comprising at least one of the antigens A, B, C or D First SPC: Papillomavirus vaccine composition comprising A+B+C+D Second SPC: Papillomavirus vaccine composition comprising C+D Further SPCs were filed for in respect of A, B, C, and D individually. All SPC applications relied on the first marketing authorization (MA1) that covered the combination product (A+B+C+D). Multiple SPCs per patent available if each API is protected per se SPCs available for combinations of APIs, as well as individual API, based on same MA 17

18 (2) U.S. - Patent term extensions for combination products Combination products are only eligible for PTE if one of the actives is has not been previously marketed. The Arnold Partnership v Dudas (Fed. Cir. 2004) new combination product of hydrocodone and ibuprofen not eligible for PTE, even if synergistic effects are demonstrated, because both actives had been previously approved as separate drugs. 18

19 (2) U.S. - Patent term extensions for combination products However: New enantiomers may be eligible for PTE as a new product Ortho-McNeil v Lupin, (Fed. Cir. 2010) Levofloxacin (S(-) enantiomer of the racemate ofloxacin held to be a new product compared to the racemate. Esters may be considered new products from previously approved salts Photocure v. Kappos, (Fed. Cir. 2010) methyl aminolevulinate hydrochloride (MAL HCl), which is a methyl ester of previously approved aminolevulinic acid (ALA) held to be a new product. Glaxo v. Quigg, (Fed. Cir. 1990) cefuroxime axetil, which is an acid ester of previously approved cefuroxime salts held to be a new product. 19

20 (2) JP Patent term extensions for combination products Is a PTE available for a new combination of previously approved products? Yes, if the following Conditions are met: 1. The patent claims can be read on the approved drug. 2. This is the first approval for any of the components, dosage and administration, or indication. Scenario 1: Patent Claim: A / Approved Product A + B Patent Approvals Extendable? Remarks (Basic Patent) A pharmaceutical composition comprising compound A. 1 st API: compound A Indication: psoriasis 2 nd API: compounds A + B Indication: psoriasis 3 rd API: compounds A + B Indication: IBD Yes Yes Yes Conditions 1 and 2 are met. 20

21 (2) JP Patent term extensions for combination products Scenario 2: Patent Claim: A + B / Approved Product A only No PTE will be granted because Condition 1 is not met. Scenario 2.1: Patent Claim : A + B / Approved Product A, but according to the label must be used in combination with B It may depend on the claim language: Claim language Extendable? Remarks A pharmaceutical composition comprising compounds A and B. A pharmaceutical composition comprising compound A for use in combination with compound B. (probably) No Yes Condition 1 is not met. Condition 1 is met (if Condition 2 is also met). 21

22 (2) EU Patent term extensions for combination products Is an SPC available for a new combination of previously approved products? Article 1 Definitions: (b) product means the active ingredient or combination of active ingredients of a medicinal product; Article 3(d) - the autorization is the first authorization to place the product on the market As a product comprising active ingredient A+B differs from a product comprising A or B, SPC protection is available, provided the conditions of Article 3 are fulfilled. 22

23 (2) EU Patent term extensions for combination products Must the Patent claim match the active ingredients of the approved product? Article 3: Conditions for obtaining a certificate A certificate shall be granted if, in the Member State if at the date of that application: (a) the product is protected by a basic patent in force; (b) a valid authorisation to place the product on the market as a medicinal product has been granted It has been the general consensus that the term product as used in the SPC Regulation must always have the same meaning. As a consequence, it was assumed that the SPC product definition must correspond to the active ingredient(s) of the approved product. Patent Claim: A+B / Approved product: A+B no problem But what if there is a mismatch between patent claim and the approved product? 23

24 (2) EU Patent term extensions for combination products Medeva and its Progeny Infringement test not applicable SPC for combinations of APIs only if they are "specified" in the wording of the claims The SPC product definition must be commensurate with the claims An SPC is availabe for API(s) "specified" in the wording of claims, even if MA contains additional API(s) if patent only claims combination, no SPC for individual API SPC for single API will be infringed by combination comprising this API See also C-422/10 Georgetown, C-630/10 Queensland, C-6/11 Daiichi, C-518/10 Yeda (all of 24/25 November 2011) 24

25 (2) EU Patent term extensions for combination products CJEU in Medeva and its Progeny - a Teleological approach A strict approach to Article 3(a) (i.e. the API having to be specified or identified in the claims of the basic patent) necessitates a balanced, more purposive or teleological approach to interpreting Article 3(b). Otherwise no SPC extension would be available for manufacturers of medicinal products who are obliged, for legal or practical reasons, to market an active ingredient as a fixed combination with other active ingredients. Such an interpretation of the Regulation would run counter to its very aims. Article 3 A certificate shall be granted if, in the Member State if at the date of that application: (a) the product is protected by a basic patent in force; (b) a valid authorisation to place the product on the market as a medicinal product has been granted The product in accordance with Art.3(a) does not have to be identical with the product of Art. 3(b). 25

26 (2) EU Patent term extensions for combination products Must the Patent claim match the active ingredients of the approved product? Scenario 2: Patent Claim: A + B / Approved Product A only As Product A per se is not protected by the patent no SPC (confirmed by CJEU in Medeva and its Progeny) Scenario 2.1: Patent Claim: A + B / Approved Product A, but according to the label must be used in combination with B National courts, prior to Medeva (High Court CH2010 APP 0137 Yedas, CH2010 APP 0137 of 12 July 2010 and Bundesgerichtshof Pantoprazole, X ZB1/08 of 8 July 2008) have rejected the issue of an SPC under these circumstances. 26

27 (2) EU Patent term extensions for combination products Scope of protection Medeva/ Georgetown (C-322/10 & C-422/10) CJEU case Claims API of MA SPC product definition Medeva A+B A+B+C+D A+B Georgetown A A+B A Scope SPC for "A" will be infringed by product comprising A+B SPC for "A+B" will be infringed by product comprising A+B+C (confirmed by CJEU in C-442/11 Valsartan of 9 December 2012) 27

28 (3) U.S. - The level of disclosure required to what extent must a patent disclose or claim the active ingredient(s)? 37 CFR Patents subject to extension of the patent term (a) A patent is eligible for extension of the patent term if the patent claims a product as defined in paragraph (b) of this section, either alone or in combination with other ingredients that read on a composition that received permission for commercial marketing or use, or a method of using such a product, or a method of manufacturing such a product. (b) The term product referred to in paragraph (a) of this section means (1) The active ingredient of a new human drug, antibiotic drug, or human biological product including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient; or (2) The active ingredient of a new animal drug or veterinary biological product that is not primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes including site specific genetic manipulation techniques, including any salt or ester of the active ingredient, as a single entity or in combination with another active ingredient; or (3) Any medical device, food additive, or color additive 28

29 (3) U.S. - The level of disclosure required to what extent must a patent disclose or claim the active ingredient(s)? Hoechst-Roussel v. Lehman, (Fed. Cir. 1997) Claims were directed to 1-hydroxy-tacrine and a method of treating a patient with 1-hydroxy-tacrine. The approved product was tacrine hydrochloride, which is metabolized into 1-hydroxy-tacrine by the body. Patent did not claim tacrine hydrochloride or methods of using tacrine hydrochloride, therefore the claims were not entitled to patent term extension. Merck v. Teva, (Fed. Cir. 2003) Claims that recited 4-amino-1-hydroxybutane 1, 1- bisphosphonic acid (i.e. acid form) were held to encompass the approved product of 4- amino-1-hydroxybutane 1, 1-bisphosphonic acid monosodium salt trihydrate (i.e. salt form) because the specification was clear that acids encompassed salts forms. 29

30 (3) JP The level of disclosure required to what extent must a patent disclose or claim the active ingredient(s)? Generally, the JPO requires that the active ingredient(s) be defined in the claims as follows: Chemical Compounds Regarding compound claims, the compound must be defied by the structural formula; or conventional or IUPAC nomenclature. Functional/ generic definition may be allowed if the patent is principally directed to an inventive compound, i.e. additional compounds in the sebsequent claims may be defined functionally or generically. Markush formula is allowed. Antibodies Rrgarding antibody claims, the antibody must be defied by the amino acid sequence (full or at least six CDRs). Functional /generic definition may be allowed in use claims, e.g. "A pharmaceutical composition for treating cancer comprising an antibody specifically binds to antigen X." 30

31 (3) JP The level of disclosure required to what extent must a patent disclose or claim the active ingredient(s)? Is it necessary that each active ingredient is identified in the claims? Case 1: Patent is principally directed to compound A and subsequently claims a combination of compound A and e.g. a diuretic. Approved Product is a combination of compound A and HCTZ. PTE may be granted because Condition 1 is met (and if Condition 2 is also met) even though HCTZ is neither explicitly claimed nor described in the specification. Case 2: Patent is directed to an inventive combination. The JPO is very unlikely to allow claims only broadly reciting, e.g. compound A and a diuretic, and would probably require that the diuretic be defined by the chemical structure. Case 3: Patent is directed to a therapeutic use of an antibody that is defined functionally, e.g. specifically binds to antigen X. Approved Product is Antibody A that specifically binds to antigen X. PTE may be granted for the use patent because Condition 1 is met (and if Condition 2 is also met) even though Antibody A is neither explicitly claimed nor described in the specification. 31

32 (3) EU The level of disclosure required to what extent must a patent disclose or claim the active ingredient(s)? Medeva and its Progeny Question referred: What are the criteria for deciding whether the product is protected by a basic patent in force in Article 3(a) of the SPC Regulation? CJEU: In the absence of EU harmonization of patent law, the extent of patent protection can only be determined by the non-european Patent rules Infringement test (Art. 69 EPC) is not sufficient SPC are not available for active ingredients which are not "specified/ identified" in the wording of the claims What are these non-european Patent rules? Medeva and its Progeny (see also CJEU Georgetown (C-422/10), as well as the reasoned orders Yeda (C-518/10), Queensland (C-630/10) and Daiichi (C-6/11)) 32

33 (3) EU The level of disclosure required to what extent must a patent disclose or claim the active ingredient(s)? Chemical Compounds INN, IUPAC Antibodies INN Functional/ generic definition? Functional /generic definition? Markush formula Multiple further referrals to CJEU 1. CJEU C-493/12 Eli Lilly (Functional definition of an antibody) 2. CJEU C-121/17 Gilead (Truvada) (Generic definition of active ingredient) 3. UK Court of Appeal [2017] EWHC 987 (Pat) Searle (Markush-type Formula) 4. German Federal Patent Court 14 W (pat) 12/17 Sitagliptin ( C-650/17) (Functional definition of active ingredient) 33

34 (3) EU The level of disclosure required to what extent must a patent disclose or claim the active ingredient(s)? Facts: CJEU in C-493/12 Eli Lilly of 12 December 2013 Functional definition of an antibody Patent claims very broadly antibodies that bind specifically to Neutrokine alpha. Question referred: What are the criteria for deciding whether the product is protected by a basic patent in force in Art. 3(a) of the Regulation? " in order for an active ingredient to be regarded as 'protected by a basic patent in force', it is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula. Departure from Medeva? Where the active ingredient is covered by a functional formula in the claims, Art. 3(a) does not preclude the grant of an SPC on condition that it is possible to reach the conclusion on the basis of the claims, interpreted inter alia in the light of the description of the invention, as required by Article 69 [EPC] that the claims relate, implicitly but necessarily and specifically, to the active ingredient in question, which is a matter to be determined by the referring court. The Rt Hon. Professor Sir Robin Jacob: This is close to gibberish R. Jacob, IP and Other Things (Hart Publishing, ISBN-10: ). 34

35 (3) EU The level of disclosure required to what extent must a patent disclose or claim the active ingredient(s)? Recap: Gilead Truvada (tenofovir) CJEU in C-121/17 Truvada (Teva v Gilead) of 25 July 2018 Approved Product: Basic Patent (filing date 1997): Tenofovir + Emtricitabine Tenofovir + "compound of claim 1 together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients" Application as filed does not disclose Emtricitabine, which was only approved as an anti-hiv agent in J Arnold: The Court of justice [in Eli Lilly] has once again (sic) failed to give national authorities clear guidance as to the proper interpretation of Art. 3a. What does relate implicitly but necessarily and specifically mean? What are the criteria for deciding whether the product is protected by a basic patent in force? 35

36 (3) EU The level of disclosure required to what extent must a patent disclose or claim the active ingredient(s)? CJEU in C-121/17 Truvada (Teva v Gilead) of 25 July 2018 A product composed of several APIs is protected by a basic patent in force within the meaning of that provision, even if the combination of APIs is not expressly mentioned in the claims, provided that the claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent. the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent. SPC revoked in Germany (4 Ni 12/17 of 15 May 2018) Pending cases in the UK, FR and ES are likely to be rejected 36

37 (3) EU The level of disclosure required to what extent must a patent disclose or claim the active ingredient(s)? Swiss Federal Patent Court in O2017_001 Truvada (Teva v Gilead) of 3 October 2017 Recap: Swiss Patent Court in BGE 124 III 375 Fosinopril of 10 July 1998 Infringement Test Swiss SPC provisions are based on and should mirror EU provisions Strive for harmonization Swiss Federal Patent Court in O2017_001 Truvada (Gilead) of 3 October 2017 The guidance provided by the CJEU [in Medeva and its Progeny] is a terminological mess ; as such harmonization of Swiss case law is premature, as long as the CJEU does not provide clear and implementable guidance. 37

38 (3) EU The level of disclosure required to what extent must a patent disclose or claim the active ingredient(s)? Swiss Federal patent Court (O2017_001) Truvada of 3 October 2017 CJEU Decision Medeva Yeda Actavis v Sanofi Queensland and Daiichi Eli Lilly Actavis v Boehringer Core message which are not specified in the claims is not the subject of any claims relating to that active ingredient core inventive advance that is subject matter of the basic patent which are not identified in the wording of the claims of the basic patent the claims relate, implicitly but necessarily and specifically to the active ingredient in question the subject matter of the invention which constitutes the sole subject matter of the invention 38

39 (3) EU The level of disclosure required to what extent must a patent disclose or claim the active ingredient(s)? Swiss Federal Supreme Court in 4A_576/2017 Truvada ( Teva v Gilead) of 11 June 2018 The need for strive for harmonization implies that the Swiss authorities cannot ignore the case law and practice of the EU Infringement Test no longer applicable Medeva case law applicable also in CH as of June 2018 No retroactive effect 39

40 (4) Best Practices for Pharma Companies in Complying with Patent Term Extension Deadlines Patent Term Extension Countries: (US, EU, Japan, Korea, Canada, Australia, Russia, Eurasian Patent Office, Israel, Chile, Taiwan, Central American countries) Timing of Filing for Patent Term Extension Based on Date of Marketing Approval (assuming that the relevant patent has granted for example, 6 months in Australia, 3 months in Korea, Taiwan; 60 days in the US, Dominican Republic), or Based on Patent Grant Date Communication with the Internal Regulatory Groups Communication with Internal Business Groups in PTE Countries Role of Outside Patent Counsel 40

41 Thanks for your attention!