Parikh & Parikh, Aggarwal & Partners

SUI GENERIS PROTECTION FOR PHARMACEUTICALS AND ITS IMPACT ON GENERIC COMPANIES:

INTRODUCTION:

The pharmaceutical industry is composed of two main groups: the research-based pharmaceutical industries (innovators) and the generic industries. The former discovers and develops new medicines while the later replicates, manufactures and distributes the bioequivalent or biosimilar “copies” of the innovative product. 1 These research-based pharma industries, undoubtedly invest billions of dollars and many years of research to finally produce a drug. 2 Moreover, these drugs are further tested through the preclinical and three phases of clinical trials. 3 These trials normally take 10-15 years before the final result is approved by the respective drug regulatory authority. 4 The trials are conducted by the pharma industries after the particular drug has been granted a patent license. Hence, such trials eat up into the 20 years of patent term protection given to the pharmaceuticals. So usually, the pharma industries are left with just 5-10 years of patent protection, and more importantly to cover up the costs and make profits out of it. Such a procedure is unique and applies just too pharmaceutical and other related innovations. 5 Due to the strict and exhaustive procedure, the pharma industries are a granted patent extension and other forms of protection. Data exclusivity is a form of product exclusivity right for medicinal products and a market exclusivity is a related form of additional protection. 6 The rising economic significance of data exclusivity is a combination of three factors:7 (i) The lengthy and costly process of clinical trials; (ii) The ongoing innovative productivity challenges faced by the pharmaceutical industry and (iii) The legal disputes between research-based and generics-based pharmaceutical companies. This essay will deal with the implementation of data and market exclusivity in the European Union and the United States of America and its effect on the generic pharma industries.

DATA AND MARKET EXCLUSIVITY:

“Investments in discovering and developing a single new biologic (including the cost of failures and cost of capital) are now estimated at over a billion dollars with an increasingly focused Food and Drug Administration (FDA) requiring more, not less, investment prior to approval. Given these high upfront costs, data exclusivity is designed to provide a sufficient period of inmarket exclusivity to encourage innovation when patent protection is limited or uncertain in value”8 . The United States and the European Union systems go a step beyond the minimum obligations as set out under the TRIPS. 9 Data Exclusivity is a period of time during which a company cannot cross- refer to the data in support of another marketing authorization. 10 Data exclusivity is designed to preserve innovation, incentives and recognizes the long, costly and risky process necessary for the innovator company to gain regulatory appeal. 11 The protection of this test data is a legally required and economically necessary component of the intellectual property that provide incentives for the development of innovative pharmaceutical products. 12 Further, this data is important for the innovator company so as to get a market authorization from appropriate drug authority. Some experts consider data exclusivity as an independent intellectual property right and not part of patent protection. 13 Hence, data protection is available even if the drug is not protected by a patent. The Trade Related Intellectual Property Rights (TRIPS) agreement also recognises the need to protect such an undisclosed data under Article 39.3. TRIPS Article 39.3 states that “Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use” 14 The phrase “a considerable effort” in the TRIPS article 39.3 (in the case of pharma industries) means the pre-clinical testing and the three phases of the clinical trials, which have to be conducted before the market approval is granted. Article 39(3) essentially imposes three obligations on governments15: 1. To protect data on new chemical entities, the collection of which involved considerable effort, against unfair commercial use. 2. To protect such data against disclosure, except where necessary to protect the public 2. To protect such data against disclosure, except where necessary to protect the public3. To protect such data against disclosure, unless steps are taken to ensure that the data is protected against unfair commercial use.

EUROPE

Data exclusivity was first introduced in the European Union in 1987 with the 87/21/EEC Directive, which amended the 65/65/EEC Directive. 16 In July 2001 the E.U. revised key aspects of the pharmaceutical legislation; data exclusivity being one of the key topics. 17 Subsequently, the changes were brought into the 2004/27/EC Directive that amended the 1987 Directive. 18 It is not retroactive directive; it does not affect exclusivity periods for products for which applications were submitted before the effective date, ie, late 2005. Hence, if an application is made before November 2005, then the data exclusivity will depend on the earlier laws of the member state, where data exclusivity varied from 6 -10 years.19 The EU Pharmaceutical Legislation, Directive 2004/27/EC adopted in 2004 created a harmonised eight year data exclusivity provision with an additional two years market exclusivity provision. 20 This effective ten year market exclusivity can be extended by an additional one year for new therapeutic indications. 21 This is also referred to as the “8+2+1 formula”. This formula applies to all new chemical entities (NCEs) from 1st November 2005 onwards. 22 This formula allows the generic company to file a patent application after the first 8 years of the data exclusivity but would be restrained to market the drug due to the extended market authorization with the innovator company. Therefore, if a generic company wants to apply for a generic product within the stipulated 8 years of the data exclusivity time period, then it will have to perform its own clinical trials and other safety and toxicology work.23 The E.U. data exclusivity does not grant additional periods of protection for subsequent improvements (like the concept of “ever greening” in the U.S.A) brought to a drug, for example new therapeutic indications, dosage forms, doses and dosage schedule.24Any new strengths, pharmaceutical forms, routes of administration, and presentations, as well as any extensions or variations, are to be considered as belonging to the same “global authorization” for purposes of the abridged application rules 25and therefore there is no data protection for these changes. 26

Comprehensive Economic and Trade Agreement between Canada and the European Union (CETA):

Article 10 of the intellectual property chapter in CETA provides protection of undisclosed data in relation to pharmaceutical products.27 Clause 2(b) of the said article states that no person other than the person that submitted the undisclosed information may, without the latter’s permission, rely on such data in support of an application for marketing authorisation during a period of not less than six years from the date on which the Party granted approval to the person that produced the data for approval to market its product, and no Party shall grant to any person who relies on such data during a period of not less than eight years from the date on which the Party granted authorisation to the person that produced the data for authorisation to market its product, unless the person or entity who produced this data provides its permission.28 In CETA, there are two levels of protection, firstly, the data authorization; which is valid for 8 years after it is submitted to the respective drug authority. Secondly, the market authorization; which is valid for 6 years from the date the innovator pharma company was granted the permission to market the drug. EXAMPLE: A pharma company ‘X’ is granted a patent in 2010. After its preclinical and clinical trials, it submits the data in 2020, ie 10 years after the grant of the patent. After the data is submitted, this undisclosed information gets data protection through 8 years of data exclusivity in accordance with the clause (b) of Article 10 in CETA, as mentioned above. Hence, the generic pharma companies cannot rely on the data till 2028. The other incentive provided to the company ‘X’ is the marketing exclusivity for 6 years. If the said company gets authorization to market the drug in the year 2024, it will last till 2030. While reading the above example, it must be kept in mind that the patent term protection will last till 2030 (as the patent term is 20 years). Hence, as the data and market exclusivity are treated separately from patents, such exclusive rights may terminate or exist after the patent term is over, depending on the factual circumstances. In this case, all the protections terminate in 2030.

THE UNITED STATES OF AMERICA:

The United States has a very strong domestic pharmaceutical industry. 29 In the United States, both U.S. Patent Law and U.S. Food and Drug Administration (FDA) law govern the exclusivity rights for new pharmaceutical products.30 In addition, the U.S. Federal Food, Drug and Cosmetic Act (FDCA), provides several exclusivity opportunities, including 1) new chemical entity (NCE) exclusivity; 2) clinical investigation exclusivity; 3) orphan drug exclusivity; and 4) paediatric exclusivity. 31 This essay will specifically deal with the NCE exclusivity Obtaining the U.S. patents is not enough but the drug must be properly listed in the FDA Orange Book for them to have the desired exclusivity effect in delaying the approval of any ANDA for that drug. 32 A pharmaceutical manufacturer can gain NCE Exclusivity in the United States by introducing a drug that contains an “active moiety” that has not been previously approved by FDA in a new drug application (NDA).33 An “active moiety” is defined as the molecule or ion responsible for the drug substance’s physiological or pharmacological action.34 “HATCH-WAXMAN ACT” AMENDMENTS: The Drug Price Competition and Patent Term Restoration Act, 1984 (“Hatch-Waxman” amendments) acts as a compromise between the interest of generic manufacturers obtaining faster entry into the market, and the interest of brand-name pharmaceutical companies in regaining patent term lost during the regulatory process. 35 Mechanism of the Hatch-Waxman Amendments: Before the amendment, a generic drug company could offer competing drug products to consumers after intense FDA scrutiny but they could not manufacture and conduct studies on competing products during the term of the patent without infringing. 36 The United States Drug Price Competition and Patent Term Restoration Act 1984 (“HatchWaxman”) 35 U.S.C. Sec. 271(e) (1) states: “It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention…solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs…”37 Moreover, Section 21 U.S.C. 355(j) (2) (A) (vii) establishes a more streamlined route for the ANDA approval process and hence entry of generics into the market. 38 An ANDA can be filed for a new drug if the applicant can show that the new drug has the same active ingredients, as a previously approved drug requiring only a demonstration of bioequivalence.39 The ANDA is subject to automatic approval within 180 days of submission unless it fails to meet one of the criteria mentioned in the section.40 Anyone filing an ANDA has to make a certification. 41 Paragraph IV42 of the section requires a certification that the original patent is invalid or will not be infringed by the generic drug’s manufacture, use or sale. The paragraph IV certification complicates things. A paragraph IV applicant must give notice to each owner of the patent and each holder of the approved application that an ANDA has been filed. 43The patent holder then has 45 days from receipt of this notice. 44 If an action is not brought, approval will be made effective immediately. However, if an infringement action is brought, approval will be made effective at the end of the thirty-month period beginning with receipt of this notice45 unless, before this period expires, the court finds the patent is invalid or not infringed. But there are certain limitations on how early a brand name drug’s exclusivity can be challenged. “An ANDA, or a NDA for a previously approved drug, cannot be filed within five years of the approval date of the first application for the drug, unless the new drug ANDA or NDA contains a paragraph IV certification, in which case it can be filed within four years of the approval of its predecessor, but if the thirty month suspension of approval is triggered by the initiation of an infringement action in the fourth year, the suspension of approval must be extended (by up to twelve months) such that it terminates seven and a half years after the initial approval”. 46 Protection of Undisclosed test or other data under Trans-Pacific Partnership (TPP): Under TPP Chapter 18, Section C (Article 18.50): Protection of Undisclosed Test or Other Data w.r.t pharmaceuticals says that “A party will not be permit any third person, without a prior consent or authorization of the person that previously submitted such information, to market the same or a similar product on the basis of: (i) that information; or (ii) the marketing approval that has been granted to the person that submitted such information, for at least five years from the date of marketing approval of the new pharmaceutical product in the territory of the Party”. 47

CONCLUSION:

It is clear that national laws and international trade agreements are trying to protect the investment and the interests of the research-based pharma companies, which severely affects the entry of generic medicines into the market. Even though legislative frame works like the Hatch-Waxman Act, try to seek a balance between the research-based and the generic manufacturers, but the former have learned to exploit loopholes in the Act prolonging their monopolies. 48 Such a monopolistic approach results in expensive medicines (especially lifesaving drugs) in the market. This directly influences the consumers who may not be able to buy such high priced drugs and hence, infringe their right to access affordable medicines. In conclusion, there is no obligation in TRIPS to provide the high standards to protect undisclosed information. But as the protection of such information been held necessary in the case of pharmaceuticals by various developed countries, the implementation of these laws should be viewed through the eyes of the consumers as they are the ones who will ultimately be affected.

BIBLIOGRAPHY:

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PUGATCH M, ‘Intellectual Property and Pharmaceutical Data Exclusivity in the Context of Innovation and Market Access’ (http://www.iprsonline.org/, 2014) <http://www.iprsonline.org/unctadictsd/bellagio/docs/Pugatch_Bellagio3.pdf> accessed 2 March 2016. 23. R v MCA (“The RPR Zimovane Case”) (1994) C-94/98 24. Roche Products, Inc. v. Bolar Pharmaceutical Co., 733 F.2d 858 (Fed. Cir. 1984). 25. ‘The Hatch-Waxman Balancing Act'(Dash.harvard.edu) <https://dash.harvard.edu/bitstream/handle/1/10015297/Paper1.html?sequence=2> accessed 11 April 2016. ================================================================================================================ 1 Ravi H. Mistry and Dr. Dilip G. Maheshwari, ‘REGULATORY EXCLUSIVITY STRATEGIES: FURTHER PROTECTION FOR PHARMACEUTICALS IN US, EUROPE AND JAPAN’ (2014) Volume 4, WORLD JOURNAL OF PHARMACY AND PHARMACEUTICAL SCIENCES 2 Dr. Harvey E. Bale, Jr, Encouragement of New Clinical Drug Development: The Role of Data Exclusivity (1st edn, 2000 by IFPMA, International Federation of Pharmaceutical Manufacturers Associations 2016) <http://www.who.int/intellectualproperty/topics/ip/en/DataExclusivity_2000.pdf> accessed 17 January 2016 3 Gargi Chakrabarti, ‘Need Of Data Exclusivity: Impact on Access to Medicines’ (2014) 19 Journal of Intellectual; Property Rights 4 Dr. Harvey E. Bale, Jr, Encouragement of New Clinical Drug Development: The Role of Data Exclusivity (1st edn, 2000 by IFPMA, International Federation of Pharmaceutical Manufacturers Associations 2016) <http://www.who.int/intellectualproperty/topics/ip/en/DataExclusivity_2000.pdf> accessed 17 January 2016. 5 Bruce Lehman, ‘The Pharmaceutical Industry and the Patent System’ (2003) <http://users.wfu.edu/mcfallta/DIR0/pharma_patents.pdf> accessed 9 April 2016. 6 Tamsin Cornwell, ‘Data Exclusivity for Medicinal Products in Europe’ (United-kingdom.taylorwessing.com, 2016) <http://united-kingdom.taylorwessing.com/synapse/regulatory_dataexclusivity.html> accessed 30 March 2016. 7 Meir Perez PUGATCH, ‘Intellectual Property and Pharmaceutical Data Exclusivity in the Context of Innovation and Market Access’ (http://www.iprsonline.org/, 2014) <http://www.iprsonline.org/unctadictsd/bellagio/docs/Pugatch_Bellagio3.pdf> accessed 2 March 2016. 8 Henry Grabowski, ‘Data Exclusivity for Biologics: What Is the Appropriate Period of Protection?’ (AEI, 2009) <http://www.aei.org/publication/data-exclusivity-for-biologics-what-is-the-appropriate-period-of-protection/> accessed 20 March 2016 9 Judit Rius Sanjuan, U.S And E.U Protection Of Pharmaceutical Test Data (2nd edn, Creative Commons, 543 Howard Street, 5th Floor, San Francisco, California, 94105, USA 2016). 10 <http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2013/05/WC500143122.pdf> accessed 30 March 2016. 11 Gargi Chakrabarti, ‘Need Of Data Exclusivity: Impact on Access to Medicines’ (2014) 19 Journal of Intellectual; Property Rights. 12 Dr. Harvey E. Bale, Jr, Encouragement of New Clinical Drug Development: The Role Of Data Exclusivity By (1st edn, 2000 by IFPMA, International Federation of Pharmaceutical Manufacturers Associations 2016) <http://www.who.int/intellectualproperty/topics/ip/en/DataExclusivity_2000.pdf> accessed 17 January 2016. 13 ibid 14 WTO TRIPS Agreement 15 Anatole F Krattiger, Intellectual Property Management In Health And Agricultural Innovation (MIHR 2007).<http://www.iphandbook.org/handbook/authors/A36>http://www.iphandbook.org/handbook/authors/A36 16 Judit Rius Sanjuan, U.S And E.U Protection Of Pharmaceutical Test Data (2nd edn, Creative Commons, 543 Howard Street, 5th Floor, San Francisco, California, 94105, USA 2016). 17 ibid 18 ibid 19 ‘DRUG REGULATORY AFFAIRS INTERNATIONAL’ (DRUG REGULATORY AFFAIRS INTERNATIONAL, 2016) <https://amcrasto.wordpress.com> accessed 30 March 2016. 20 Elias Mossialos, Monique Francine Mrazek and Tom Walley, Regulating Pharmaceuticals In Europe (Open University Press 2004). 21 ibid 22 ‘Business Intelligence Consultancy & Patent Expiries, Spcs, Licences and Authorisation Data for the European Pharmaceutical Industry | MPA Business Services’ (Mpasearch.co.uk, 2016) <http://www.mpasearch.co.uk/> accessed 30 March 2016 23 ‘Anna Mckay’ (Annamckay.com, 2016) <http://www.annamckay.com/article10.html> accessed 28 March 2016. 24 R v MCA (“The RPR Zimovane Case”) (1994) C-94/98 25 Article 6.1 of the Directive 2001/83/EC, as amended 26 Novartis Europharm -v- Commission [2014] CJEU, T-511/14 (CJEU) 27 (2016) <http://trade.ec.europa.eu/doclib/docs/2016/february/tradoc_154329.pdf> accessed 8 April 2016. 28 ibid 29 Mary Atkinson, ‘PATENT PROTECTION FOR PHARMACEUTICALS: A COMPARATIVE STUDY OF THE LAW IN THE UNITED STATES AND CANADA’ (2002) VOL. II PACIFIC RIM LAW & POLICY JOURNAL <https://digital.lib.washington.edu/dspacelaw/bitstream/handle/1773.1/750/11PacRimLPolyJ181.pdf?sequence=1> accessed 10 April 2016. 30 Richard B. Racine, ‘The Interplay between U.S. Pharmaceutical Patents and FDA Law | Articles | Finnegan’ (Finnegan.com, 2010) <http://www.finnegan.com/resources/articles/articlesdetail.aspx?news=ad4b058b-0150- 4ec7-90f4-57e6641272a6> accessed 10 April 2016 31 Carolyne Hathaway, John Manthei and Cassie Scherer, ‘Exclusivity Strategies in the United States and European Union’ [2016] FDLI <https://www.lw.com/upload/pubcontent/_pdf/pub2655_1.pdf> accessed 10 April 2016. 32 Mary Atkinson, ‘PATENT PROTECTION FOR PHARMACEUTICALS: A COMPARATIVE STUDY OF THE LAW IN THE UNITED STATES AND CANADA’ (2002) VOL. I I PACIFIC RIM LAW & POLICY JOURNAL <https://digital.lib.washington.edu/dspacelaw/bitstream/handle/1773.1/750/11PacRimLPolyJ181.pdf?sequence=1> accessed 10 April 2016 33 ‘New Chemical Entity Exclusivity Determinations For Certain Fixed combination Drug Products: Guidance for Industry’ [2014] Centre for Drug Evaluation and Research (CDER) <http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm386685.pdf> accessed 11 April 2016. 34 ibid 35 Mary Atkinson, ‘PATENT PROTECTION FOR PHARMACEUTICALS: A COMPARATIVE STUDY OF THE LAW IN THE UNITED STATES AND CANADA’ (2002) VOL. I I PACIFIC RIM LAW & POLICY JOURNAL <https://digital.lib.washington.edu/dspacelaw/bitstream/handle/1773.1/750/11PacRimLPolyJ181.pdf?sequence=1> accessed 10 April 2016 36 Roche Products, Inc. v. Bolar Pharmaceutical Co., 733 F.2d 858 (Fed. Cir. 1984). 37 See 35 U.S.C Sec 271(e)(1) 38 ‘New Chemical Entity Exclusivity Determinations For Certain Fixed combination Drug Products: Guidance for Industry’ [2014] Centre for Drug Evaluation and Research (CDER) <http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm386685.pdf> accessed 11 April 2016 39 See 21 U.S.C. § 355(j)(1) 40 See 21 U.S.C. § 355(j) (4). 41 See 21 U.S.C. § 355(j)(2)(A)(vii) 42 ibid 43 See 21 U.S.C § 355(j)(5)(B)(iii) 44 ibid 45 See § 355(j)(5)(B)(iii) 46 ‘The Hatch-Waxman (Im) Balancing Act’ (Dash.harvard.edu) <https://dash.harvard.edu/bitstream/handle/1/10015297/Paper1.html?sequence=2> accessed 11 April 2016. 47 (2016) <https://ustr.gov/trade-agreements/free-trade-agreements/trans-pacific-partnership/tpp-full-text> accessed 11 April 2016. 48 ‘The Hatch-Waxman (Im) Balancing Act’ (Dash.harvard.edu) <https://dash.harvard.edu/bitstream/handle/1/10015297/Paper1.html?sequence=2> accessed 11 April 2016