Journal of Intellectual Property Rights Vol 14, July 2009, pp 299-306 Evergreening – A Controversial Issue in Pharma Milieu* Inderjit Singh Bansal, Deeptymaya Sahu, Gautam Bakshi and Sukhjeet Singh† Panacea Biotec Ltd, Formulation & Research Facility, Sampann R&D, Ambala - Chandigarh Highway, Lalru, Punjab 140 501 Received 18 March 2009, revised 22 June 2009 A patent is an exclusive right awarded by the intellectual property (IP) authority of a state to an inventor or his assignee for a limited period of time in lieu of disclosure of an invention for the benefit of mankind. In recent times, it has become a practice by a number of innovator companies to extend the patent term of their innovative molecules to maintain market dominance. The extension of monopoly term ‘Evergreening’ is a predominant aspect of pharmaceutical patenting. ‘Evergreening’ refers to different ways wherein patent owners take undue advantage of the law and associated regulatory processes to extend their IP monopoly particularly over highly lucrative ‘blockbuster’ drugs by filing disguised/artful patents on an already patent-protected invention shortly before expiry of the ‘parent’ patent. These artful patents tend to protect delivery profiles, packaging, derivatives, and isomeric forms, mechanism of action, dosing regimen, and dosing range, and dosing route, different methods of treatment, combinations, screening methods, biological targets and field of use for the same old molecule. This provides the innovator companies sufficient time to recoup their controversially estimated R&D costs. Patent monopolies thus should be designed to function at an optimum level wherein maximum incentive is accorded to investment in research followed by simultaneous accessibility of the protected inventions to the public. The TRIPS compliance has compelled pharma industries of the developing countries to innovate in order to cater to the requirement of current and future drugs. This paper covers different aspects of ‘evergreening’, its impact in the pharma IP domain and identifies means adopted for limiting evergreening. Keywords: Evergreening, TRIPS Agreement, Hatch-Waxman Act, market exclusivity, patent strategy, generics, paroxetine ‘Evergreening’ is an aspect of patenting that leads to continuation patent application, divisional patent ‘patent life cycle enhancement technique’ largely application, continuation-in-part patent application, employed by the pharmaceutical organizations to and application for patent of addition. ‘Evergreening’ develop ‘bullet proof’ patent portfolios around is a clever way of inducing extortion/threats to lucrative drug molecules .This is done in an artful competitors in the market about an innovator’s manner by protecting a large number of inventive tactical use of patents which results in potential loss to aspects over the basic invention (viz. NCE, NME, the competitors.2 Innovators thus erect ‘picket fences’ formulations etc.) by avoiding any imminent double or families of dozens of patents around a single drug patent rejection and eventually leading to extension of product and block a possible entry into the domain of patent terms to a further 20 year term for a single drug the innovator. product. Protection on such family of so called The controversial ‘Evergreening’ raises a number ‘lucrative molecules’ can at times act as a jackpot to of fundamental issues. Unless the later applications the multinational pharmaceutical organizations and disclose independent inventions, though linked to the continue to retain market monopoly. However, invention disclosed in the basic application, the ‘Evergreening’ perspective leads to the extension of allowance of the later application(s) can lead to patent terms provided the national patent law allows double patenting. Further, inclusion of multiple such flexibilities.1 inventions (consequently multiple independent The different methods to cover adjunct possibilities claims) in a single application can lead to objection on not disclosed in the basic patent are done by filing of the grounds of ‘unity of invention’. ________________ *The views expressed in this paper are those TRIPS Perspective of the authors alone and do not represent the views The TRIPS Agreement awards a negative or opinions of their employer organization (Panacea Biotec monopoly over rivals from using patented invention Limited) or its staff. The authors assume no legal responsibility for the views/information expressed in this paper. without consent of the patent holder for a term of †Email:Corresponding author: [email protected] 20 years irrespective of the field of technology. 300 J INTELLEC PROP RIGHTS, JULY 2009 Article 27.1 of TRIPS stipulates that ‘patents shall be the poor even further out of reach ‘OR’ to give priority available for any inventions, whether products or to public health protections available within the TRIPS processes, in all fields of technology without Agreement. Debate is still going on and the Doha rounds discrimination, subject to the normal tests of novelty, have still not been able to deal with this aspect in the inventiveness and industrial applicability. It is also international perspective particularly with respect to the required that patents be available and patent rights developing and the least developed nations. enjoyable without discrimination as to the place of invention and whether products are imported or locally Evergreening Strategies in Pharma produced’. Its features involve maintaining standards, A number of strategies have been followed by the causing enforcement and dispute settlement in varied innovator companies to extend the term of patent, viz. areas of IP. It has ensured protection of IP of methods of treatment, mechanism of action, packaging, pharmaceutical companies’ thus indirectly enhancing derivatives, isomeric forms, delivery profiles, dosing patient compliance by providing access to essential regimen, dosing range, dosing route, combinations, medicines at cost effective price.3 The signatories to the screening methods, biological targets and field of use. TRIPS adhere to strict regulations wherein minimum These strategies involve skilled addition of patents to the standards are maintained in order to provide product product by the innovator companies that force the patents for pharmaceuticals and chemicals. This further generic manufacturer to maintain forbearance for all the increases growth of pharmaceutical industries, thus patents to expire and applying for marketing facilitating the birth of a wider range of inventions and authorization (as and when applicable), bearing the risks subsequently aid in providing affordable medicines for of litigation and associated penalties and delays.4 The different diseases and disorders. innovator companies in the name of ‘life-cycle Although TRIPS has provided stricter standards to management’ maximize revenues from their so called provide patents for pharmaceuticals and chemicals ‘evergreen’ products and choke generic competition at and facilitate growth of wider range of inventions, the outset of product life-cycles. Although the strategies there is still a dilemma which is faced by a number of followed by the innovator companies foray through pharmaceutical companies working in HIV/AIDS strictest legal framework, the irony is that still most of programmes in majority of developing and developed these companies represent misuse of pharmaceutical countries as they do not have adequate manufacturing patents and regulations governing authorization. capacity which results in compromised access to Evergreening strategies that have been usually medicines for treatment of HIV/AIDS. This lead to an followed by the pharmaceutical industries involve: uproar in the public which forced WTO member (a) redundant extensions and creation of ‘next generation countries to adopt a declaration in the Doha drugs’ which result in superfluous variation to a product ministerial meeting, ‘The World Trade Organization’s and then patenting it as a new application, Declaration on the TRIPS Agreement and Public (b) prescription to OTC switch, (c) exclusive Health of 2001’ that affirmed the flexibilities partnerships with cream of generic players in the market available under the TRIPS Agreement to member prior to patent expiry thus significantly enhancing the states seeking to protect public health. brand value and interim earning royalties on the product, Although the Doha Declaration supports important (d) defensive pricing strategies practice wherein the principles under the TRIPS Agreement still challenges innovator companies decrease the price of the product in are being faced with respect to the international trade line with the generic players for healthy competition and law regarding protection of public health. Developing (e) establishment of subsidiary units by respective and under-developed countries are facing acute pressure innovator companies in generic domain before the on access to export markets in well established advent of rival generic players.5 Strategies employed industries in developed countries and have to prioritize find a basis in a classic example on a patent obtained on trade over public health protections. This is loratadine (Claritin) by an innovator company, Schering. disadvantageous to the said developing and under- Schering applied for and obtained 46 months of patent developed nations which have to compromise public extension owing to regulatory review time and changes health over trade. Thus, one choice