Enforcement of Pharmaceutical Patents in Pakistan - Research Proposal Example

nfоrсеmеnt оf Рhаrmасеutiсаl Раtеnts in Раkistаn Introduction A significant amount of controversy is generated in the developing countries, with respect to patent enforcement, specifically when the patent relates to a life-saving drug. The registration of patents in Pakistan is under the Patents & Designs Act of 1911, whereas trademarks are registered under the 1940 Trademarks Act. Patent protection is limited to processes and the protection ceases after 16 years. Under the Patents & Designs Act, patentees obtain an exclusive right to manufacture, sell and use their inventions across Pakistan and to authorise others to do the same. This Act primarily aims to safeguard new inventions and to promote industrial growth in Pakistan. Upon receiving inadequate remuneration for an invention, its patentee can apply to the Federal Government for a patent extension. However, this has to be done not later than six months prior to the expiry of the patent period.1 Thereafter, the government may refer the issue to the High Court, which could grant a five-year extension. As such, Pakistan does not provide adequate patent protection for pharmaceuticals. Furthermore, there are several other lacunae, including; first, inadequate protection for the right of patentees, resulting in the free manufacture of counterfeit goods by infringers. Second, the workload of the High Courts is extraordinary, and this causes inordinate delay in taking up cases and passing judgment. Hence, the patentee cannot obtain an injunction order against infringers, expeditiously. Third, the right to file suit against infringers is limited to the patent owner. This deprives a licensee of pharmaceutical products from initiating legal proceedings against infringers. Fourth, compulsory licensing can bring about the revocation of a patent, and this danger is always present.2 Thesis Statement Enforcement of Pharmaceutical patents is not effective in Pakistan due to the absence of strict laws and their proper implementation. The following discussion establishes this contention. Aims & Objectives This research work establishes that patent enforcement is ineffective in Pakistan: First, due to lack of stringent pharmaceutical patent laws. Second, the Pakistani government’s negligent attitude, which results in poor implementation of laws. Research Questions Whether the patent laws are sufficiently effective in Pakistan? Whether the government is committed towards, implementing pharmaceutical patent laws? Methodology This research will be conceptual or literature based and will rely upon qualitative research methods. Qualitative research will be the most suitable for examining sociological problems. In this regard, various academic books, authoritative journals and public documents will be consulted. In addition, primary sources such as statutes and relevant case law will be scrutinised. Moreover, secondary sources will provide the latest information on the topic and help the researcher to undertake a meaningful and fruitful exploration of the topic in question. This research intends to establish that pharmaceutical patent enforcement in Pakistan is ineffective due to absence of stringent pharmaceutical patent laws and the lack of commitment on the part of the government, vis-à-vis the implementation of these laws. Literature Review In the year 2000, Pakistan enacted a patent law for protecting product and process patents. This law permitted the patent owner and licensees to file a case against infringers. However, this was emasculated by the Patent Ordinance of 2002, which removed use patents from the ambit of this law, and limited patent filing to single chemical entities, restricting protection for derivatives, and imposing impediments to patenting inventions in biotechnology.3 Moreover, Pakistan does not provide protection against the unfair commercial use of data, thereby violating a crucial requirement of the Trade Related Aspects of Intellectual Property Rights (TRIPS). Furthermore, the Pakistan government authorises the sale of drugs for which another firm possesses an active patent. The Pakistani courts grant injunction orders against firms that sell drugs in violation of patent holder rights.4 . However, these orders are not enforced to any significant extent Furthermore, the Patents & Designs Act oversees process patents registered in Pakistan, and the manufacture of the same item via a different process does not constitute patent infringement. The outcome is the presence of very few patent infringement cases in Pakistan. In addition, the possibility always exists of some individual manufacturing the same product through a marginally different process.5 Such products can be market with the same legality as the initial product. The primary issues in Pakistan, with respect to patents are; first, legal enforcement has to be substantially improved. Second, the patenting of products should be permitted. The extant law is in urgent need of amendment, and several terms have to be clarified with respect to providing unambiguous protection to the genuine and original patent holders. The process patents of these patent holders tend to be infringed by others who adopt a slightly different manufacturing process.6 Advantages of Patents Patents, in general, safeguard new and useful ideas and provide inventors with a temporary shelter from market competition. This shield is conditioned by the exact terms of the patent. However, it is robust and remain inforce for several years. The patent system is based upon the principle that such shelter and the consequent competitive advantage promote invention, as inventors can transform their ingenuity and realise a pecuniary benefit.7 Furthermore, the patent mechanism facilitates business and technological competition, as patent holders have to divulge the details of their discovery in lieu of a specific period, wherein they enjoy absolute rights over the economic use of their invention. This causes inventors and their competitors to strive for the improvement of their inventions and to create new inventions. The necessity for furnishing all the details of a patented invention has a major benefit. This information is stored on patent databases, which in addition to being public are accessible via the Internet.8 Such databases constitute a tremendous repository of technical information, which proves to be of immense benefit for further improvement in products and for new inventions. Disadvantages Some of the drawbacks associated with obtaining a patent are enumerated below. First, technical information regarding the concerned invention has to be made public. At this juncture it has to be realised that quite frequently, concealing the details of an invention could be of significant help in reducing competition. Second, the process of applying and procuring a patent tends to be lengthy and time consuming. In several instances, technology breakthroughs had rendered an invention obsolete by the time the patent had been granted. Third, a substantial amount of money has to be spent while obtaining a patent. Fourth, sizeable annual fees have to be paid regularly, otherwise the patent will lapse. Fifth, the patent owner has to be vigilant and prepared to defend it, and initiating action against infringers proves to be an expensive proposition.9 The following case law reveals the truth that there is inadequate implementation of patent laws in Pakistan. The Karachi High Court granted an interim injunction to Glaxo against Evron in Glaxo Group Limited and others v Evron (Private) Limited and another.10 Evron had been importing the drug Malfax, which contained ranitidine from Canada. During that period, Glaxo’s process patent for preparing ranitidine in Pakistan had been valid. The Court held that an infringement transpired, whenever an individual employed processes that would infringe process in Pakistan, while making a product overseas. Such processes had to be central to the manufacture and that article had to be imported into Pakistan, for the infringement to transpire.11 The import of such products would deprive Pakistani Patentees of the benefit of their invention. Furthermore, in Smith Kline Beecham Corporation and others v Pharma Evo (Pvt) Ltd,12 the Karachi High Court granted an interim injunction to Smith Kline Beecham, whilst prohibiting Pharma Evo from offering for sale, importing, or manufacturing Rosiglitazone. This decision was based upon the fact that Smith Kline Beecham possessed a valid process patent for manufacturing Rosiglitazone.13 Although, Pharma Evo had registered its product with appropriate authority in Pakistan, the Court granted the interim injunction to Smith Kline Beecham. The emergence of several land mark rulings by the courts on safeguarding patents and preventing the sale of generic products, reveals the fact that there is lack of commitment in this regard on the part of the government of Pakistan.14 Moreover, the Pakistani law has been protecting process patents for 16 years, and its government has claimed that it will protect product patents eventually, in order to comply with its World Trade Organisation (WTO) obligations. There have been numerous complaints that patentee’s right is not protected adequately, thereby allowing patent infringers to manufacture illegal products with impunity.15 In addition, the large number of cases and slow judicial procedures have ensured that injunction orders against infringers are not issued expeditiously. Furthermore, the Commercial Law Development Program (CLDP) has been developed by the DOC’s Office of General Counsel. It is seized with providing technical assistance in commercial law to the private sector and government of impermanent and developing nations. Thus, the CLDP Judicial Capacity Building in Intellectual Property Enforcement in Pakistan is a programme that identifies and deals with the absence of actual implementation of intellectual property rights in Pakistan.16 These endeavours have caused the Supreme Court of Pakistan to form a special court for trying intellectual property infringement cases. Conclusion Patents promote overpricing and monopoly; however, they are indispensable as, in their absence, no firm would endeavour to develop new products. Innovation is critically dependent upon patent protection. Consequently, patents are imperfect but effective devices that facilitate the development of novel products. With regard to pharmaceutical patent protection, it is crucial to comprehend that such protection functions efficiently only in the high income nations, wherein the residents can afford the expensive patented drugs. In the developing and least developed nations, patent protection is seriously compromised due to several reasons, such as the requirement of the populace to have affordable access to medicines, corruption of the authorities, political compulsions, ineffective judiciary, and inadequate enforcement of patent laws. Nevertheless, Pakistan adopts a lenient attitude towards patent infringement, and the punishment for this crime should be made much more stringent. In addition, a dedicated government authority has to be constituted to address patent infringements. Moreover, the judges dealing with patent cases should be provided with proper training and exposure to the intricacies involved. According to the above discussion and case law, it can be surmised that pharmaceutical patents cannot be enforced effectively in Pakistan, chiefly due to inadequate laws and the negligent attitude of the government towards their implementation. Bibliography “2006 National Trade Estimate Report on Foreign Trade Barriers — Pakistan.” Executive Office of the President of the United States. https://ustr.gov/archive/assets/Document_Library/Reports_Publications/2006/2006_NTE_Report/asset_upload_file797_9198.pdf (accessed December 31, 2015). Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), April 15, 1994. “Get patent protection for your business.” Ni business info. https://www.nibusinessinfo.co.uk/content/advantages-and-disadvantages-getting-patent (accessed January 1, 2016). Glaxo Group Limited and others v Evron (Private) Limited and another [1992] CLC 2382 (Karachi). “Intellectual Property Enforcement (2010): Annual Report of the U. S. Intellectual Property Enforcement Coordinator.” Executive Office of the President of the United States. https://www.whitehouse.gov/sites/default/files/omb/IPEC/ipec_annual_report_feb2011.pdf (accessed December 31, 2015). “IPR Toolkit – Pakistan Patents” Embassy of the United States Islamabad Pakistan. http://islamabad.usembassy.gov/root/pdfs/ipr_patents.pdf (accessed December 31, 2015). Khan, Hasan Irfan, IP Value 2008 (London, UK: Globe White Page Ltd, 2007). Mansoor, Khawaja, “Intellectual Property Law and Globalisation.” Supreme Court of Pakistan. http://supremecourt.gov.pk/ijc/Articles/19/2.pdf (accessed January 1, 2016) “Pakistan’s Legal Environment.” American University Washington DC. http://www1.american.edu/carmel/as5514a/pakistas_legal_environment.htm (accessed December 31, 2015). Patents & Designs Act, 1911. Patents Ordinance, 2000. Patents (Amendment) Ordinance, 2002. “Priority Watch Country – Pakistan Intellectual Property Protection.” Consumer Project on Technology. http://www.cptech.org/ip/health/phrma/301-99/pakistan.html (accessed December 31, 2015). Smith Kline Beecham Corporation and others v Pharma Evo (Pvt) Ltd [2006] CLD 716 (Karachi). Trade Mark Act, 1940. Read More