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IP Views The Clever Art of Evergreening Within the lifespan of a patent, there is enormous leeway on the part of the inventor, or anyone deriving right from him, to exclusively exploit the commercial value of the invention. This much is true with respect to patents pertaining to pharmaceutical or therapeutic products ("pharma patents"). Pharmaceutical companies pour resources into research and development ("R&D") of medical solutions or compounds. Pharmaceutical companies eventually secure patents for every product they develop. Grant of monopoly over inventions is recognition of an inventor's ingenuity and a means to encourage inventiveness. In the case of pharmaceutical companies, monopolies over the fruits of their R&D efforts are but reasonable vehicles through which they could recoup huge investments. If only to sustain the profitability of patented pharmaceutical products under their respective turfs, pharmaceutical companies invest on what is known as "evergreening", a term which describes an overt effort to perpetuate a patent's term (before its expiration) by seeking separate patent protection for a patented product's "multiple attributes" or on "updates" to the patent. The strategy is coursed through the effective use of permissible patent prosecution routes. Patent perpetuation or "evergreening" is effected in various forms. A common form of "evergreening" occurs when "the originator manufacturer stockpiles patent protection by obtaining separate 20-year patents on multiple attributes of a single product."3 Nonetheless, a whole lot of ingenuity is required before one could successfully prosecute "evergreening" patents. The bottom-line insofar as "evergreening" is concerned, however, is that the new or later applications earmarked to perpetuate basic patents should disclose independent inventions or inventive aspects. Otherwise, allowance of patent applications could be rendered futile if challenged on the ground of double patenting. This was the fate suffered by pharma giant Glaxo SmithKline ("GSK"). Seven GSK patents on antibiotic clavulanate were invalidated by the US Court of Appeals for the Federal Circuit on the ground of double-patenting.4 The invalidation of GSK's seven patents on antibiotic clavulanate had cleared all legal obstacles against the introduction and marketing of generic versions of "Augmentin", which is GSK's well-known antibiotic formulation. Obviously, there is now wider latitude for other pharmaceutical companies to introduce generic versions of "Augmentin" considering the absence of any valid or effective patent on antibiotic clavulanate. "Evergreening" is becoming a serious concern in a number of jurisdictions such as the US, Europe, Canada, Australia and India, among others. There is actually heightened debate on how "evergreening" deprives the public of affordable and convenient access to pharmaceuticals products. This situation is further fueled by the aggressive stance taken by generic drugs manufacturer in their efforts to capitalize from expiring patented pharmaceutical products. With the increasing vigilance against "evergreening" in certain jurisdictions such as the US and Europe, there is a possibility that pharmaceutical companies based in these countries would revert their "evergreening" campaign towards so-called "unchartered" forefronts where they could have comfortable leeway in prosecuting patents. GSK, for instance, could file numerous patent applications for its antibiotic clavulanate compound in the Philippines and conveniently avoid double patenting because the basic patent on such particular formulation was not obtained in the Philippines. Evading prior art limitations is an entirely different matter. For sure, "evergreening" advocates are much aware of the imperative that patent applications and claims should be cleverly drafted to avoid such limitations. Nonetheless, developing countries like the Philippines could possibly be future battlegrounds between pharmaceutical companies dealing with branded medicines and those manufacturing generic drugs. Pharmaceutical companies (with R&D resources) can always test the waters in the Philippines insofar as the prospects for "evergreening" are concerned; as a consequence, generic drug manufacturers will continue to penetrate this lucrative industry. All told, the expected proliferation of "evergreening" patent applications in Philippine jurisdiction will definitely pose enormous challenge upon the Intellectual Property Office. Patent applications relating to pharmaceutical products should be given a second look with respect to prior art restrictions and the strict requirements of the law on "unity of invention."5 Under Philippine patent law, "evergreening" patent applications, as any other patent application, will have to surpass the three-fold test of patentability, that is novelty, inventiveness and industrial applicability.6 Insofar as "evergreening" patent applications are premised on some basic patents, it is in the aspect of novelty where patent prosecution could encounter rough sailing. The basic patents could be appreciated as prior art references. Double-patenting as a ground for rejecting patent applications and for invalidating patents, on the other hand, has yet to find statutory basis or gather recognition from Philippine jurisprudence. "Evergreening" should be a potential policy issue insofar as the Philippine government is concerned. For one, it poses serious threats against the government's drive to make pharmaceutical and therapeutic products conveniently available to the public at minimum cost. Second, it would stifle competition in the pharmaceutical industry. Lastly, it could be seen as an abuse or misuse of the Philippine patent system. While fundamentals of Philippine patent law can deal with sinister attempts to evergreen, serious efforts from both the executive and legislative fronts at reviewing and fine-tuning the applicable law and rules to curb patent perpetuation are still needed. The government should strike a reasonable balance between legitimate intellectual property rights and the public need to be assured of a continuous supply of affordable medicines. 1Paulik v. Rizkalla, 760 F.2d 1270, 226 USPQ2d 224 (Fed. Cir. 1985) 2Harmon, Patents and the Federal Circuit(3rd Ed.), p. 11. 3 http://www.egagenerics.com/gen-evergrn.htm 4Geneva Pharmaceuticals, Inc., et al. v. GlaxoSmithKline PLC, et al, US Court of Appeals for the Federal Circuit, November 21, 2003. 5Section 38, R.A. No. 8293 6Sections 21 to 27, R.A. No. 8293. |
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