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Legal Affairs Safe-Harbor Protection In reaching its decision, the Supreme Court recognized the difficulties in develop- ing new drugs in the face of high rates of fail- ure. Most drug research activities, although intended to generate information for submis- sion to the FDA, become fruitless. Denying safe-harbor protection just because the in- formation is ultimately not submitted would stifle innovation as one cannot predict which drug candidate will be successful and lead Continued from page 11 to information that will be submitted to the FDA. Thus, in Merck, the intent and purpose of the activities dominate the interpretation of "reasonably related." Unlike testing-method patents, composi- tions of matter or methods-of-use patents, for which the effect of the exemption is minimal, enjoy their full force and effect by delaying generic entry until expiration of the patent, and thus cannot be exploited by others for commercial gain. In contrast, Momenta's testing patent realizes its value chiefly during the post-approval period. The Federal Cir- cuit's decision has rendered Momenta's patent worthless, contrary to the intent of the legis- lature to limit the impact of the safe-harbor exemption on the patent holder. As if to diminish the impact on other patent owners, and on the pharmaceutical industry, the court wisely distinguished this Isabelle Blundell (iblundell@sunsteinlaw. com) is a member of the Life Sciences Prac- tice Group of Sunstein Kann Murphy & Timbers. Web: www. sunsteinlaw.com. case from its earlier decision in Classen v. Biogen (2011). That case reviewed the leg- islative history in close detail to support the conclusion that the safe-harbor provision, intended to cover only pre-marketing ac- tivities and facilitate the market entry of the generic drug, was not meant to impair the value of patents. Here, revisiting Classen, the court brought a different perspective in extending the safe- harbor exemption to post-marketing activi- ties. In the process, it distinguished two types of activities. In Classen, the post-approval activities were deemed to be routine, unlike Ampha- star's which were required by the FDA to maintain its approval to market its generic version of enoxaparin. Classen's patent was directed to a prophylactic method of treat- ment by following a specific regimen. Specifically, Biogen provided vaccines, advised on immunization schedules, and reported any adverse vaccine effects to the FDA. None of these activities were consid- ered to be directed to producing information for an investigational new drug or a new drug application during a phase of research and thus not worthy of protection under the safe harbor provision. For the sake of safeguarding access to generics, the Momenta decision makes clear that maintaining approval of a generic drug is as important as obtaining approval in the first place and merits safe-harbor protection. Despite the lengthy quotes in Classen from the legislative history about limiting the exemption to pre-approval activities, the court could not ignore the fact that the stat- ute does not explicitly limit such activities to a particular timeframe. Instead, the statute looks to the intent and purpose of the generic drugmaker's activities; so long as they are "reasonably related" to producing information required by federal laws directed to regulating the manufacture, use, or sale of drugs, those activities remain within the safe harbor. CELEBRATING 40 YEARS OF COMFORTABLE PRECISION AND ACCURACY WITH SO MUCH MORE TO COME. Join our celebration at PIPETMAN40.COM 12 | October 1, 2012 | genengnews.com | Genetic Engineering & Biotechnology News Reprints GEN offers reprints of specific articles in an 8.5 x 11 format. Order today! 914-740-2100 reprints@liebertpub.com