Arie Michelsohn

The Hatch-Waxman Act and the Biologic Price Competition and Innovation Act are both forged from a noble ideal, grounded in a commitment to a robust and earnest patent system that rewards real innovation… By the power vested in them by specially-reserved patent laws, drug patents are a patent species of their own universe. They can have the economic power of nuclear warheads, in an industry built on an exclusivity model worth hundreds of billions of dollars, per year. We simply cannot afford to fill the silos of those warheads with patent waste that does not innovate or improve upon anything, but which can wreak economic and social havoc, while feeding the general public’s perception that all patents stink.

The price-tag for non-innovative drug patents, such as these second-wave Restasis patents, is substantial. Indeed, one cannot help but question Allergan’s true motivations for attempting to evade PTAB scrutiny of these patents by reliance on Tribal Immunity based on its deal with the St. Regis Mohawk Tribe. The PTAB, unlike the examiner corps, does have the ability to consider rebuttal expert testimony, and is thus not-so handicapped in its capacity to vet drug patents of questionable validity, with aplomb.

AbbVie’s maneuver worked like clockwork to induce regulatory gridlock, which prevented generic competition and kept the company’s profits high at public expense, for years. Fortunately, the FTC would have none of it. The agency filed suit against AbbVie in the Eastern District of Pennsylvania in 2014, accusing the company of illegal monopolization under the antitrust laws. The gravamen of the FTC’s complaint was that AbbVie wrongfully filed objectively-baseless sham litigations, to block generic competition.

Ever since the Supreme Court decided KSR v. Teleflex, it has been appropriate to reject a patent claim because it was obvious to try. If twice the dose intravenously, half as often works, why wouldn’t the highly-educated person of skill in the art – who would hold an M.D. or Ph.D. level education with years of experience – not be tempted to try the same thing subcutaneously? And if they do try it and the results are as expected that should mean, under KSR, that the claimed invention is obvious. Somehow in the pharmaceutical arts KSR does not get applied that way.

If a drug company plants a more than 100-patent thicket to protect market exclusivity, then it had better be able to justify why it should deserve the cumulative protection of patent term. Yes, the patent on the original formulation will fall into the public domain and may be capable of being made by generics long before the last of the patents expire, but often-times those follow on “innovations” are the kind of trivial advances that ordinarily shouldn’t support a fresh patent.