Posts Tagged: "Drug"

District Court Upholds Orexo Patent for Opioid Dependency Treatment Over Actavis’ Generic

On January 10, the U.S. District of Delaware held that Actavis’ generic version of Orexo’s opioid dependency treatment infringed an Orexo patent. The patent-at-issue in this order was U.S. Patent No. 8940330, titled Abuse-Resistant Pharmaceutical Composition for the Treatment of Opioid Dependence. This non-appealable infringement judgment prevents Actavis from commercializing its generic opioid dependency treatment until Orexo’s patent rights expire in September 2032. The judgment covers all dosage levels of the Actavis generic product.

China extends drug patent exclusivity to 25 years

Among members of the news media, patents have been a popular whipping boy when contemplating why Americans pay higher drug prices relative to the rest of the world. Meanwhile, the Chinese national government extended the period of exclusivity on pharmaceutical patents from 20 years up to 25 years. While China makes moves to embrace further innovation in the pharmaceutical sector by extending exclusivity for drug developers, the United States has evidenced an incredible amount of skepticism regarding the activities of pharmaceutical patent owners trying to protect their property.

Drug Patents and the High Cost of Healthcare: Case of Over-Advocacy for Under-Patentability

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.

Drug-Patent Abuse and the High Cost of Healthcare: Case of the Double-Half Dose-Time Injection

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.

Some Observations on Drug Patents – A Response to Arie Michelsohn

Nothing in my own experience leads me to believe that the PTO applies a lower anticipation or obviousness standard to pharmaceuticals, and I expect this would be news to my colleagues in the industry too. I do, however, often get questions from policymakers, journalists, and others who have been misinformed and led to believe that pharmaceutical companies are re-patenting old drugs to keep prices high, and that our industry is spending “too much” effort on trivial modifications to old medicines rather than creating new ones. Be assured – there is no such thing as “re-patenting,” and our industry is spending plenty on true innovation – but Dr. Michelsohn is certainly raising a fashionable complaint. Public debate by and large seems to have accepted that any given smartphone model is covered by hundreds of patents, but when a complex pharmaceutical product is covered by more than one patent there’s immediate scrutiny and concern.