Don't Blame Patents For High Drug Prices

Before his recent arrest, Martin Shkreli, the former CEO of Turing Pharmaceuticals, gained notoriety for increasing the price of the AIDS drug Daraprim® (pyrimethamine) from about $13.50 to about $750 per pill. He also was reported to be considering a similar price hike for benznidazole, for which his new company, KaloBios Pharmaceuticals, was going to seek FDA approval for treating Chagas disease. Complaints about Shkreli’s drug price hikes often turn into complaints about the supposed pernicious effects of pharmaceutical patents, but you can’t blame patents for Shkreli’s conduct because the patents on pyrimethamine and benznidazole expired long ago. Rather, the recent developments surrounding these drugs illustrate how the market functions without patents.   Continue reading this entry

A Delicious Look At A Cookie Press Patent

I like to bake cookies, and this time of year gives me the perfect excuse to bake a lot of cookies. One of my favorite recipes uses a cookie press, which made me curious about cookie press patents. There are only a few granted U.S. patents with “Cookie Press” in the title, but U.S. Patent 6,708,853 seems to claim technology that I put to good use every December.  Continue reading this entry

Australian Patent Office Provides Patent Eligibility Guidance

The Australian Patent Office (IP Australia) has issued final patent eligibility guidance under the Australian High Court’s decision in D’Arcy v. Myriad Genetics, Inc. Where the USPTO extrapolated from the U.S. Supreme Court decision when it promulgated its patent eligibility guidance, IP Australia seems to have taken a more conservative approach. This means that despite similar rulings against the patent eligibility of Myriad’s BRCA DNA claims, it may be possible to patent subject matter in Australia that no longer can be patented in the U.S.   Continue reading this entry

Biosimilar Pre-Marketing Notice Always Required

Judge Cohn of the U.S. District Court for the Southern District of Florida has issued another decision interpreting the complicated provisions of the Biologics Price Competition and Innovation Action (BPCIA), ruling that the statute requires a biosimilar applicant to give 180 days’ pre-marketing notice after FDA approval even if it has engaged in the BPCIA’s patent dance. The decision came in an order granting Amgen’s motion for a preliminary injunction in Amgen, Inc. v. Apotex Inc. where the biosimilar at issue relates to Amgen’s Neulasta® (pegfilgrastim) product.  Continue reading this entry

Interference Statute Does Not Require Diligence For Re-Presenting Claims

In In re: Commonwealth Scientific & Industrial Research Organisation, the Federal Circuit held that pre-AIA 35 USC §135(b)(1) does not embody a diligence requirement, such that interfering claims presented more than 5 years after originally presented claims were abandoned were not time-barred by the statute. Although the decision was non-precedential, because it reversed a decision of the Patent Trial and Appeal Board on an important issue in interference proceedings, it seems worth noting. Continue reading this entry