Posts Tagged: "drug patents"

FTC’s 100-Patent Orange Book Challenge Creates Uncertainty for Pharma Patent Listings

On October 7, the Federal Trade Commission (FTC) sent letters to 10 pharmaceutical companies notifying them of the agency’s intent to challenge allegedly improper patent listings in the U.S. Food and Drug Administration’s (FDA) Orange Book. While the FTC argues that improperly listed patents can delay consumer access to affordable generics, some have questioned whether the FTC’s regulatory action could slow the development of new treatments, which would in turn delay access to new generics.

The Fraction-of-a-Fraction Problem—Why the Math Doesn’t Support Blaming Drug Patents for the High Cost of U.S. Healthcare

Healthcare costs in the United States continue to rise, placing an ever-increasing burden on patients and government payer programs. Popular discourse blames patented drugs as the culprit for these rising costs. In a move that previously would have been unthinkable, policymakers have even called upon the Department of Health and Human Services to exercise a mechanism known as Bayh-Dole “march-in” rights, to break the patents on drugs that the private sector has spent billions developing, in order to lower their prices. But this fixation on patents as a major driver of America’s medical spend is misplaced.

Bankrupting Big Pharma Isn’t a Solution

Believe it or not, a recent op-ed in the Washington Post written by Robin Feldman took the position that pharmaceutical companies should charge prices for their drugs that would surely guarantee that they go bankrupt. An absurd position even for a law professor who is ideologically predisposed to an irrational hatred of patents, but precisely the position Feldman articulated. How someone as smart as a law professor does not understand basic business reality raises important questions about her intellectual honesty—or at the very least raises questions about whether she is truly an expert on this topic.

China’s NMPA and CNIPA Propose Draft Measures on Patent Linkage for Public Comment: Implications for the Future of Innovative and Generic Drugs

The National Medical Products Administration (NMPA), in conjunction with the China National Intellectual Property Administration (CNIPA), recently solicited public comments on the draft of “Measures For the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial)” (“Draft Measures”). The purpose of the Draft Measures is to establish an early resolution mechanism for drug patent disputes. The deadline for submission of comments is October 25, 2020.

Federal Circuit Reinstates Jury Verdict Finding Claims of Biogen’s MS Drug Were Anticipated

On Monday, the U.S. Court of Appeals for the Federal Circuit issued a precedential decision in Biogen MA, Inc. v. EMD Serono, Inc., reversing the U.S. District Court for the District of New Jersey’s judgment as a matter of law (JMOL) for Biogen. The New Jersey court had found no anticipation of Biogen’s patent claims, overturning a jury’s finding that the claims were anticipated by the prior art. The Federal Circuit’s decision, which turned on the issue of applying a product-by-process novelty analysis to certain nested claim limitations, said that a reasonable jury could find the claims anticipated and remanded with instructions to reinstate the jury verdict.