A Misguided Op-Ed, a Key Report, and Why Holding the US Lead in the Life Sciences is More Important Than Ever

“As those involved in these efforts at the National Institutes of Health will readily attest, companies working with them to develop critically needed drugs and vaccines to combat COVID-19 are hardly getting a free ride. They are assuming the majority of the costs and all the risks.” Ulysses and the Sirens by JW Waterhouse: https://www.ngv.vic.gov.au/explore/collection/work/4457/ … Read more

Calls for WTO to Suspend IP Rights for Vaccine Innovation Would Jeopardize Incredible Progress

“Weaking intellectual property protections, as the WTO wavever proposal would do, will not increase access to the tools we need to fight COVID-19; In fact, they would hinder access to the COVID-19 tools we’ve already discovered.” The biggest vaccination effort in the history of medicine is underway to eradicate the global pandemic, with several strong … Read more

Should the Biden Administration Look to Pharma for New USPTO Director?

“Strong patent rights that are enforceable against infringers are crucial for firms that engage heavily in research and development activities, and now is a perfect time for the pharmaceutical sector to inform the public debate on how enforceable patent rights encourage a strong innovation economy.” The United States is not even two weeks into the … Read more

Pfizer Rejects Accusations it Infringed COVID-19 Vaccine Assay Technology

“’The alleged patent infringement—asserted uses by Pfizer and BioNTech of the patented invention to generate data from clinical trials in support of seeking FDA approval—are precisely the type of activity that is protected by the ‘safe harbor’ from patent infringement claims under 35 USC § 271(e)(1).”’ – Pfizer Memorandum on Motion to Dismiss Pfizer and … Read more

Industry Comments on Proposed Changes to Bayh-Dole Regulations Zero in on March-In Language

“Skeptics mistakenly believe – on purpose – that Bayh-Dole should be used as part of a price control regime to lower drug prices…. No one likes to pay high prices, of course. So, why not just have the federal government mandate price controls? They seem to think innovation will continue to happen even though profit … Read more

House Committee Targets AbbVie Patent Practices, Urges FTC to Investigate

“It took 155 years for the USPTO to issue its first 5 million patents in 1991; it has taken less than 1/5 of that time to issue the next 6 million. Have we really become more inventive in the last 30 years or have we just got better at inventing patents?” Tamir Amin, Initiative for … Read more

Federal Trade Commission Urges SCOTUS to Deny AbbVie Petition

“Although there was no direct evidence of AbbVie’s subjective intent, the district court inferred subjective intent from the fact that AbbVie’s lawyers were very experienced with patent matters and would know that litigation would delay generic competition.” On Wednesday, May 19, the response brief of the Federal Trade Commission (FTC) was filed with the US … Read more

A Guide for Foreign Chinese Patent Holders

“Speed ​​will be of the essence if China’s patent linkage system is to be useful to US patent holders.” In compliance with the Phase One Trade Agreement, China has implemented a patent linkage system in their amended patent law, which became effective June 1, 2021 (Article 76 of the Patent Law of the People’s Republic … Read more

Federal Circuit Affirms Dismissal of Celgene’s Hatch-Waxman Suit Against Mylan

“[T]he Federal Circuit noted that venue in Hatch-Waxman cases is predicated on past acts of infringement instead of planned future conduct, and that such past acts can only happen in districts related to the submission of the ANDA filing.” On November 5, the US Court of Appeals for the Federal Circuit (CAFC) issued a precedential … Read more

Two Pharma and Biotech Cases to Watch in 2022

“Based on the similarity of the questions presented to those that the Supreme Court declined to answer in Idenix v. Gilead, Amgen’s petition has a slim chance of success. Regardless, patent owners should be wary of asserting claims that characterize a monoclonal antibody purely on its function.” Monty Python and the Holy Grail: “I’m Not … Read more