The EU initiated a dispute complaint with the World Trade Organization over China’s intellectual property (IP) enforcement allowing Chinese courts to block infringement litigation worldwide. The Feb. 18 complaint, posted by the WTO last week, takes issue with Chinese courts issuing global injunctions barring patent holders from asserting their rights through legal proceedings in other countries until the case is settled in China.
Chinese investment in U.S. companies is dropping, but Chinese biopharma firms are increasingly eyeing licensing deals on early stage inventions patented by U.S. universities, Lin Sun-Hoffman, founding partner at Liu, Chen & Hoffman LLP, said during a Feb. 24 U.S. Patent and Trademark Office webinar on biopharma patents in China.
Over the past few years, China has been quick to make promises to improve its regulatory and patent schemes for biopharmaceuticals and medical devices in keeping with its World Trade Organization (WTO) commitments, but it’s been slow to fulfill those promises – at least in the eyes of the Office of the U.S. Trade Representative (USTR).
U.S. Health and Human Services Secretary Xavier Becerra is getting more pressure to take the unprecedented step of marching in on the patent rights protecting Astellas Pharma Inc.’s prostate cancer drug, Xtandi (enzalutamide), because of its U.S. price. Referencing the provision under the Bayh-Dole Act that allows federal agencies to march in on licensed patents stemming from federally funded research when the products are not available to the public on “reasonable terms,” a dozen Democratic congressional members wrote to Becerra Feb. 8 urging him to move forward on the Xtandi patents.
Gilead Sciences Inc. is making a one-time $1.25 billion payment, with a commitment for a royalty that analysts predict could add as much $1.5 billion more, to Viiv Healthcare Ltd., in a deal designed to resolve all global pending or potential patent infringement claims relating to sales of HIV drug Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide). The initial payment, recorded in the fourth quarter of 2021, put a significant dent in Gilead’s earnings per share but removes the uncertainty of a trial outcome and clears the way for future bictegravir-containing products.
The U.S. Patent and Trademark Office (PTO) has been scrambling to adjust to recent developments in case law for patent subject matter eligibility, and the latest PTO response is a pilot program for new patent applications.
A split decision from the U.S. Court of Appeals for the Federal Circuit could give Novartis AG’s blockbuster multiple sclerosis drug, Gilenya (fingolimod), a little more breathing room from unlicensed generics.
PERTH, Australia – Australia attracted international attention in July when a Federal Court ruled that artificial intelligence can be named as the inventor of a patent. In Thaler v. Commissioner of Patents, Federal Court Justice Jonathan Beach ruled that under Australian patent law, inventors don’t necessarily have to be human. The decision challenges the assumption that only human beings can be inventors. Beach did rule, however, that an AI system cannot apply for a patent or receive a patent.
Although Pfizer Inc.’s COVID-19 oral antiviral candidate, Paxlovid (PF-07321332; ritonavir), has yet to be authorized anywhere, the push for compulsory licensing of the drug has begun.
A Chinese patent covering methods and compositions for the use of CRISPR-Cas9 in eukaryotes has been granted to Dublin-based Ers Genomics Ltd., making what Michael Arciero, vice president of intellectual property and commercial development at the company, called “a strong but not surprising statement by China,” which has made the biotechnology industry one of its top national priorities.