On February 24, the USPTO extended the written comment period for Joint USPTO–FDA Collaboration Initiatives until March 10, 2023. As we previously reported, the USPTO requested public input on areas for USPTO-FDA collaboration and engagement in response to President Biden’s Executive Order to “help ensure that the patent system, while incentivizing…
On January 19, 2023, the FDA Commissioner, Robert M. Califf, delivered remarks at the FDA-USPTO Public Workshop. He noted that, since the issuance of President Biden’s 2021 Executive Order on Promoting Competition, the FDA and USPTO have been working together to leverage their combined expertise to promote competition and access…
As we previously reported, Mylan recently filed three IPR petitions challenging claims of Regeneron patents directed to treating angiogenic eye disorders with aflibercept, the active ingredient in Regeneron’s Eylea product—IPR2022-01225 (challenging U.S. Patent No. 10,130,681), IPR2022-01226 (challenging U.S. Patent No. 10,888,601), and IPR2023-00099 (challenging U.S. Patent No. 10,857,205). This week, the PTAB granted institution on two…
As 2022 comes to a close, we review Big Molecule Watch’s top five biosimilar regulatory developments of the year: USPTO Outlines New Initiatives Regarding Drug Pricing In July, we reported that Katherine Vidal, the Undersecretary of Commerce for Intellectual Property and Director of the USPTO, published a letter summarizing several…
On September 10, 2021, Janet Woodcock, the acting FDA Commissioner of Food and Drugs at the FDA, sent a letter to Andrew Hirshfield, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office (USPTO) “pursuant to Executive Order 14036, and in the hope…
As we previously reported, in October 2018, Pfizer persuaded the Patent Trial and Appeal Board (PTAB) that the claims of Biogen’s U.S. Patent No. 8,821,873, directed to a method of treating lymphoma with anti-CD20 antibodies and covering the cancer therapeutic RITUXAN (rituximab), were unpatentable on obviousness grounds. After appealing to…
On October 2, 2020, the United States Patent and Trademark Office (USPTO) adjusted its patent fees for the first time in almost three years, including an approximately 5% increase to most fees impacted by the rule. For IPRs, the minimum fees increased from $30,500 to $41,500, including the fee for a…
On April 28, 2020, the U.S. Patent and Trademark Office (USPTO) issued a notice to extend certain patent and trademark deadlines to June 1, lengthening extensions that the USPTO had announced on March 31. Pursuant to the Coronavirus Aid, Relief, and Economic Security Act (CARES Act), certain deadlines between March…
Last week, the U.S. Patent and Trademark Office issued a notice pursuant to the Coronavirus Aid, Relief, and Economic Security (CARES) Act. Specifically, “[u]ntil further notice, examiner and examining attorney interviews, Patent Trial and Appeal Board (PTAB) and Trademark Trial and Appeal Board (TTAB) oral hearings, and other similar in-person…
On July 31, the United States Patent and Trademark Office (USPTO) issued a Notice of Proposed Rule Making (NPRM) outlining proposed increases in patent fees in a number of categories. In particular, America Invents Act (AIA) fees are subject to a 26% increase, substantially more than the 5% increase in…