For the first time, the U.S. International Trade Commission (“ITC”) has set forth and applied its legal standard for a theft or conversion claim in a Section 337 of the Tariff Act of 1930 investigation. Section 337 gives the ITC broad powers to investigate and address unfair acts in the importation of articles into the … Continue Reading
Every single word matters. Nowhere was this truer than when the Federal Circuit recently held, in an appeal from the Patent Trial and Appeal Board captioned Pacific Biosciences of California, Inc. v. Personal Genomics Taiwan, Inc., that an apparatus for identifying a single biomolecule meant examining one biomolecule alone and not inferring its identity from … Continue Reading
Most drugs are covered by multiple patents, with initial patents directed broadly to the compound and later patents directed to increasingly narrower uses of the compound. This provides opportunities for the compound to be approved as a generic drug before expiration of all of the patents, based on a “skinny” label – i.e., a label … Continue Reading
The UK Parliament and EU Commission have now agreed on a wide-ranging EU-UK Trade and Cooperation Agreement, focused on the supply of goods. Pharmaceuticals are highlighted in a number of areas. For example, Annex TBT-2 of the Agreement provides for recognition of Good Manufacturing Practice (GMP) inspections for medicinal products carried out in the other … Continue Reading
Back in July we wrote about the doctrine of equivalents (DOE) in bio/pharma cases in general, and the on-going saga of DOE in Lilly’s ALIMTA® litigation specifically. Last week, the Federal Circuit penned a new chapter, issuing a non-precedential decision in Eli Lilly and Company v. Apotex, Inc. Didn’t this all end last June? Not … Continue Reading
On August 27, 2020, the Federal Circuit issued a decision in Baxalta Inc. v. Genentech, Inc. overturning the District Court’s ruling that Genentech did not infringe the claims of US Patent No. 7,033,590 and remanded for further proceedings. The Federal Circuit’s decision was based on its finding that the District Court’s claim construction was erroneous … Continue Reading
Back in June, the United States Food and Drug Administration (FDA), “as part of an Agency-wide effort to modernize the Orange Book,” published a request for comments relating to patent listing. Apparently prompting this request was FDA’s recognition that New Drug Application Sponsors have “submitted patents for listing in the Orange Book, including certain types … Continue Reading
In the U.S., patent ownership vests with inventors, and each inventor can exploit their rights without accounting to the other. Neglecting to identify the true inventors of a claimed invention, and obtain assignments of their rights, can create chaos. This is what happened in Dana-Farber Cancer Institute, Inc. v. Ono Pharmaceutical (Fed. Circ., 2020), where … Continue Reading
Our monthly newsletter reports on the patent law developments in biotech, biologics and pharmaceutical cases, legislation and federal agency actions. This month’s issue covers relevant news from February 2020, including:… Continue Reading
Our monthly newsletter reports on the patent law developments in biotech, biologics and pharmaceutical cases, legislation and federal agency actions. This month’s issue covers relevant news from January 2020, including: The Federal Circuit holds that post-priority evidence can be used to show inherency in the obviousness context The Federal Circuit explains that enablement of an allegedly anticipatory … Continue Reading
