The parties (University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier, Junior Party, and The Broad Institute, Massachusetts Institute of Technology, and Harvard University, Senior Party) to the...more
The interplay (or perhaps utilization) of inter partes review (IPR) in ANDA litigation was illustrated by the Federal Circuit in last month's Dr. Falk Pharma GmbH v. Generico, LLC nonprecedential decision....more
There has been much commentary, some of it incendiary, regarding whether the Court of Appeals for the Federal Circuit is fulfilling its responsibilities under its enabling statute or failing to provide the proper pro-patent...more
Last month, the Federal Circuit affirmed decisions from four separate trials in the District of Delaware involving seven different defendants regarding validity and infringement of patents directed to an opioid addiction...more
The Federal Circuit continued its explication of the circumstances wherein an inter partes review petition is time-barred under 35 U.S.C. § 315(b) in Mayne Pharma Int'l v. Merck Sharp & Dohme Corp., decided earlier this...more
On Friday, July 19, 2019, Sigma-Aldrich filed a self-described "extraordinary" petition to the Director of the U.S. Patent and Trademark Office (under 37 C.F.R. §§ 1.181-1.183) and the Chief Judge of the PTAB (under 37 C.F.R....more
Those with moderate memories may recall that there was a spate of qui tam actions several years ago for false marking of patented articles, aimed at manufacturers who had neglected to remove patent marking from their products...more
The doctrine of equivalents, a Supreme Court-created patent doctrine of vintage similar to inequitable conduct, arose in Graver Tank & Mfg. Co. v. Linde Air Products Co., 339 U.S. 605 (1950) (an uncharacteristically...more
On June 24th, the U.S. Patent and Trademark Office declared an interference (No. 106,115) between patents and applications owned by the Regents of the University of California, the University of Vienna, and Emmanuelle...more
On June 24th, the U.S. Patent and Trademark Office declared an interference between patents (and an application) assigned to the Broad Institute (and other institutions) and applications assigned to the University of...more
On Monday, the U.S. Supreme Court issued an opinion in Iancu v. Brunetti, No. 18-302, finding that the Lanham Act prohibition against registration of scandalous or immoral trademarks violates the First Amendment of the U.S....more
6/28/2019
/ Appeals ,
Constitutional Challenges ,
First Amendment ,
Free Speech ,
Iancu v. Brunetti ,
Lanham Act ,
Reaffirmation ,
Reversal ,
Scandalous/Immoral Marks ,
SCOTUS ,
Trademark Registration ,
Trademarks ,
USPTO ,
Viewpoint Discrimination
With great fanfare (and a seeming exercise of appropriate diligence), Senators Thom Tillis (R-NC) and Chris Coons (D-DE), chair and ranking member of the Intellectual Property Subcommittee of the Senate Judiciary committee,...more
The coming of the genomic age has made popular genetic explanations of traits (behavioral as well as structural) in plants, animals, and humans. Because of their importance (economically, historically, and emotionally), dogs...more
On May 9th, Senators John Corbyn (R-TX) and Richard Blumenthal (D-CT), joined by co-sponsors Shelley Moore Capito (R-WV), Patty Murray (D-WA), Rick Scott (R-FL), John Kennedy (R-LA), and Josh Hawley (R-MO), introduced a bill,...more
The Federal Circuit handed down its decision in Regents of the University of Minnesota v. LSI Corp. on Friday, and perhaps not surprisingly (in view of its decision last summer in Saint Regis Mohawk Tribe v. Mylan...more
"Solving" the problem of high prescription drug prices has been on the minds of our representatives in Congress lately, and the desire to "do something" about it has reached the point that just doing something (or being...more
Genetic Engineering News published the results of a study on Monday entitled "Top 50 NIH-Funded Institutions of 2019." The report sets forth the context of these expenditures, with the Trump administration proposing large...more
It is perhaps not surprising that several medical groups, as well as other organizations with little regard for the patent system, and their legal accomplice, the American Civil Liberties Union, would oppose the recent...more
Last week, in Merck Sharp & Dohme Corp. v. Albrecht, the Supreme Court continued its explication of the balance between state law tort liability that can be imposed on drug makers and the extent to which this liability can be...more
5/28/2019
/ Agency Disapproval ,
Clear Evidence Standard ,
Failure To Warn ,
FDA Approval ,
Federal v State Law Application ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Jury Trial ,
Manufacturers ,
Merck Sharp & Dohme Corp. v. Albrecht ,
Preemption ,
Prescription Drugs ,
Question of Fact ,
Question of Law ,
Remand ,
SCOTUS ,
State Law Claims ,
Vacated ,
Warning Labels
The parlous state of patent law as applied to biotechnology (and to a slightly lesser extent, pharmaceuticals) generally over the past several years has been thoroughly explicated, and the recalcitrance engendered by stare...more
There are provisions and interpretations of U.S. patent law that can be in tension depending on the circumstances under which they are argued, whether before an Examiner or during litigation. One of these is the dichotomy...more
The Federal Circuit exhibited the current status of its obviousness jurisprudence in affirming the District Court's determination that the asserted claims of U.S. Patent No. 8,410,131 were obvious in a decision handed down...more
Late last week, the U.S. Food and Drug Administration issued a final version of its "Guidance for Industry," entitled "Considerations in Demonstrating Interchangeability With a Reference Product" regarding the as-yet...more
The latest chapter in the long-running dispute between Amgen and Sandoz over Sandoz's Zarxio® biosimilar to Amgen's Neupogen® biologic drug came to a close last week when the Federal Circuit affirmed grant of summary judgment...more
The International Trade Commission, although having limited jurisdiction, can be a very powerful ally to U.S. industries facing foreign competition. The Commission's power to interdict importation of infringing articles can...more