Ever since the Supreme Court handed down its decisions in Octane Fitness, LLC v. ICON Health & Fitness, Inc. and Highmark Inc. v. Allcare Health Mgmt. Sys., Inc. about five years ago, liberalizing (or at least simplifying)...more
Last Friday, May 3, 2019, the Federal Circuit affirmed a decision by the District Court that Defendants Actavis LLC and Teva Pharmaceuticals did not show by clear and convincing evidence that the claims asserted by Endo...more
On April 25th, Ambassador Robert Lighthizer, U.S. Trade Representative (USTR), issued the 2019 Special 301 Report. In a press release, the USTR stated that "over the coming weeks, USTR will review the developments against...more
Last Tuesday, April 23, 2019, the U.S. Patent and Trademark Office granted (at long last) to the University of California/Berkeley, the University of Vienna, and inventor Emmanuelle Charpentier a patent corresponding to the...more
Rising drug prices is an issue that everyone from the President to both Houses of Congress (Democrats and Republicans), Wall Street, and Main Street can agree must be alleviated, and perhaps the most expensive drugs are those...more
A great deal of faith has recently been given to Congress by the patent community, spurred by efforts to solve the conundrums in patent law created by several recent Supreme Court decisions (and aided and abetted by the U.S....more
Over the past six years, since the Supreme Court handed down its decision in Mayo Collaborative Services, Inc. v. Prometheus Laboratories, it has become more and more evident that correction of the path embarked upon by the...more
On April 15, 2019, the U.S. Supreme Court denied a petition for writ of certiorari by the St. Regis Mohawk Indian Tribe on the question (answered in the negative by the Patent Trial and Appeal Board and the Federal Circuit)...more
Durum wheat, Triticum turgidum L. ssp. durum (Desf.) Husn., used principally for pasta production, was derived from wild emmer wheat, T. turgidum ssp. dicoccoides (Körn. ex Asch. & Graebn.) Thell. from domesticated emmer...more
FiercePharma reported sales rankings for the top 15 pharmaceutical companies in 2018, in comparison to 2017 sales. As reported today, "the top 15 names are the same against prior year rankings, but the order has shifted." ...more
Having been instructed once again by the Supreme Court that the Federal Circuit is not special when it comes to review of district court decisions (see, e.g., Teva Pharm. USA, Inc. v. Sandoz, Inc.), the Federal Circuit has...more
On March 8th, a canonical "bipartisan of Senators" (a phrase used to signal bills that must be in the public interest because these Senators put aside business as usual to reach across the aisle) introduced S.659, entitled...more
More than two years ago, on January 17, 2017, the U.S. Food and Drug Administration released its Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation...more
The portion of the eukaryotic world inhabited by plants exhibits a genetic complexity not shared by members of the animal world (see, for example, "Rose Genome Reveals Its Exquisite Complexities"). The strawberry...more
On March 14, 2019, The U.S. Patent and Trademark Office announced a new pilot program relating to motions to amend in post-grant review proceedings (post-grant review, inter partes review, and covered business methods...more
On March 13, 2019, the U.S. Patent and Trademark Office's Patent Trial and Appeal Board announced that it had updated its Motion to Amend Study to include all trials under the post-grant review proceedings enacted in the...more
The U.S. Patent and Trademark Office today granted U.S. Patent 10,227,611 to Jennifer Doudna, Martin Jinek, Krzysztof Chylinski, and Emmanuelle Charpentier, the patent entitled "Methods and compositions for RNA-directed...more
Patent law is known for its several challenges in sufficiently capturing an invention, tangible in form and substance, in words with all their limitations. Patent law is known for being littered with traps for the unworthy. ...more
A rose may be a rose may be a rose (to paraphrase Gertrude Stein) but genetically roses (like many plant species) are wickedly complex. The genus Rosa comprises about 200 species, although only 8-20 species are thought to...more
One of the criticisms of the post-grant review proceedings instituted under the Leahy-Smith America Invents Act (post-grant review, inter partes review, and covered business method review) was the (relative) unavailability of...more
Legal creativity in argument is the lifeblood of the litigator's craft, and nowhere more than in patent litigation in view of the complexities of the law applied to technological fact. But occasionally creative arguments can...more
Inventorship, particularly assertion of proper inventorship, has a unique place in U.S. patent law. This is based in large part on the language of Article I, Section 8, Clause 8 of the U.S. Constitution, which gives Congress...more
This decision of the Federal Circuit in Dr. Falk Pharma GmbH v. GeneriCo, LLC involves disqualification due to conflict of interest of counsel representing Mylan Pharmaceuticals in three separate appeals. As set forth in the...more
Sherry Knowles, former chief patent counsel of GlaxoSmithKline, and Dr. Anthony Prosser, a member of her team at Knowles Intellectual Strategies LLC, have written an article recently published in The John Marshall Review of...more
Earlier this month, the Federal Circuit affirmed a decision by the Patent Trial and Appeal Board (PTAB) that the claims of U.S. Reissue Patent No. RE38,551 challenged in inter partes review were not unpatentable for...more