When a prevailing challenger withdraws from an appeal in post-grant proceedings, the Director can intervene under 35 U.S.C. § 143, which is what happened in an appeal in Sage Products, LLC v. Stewart after Challenger Becton...more
The inter partes review provisions of the Leahy-Smith America Invents Act have been criticized for the propensity of the Patent Trial and Appeal Board (PTAB) to find invalid all or at least some of the challenged claims,...more
Completing a recent jurisprudential "hat trick,"* the Federal Circuit affirmed a District Court grant of a preliminary injunction against a biosimilar applicant for Regeneron's EYLEA biologic drug in Regeneron...more
After creating something of a frisson due to the apprehension that the Federal Circuit might be convinced to re-evaluate whether it was a necessary element for establishing obviousness for the skilled artisan to have had a...more
Note: This post addresses two Federal Circuit decisions issued on January 29, 2025. Both appeals involved Plaintiff-Appellee Regeneron Pharmaceuticals, Inc., with the first appeal involving Defendant-Appellant Formycon AG...more
2/18/2025
/ Biologics ,
BPCIA ,
Multidistrict Litigation ,
Obviousness ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Personal Jurisdiction ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preliminary Injunctions
The U.S. Patent and Trademark Office has a history of attempting to challenge judicial decisions that the Office, usually for its own policy reasons, takes issue with.[1] Recently, the Office decided to challenge the...more
One of the anticipated consequences of the Supreme Court's Loper decision is that it will unleash judges to impose their statutory interpretations of administrative agencies' applications of the law within their areas of...more
A preliminary injunction is one of the most potent weapons in a patent plaintiff's arsenal, being capable of shutting down an accused infringer's continued infringement, prohibiting the infringing product from the stream of...more
Last week the Federal Circuit handed down a pair of non-precedential decisions affirming the Patent Trial and Appeal Board (PTAB) in inter partes review (IPR) proceedings. This post concerns the decision in Medtronic, Inc....more
Although merely exemplifying the burden imposed on an appellant by the Federal Circuit's substantial evidence standard of review over decisions by the U.S. Patent and Trademark Office regarding the facts underlying legal...more
12/8/2023
/ Claim Construction ,
Entitlements ,
Intellectual Property Protection ,
Inter Partes Review (IPR) Proceeding ,
Nonobvious ,
Obviousness ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
PTAB Precedential Opinion Panel (POP) ,
Trademark Litigation ,
Trademarks ,
USPTO
The Federal Circuit decided a question left open during a recent spate of opinions involving the judicially created doctrine of obviousness-type double patenting (ODP): the effect patent term adjustment (PTA) can (or should)...more
The Federal Circuit reviewed the latest decision from the Patent Trial and Appeal Board (PTAB) in an inter partes review that claims 3-6 and 10 of U.S. Patent No. 6,548,019 are obvious, in Rembrandt Diagnostics LP v. Alere,...more
In its recent review of a district court decision the Federal Circuit characterized as "a thorough opinion," the Federal Circuit affirmed invalidation for obviousness of four claims from four different Orange Book-listed...more
An appellant's burden on appeal is never easy but it is particularly difficult when the questions at issue are based on factual evidence. The appellate judiciary is loathe (generally) to second guess a district court judge...more
Minerva and Hologic, competitors selling devices used for ablating uterine endometrial tissue, are notable for their dispute last year that gave the Supreme Court an opportunity to reassess an established patent law doctrine,...more
The Federal Circuit recently affirmed a district court judgment of invalidity for obviousness and for noninfringement for a series of patents challenged in ANDA litigation, in Genentech Inc. v. Sandoz Inc. In doing so, a...more
The Federal Circuit affirmed the Patent Trial and Appeal Board's (PTAB) Final Written Decision (FWD) in an inter partes review (IPR) that Mylan Pharmaceuticals failed to show the claims of U.S. Patent No. 7,326,708 were...more
The Federal Circuit soon will have the opportunity to decide a question left open during a recent spate of opinions involving the judicially created doctrine of obviousness-type double patenting (OTDP): the effect patent...more
Almost four years ago, in a relatively rare occurrence based on there being an insufficient factual record to permit proper appellate review, the Federal Circuit vacated a District Court decision rendering invalid the claims...more
The Federal Circuit recently granted a panel rehearing and vacated a panel decision between these parties decided earlier this year (see Novartis Pharmaceuticals Corp. v. Accord Healthcare), and rendered a decision that...more
Last month in Cornell Research Foundation, Inc. v. Vidal, the Federal Circuit affirmed the Patent Trial and Appeal Board's determinations in six inter partes review proceedings that invalidated the challenged claims for being...more
One of the casualties of the Leahy-Smith America Invents Act in 2012 was 35 U.S.C. § 145, which had provided recourse to U.S. District Courts for U.S. patent applicants disgruntled with a determination of unpatentability...more
In a crowded pharmaceutical art, the deficiencies thereof being so patent that the FDA encouraged industry to address and correct them, concerning a formulation developed to address the opioid crisis raging earlier in this...more
On November 19th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") filed its Substantive Miscellaneous Motion No. 4 in Interference No. 106,132...more
There are some cases where the Federal Circuit makes its decision based on the eternal verities of patent law (insofar as there are any eternal verities in patent law). One such decision arose earlier this month when the...more