On June 10th, Judge Manish S. Shah, U.S. District Court Judge for the Northern District of Illinois, dismissed (without prejudice) a class action lawsuit against AbbVie and AbbVie Biotechnology Ltd. by consumer groups, drug...more
6/23/2020
/ AbbVie ,
Antitrust Litigation ,
Antitrust Violations ,
Biosimilars ,
Biotechnology ,
Class Action ,
Competition ,
Generic Drugs ,
Patent Applications ,
Patent Dance ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Sherman Act
The written description requirement has had a twenty-five year renaissance, particularly in the chemical and biotechnology arts as a way of restricting claim scope to what an inventor has actually invented (see Regents of the...more
6/22/2020
/ Abbreviated New Drug Application (ANDA) ,
Collateral Estoppel ,
Final Written Decisions ,
Inter Partes Review (IPR) Proceeding ,
Mylan Pharmaceuticals ,
Obviousness ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Written Descriptions
The Federal Circuit during 2019 and 2020 has issued a spate of decisions on the proper application of the Doctrine of Equivalents (see, e.g., UCB, Inc. v. Watson Laboratories Inc. and Galderma Laboratories, L.P. v. Amneal...more
The inherent, ineluctable unpredictability of biology can be the basis for biological patent claims being non-obvious (lacking the requisite "reasonable expectation of success"; see, e.g., OSI Pharmaceuticals v. Apotex) and...more
In the Supreme Court's recent clarifying campaign through the Federal Circuit's U.S. patent law jurisprudence, one section of the statute, 35 U.S.C. §112(a) has been noticeably left unscathed. Indeed, avoidance of this...more
6/1/2020
/ Claim Limitations ,
Denial of Certiorari ,
Expert Testimony ,
Patent Applications ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art ,
SCOTUS ,
Section 112 ,
Statutory Requirements ,
Written Descriptions
Infringement under the doctrine of equivalents (as a basis of a successful cause of action having renewed vigor before the Federal Circuit recently (see, e.g., "Galderma Laboratories, L.P. v. Amneal Pharmaceuticals LLC") is...more
5/13/2020
/ Abbreviated New Drug Application (ANDA) ,
Declaration ,
Dedication-Disclosure Defense ,
Dismissals ,
Doctrine of Equivalents ,
Expert Witness ,
Judgment As A Matter Of Law ,
Judicial Discretion ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Prosecution History Estoppel ,
Reaffirmation
The Federal Circuit continued its explication of the standing issue for unsuccessful petitioners in inter partes review (see "Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp. (Fed. Cir. 2020)") in Pfizer Inc. v....more
5/11/2020
/ Appeals ,
Burden of Proof ,
Dismissals ,
Final Written Decisions ,
Injury-in-Fact ,
Inter Partes Review (IPR) Proceeding ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pfizer ,
Pharmaceutical Patents ,
Standing
Last week, the Federal Circuit had the occasion to address anew the requirements for standing to appeal an adverse decision of the Patent Trial and Appeal Board in an inter partes review proceeding under Article III of the...more
In 1984, Senator Orrin Hatch (R-UT) and Rep. Henry Waxman (D-CA) shepherded a grand legislative compromise through Congress that balanced the rights and solved inefficient regulatory consequences for both branded and generic...more
5/4/2020
/ Abbreviated New Drug Application (ANDA) ,
Appeals ,
Dismissals ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Motion to Dismiss ,
Patent Infringement ,
Patent Litigation ,
Patent Term Extensions ,
Patents ,
Pharmaceutical Patents ,
Reaffirmation
Summary judgment, while clearly advantageous, requires that there be no disputed question of material fact and that the moving party is entitled to judgment as a matter of law. When a district court grants judgment...more
The Federal Circuit continued its recent willingness to affirm findings of infringement under the doctrine of equivalents (see, e.g., "Eli Lilly & Co. v. Hospira, Inc. (Fed. Cir. 2019)"), in Galderma Laboratories, L.P. v....more
Ever since the Supreme Court's decision in Dickinson v. Zurko, patent applicants (and with the advent of inter partes review proceedings before the Patent Trial and Appeal Board, patentees) have found it difficult to overcome...more
3/30/2020
/ Appeals ,
Claim Construction ,
Final Written Decisions ,
Inter Partes Review (IPR) Proceeding ,
Obviousness ,
Patent Invalidity ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Prior Art ,
Remand ,
Treatment Method Patents ,
Vacated
Recently, the Federal Circuit has taken up issues relating to infringement under the doctrine of equivalents (DOE) and a related doctrine, prosecution history estoppel (PHE), that limits the scope of equivalents that can be...more
3/21/2020
/ Appeals ,
Doctrine of Equivalents ,
Eli Lilly ,
Hospira ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Petition for Writ of Certiorari ,
Pharmaceutical Patents ,
Prosecution History Estoppel ,
Tangential Relationship Test
The latest Federal Circuit decision on subject matter eligibility in the life sciences came down (by a divided court) in favor of eligibility, in Illumina, Inc. v. Ariosa Diagnostics, Inc. The claims at issue fell into the...more
3/20/2020
/ Appeals ,
CLS Bank v Alice Corp ,
Life Sciences ,
Mayo v. Prometheus ,
Myriad ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Patents ,
Popular ,
Product of Nature Doctrine ,
Reversal ,
Section 101
On January 9th, Junior Party the University of California, Berkeley; the University of Vienna; and Emmanuelle Charpentier (collectively, "CVC") filed its motion in opposition to Senior Party the Broad Institute (joined by...more
There is a belief in some quarters that the most significant barrier to patent subject matter eligibility reform is an implacable opposition by companies in the high tech sector because those companies are convinced that the...more
2/19/2020
/ Biotechnology ,
CLS Bank v Alice Corp ,
Legislative Agendas ,
Mayo v. Prometheus ,
Myriad ,
Patent Infringement ,
Patent Reform ,
Patent Trolls ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Patents ,
SCOTUS ,
Technology Sector ,
Treatment Method Patents
Ever since the Supreme Court's decision in Mayo Collaborative Services v. Prometheus Laboratories was handed down in 2012, diagnostic method claims have been routinely invalidated by the district courts and those decisions...more
2/13/2020
/ Appeals ,
Diagnostic Method ,
Dissenting Opinions ,
Life Sciences ,
Mayo v. Prometheus ,
Patent Invalidity ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Patents ,
Product of Nature Doctrine ,
Section 101
On January 9th, Junior Party the University of California/Berkeley, the University of Vienna, and Emmanuelle Charpentier (collectively, "CVC") filed a Motion in Opposition to Senior Party The Broad Institute, Harvard...more
2/11/2020
/ CRISPR ,
Evidence ,
Interference Claims ,
Life Sciences ,
Patent Litigation ,
Patent Oppositions ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Prior Art ,
Rebuttable Presumptions ,
Universities
Continuing explication of the motions submitted on January 9th to the U.S. Patent and Trademark Office Patent Trial and Appeal Board in Interference No. 106155 between Senior Party The Broad Institute, Harvard University, and...more
It seems that memes can be as compelling in the law as in social media, and the meme of the moment in patent law is inherency, particularly as applied to obviousness determinations (see, for example, Persion Pharmaceuticals...more
Transitional terms in patent law (conventionally, "comprising," "consisting of," and the more arcane "consisting essentially of") have their own provenance and meaning, denoting limitations that are "open" (comprising) or...more
Last week, the Federal Circuit affirmed a District Court decision (by Circuit Judge Bryson, sitting by designation) in an ANDA litigation, finding obvious claims asserted for treating patients having mild to moderate hepatic...more
The Federal Circuit has grappled with, divisively in some instances, the extent to which the safe harbor provisions of 35 U.S.C. § 271(e)(1) extend to activities not strictly for obtaining regulatory approval, such as...more
Section 112 of the Patent Act as codified, entitled "Specification" in the statute, specifies the amount of disclosure required to support a patent claim (among other requirements). Section 112(a) contains three...more
The Federal Circuit earlier this week affirmed a District Court's decision invalidating almost all of the claims asserted against an ANDA filer, in HZNP Medicines LLC v. Actavis Laboratories UT, Inc. Nevertheless, because a...more