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Millennium Pharmaceuticals, Inc. v. Sandoz Inc. (Fed. Cir. 2017)

In multiple ANDA litigations against multiple defendants, Millennium Pharmaceuticals, Inc. had several of its asserted claims held invalid for obviousness at the district court. The Federal Circuit reversed these decisions...more

The Effects of the Actavis Decision on Reverse Payment Settlement Agreements in ANDA cases -- Four Years After

In 2013, the U.S. Supreme Court rendered its decision in FTC v. Actavis, finding that although so-called reverse payment settlement agreements were not per se antitrust violations in cases brought against generic drug makers...more

Board of Trustees of the Leland Stanford Junior University v. Chinese University of Hong Kong (Fed. Cir. 2017)

Detection of paternal cell-free fetal DNA (cffDNA) in maternal blood (the technology at issue in Ariosa v. Sequenom) was in a different incarnation the subject of an interference between professors at two universities; the...more

SCOTUS: Supreme Court Lifts Biosimilars by Allowing Early Commercial Marketing Notice

The Supreme Court handed down its opinion in Sandoz Inc. v. Amgen Inc., marking the first time the Court has interpreted the Biologics Price Competition and Innovation Act (“BPCIA”) for the approval of biosimilar drugs. On...more

Cleveland Clinic Foundation v. True Health Diagnostics LLC (Fed. Cir. 2017)

Most people have had the experience of becoming lost and, having arrived at their destination, realizing that it was only one false turn that caused their confusion. For those with a physics background one can recall the...more

Top 100 Universities Worldwide Granted U.S. Patents in 2016

The National Academy of Inventors and the Intellectual Property Owners Association released a report last week on the top 100 universities worldwide granted patents in 2016. Overall, universities were granted 6,768 patents;...more

Sandoz Inc. v. Amgen Inc. (2017)

On June 12, 2017, the Supreme Court handed down its opinion in Sandoz Inc. v. Amgen Inc., marking the first time the Court has interpreted the Biologics Price Competition and Innovation Act ("BPCIA") for the approval of...more

SCOTUS: Supreme Court Limits Patent Owners’ Post-Sale Power

The Supreme Court handed down its opinion in Impression Products v. Lexmark, reversing the Court of Appeals for the Federal Circuit regarding the scope of the patent exhaustion doctrine. The Court held that patent rights are...more

Impression Products, Inc. v. Lexmark International, Inc. (2017)

The U.S. Supreme Court handed down its decision today in Impression Products, Inc. v. Lexmark International, Inc., unsurprisingly reversing the Federal Circuit regarding the metes and bounds of the patent exhaustion doctrine....more

Mylan Institutional LLC v. Aurobindo Pharma Ltd. (Fed. Cir. 2017)

Last week, the Federal Circuit reviewed the rare event of a preliminary injunction being granted in a lawsuit over a chemical invention, made rarer still by the evidence of likelihood of success on the merits required for the...more

AIPLA Proposes Legislative Changes to 35 U.S.C. § 101

Like the Intellectual Property Owners (see "What to Do about Section 101? IPO Provides Its Answer") and the IP Law Section of the American Bar Association (see "ABA IP Law Section Sends Section 101 Revision Proposal to USPTO...more

Braintree Laboratories, Inc. v. Breckenridge Pharmaceutical, Inc. (Fed. Cir. 2017)

The Federal Circuit's decision on Friday, in Braintree Laboratories, Inc. v. Breckenridge Pharmaceutical, Inc., illustrates the risks a litigant can take when agreeing to stipulation in an effort at least to reduce litigation...more

U.S. Trade Representative Issues 2017 Special 301 Report

On April 28th, Ambassador Robert Lighthizer, U.S. Trade Representative (USTR), issued the 2017 Special 301 Report. According to the USTR website, "[t]he 2017 Special 301 Report underscores the Administration's key trade...more

Duke University v. Biomarin Pharmaceutical Inc. (Fed. Cir. 2017)

Last week, the Federal Circuit completed its review of a series of patents relating to treating Pompe disease and invalidated by inter partes review before the U.S. Patent and Trademark Office's Patent Trial and Appeal Board...more

Sandoz, Amgen, and the Federal Government at the Supreme Court -- Timing of BPCIA 180-Day Notice of Commercial Marketing...

On April 26, 2017, the Supreme Court heard oral arguments in Sandoz Inc. v. Amgen Inc. from Sandoz counsel (Deanne E. Maynard), Amgen counsel (Seth P. Waxman), and presenting the opinion of the United States, an Assistant to...more

Supreme Court Preview -- Sandoz Inc. v. Amgen Inc. -- 180 Day Notice of Commercial Marketing Provisions of BPCIA

On Wednesday, April 26, the Supreme Court will hear oral arguments in Sandoz Inc. v. Amgen Inc, involving interpretation for the first time of the Biologics Price Competition and Innovation Act ("BPCIA"), which was enacted...more

Ali v. Carnegie Institution of Washington (Fed. Cir. 2017)

It has been the experience of more than a few first-year law students taking Civil Procedure I that the only correct answer to a complex procedural problem is that there is no way for a plaintiff to bring suit. The student...more

FDA Relents, Grants Premarket Authorization to 23andMe Genetic Diagnostics Test

On April 6th, the U.S. Food and Drug Administration (FDA) continued to loosen the reins on the genetic diagnostic and DNA analysis company 23andMe with regarding to direct-to-consumer (DTC) genetic testing related to...more

University of California/Berkeley Appeals Adverse CRISPR Decision by PTAB

In February, the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office rendered judgment that there was no interference-in-fact between the claims in interference between the Regents of the University...more

The Medicines Company v. Mylan, Inc. (Fed. Cir. 2017)

The Federal Circuit returned to its consideration of the outcome in the District Court of The Medicines Company's ANDA litigation against Mylan and Bioniche Pharma over a proposed generic version of Medicines' bivalirudin...more

ABA IP Law Section Sends Section 101 Revision Proposal to USPTO Director Lee

The Intellectual Property Law Section of the American Bar Association (ABA-IPL) sent today to continuing U.S. Patent and Trademark Office Director Michelle Lee a letter containing its proposal for revising 35 U.S.C. § 10i in...more

University of Utah v. Max-Planck-Gesellschaft Zur Foerderung der Wissenschatfen E.V. (Fed. Cir. 2017)

Despite the Supreme Court's admonition, in Octane Fitness, LLC v. ICON Health & Fitness, Inc. and Highmark Inc. v. Allcare Health Mgmt. Sys., Inc., that attorney's fees and other measures of enhanced damages be granted, in a...more

SCA Hygiene Products Aktiebolag v. First Quality Baby Products, LLC (2017)

The U.S. Supreme Court overturned another Federal Circuit decision today (this one having been decided en banc by the appellate court), in SCA Hygiene Products Aktiebolag v. First Quality Baby Products, LLC. The outcome was...more

Judge Bryson Rules That Jury Need Not Be Apprised of Presumption of Validity Standard for Granted Claims

This is a time when the eternal verities are routinely called into question, particularly in patent law. For example, Judge Linn can state in a concurrence that, while there is no reason "in policy or statute" why the claims...more

Los Angeles Biomedical Research Institute v. Eli Lilly & Co. (Fed. Cir. 2017); Eli Lilly & Co. v. Los Angeles Biomedical Research...

The Federal Circuit handed down two related opinions last week, Los Angeles Biomedical Research Institute v. Eli Lilly & Co. and Eli Lilly & Co. v. Los Angeles Biomedical Research Institute, one of which raised the question...more

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