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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

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

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

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

SCOTUS: Section 271(f)(1) Does not Embrace the Supply of a Single Component

In an opinion by Justice Sotomayor, the Supreme Court today reversed the Federal Circuit's decision in Life Tech. Corp. v. Promega Corp. involving the proper scope of infringement under 35 U.S.C. § 271(f)(1). This provision...more

PTAB Decides CRISPR Interference in Favor of Broad Institute -- Their Reasoning

On February 15, 2017, 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...more

Shire Development LLC v. Watson Pharmaceuticals Inc. (Fed. Cir. 2017)

The Federal Circuit, in its third opinion involving ANDA litigation between these parties over Shire's LIALDA® (mesalamine) product, has apparently brought this case to a close in generic drug maker Watson's favor, in a...more

What to Do about Section 101? IPO Provides Its Answer

In the aftermath of the Supreme Court's decision not to grant certiorari in Sequenom v. Ariosa (and in some quarters, considerably before that), many have voiced the opinion that only Congress can resolve the acknowledged...more

Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC (Fed. Cir. 2017)

The Federal Circuit had the opportunity to provide guidance on a question now in its twilight: what is the standard for determining who is the true inventor under pre-AIA 35 U.S.C. § 102(f), in Cumberland Pharmaceuticals...more

Eli Lilly & Co. v. Teva Parenteral Medicines, Inc. (Fed. Cir. 2017)

From the nadir of the Supreme Court's allegations that the Federal Circuit "fundamentally misunderstood" the law of inducing infringement in Limelight Networks, Inc. v. Akamai Technologies, Inc., the nation's specialized...more

Ex parte Itagaki and Nishihara (PTAB 2016)

A great deal of angst has been generated by the Patent Trial and Appeal Board's decision, in Ex parte Itagaki and Nishihara, regarding the panel's application of Section 101 (sua sponte as a new ground of rejection under 37...more

Addressing Increased Drug Costs -- A Proposal

The New York Times in a recent video (see "'Could You Patent the Sun?'") has returned to its theme against patenting, particularly with regard to patents for life-saving drugs. This time the paper invokes the meme of Jonas...more

Solicitor General Recommends that Supreme Court Grant Certiorari in Sandoz v. Amgen

The Federal Circuit's decision in Amgen v. Sandoz, regarding litigation "under" (or at least based upon) the Biologics Price Control and Innovation Act (BPCIA), interpreted for the first time two provisions of the law. The...more

The Failed Trans-Pacific Partnership: What It Might Have Meant To Biotech and Pharma

The Trans-Pacific Partnership (TPP) was the latest in a series of multination international agreements aimed at reducing trade barriers and promoting global free trade. Most of these agreements are “regional,” like the North...more

In re Nuvasive (Fed. Cir. 2016)

In a precedential decision the Federal Circuit vacated and remanded a Patent Trial and Appeal Board decision invalidating claims from Nuvasive's U.S. Patent No. 8,361,156 in an inter partes review instituted on a petition by...more

Perfect Surgical Techniques, Inc. v. Olympus America, Inc. (Fed. Cir. 2016)

Diligence is a patent concept whose applicability was severely restricted under the changes in U.S. patent law created under the Leahy-Smith America Invents Act. Diligence is important when determining whether an invention...more

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