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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

Icon Health & Fitness, Inc. v. Strava, Inc. (Fed. Cir. 2017)

In an otherwise unremarkable albeit precedential decision, the Federal Circuit set forth an explication of when the Patent Trial and Appeal Board has, and has not, given the court enough information to determine whether its...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

Why President Trump Is Wrong about Trans-Pacific Partnership Agreement

On Monday, President Trump made good on one of his signature campaign promises and notified the other twelve countries (Australia, Brunei, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore, and Vietnam)...more

Evidence of Geographic Change in Central America from Genome Studies of Eciton Ant Species

"It was a sight no one could ever forget. Over the range of hills, as far as eye could see, crept a darkening hem, ever longer and broader, until the shadow spread across the slope from east to west, then downwards,...more

1/24/2017  /  Life Sciences

FDA Issues Guidance Regarding Interchangeability of Biosimilar and Biologic Drugs

On Tuesday, the U.S. Food and Drug Administration released its latest Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation Act of 2009 (BCPCIA). This...more

FDA Issues Guidance Regarding Biologic Drug Naming

Late last week, the U.S. Food and Drug Administration released its latest Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation Act of 2009 (BCPCIA). ...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

FDA Issues Newest Guidance Regarding Biosimilar Application Process

On December 29, the U.S. Food and Drug Administration released its latest Guidance for Industry relating to the biosimilar application process set forth in the Biologic Price Competition and Innovation Act of 2009 (BCPCIA). ...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

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