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Using Genetics to Uncover Human History

Human history is often something modern man only sees as through a glass, darkly. This is particularly the case when that history did not occur in the Mediterranean, the Nile Valley, India, or China, or when there is no...more

MiMedx Group, Inc. v. Liventa Bioscience, Inc. (N.D. Ga. 2017)

In the general chaos that has resulted from the Supreme Court's recent forays into trying to delineate the proper standards for patent subject matter eligibility (AMP v. Myriad Genetics, Mayo Collaborative Labs v....more

AIA America, Inc. v. Avid Radiopharmaceuticals (Fed. Cir. 2017)

As patent practitioners learned to their chagrin in the AMP v. Myriad Genetics case, sometimes broader Constitutional issues arise even in patent law. This is also true of matters relating to the Bill of Rights; for example,...more

Berkeley Files Opening Brief in CRISPR Appeal

The University of California/Berkeley filed its opening brief to the Federal Circuit last week, asking that Court to overturn the Patent Trial and Appeal Board's decision that there was no interference-in-fact between...more

Regeneron Pharmaceuticals, Inc. v. Merus N.V. (Fed. Cir. 2017)

In a decision that took an inordinately long time to arrive (oral argument was held in mid-January), the Federal Circuit in Regeneron Pharmaceuticals v. Merus today affirmed the District Court's decision that the claims of...more

Silver Birch Genetics Explained

A recent report in the scientific journal Nature Genetics 49: 904–12 (May 2017), doi:10.1038/ng.3862, disclosed the results of genomic DNA sequencing and analysis of Betula pendula, the silver birch tree....more

7/28/2017  /  Genetic Materials

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

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