News & Analysis as of

Examination of Myriad-Mayo Guidance Comments -- International Bioindustry Associations

On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum, entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

Examination of Myriad-Mayo Guidance Comments -- ACLU

On March 4, the U.S. Patent and Trademark Office issued a guidance memorandum entitled "Guidance For Determining Subject Matter Eligibility Of Claims Reciting Or Involving Laws of Nature, Natural Phenomena, & Natural...more

Docs @ BIO: BNA Issues Report on PTO's Patent Eligibility Guidance

Sounding an appropriately alarmist note, the Bureau of National Affairs (BNA) Life Sciences Law and Industry Report issues the results of a study on how the U.S. Patent and Trademark Office is administering its March 4, 2014...more

Myriad - One Year Later

The Supreme Court decision last year on June 13, 2013 in Association of Molecular Pathology v. Myriad Genetics may have been a watershed moment for the biotechnology industry. So far the effects have been hard to detect, but...more

Sherry Knowles Speaks Truth to the Power of the PTO on § 101 Guidelines

Last week, Sherry Knowles, former chief patent counsel for GlaxoSmithKline and now principal at Knowles Intellectual Property Strategies, LLC submitted to Managing Intellectual Property magazine a detailed critique of the...more

USPTO Tries to Address Public Misunderstandings Regarding Myriad-Mayo Guidance

The U.S. Patent and Trademark Office spent the entire afternoon session of today's biotechnology/chemical/pharmaceutical (BCP) customer partnership meeting focusing on the guidance memorandum for determining the subject...more

Five Things You Should Know About the USPTO Patent Subject Matter Eligibility Guidelines

The new USPTO patent subject matter eligibility guidelines set forth a detailed analytical framework for evaluating whether claims satisfy the patent subject matter eligibility requirement of 35 USC § 101. If you are an...more

Institut Pasteur Obtains Reversal of USPTO Board Decision of Obviousness of Eukaryotic Site-Directed Mutagenesis Methods

In Institut Pasteur v. Focarino, the Federal Circuit found that the obviousness determination by the USPTO Board of Patent Appeals and Interferences was not supported by substantial evidence, and rested on an “erroneous...more

The Life Sciences Report - Fall 2013

In this issue: - How to Expedite Examination of a Patent Application - The FDA Releases Final Guidance for Mobile Medical Applications - Creating Value in the Medtech Industry Using a Gender Lens -...more

Court Report - September 9, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Senju Pharmaceutical Co., Ltd. et al. v. Akorn, Inc. 1:13-cv-06080; filed August 28, 2013 in the Southern District of...more

BIO Urges Rehearing En Banc in Fresenius v. Baxter Int'l.

In a case that raises important issues of perhaps Constitutional dimensions (at least in Circuit Court Judge Newman's view), the Biotechnology Industry Organization (BIO) urged the Federal Circuit to rehear the panel decision...more

BakerHostetler Patent Watch: Novozymes A/S v. DuPont Nutrition Biosciences APS

On July 22, 2013, in Novozymes A/S v. DuPont Nutrition Biosciences APS, the U.S. Court of Appeals for the Federal Circuit (Rader, Schall,* Bryson) affirmed the district court's judgment as a matter of law that U.S. Patent No....more

In re Adler (Fed. Cir. 2013)

Ever since the Supreme Court handed down its decision in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007), both the U.S. Patent and Trademark Office and the courts have found it easier to render a decision that a claimed...more

Hatch-Waxman Watch: Safe Harbor Edition

Last week, two district courts dispensed with lawsuits based on the protections afforded by the safe harbor provision of the Hatch-Waxman statute. Both of the cases relied heavily on the Federal Circuit case Momenta Pharm....more

Court Report -- July 21, 2013

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. UCB Inc. et al. v. Aurobindo Pharma Ltd., et al. 1:13-cv-01210; filed July 10, 2013 in the District Court of Delaware...more

Post-Myriad Strategies for Claiming Biotech Inventions in the United States

The United States Supreme Court recently ruled that genes or other naturally-occurring pieces of DNA are patent ineligible subject matter in Association for Molecular Pathology, et al. v. Myriad Genetics, Inc., et al. No....more

Supreme Court To Hear Oral Arguments in Landmark Patent Case

April 15 is a big day for biotechnology, pharmaceutical, and medical diagnostic companies at the Supreme Court, as justices begin a new session by hearing oral arguments in a landmark case involving the patentability of...more

Federal Circuit Upholds Board Determination That Biotechnology Invention Was Obvious

In In re Droge, the Federal Circuit upheld the decision of the USPTO Board of Patent Appeals and Interferences that found that claims directed to recombinant biotechnology methods were obvious. At 8 pages, the decision is one...more

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