Biotechnology Patent-Eligible Subject Matter

News & Analysis as of

Biotech-specific Subject Matter Eligibility Materials Delayed

Pursuant to the Notice published in the Federal Register today, the U.S. Patent and Trademark Office provided additional materials related to the Office's interpretation of what does (and what does not) satisfy the subject...more

Federal Circuit Review | July 2015

Nunc Pro Tunc Assignments Insufficient To Confer Retroactive Standing - In ALPS SOUTH, LLC v. OHIO WILLOW WOOD CO., Appeal Nos. 2013-1452, 2013-1488, 2014-1147, and 2014-1426, the Federal Circuit reversed the denial of a...more

Federal Circuit’s Latest Patent Subject Matter Decision in Ariosa v. Sequenom Renders Many Biotech Patents at Risk

On June 12, 2015, the Federal Circuit issued its decision in Ariosa Diagnostics, Inc. v. Sequenom, Inc., finding that Sequenom’s patent claiming methods of using cell-free fetal DNA (“cffDNA”) for prenatal diagnosis test is...more

What Constitutes Patentable Subject Matter in Biotechnology? New Federal Circuit Decision Says “Even Less Than You Thought!”

With its recent (June 12, 2015) decision in Ariosa v. Sequenom, the Court of Appeals for the Federal Circuit affirmed the Northern District of California’s broad interpretation of the U.S. Supreme Court’s Prometheus v. Mayo...more

Patent for Technology that “Revolutionized Prenatal Care” Nonetheless Invalid as Patent Ineligible

The Federal Circuit Friday held in Ariosa Diagnostics, Inc. v. Sequenom, Inc. that Sequenom’s patent directed toward its MaterniT21 test—involving methods of detecting and using cell-free fetal DNA— was invalid for lack of...more

U.S. Appeals Court Finds Prenatal DNA Test Unpatentable

The United States Court of Appeal for the Federal Circuit in the District of Columbia came down with another blow for the patentability of biotech testing products on Friday, June 12, 2015. The Court affirmed the 2013...more

Refashioning IP Asset Protection Strategies for Biotechnology and BioPharma Clients in View of the New Legal Realities of Subject...

In the 1970s, the biotechnology industry was in its infancy. Many academic researchers were developing faster, more efficient ways to clone and characterize gene products of interest, and companies arose to provide practical...more

Is Biotech Patentable Subject Matter? [Video]

The issue of patent eligibility has been a hotly litigated issue in the field of intellectual property law, and both the Federal Circuit and the Supreme Court have issued numerous decisions in recent years--particularly in...more

More Biotech and Diagnostic Patents At Risk After Federal Circuit Decision

On December 17, 2014, the Federal Circuit Court of Appeals found that certain claims relating to Myriad’s BRCA1 genetic test for breast and ovarian cancer were invalid under 35 U.S.C. § 101 as being ineligible for patent...more

Myriad Disappointments for Biotech, but Hope Remains

CAFC extends the reach of subject-matter ineligibility under Myriad - Following Myriad Genetic’s 2013 loss at the Supreme Court (Ass’n for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013), herein “Myriad...more

Patent Update for IT and Biotech Companies: New Pieces to the Patent Puzzle

In This Presentation: - PATENT ELIGIBLE SUBJECT MATTER: LIFE IN SOFTWARE/IT AFTER ALICE CORPORATION V. CLS BANK (AND OTHER RECENT 101 DECISIONS) - A Brief History with respect to Software and Biz...more

BIO IPCC Panel Discusses Impact of Myriad-Mayo Guidance

Yesterday, we reported on a session of the Biotechnology Industry Organization (BIO) Intellectual Property Counsel's Committee fall conference, which took place earlier this week in Nashville, TN, in which the U.S. Patent and...more

USPTO Provides Update on Status of Revised Myriad-Mayo Guidance

During a session of the Biotechnology Industry Organization (BIO) Intellectual Property Counsels Committee (IPCC) fall conference, which took place this week in Nashville, TN, the U.S. Patent and Trademark Office provided a...more

Examination of Myriad-Mayo Guidance Comments -- BIO Joint Comment

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

Sherry Knowles Addresses Real World Impact of Myriad-Mayo Guidance at BIO Symposium

Last month, at the Biotechnology Industry Organization (BIO) IP & Diagnostics Symposium in Alexandria, VA, Sherry Knowles of Knowles IP Strategies addressed the impact of the U.S. Patent and Trademark Office's Myriad-Mayo...more

Full Federal Court confirms isolated nucleic acids are patentable in Australia

• The Full Federal Court has unanimously confirmed that isolated nucleic acids, either DNA or RNA, are patentable in Australia. • The decision is in contrast to the recent decision of the US Supreme Court, which held a...more

Update on Mayo Myriad Patent Eligibility From USPTO BCP Partnership Meeting

On September 17, 2015, the USPTO held the first “bicoastal” Biotechnology/Chemical/Pharmaceutical Customer Partnership meeting, with live participation from the USPTO’s main campus in Alexandria, VA and from San Jose...more

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

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

California Court Holds Diagnostic Claims Not Patent-Eligible

In one of the first district court decisions applying the U.S. Supreme Court’s new Myriad patent-eligibility standard, the Northern District of California held that diagnostic claims containing only conventional and existing...more

23andMe Patent Creates Controversy

A patent issued to 23andMe, Inc. last month has created some controversy, and in response, the biotech company, based in Mountain View, California, has posted its side of the story on the 23andMe blog. The patent, U.S....more

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