Biotechnology Patent-Eligible Subject Matter

News & Analysis as of

Federal Circuit’s Application of Mayo Revives Biotech Patent

In Rapid Litig. Mgmt. Ltd v. CellzDirect, Inc., the Federal Circuit reversed a ruling of patent invalidity under Section 101, reviving a biotech patent to a method of preserving hepatocytes, liver cells, for medical use. The...more

Packing Your Patent Application for Europe: Avoiding Problems Under European Patent Law

Planning an extended European vacation for your patent application? A lengthy stay in Munich with possible outings to The Hague, Berlin, Vienna, or Brussels? While your patent application won’t be strolling through the...more

Federal Circuit Offers Path Through Section 101 Thicket for Biotech Method Patents

In its July 5, 2016 decision in Rapid Litigation Management Ltd and In Vitro, Inc. v. CellzDirect, Inc. and Invitrogen Corp., the Federal Circuit held that patent claims directed to an improved method of cryopreserving...more

Carry on as Before: Supreme Court Refuses Sequenom’s Petition

To the surprise of many, including myself, the Supreme Court denied Sequenom’s petition for writ of certiorari (“Petition”). Sequenom asked the Court whether the inventive concept required under the Mayo/Myriad framework can...more

Seeking Shelter From the Patent Eligibility Storm: Does the DTSA Provide Sanctuary?

For many charged with the development of intellectual property portfolios in the life sciences and software industries, navigating the stormy waters of patent eligibility has recently proven difficult. U.S. Supreme Court and...more

BIO International Convention 2016 Preview

U.S. Patent Practice – the PTAB, Federal Courts, and Patent Eligibility - The 2016 BIO International Convention has already begun in San Francisco, but most of the sessions and forums get underway beginning on Tuesday,...more

IP Developments In Biotechnology And Trade Secrets

2016 has been a year of IP changes and these changes have had an effect upon biotechnology as well as trade secrets. Patents: Will the U.S. Supreme Court Grant Cert. In Ariosa v. Sequenom? Ariosa v. Sequenom was...more

Biotech Industry Supports Cert in Sequenom to Avert “Crisis of Patent Law and Medical Innovation”

The biotechnology and life sciences community has voiced broad support for Sequenom’s recent request that the Supreme Court review the Federal Circuit’s decision holding Sequenom’s diagnostic fetal DNA patent ineligible under...more

Supreme Court Asked to Clarify Limits on Diagnostic Method Patents

Arguing that the current state of the law weakens the patent system and poses a danger to life science innovators, biotechnology company, Sequenom, Inc., has filed a writ of certiorari with the U.S. Supreme Court, asking the...more

Can Science be Copyrighted? You Might be Surprised…

Biotechnology. For many, the mere mention of the word stirs up a thought of people in white lab coats working in underground bunkers trying to create superhuman mutant weapons, with beakers of green goo bubbling in the...more

Another Diagnostic Patent Falls Under 101

In Genetic Techs Ltd v Merial LLC (Fed. Cir., April 8, 2016), the Federal Circuit invalidated yet another diagnostic patent for failing to satisfy 35 U.S.C. § 101 on the ground that the claims recite nothing more than a law...more

Methods Exploiting Junk DNA May Be Useful But Lack Patent Eligibility

Striking another blow against patent eligibility in the field of biotechnology, the Federal Circuit agreed with the district court that methods that use “junk DNA” to detect genetic variations lack patent eligibility under 35...more

[Webinar] Recent Legal & Economic Developments That Affect Your Biotech Business - March 29th, 2:00pm EST

The greatest asset of a young biotech company is its intellectual property. Strategic decisions made during the initial organization and early growth of your company have a lasting impact on its success. In this webinar, we...more

Sequenom Petitions for Certiorari

Sequenom filed its anticipated petition for certiorari today for Supreme Court review of the Federal Circuit's decision in Ariosa v. Sequenom. The petition advises the Court that it "should take this opportunity to provide...more

District Court Invalidates Cleveland Clinic Diagnostic Patents On Motion To Dismiss

Judge Gaughan of the U.S. District Court for the Northern District of Ohio granted the defendant’s motion to dismiss after finding three Cleveland Clinic Foundation diagnostic patents invalid under 35 USC § 101. While the...more

Hands Tied: Patenting Diagnostic Inventions Remain a Difficult Task

What does the Federal Circuit really think about the Supreme Court’s recent § 101 jurisprudence? The denial of the petition for rehearing en banc in Ariosa Diagnostics v. Sequenom in November of 2015 answers that question....more

Obama Administration Releases Much Anticipated Text of the Trans-Pacific Partnership Agreement

This client alert examines intellectual property proposals in the Trans-Pacific Partnership from the perspective of biotechnology, pharmaceutical, and chemical industries. On November 5, 2015, the U.S. trade...more

Natera Responds to Sequenom's Petition for Rehearing En Banc

Last week, Appellee Natera, Inc. filed its response to the petition for rehearing en banc filed by Appellants Sequenom, Inc. and Sequenom Center for Molecular Medicine, LLC in August (see "Sequenom Requests Rehearing En...more

What impact will the Australian Myriad decision have on patent eligibility of diagnostic tests?

By now most will know that: (a) Australia’s final appeal Court has made adverse findings against Myriad’s patent for utilising the BRCA1 locus to diagnose breast cancer; (b) the rejected claims are only those that...more

What did the Australian High Court actually say about the patent eligibility of cDNA?

As the dust from the impact of the Australian Myriad decision begins to settle, now is the time to revisit what many have said regarding patent eligibility of cDNA, against what the final appeal Court actually said. On...more

“Does a nucleic acid constitute patent eligible subject matter under Australia law?”

That is the question that we hoped Australia’s final appeal Court to have answered in the Myriad decision that it handed down last week. Some observers have been quite forthright on the point: ‘Yes, the High Court of...more

Does a Nucleic Acid Constitute Patent Eligible Subject Matter Under Australian Law?

Clearly the High Court has given an answer to a question, but was that question the one we anticipated? That in itself is an open question!...more

Australian High Court Rules Gene Patents Unpatentable

Like the United States Supreme Court, the High Court of Australia has determined that Myriad’s patents directed to purified and isolated DNA molecules encoding the BRCA genes are unpatentable. Indeed, the Australian Court...more

News from Abroad: High Court Rules Myriad's BRCA Genes Not Patentable Subject Matter in Australia

Just over one year after the Full Federal Court of Australia unanimously upheld an earlier Federal Court decision that naturally occurring nucleic acid molecules are patentable in Australia, the High Court of Australia has...more

Australia High Court Rules Against Gene Patents

Colleagues in Australia have been spreading the bad news: The High Court of Australia followed the lead (?) of the U.S. Supreme Court and determined that Myriad cannot patent the isolated BRCA1 gene in Australia. Thanks to...more

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