Biotechnology United States Patent and Trademark Office

News & Analysis as of

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

New Patent Office Initiative Provides a Boost to Cancer Immunotherapy Patent Applications

On June 29, 2016, the United States Patent and Trademark Office (USPTO) announced that it is implementing a pilot program to more quickly review patent applications related to treating cancer using immunotherapy. This...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

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

USPTO Issues Performance and Accountability Report for FY 2015

The U.S. Patent and Trademark Office recently released its Performance and Accountability Report for Fiscal Year (FY) 2015. In describing the USPTO's strategic and performance-planning framework, the 2015 report begins by...more

Farewell the ten sequences rule. The new MPEP disposes of the old §803.04 rule.

The latest MPEP revisions make a variety of changes. Most of the attention has focused on changes to examination procedures for 35 U.S.C. §101, for the obvious reason that this is an aspect of the law that has been in...more

3D Printing Partnership: 3D Medical Limited to Acquire Mach7 Technologies

3D Medical Limited (ASX: 3DM) recently announced that it has entered into a binding Heads of Agreement (HOA) to purchase 100% of shares issued in Mach7 Technologies. According to the agreement, 3D Medical will issue 460...more

Can we patent products found in nature? It's complicated. An update on Australia's Myriad decision...

It remains to be seen if this new Myriad decision in Australia will be extended as it was in the U.S. to prevent virtually any product found in nature from being patented....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

Amicus Briefs in Support of Sequenom's Petition for Rehearing En Banc: BIO and PhRMA

Earlier this summer, in Ariosa Diagnostics, Inc. v. Sequenom, Inc., the Federal Circuit affirmed a decision by the District Court for the Northern District of California granting summary judgment of invalidity of the asserted...more

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

Sanofi Seeks IPR of Cabilly Patent

On July 27, 2015, Sanofi-aventis U.S. LLC and Regeneron Pharmaceuticals, Inc. filed a petition for Inter Partes Review (IPR) of the “Cabilly II” patent, U.S. Patent No. 6,331,415. The Cabilly II patent granted shortly after I...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

How an Insufficiently Detailed Provisional Patent Application Can Hurt You

A well-intentioned decision to reduce expenses can result in a poorly written provisional patent application that actually destroys an institution’s future patent rights in an important technology. In today’s world,...more

Patent Trial and Appeal Board Grants Rare Motion to Amend Claims in Inter Partes Review

On June 5, 2015, a three-judge panel at the Patent Trial and Appeal Board (“PTAB”), granted a motion to amend in an inter partes review (“IPR”) proceeding, ruling that the patentee Neste Oil Oyj (“Neste”) could amend the...more

Billion Dollar Question Before the USPTO in CRISPR-cas9 Fight

A revolutionary biotechnology tool is the focus of an intense biotechnology patent dispute that will have far-reaching impact in coming years. The dispute is over the rights to the CRISPR-cas9 system, a versatile molecular...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 -- University Community 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

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

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

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