Responding to the invitation from the Supreme Court, the Solicitor General for the United States has filed an amicus brief for the United States in Hikma Pharmaceuticals USC Inc. v. Vanda Pharmaceuticals Inc. Stakeholders...more
1/10/2020
/ Alice Corporation ,
Amicus Briefs ,
Bilski ,
Mayo v. Prometheus ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Personalized Medicine ,
Petition for Writ of Certiorari ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Section 101 ,
Solicitor General ,
Split of Authority
On Friday I will be speaking at the AUTM Eastern Regional Meeting, on a panel discussing patent eligibility issues for life sciences inventions. My topic relates to what the USPTO refers to as “nature-based products,” but...more
In United Cannabis Corp. v. Pure Hemp Collective, Inc., Judge Martinez of the U.S. District Court for the District of Colorado determined that UCANN's CBD patent was not invalid under 35 USC § 101. The court reached its...more
In Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit distinguished method of treatment claims that involve personalized dosing from the claims invalidated in Mayo v. Prometheus, and found them...more
4/4/2019
/ Abbreviated New Drug Application (ANDA) ,
Alice Corporation ,
Appeals ,
Endo Pharmaceuticals ,
Mayo v. Prometheus ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Section 101 ,
Teva Pharmaceuticals ,
USPTO
In Natural Alternatives Internat'l v. Creative Compounds, LLC, the Federal Circuit vacated the district court decision that held the asserted claims invalid under 35 USC § 101 at the pleadings stage. I previously wrote about...more
On June 7, 2018, the USPTO issued a memorandum to the Examining Corps providing patent eligibility examination guidance based on the recent Federal Circuit decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals....more
As announced in a Federal Register Notice dated April 20, 2018, the USPTO has issued a new memorandum to the Examining Corps providing supplemental patent eligibility examination guidance under Berkheimer, a Federal Circuit...more
In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd., a divided panel of the Federal Circuit upheld Vanda’s personalized method of treatment claims relating to its Fanapt® (iloperidone) product against a...more
In the non-precedential decision issued in Exergen Corp. v. Kaz USA, Inc., Judge Moore considered the time and money it took to develop the invention at issue when deciding that the claims satisfy the patent eligibility...more
It’s that time of year when we make resolutions to improve our health, our relationships, our careers, or other areas of our lives. I’m not starting a new diet today (although if I were, the invention described in this patent...more
1/2/2018
/ Claim Construction ,
Foreign Patent Applications ,
Intellectual Property Protection ,
Mayo v. Prometheus ,
Patent Applications ,
Patent Litigation ,
Patent Ownership ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Patents ,
SCOTUS ,
USPTO
While the patent eligibility of diagnostic method claims remains questionable in the United States, the Canadian Intellectual Property Office has issued updated guidance on the types of diagnostic method claims that can–and...more
11/30/2017
/ Biosimilars ,
Canada ,
Canadian Intellectual Property Office (CIPO) ,
CLS Bank v Alice Corp ,
Diagnostic Method ,
Guidance Update ,
Intellectual Property Protection ,
Life Sciences ,
Mayo v. Prometheus ,
Novelty ,
Patent-Eligible Subject Matter ,
USPTO
In Ex Parte Timothy, the USPTO Patent Trial and Appeal Board (PTAB) affirmed the Examiner’s rejection of personalized medicine treatment claims. This decision highlights the PTAB’s willingness to invalidate claims that it...more
10/7/2017
/ Appeals ,
Innovation ,
Intellectual Property Protection ,
Mayo v. Prometheus ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Personalized Medicine ,
Pharmaceutical Patents ,
Product of Nature Doctrine ,
Section 101 ,
USPTO
While the Supreme Court decisions in Myriad and Mayo have been applied to diagnostic-type claims, method of treatment patents were thought to be safe from the recent judicial expansion of the patent-(in)eligibility doctrine....more
3/4/2017
/ Administrative Appeals ,
Diagnostic Method ,
Ex Partes Reexamination ,
Mayo v. Prometheus ,
Method Claims ,
Patent Invalidity ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Personalized Medicine ,
SCOTUS ,
Section 101 ,
USPTO
The Federal Circuit ruled that the cryopreservation methods at issue in Rapid Litigation Mgmt. Ltd. v. CellzDirect Inc., are patent eligible under 35 USC § 101. It therefore vacated and remanded the decision of the U.S....more
7/8/2016
/ CAFC ,
CLS Bank v Alice Corp ,
Examiners ,
Mayo v. Prometheus ,
Method Claims ,
New Guidance ,
Patent-Eligible Subject Matter ,
Remand ,
Section 101 ,
USPTO ,
Vacated
The U.S. Supreme Court has denied certiorari in Sequenom, Inc. v. Ariosa Diagnostics, Inc. (No. 15-1182), declining to review the Federal Circuit’s June 12, 2015, decision that certain methods of detecting paternally...more
The new USPTO patent eligibility examples include two examples for “natural products” based inventions which appear to be consistent with the examples provided in the December 2014 set of patent eligibility examples. Although...more
The patent eligibility examples published by the USPTO on May 5, 2016 include two new examples relating to diagnostic methods and two new examples relating to “nature-based” products. This article will consider the diagnostic...more
The U.S. District Court for the District of Delaware accepted Merck’s arguments that method of treatment patents asserted by BMS against its Keytruda product “touch[] upon a natural phenomenon” such that they should be...more
5/5/2016
/ Bristol-Myers Squibb ,
CLS Bank v Alice Corp ,
Federal Rule 12(b)(6) ,
Mayo v. Prometheus ,
Merck ,
Motion to Dismiss ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Presumption of Validity ,
SCOTUS ,
Treatment Method Patents
While I do not usually write about non-precedential decisions, In re: Brown caught my eye as an interesting patent eligibility case. It does not relate to diagnostics or computer programs, but rather to the art of cutting...more
On April 5, 2016, the Federal Circuit heard oral arguments in Rapid Litigation Mgmt. Ltd. v. CellzDirect Inc., where the U.S. District Court for the Northern District of Illinois held invalid claims directed to a “method of...more
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
4/12/2016
/ Biotechnology ,
CLS Bank v Alice Corp ,
Corporate Counsel ,
Diagnostic Method ,
DNA ,
Federal Rule 12(b)(6) ,
Genetic Technologies Ltd. ,
Machine-or-Transformation Test ,
Mayo v. Prometheus ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
SCOTUS
It comes as no surprise that Sequenom has filed a petition for certiorari to the Supreme Court, asking the Court to review the Federal Circuit decision that upheld the district court decision that held its diagnostic method...more
As reported previously, the Federal Circuit has denied rehearing in Ariosa Diagnostics, Inc. v. Sequenom, Inc. I wrote about Judge ‘Dyk’s opinion concurring in the denial but offering alternative views on patent eligibility...more
As noted in a previous article, the Federal Circuit has denied rehearing in Ariosa Diagnostics, Inc. v. Sequenom, Inc.. The per curiam order was accompanied by two separate concurring opinions, one authored by Judge Lourie...more
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
10/9/2015
/ AMP v Myriad ,
Australia ,
Biotechnology ,
Chilling Effect ,
Genetic Materials ,
Innovation ,
Mayo v. Prometheus ,
Monopolization ,
Myriad ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Popular ,
Scope of the Claim ,
SCOTUS ,
USPTO