In Droplets, Inc. v. E*Trade Bank, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that Droplet’s patent was not entitled to the priority date of a provisional application because...more
In Praxair Distrib., Inc. v. Mallinckrodt Hospital Prods. IP Ltd., the Federal Circuit found that the printed matter doctrine applies equally to physically embodied information and mental steps, and can be invoked in the...more
5/29/2018
/ Claim Limitations ,
Evidence ,
Patent Invalidity ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Personalized Medicine ,
Pharmaceutical Patents ,
Printed Matter Doctrine ,
Prior Art ,
Section 101 ,
Section 102 ,
Section 103
Several important changes to Bayh-Dole Act implementing regulations took effect on May 14, 2018, that will apply to funding agreements executed after that date and may apply to existing funding agreements modified after that...more
In Sumitomo Dainippon Pharma Co. V. Emcure Pharm. Ltd., the Federal Circuit affirmed the district court’s decision that construed a chemical structure as reading on the lurasidone enantiomer that is the active ingredient of...more
Our first article on Vanda Pharmaceuticals, Inc. v. Aventisub, LLC focused on the subject matter eligibility of the personalized method of treatment claims under 35 USC § 101. Next, we considered how the Fanapt® label was...more
5/8/2018
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Section 101 ,
Subject Matter Jurisdiction
Our first article on Vanda Pharmaceuticals, Inc. v. Aventisub, LLC focused on the Federal Circuit’s decision upholding the subject matter eligibility of the personalized method of treatment claims under 35 USC § 101. Here, we...more
5/1/2018
/ Abbreviated New Drug Application (ANDA) ,
Induced Infringement ,
Method Claims ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Patients ,
Pharmaceutical Industry ,
Physicians ,
Product Labels ,
Section 101
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 a non-precedential decision issued in In re Bhagat, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that claims directed to certain lipid compositions were ineligible for...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
The USPTO issued a two page memorandum to the Patent Examining Corps noting that some of the USPTO’s written description guidance pertaining to antibody claims is “outdated.” The memo specifically notes withdrawal of the...more
In Novartis v. Lee (Fed. Cir. 2014), the Federal Circuit agreed with the USPTO that “time spent in a continued examination” does not count towards the three years the USPTO is allotted to examine a patent before if it must...more
We’ve written previously about ex parte decisions of the Patent Trial and Appeal Board (PTAB) affirming patent eligibility rejections that seem to be inconsistent with the USPTO’s Subject Matter Eligibility Guidance....more
In Genzyme Corp. v. Dr. Reddy’s Labs. Ltd., the Federal Circuit affirmed the district court decision upholding Genzyme’s Orange Book listed patent for the cancer drug Mozobil® against an obviousness challenge, because the...more
A few weeks ago I joined Kathleen Fonda, Ph.D., J.D., Senior Legal Advisor in the USPTO’s Office of Patent Legal Administration, and Gary Ganzi, J.D., Senior Counsel and Head of Intellectual Property for Evoqua Water...more
Although non-precedential, the Federal Circuit decision in Aptalis Pharmatech, Inc. v. Apotex Inc. is worth a read to see how the court “tiptoes” the “fine line between reading a claim in light of the specification, and...more
A new USPTO fee schedule took effect on January 16, 2018, which usually means that all fees must be paid at the new (higher) rate. However, thanks to revisions to 35 USC § 151 effected by the Patent Law Treaties...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
The Federal Circuit has issued its final decision in the biosimilar patent litigation between Amgen and Sandoz over the first product to be approved under the Biologics Price Competition and Innovation Act (BPCIA). Not...more
12/27/2017
/ Amgen ,
Biosimilars ,
BPCIA ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preemption ,
Sandoz ,
Sandoz v Amgen ,
Unfair Competition
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
While Congress is trying to pass a tax reform bill that would cut corporate taxes, USPTO patent fees will increase effective January 16, 2018. The 72% jump in the Inter Partes Review request fee has gotten the most attention,...more
As announced in this October 30, 2017 Federal Register notice, the USPTO is expanding the Collaborative Search Pilot Program under which applicants can request that multiple intellectual property offices exchange search...more
11/9/2017
/ Collaboration ,
Expedited Approval Process ,
Federal Register ,
Foreign Patent Applications ,
Information Disclosure Statement ,
Japan ,
KIPO ,
Korea ,
Patent Applications ,
Patents ,
USPTO ,
USPTO Pilot Program
In a non-precedential decision issued in Merck Sharp & Dohme B.V., v. Warner Chilcott Co. LLC, the Federal Circuit reversed the district court’s obviousness ruling as being improperly grounded in hindsight. This decision...more
The October 5, 2017 Federal Circuit decision in Amgen Inc. v. Sanofi is getting a lot of attention for its commercial impact, because the court vacated the permanent injunction that prevented Sanofi and Regeneron from...more
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