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
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In the non-precedential decision issued in Exergen Corp.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
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
Although non-precedential, the Federal Circuit decision in Aptalis Pharmatech, Inc. v. Apotex Inc. is worth a read to see how the court “tiptoes” the “fine line between reading a claim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
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
In Amgen Inc. v. Hospira, Inc., the Federal Circuit held that Amgen could not obtain discovery related to activities that might infringe a patent that it had not asserted in its biosimilar patent litigation against Hospira....more
8/31/2017
/ Amgen ,
Appeals ,
Biosimilars ,
BPCIA ,
Collateral Order Doctrine ,
FDA Approval ,
Federal Rules of Civil Procedure ,
FRCP 11 ,
Hospira ,
Judicial Review ,
Motion to Compel ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Writ of Mandamus
The Supreme Court could issue its decision in the Amgen v. Sandoz biosimilar patent dance case any day now. Last week I participated in a panel discussion with industry stakeholders considering how the decision might–or might...more
6/12/2017
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Inter Partes Review (IPR) Proceeding ,
License Applications ,
Life Sciences ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preponderance of the Evidence ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS
On December 2, 2016, Judge O’Grady of the U.S. District Court for the Eastern District of Virginia granted the USPTO’s motion to dismiss the complaint brought by Elm 3DS Innovations, LLC over the “holidays” declared December...more
12/28/2016
/ Administrative Procedure Act ,
Appeals ,
Dismissals ,
Electronic Filing ,
Filing Deadlines ,
Holidays ,
Inter Partes Review (IPR) Proceeding ,
Motion to Dismiss ,
Patent Litigation ,
Patents ,
Power Outages ,
Reviewability Determinations ,
USPTO
The USPTO Patent Trial and Appeal Board (PTAB) has issued a final written decision upholding Shire’s Lialda® patent over the Inter Partes Review (IPR) challenge brought by Kyle Bass and his Coalition for Affordable Drugs. The...more
The FDA approved Inflectra–Celltrion’s biosimilar version of Janssen’s Remicade® (infliximab) product–in April 2016, but according to Pfizer’s press release it’s commercial launch still “depend[s] on a number of factors”...more
In Yeda Research and Development Co. v. Abbott GmbH and Co., the Federal Circuit invoked the doctrine of inherent disclosure to uphold a priority claim to a German priority application that only partly described the claimed...more
In a “Report and Recommendation on Defendants’ Joint Motion To Dismiss,” U.S. Magistrate Judge Cabell of the U.S. District Court for the District of Massachusetts determined that TB test kit claims do not satisfy the patent...more
In Vanda Pharmaceuticals Inc. v. Roxane Labs., Inc., Judge Stark of the U.S. District Court for the District of Delaware upheld the patent eligibility of personalized medicine method claims related to Vanda’s FANAPT®...more
In Apotex, Inc. v. Wyeth LLC, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) finding that Apotex had failed to show that claims directed to a specific formulation of tigecycline...more
In Multilayer Stretch Cling Film v. Berry Plastics, the Federal Circuit provided a detailed discussion of the construction of claims that use Markush group language. The decision emphasizes the closed nature of the...more
On August 4, 2016, Abbvie Inc. filed a complaint against Amgen, Inc. under the Biologics Price Competition and Innovation Act (BPCIA), asserting that Amgen’s application for approval of a biosimilar version of HUMIRA®...more
8/10/2016
/ Abbreviated New Drug Application (ANDA) ,
AbbVie ,
Amgen ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents
In an en banc decision issued in The Medicines Company v. Hospira, Inc., the Federal Circuit determined that in order for a commercial transaction to trigger the on-sale bar of § 35 USC 102(b), it must “bear the general...more
7/22/2016
/ Amicus Briefs ,
CAFC ,
En Banc Review ,
Hospira ,
Manufacturers ,
On-Sale Bar ,
Orange Book ,
Outsourcing ,
Patent Invalidity ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Remand ,
Uniform Commercial Code (UCC)
On July 14, 2016, the USPTO issued a Memorandum to the Patent Examining Corps on patent eligibility in view of recent court decisions. The July 2016 Memorandum extracts more guidance for assessing patent eligibility from the...more
7/18/2016
/ CLS Bank v Alice Corp ,
Examiners ,
Guidance Update ,
Life Sciences ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Petition for Writ of Certiorari ,
Pharmaceutical Patents ,
Section 101 ,
Sequenom ,
USPTO
In a complaint filed June 14, 2016, Janssen Biotech Inc. seeks a preliminary injunction that would bar Celltrion and Hospira from selling the biosimilar version of Remicade® (infliximab) that received FDA approval April 2016,...more
7/15/2016
/ Actual Damages ,
Biosimilars ,
Confidentiality Agreements ,
Direct Infringement ,
Hospira ,
Induced Infringement ,
Injunctive Relief ,
Janssen Pharmaceuticals ,
On-Sale Bar ,
Patent Infringement ,
Patent Invalidity ,
Patent Litigation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Treble Damages
In Trustees of the University of Pennsylvania v. Eli Lilly and Co., the U.S. District Court for the Eastern District of Pennsylvania refused to correct improper multiple dependent claims and instead held them invalid under 35...more
“If you can’t say something nice, don’t say anything at all” can be good words to live by, but in the context of the Supreme Court’s denial of certiorari in Sequenom, the silence is deafening–and could have a chilling impact...more
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 Federal Circuit decided not to disturb the “longstanding administrative construction” of 35 USC § 120 that permits the filing of a continuation application on the same day its parent application grants as a patent. The...more