In Lexmark International, Inc., v. Impression Products, Inc., the en banc Federal Circuit upheld a patent holder’s rights against exhaustion under two circumstances: (1) where the patent holder had sold a patented article...more
Celltrion’s biosimilar version of Janssen’s Remicade® (infliximab) product cleared a significant regulatory hurdle on February 9, 2016, when the Food and Drug Administration’s (FDA’s) Arthritis Advisory Committee voted 21-3...more
In Akzo Nobel Coatings, Inc. v. Dow Chemical Co., the Federal Circuit upheld the district court’s grant of summary judgment of no infringement under the doctrine of equivalents because the patent holder had failed to...more
The Federal Circuit dismissed the appeal in Agilent Technologies, Inc. v. Waters Technologies Corp., because the appellant was not a “third-party requester” dissatisfied with the final decision in an inter partes...more
In Purdue Pharma L.P. v. Epic Pharma LLC, the Federal Circuit affirmed the district court decision holding four OxyContin patents invalid as obvious. In so doing, the court rejected Purdue’s arguments that its discovery of...more
In Pfizer v. Lee, the Federal Circuit affirmed the decision of the U.S. District Court for the Eastern District of Virginia that upheld the USPTO’s Patent Term Adjustment (PTA) calculation that stopped the clock running...more
The USPTO Patent Trial and Appeal Board (PTAB) denied institution of two Inter Partes Review challenges brought by Amgen, Inc. against two Humira patents covering stable formulations of anti-human Tumor Necrosis Factor alpha...more
In Merck & Cie v. Gnosis S.p.A., the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that held the challenged claims obvious in an Inter Partes Review (IPR) proceeding. Although the...more
In In re Urbanski, the Federal Circuit upheld the decision of the USPTO Patent Trial and Appeal Board (PTAB) finding the claims of Urbanski’s patent application obvious. Urbanski had argued that the cited references taught...more
In Ariosa Diagnostics v. Verinata Health, Inc., the Federal Circuit vacated and remanded two parallel final written decisions in favor of the Patent Owner, because it could not discern whether the Board had incorrectly...more
The Australian Patent Office (IP Australia) has issued final patent eligibility guidance under the Australian High Court’s decision in D’Arcy v. Myriad Genetics, Inc. Where the USPTO extrapolated from the U.S. Supreme Court...more
In In re: Commonwealth Scientific & Industrial Research Organisation, the Federal Circuit held that pre-AIA 35 USC §135(b)(1) does not embody a diligence requirement, such that interfering claims presented more than 5 years...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
The Federal Circuit has denied the petition for rehearing en banc in Ariosa Diagnostics, Inc. v. Sequenom, Inc., despite the filing of twelve amicus briefs in support of the petition, including briefs filed by Biotechnology...more
In Prometheus Laboratories, Inc. v. Roxane Laboratories, Inc., the Federal Circuit affirmed the district court’s finding that Prometheus’ claims were invalid as obvious, but in so doing it cited its own precedent regarding...more
In a single decision issued for companion cases Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc. and Momenta Pharmaceuticals, Inc. v Amphastar Pharmaceuticals, Inc., the Federal Circuit interpreted two important...more
In Dynamic Drinkware, LLC v. National Graphics, Inc., the Federal Circuit held that in order for a patent to qualify as prior art as of its provisional application filing date, the provisional application must support the...more
In its 2013 decision in In re Morsa, the Federal Circuit vacated an anticipation rejection where “both the Board and the examiner failed to engage in a proper enablement analysis” to establish the enabling quality of the...more
The Federal Circuit denied the petitions for rehearing en banc filed in Amgen Inc. v. Sandoz Inc., which was the court’s first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA). Perhaps the...more
10/20/2015
/ Amgen ,
Amicus Briefs ,
Biosimilars ,
BPCIA ,
FDA Approval ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Petition For Rehearing ,
Sandoz ,
Sandoz v Amgen
After filing over thirty petitions for Inter Partes Review of Orange Book-listed patents for various drugs, Kyle Bass and his Coalition for Affordable Drugs finally have made it over the first hurdle. The USPTO Patent Trial...more
10/13/2015
/ Abbreviated New Drug Application (ANDA) ,
FDA Approval ,
Generic Drugs ,
Hedge Funds ,
Inter Partes Review (IPR) Proceeding ,
Likelihood of Success ,
Obviousness ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs ,
Real Party in Interest ,
USPTO
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
Recent jurisprudence on the issue of divided infringement has arisen in the context of computer-related technologies, where a user or customer performs one or more steps of a patented method. Now the issue has arisen in the...more
10/1/2015
/ Abbreviated New Drug Application (ANDA) ,
Direct Infringement ,
Divided Infringement ,
Eli Lilly ,
En Banc Review ,
Generic Drugs ,
Induced Infringement ,
Limelight v Akamai ,
Method Claims ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Patients ,
Pharmaceutical Industry ,
Physicians ,
Product Labels
Many pharmaceutical companies have complained about the IPR petitions filed by Kyle Bass and the Coalition for Affordable Drugs against Orange Book-listed patents covering approved pharmaceutical products, but Celgene Corp....more
9/28/2015
/ Abuse of Process ,
America Invents Act ,
Hedge Funds ,
Innovation Act ,
Inter Partes Review (IPR) Proceeding ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Sanctions
In Astornet Technologies, Inc. v. BAE Systems, Inc., the Federal Circuit affirmed the district court’s dismissed of actions for induced infringement where the alleged direct infringer was the U.S. government. In particular,...more