For the first time in nearly 15 years, the U.S. Patent and Trademark Office (USPTO) has issued “Updated Guidance for Making a Proper Determination of Obviousness” under the U.S. Supreme Court’s ruling in KSR Int’l Co. v....more
4/23/2024
/ America Invents Act ,
Decision-Making Process ,
Ex Partes Reexamination ,
Graham Factors ,
Guidance Update ,
Inventions ,
New Guidance ,
Obviousness ,
Patent Applications ,
Patent Examinations ,
Prior Art ,
USPTO
In Eli Lilly and Co. v. Teva Pharmaceuticals International GmbH, the Federal Circuit affirmed the USPTO Patent Trial and Appeal Board decision upholding Teva’s patents directed to specific methods of treatment using an...more
In Liqwd, Inc. v. L’Oreal USA, Inc., the Federal Circuit vacated a decision of the USPTO Patent Trial and Appeal Board (PTAB) that failed to take into account evidence of copying in its obviousness analysis. The Federal...more
In OSI Pharmaceuticals LLC v. Apotex, Inc., the Federal Circuit reversed the PTAB’s determination that a Tarceva® patent was invalid as obvious because the decision was not supported by a reasonable expectation of success....more
10/17/2019
/ Apotex ,
Clinical Trials ,
Obviousness ,
Patent Invalidity ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Prior Art ,
Reasonable Expectations Test ,
Reversal
I previously wrote about the standing issue addressed in Amerigen Pharmaceuticals v. UCB Pharma GMBH. In this article, I look at the lead compound analysis that led the USPTO Patent Trial and Appeal Board (PTAB) to uphold the...more
In Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc., Novartis scored another obviousness-type double patenting (OTDP) win when the Federal Circuit held that a post-URAA child patent could not be cited as an...more
12/18/2018
/ Abbreviated New Drug Application (ANDA) ,
Novartis ,
Obviousness ,
Orange Book ,
OTDP ,
Patent Litigation ,
Patent Term Adjustment ,
Patent Term Extensions ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Pre-GATT ,
USPTO
In Novartis AG v. Ezra Ventures LLC, the Federal Circuit addressed “the interplay between a patent term extension (PTE) granted pursuant to 35 U.S.C. § 156 and the obviousness-type double patenting doctrine.” In upholding the...more
In In re Copaxone Consolidated Cases, the Federal Circuit affirmed the district court decision finding four patents directed to a specific dosing regimen for using COPAXONE® 40 mg/ml to treat patients with relapsing multiple...more
The Federal Circuit decision in Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc. addressed several aspects of obviousness doctrine. We previously wrote about the impact of a blocking patent on consideration of objective...more
In Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc., the Federal Circuit affirmed the district court decision finding four Acorda Orange Book-listed patents for Ampyra® invalid as obvious. Acorda raised a number of...more
In E.I. DuPont De Nemours & Co. v. Synvina C.V., the Federal Circuit reversed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that had upheld Synvina’s chemical process patent against an obviousness challenge...more
Petitioners in Inter Partes Review proceedings have looked beyond typical patent and scientific literature to find a “printed publication” that might invalidate a patent. This has given the USPTO Patent Trial and Appeal Board...more
In Impax Laboratories Inc. v. Lannett Holdings Inc., the Federal Circuit upheld the district court decision finding that defendants had failed to establish obviousness of AstraZeneca’s Zomig patents (directed to intranasal...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
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
In recent decisions, the Federal Circuit has found error in the USPTO Patent Trial and Appeal Board’s approach to obviousness rejections, including its reliance on the doctrine of routine optimization without evidence of an...more
In Southwire Co. v. Cerro Wire LLC, the Federal Circuit upheld the USPTO decision rendered in an inter partes reexamination proceeding that found Southwire’s patent invalid as obvious. Although the court found that the USPTO...more
9/16/2017
/ Administrative Appeals ,
Appeals ,
CAFC ,
Harmless Error ,
Inherency ,
Inter Partes Review (IPR) Proceeding ,
Obviousness ,
Patent Invalidity ,
Patents ,
Prior Art ,
USPTO
In a split decision with Judge Lourie dissenting, the Federal Circuit vacated an obviousness rejection that had been affirmed in an ex parte appeal to the USPTO Patent Trial and Appeal Board. The decision was rendered in In...more
9/11/2017
/ Appeals ,
Burden of Proof ,
Burden-Shifting ,
CAFC ,
Ex Parte ,
Obviousness ,
Patent Examinations ,
Patent Trial and Appeal Board ,
Patents ,
USPTO ,
Vacated
In Honeywell International, Inc. v. Mexichem Amanco Holdings S.A. DE C.V., the Federal Circuit vacated the decision of the USPTO Patent Trial and Appeal Board that invalidated Honeywell’s patent in an inter partes...more
In Millennium Pharmaceuticals, Inc. v. Sandoz, the Federal Circuit reversed the district court decision that invalidated one of the Orange Book-listed patents covering the anti-cancer drug Velcade. In so doing, the court...more
In Novartis AG v. Torrent Pharmaceuticals Ltd., the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) invalidating all claims of U.S. Patent 8,324,283, which is one of four Orange...more
4/25/2017
/ FDA Approval ,
Final Written Decisions ,
Inter Partes Review (IPR) Proceeding ,
Nexus ,
Novartis ,
Obviousness ,
Orange Book ,
Patent Invalidity ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Patents ,
Substantial Evidence Standard
The Federal Circuit decision in Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC may be more interesting for what Mylan argued than for what the Federal Circuit decided. However, it could be an important decision...more
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 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