In In re Cellect, the Federal Circuit effectively held that Patent Term Adjustment (PTA) awarded under 35 USC § 154 is not protected from obviousness-type double patenting (OTDP) in view of a patent with the same 20-year...more
In UCB Inc. v. Actavis Laboratories UT Inc., the Federal Circuit affirmed the district court’s judgement of invalidity on obviousness grounds but reversed the finding of anticipation. In reaching its decision on anticipation,...more
In Minerva Surgical, Inc. V. Hologic, Inc., the Supreme Court limited the equitable doctrine of assignor estoppel that prevents an assignor from subsequently challenging the validity of the patent he or she assigned. The...more
The January 29, 2020, Federal Circuit decision in Galderma Laboratories, L.P. v. Teva Pharmaceuticals USA, Inc., is a non-precedential decision that was issued on the briefs (without oral argument), but is worth reviewing for...more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
In Nuvo Pharmaceuticals, In. v. Dr. Reddy’s Laboratories Inc., the Federal Circuit reversed the district court and found the asserted patents invalid for failing to satisfy the written description requirement. This decision...more
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
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
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
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 38 page decision with a 19 page dissent by Judge Newman, the Federal Circuit determined that Regeneron’s transgenic mouse patent is unenforceable due to inequitable conduct. The decision was rendered in Regeneron...more
8/4/2017
/ Adverse Inference Instructions ,
Appeals ,
But For Causation ,
Discovery ,
Due Process ,
Fourteenth Amendment ,
Inequitable Conduct ,
Intent ,
Materiality ,
Patent Invalidity ,
Patent Prosecution ,
Patents ,
Pharmaceutical Patents ,
Sanctions ,
USPTO
The U.S. District Court for the Southern District of California invalidated several dietary supplement product and method patents as being directed to ineligible subject matter, even though they claimed products providing a...more
7/12/2017
/ Biotechnology ,
CLS Bank v Alice Corp ,
Dietary Supplements ,
Motion to Dismiss ,
Myriad-Mayo ,
Patent Invalidity ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Patents ,
Product of Nature Doctrine ,
Section 101
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
In Novartis v. Noven Pharmaceuticals, Inc., the Federal Circuit affirmed the USPTO Patent Trial and Appeal Board (PTAB) decisions invalidating certain claims of two Orange Book-listed Exelon patents. This decision has...more
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 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
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 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)
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
In Merck & CIE v. Watson Laboratories, Inc., the Federal Circuit found communications between Merck and a potential joint venture partner amounted to a commercial offer to sell that invalidated the Orange Book-listed folate...more
5/31/2016
/ Abbreviated New Drug Application (ANDA) ,
America Invents Act ,
Confidentiality Agreements ,
Generic Drugs ,
Joint Venture ,
Merck ,
Non-Compete Agreements ,
On-Sale Bar ,
Patent Invalidity ,
Patent Litigation ,
Pharmaceutical Patents ,
Reversal ,
Watson Pharmaceuticals
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
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
The Federal Circuit is set to hear oral arguments in Immersion Corp. v. HTC Corp. on May 6, 2016. According to the amicus brief filed on behalf of the United States, if the court affirms the district court decision “over...more