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Federal Circuit Finds Velcade Patent Not Obvious Under Lead Compound Analysis

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

Cleveland Clinic Decision Highlights Catch-22 Of Personalized Medicine Patents

The Federal Circuit decision in Cleveland Clinic Foundation v. True Health Diagnostics LLC, strikes another blow against the patent eligibility of diagnostic methods and highlights the difficulty of enforcing personalized...more

Industry Perspectives On The Biosimilar Patent Dance

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

How Will The Supreme Court Choreograph The Biosimilar Patent Dance?

On April 26, 2017, the Supreme Court heard oral arguments in Amgen v. Sandoz, where the parties have asked the Court to interpret two of the biosimilar patent dance provisions of the Biologics Price Competition and Innovation...more

Court Rejects Theory Of Derivation Based On FDA Requirement

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

How Will Trump Change The FDA?

President-elect Trump’s plans for his first 100 days in office include “cutting the red tape at the FDA” and “speed[ing] the approval of life-saving medications.” Here, we consider specific steps Trump could take–without or...more

What Is The Trump Pharmaceutical Policy?

Pharmaceutical stocks took a hit after President-elect Trump criticized the industry during his January 11, 2017 press conference. But he also expressed support for the domestic pharmaceutical industry. What is the Trump...more

Supreme Court Will Judge Biosimilar Patent Dance

The U.S. Supreme Court has agreed to review some of the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). The Court granted certiorari in the dispute between Amgen and Sandoz,...more

District Court Upholds Eligibility Of Personalized Medicine Method Claims For FANAPT

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

AbbVie Sues Amgen On 10 Of 100 Humira Patents

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

The Promise And Pitfalls Of 3D Printing

3D printing offers great promise for innovation and manufacturing, but this tool has expanded the scope of patented products that can be easily and cheaply copied, and may make it harder to identify and prosecute infringers....more

En Banc CAFC Requires UCC Sale For On Sale Bar

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

Janssen Seeks Injunction Against Remicade Biosimilar Based On Cell Culture Patent

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

The PRICED Act Would Expedite Biosimilar Market Entry

Although the 12-year exclusivity period for original biologic products was a heavily negotiated provision of the Biologics Price Competition and Innovation Act (BPCIA), increased spending on biologic drugs has led to calls to...more

Federal Circuit Requires 180 Day Notice For All Biosimilars, Even After Patent Dance

In Amgen v. Apotex, the Federal Circuit rejected Apotex’s arguments that the 180-day pre-marketing notice requirement does not apply to biosimilar applicants who participated in the “patent dance” process of the Biologics...more

Amgen And Sandoz Do The Biosimilar Patent Dance Over Neulasta

Amgen Inc. has filed a complaint under the Biologics Price Competition and Innovation Act (BPCIA), asserting that a biosimilar application filed by Sandoz Inc. seeking approval of a biosimilar version of Neulasta® infringes...more

Jazz Xyrem + Valproate Patent Claims Avoid IPR

The USPTO Patent Trial and Appeal Board (PTAB) decided not to institute inter partes review (IPR) of key claims of Jazz’s U.S. Patent 8,772,306, which is listed in the Orange Book for Xyrem®. Although the PTAB did institute...more

En Banc Federal Circuit Limits Patent Exhaustion

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

Divided Infringement Between Doctor and Patient

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

Amgen and Apotex do the Biosimilar Patent Dance

Amgen has filed a complaint under the Biologics Price Competition and Innovation Act (BPCIA), asserting that a biosimilar application filed by Apotex, Inc. infringes two of its patents. Although several complaints have...more

Lumigan Patents Upheld by Unexpected Results

In Allergan, Inc. v. Sandoz, Inc., the Federal Circuit affirmed the district court decision that upheld the validity of the Allergan patents relating to Lumigan® 0.01% glaucoma eye drops. This decision shows that it is still...more

Biosimilars Can Sit Out Patent Dance, But May Have To Wait Out Second Exclusivity Period

In Amgen v. Sandoz, Fed. Cir., No. 15-1499 (July 21, 2015), a divided panel of the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that...more

Federal Circuit Finds Biosimilar Patent Dispute Resolution Procedures Optional

In Amgen v. Sandoz, a divided panel of the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that appears to favor biosimilar applicants...more

Federal Circuit Strikes Final Blow to Celebrex Patent

In 2008, the Federal Circuit determined that claims 1-4 and 11-17 of U.S. Patent No. 5,760,068 were invalid for obviousness-type double patenting (OTDP) over a related parent patent, in part because the ‘068 patent was filed...more

Federal Circuit Hears Oral Arguments in Neupogen Biosimilar Case

On June 3, 2015, the Federal Circuit heard oral arguments in Amgen v. Sandoz regarding the patent dispute resolution provisions of the Biologics Price Competition and Innovation Act (BPCIA). As reflected in Judge Lourie’s...more

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