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Protecting Plant Innovations

The development of new plant varieties can be a costly and time-consuming process. To incentivize breeding endeavors, governments around the world have developed legal mechanisms that effectively provide breeders with a...more

Strawberries in Spain - Plant Patent Infringement Under Several Theories

On April 27, 2017, the United States District Court for the Northern District of California (the “Court”) ruled on a wide variety of summary judgment motions, several of which present interesting issues related to plant...more

Sandoz v. Amgen—Biosimilars at the Supreme Court—Decisions Forthcoming?

All nine Supreme Court Justices heard argument on Wednesday, April 26, in Sandoz Inc., v. Amgen Inc. The Supreme Court is reviewing interpretations of the Biologics Price Competition and Innovation Act (“BPCIA”) made by the...more

To the Federal Circuit, Some Petitioners Have No Appeal Whatsoever

On January 9, 2017, the Federal Circuit held that Phigenix lacked standing to appeal the final written decision of nonobviousness from the U.S. Patent Trial and Appeal Board (“PTAB”) because Phigenix did not offer sufficient...more

Remicade® Update: Double Patenting Redoubles in Post-Gilead Biosimilar Case

On August 17, 2016, in Janssen Biotech, Inc. v. Celltrion Healthcare Co., District of Massachusetts Judge Mark Wolf faced a double patenting fact pattern that had not been adjudicated in a district court case since the...more

Humira® Update: Big Guns Take Aim at Top-Selling Biologic

AbbVie Inc.’s Humira® (adalimumab) was the top selling drug in 2015. Unsurprisingly, it is the focus of biosimilar applicants and patent challengers aiming to get into the market. We provide this update on three events...more

Federal Circuit Confirms Post-Licensure Notice of Commercial Marketing Is Mandatory in Biosimilar Litigation

On July 5, 2016, a unanimous Federal Circuit panel held that Apotex failed to give Amgen proper notice of commercial marketing required by the Biologics Price Competition and Innovation Act (“BPCIA” or “Biologics Act”) and...more

Patent Office Propounds New Post-Prosecution Pilot Program

On Monday, July 11, 2016, the U.S. Patent and Trademark Office (PTO) launched its new Post-Prosecution Pilot Program, or “the P3.” The P3 is designed to test its impact on enhancing prosecution after a final office action but...more

Abstract Ideas and the USPTO: Examiner Guidance Post Enfish and TLI

On May 19, 2016, the U.S. Patent and Trademark Office issued a memorandum containing a summary of two recent Federal Circuit decisions along with a directive for how patent examiners should apply the holdings of the...more

USPTO Clarifies Subject Matter Eligibility Procedure

On May 4, 2016, the United States Patent and Trademark Office (“USPTO”) published a memorandum to assist patent examiners (“Examiners”) in crafting subject matter eligibility rejections and analyzing applicant responses to...more

U.S. Patent Office Issues New Examples of Patent Eligibility Analysis of Life Sciences Claims

On May 4, 2016, the United States Patent Office published a subject matter eligibility update for determining patent eligibility under 35 U.S.C. § 101. The Update supplements the previous guidelines and includes additional...more

The Next Move in the Name Game: FDA Provides Long-Awaited Draft Guidance on Biosimilar Labeling

On March 31, 2016, the U.S. Food and Drug Administration (FDA) released its long-awaited Draft Guidance on labeling for biosimilar products (the “Draft Guidance”) and is currently soliciting comments on its proposals. The...more

Quality, Quantity and Comments: USPTO’s New Patent Quality Metrics

On Friday March 25, 2016, the U.S. Patent and Trademark Office introduced its new patent quality metrics and requested comments from stakeholders on how to further improve the proposed changes (“2017 Proposed Changes”). The...more

What Constitutes Interchangeability? AbbVie Submits Citizen Petition to Suggest Requirements

On December 16, 2015, AbbVie submitted a citizen petition regarding the requirements necessary to show interchangeability of a biosimilar product. This petition follow’s AbbVie previous citizen petition and supplement...more

The Name Game: Institutional Investors Submit Citizen Petition Regarding Biosimilar Labeling

On November 23, 2015, a group of fifteen institutional investors submitted a citizen petition to the FDA regarding biosimilar labeling (“Investors’ Citizen Petition”). The group includes investors from the public sector and...more

BPCIA: Amgen Begins the Patent Dance With AbbVie

On November 25, 2015, Amgen Inc. (“Amgen”) announced it submitted its first biologics license application (“BLA”) to the FDA under the Section 351(k) biosimilar approval pathway provided in the Biologics Price Competition and...more

BPCIA Statute: Has the Music Stopped or Will the Patent Dance Continue?

In July, a divided Federal Circuit issued a ruling in the Amgen Inc. et al. v. Sandoz Inc., Case No. 2015-1499 appeal and held: (1) the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) “patent dance” provisions...more

The Name Game Continues: AbbVie Files Supplemental Citizen Petition Raising Additional Concerns Regarding Biosimilar Labeling

AbbVie previously filed a citizen petition to the FDA arguing against its interim labeling requirements for biosimilars under the Biologics Price Competition and Innovation Act (“BPCIA”). In its supplemental petition, AbbVie...more

BPCIA Statute: Patent Dance Is Optional, But Opting Out Has Consequences

The Federal Circuit issued a ruling on July 21, 2015 in the Amgen Inc. et al. v. Sandoz Inc., Case No. 2015-1499, appeal after hearing oral arguments on June 3, 2015. See BPCIA: A “Choose Your Own Adventure” Statute?...more

The Name Game: AbbVie’s Citizen Petition Regarding Biosimilar Labeling

On June 2, 2015, AbbVie submitted a citizen petition to the FDA arguing against its interim labeling requirements for biosimilar products under the Biologics Price Competition and Innovation Act (“BPCIA”). As of now, the FDA...more

BPCIA: A “Choose Your Own Adventure” Statute?

On June 3, 2015, the Federal Circuit heard oral argument on Amgen Inc.’s (“Amgen”) appeal of the Northern District of California’s decision holding that the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) “patent...more

Amgen Prevails on Temporarily Excluding Zarxio® From Market

After an unsuccessful attempt to obtain a preliminary injunction against Sandoz Inc.’s (“Sandoz”) Zarxio® in the District Court for the Northern District of California, Amgen Inc. (“Amgen”) has prevailed before the Federal...more

Zarxio®, First BPCIA Approved Biosimilar, Added to Purple Book

In September 2014, the FDA published the first edition of the Purple Book: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (“Purple Book”), the...more

Denied Again: FDA Denies Amgen’s Citizen Petition Requesting Certification of Compliance with BPCIA Patent Dance

As discussed previously in Next Steps in the Dance: Amgen Files Citizen Petition at FDA Requesting Mandatory Compliance with BPCIA Patent Procedures, Amgen Inc. (“Amgen”) filed a Citizen Petition with the FDA requesting that...more

Dancing Not Required: District Court Denies Amgen’s Bid for Preliminary Injunction, Finds BPCIA “Patent Dance” Optional

The biologics industry has been closely monitoring Amgen Inc.’s (“Amgen’s”) lawsuit against Sandoz Inc. (“Sandoz”) for refusing to engage in the BPCIA’s “patent dance” with respect to Sandoz’s application for Zarxio®, a...more

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