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Administrative Agency Intellectual Property Health

Read need-to-know updates, commentary, and analysis on Administrative Agency issues written by leading professionals.

Sportbrain Sues Smartwatch Manufacturers, PTAB institutes IPR against Patent-in-Suit

Sportbrain Holdings LLC (“Sportbrain”) is a company that was previously engaged in the business of selling fitness trackers. Sportbrain recently sued eight smartwatch manufacturers for alleged infringement of its U.S. Patent...more

More Digital Health Device Makers Expected to Seek FDA Clearance

Investors are increasingly interested in companies with technologies that will be subject to U.S. Food and Drug Administration (FDA) regulation. Until recently, some investors shied away from companies targeting the...more

Basics of the BPCIA

The FDA broadly defines biologics as medical products derived from living sources (human, animal, plant, or microorganism) intended to treat or prevent diseases. Biologics thus include such varied vehicles of medical...more

USPTO Launches Patents 4 Patients

by Foley & Lardner LLP on

To support the National Cancer Moonshot initiative, the USPTO has launched the Patents 4 Patients program, also known as the Cancer Immunotherapy Pilot Program. Under this program, applicants can obtain expedited examination...more

Teaming Up to Cure Cancer "Patents 4 Patients" – Fast Track Review

by Miles & Stockbridge P.C. on

The United States Patent and Trademark Office “USPTO” is launching the “Patents 4 Patients” initiative, which will provide an accelerated review for methods of cancer treatments. Effective on June 29, 2016 the new “Cancer...more

Federal Circuit Confirms Both New Biosimilar Bring-to-Market Procedural Option and Additional Six-Month Exclusivity Period for...

by BakerHostetler on

On July 21, 2015, brand-name biologics companies and companies developing biosimilars received a split in a significant decision with industry-wide ramifications in the high-stakes battle about how and when biosimilar...more

The Life Sciences Report - Spring 2015

In This Issue: - The Rise of Companion Diagnostics in Personalized Medicine: Challenges and Opportunities - Department of Justice Imposes More Than $110 Million in Fines on Medical Device Makers - Life...more

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

by K&L Gates LLP on

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

New Judicial Interpretations on Scope of Hatch-Waxman Safe Harbor

by Polsinelli on

The Federal Circuit recently provided additional clarity about the scope of the Hatch-Waxman safe harbor. In Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc., the appellate court sharpened the line between...more

Otsuka Suit Results in Victory for FDA

by BakerHostetler on

According to a recent decision by a Maryland federal court, the Food and Drug Administration (FDA) acted permissibly when it approved generic versions of Otsuka Pharmaceutical Co. Ltd.’s (Otsuka) product Abilify even though...more

District Court Decision Opens Door to Five-Year NCE Exclusivity for Single Components of Previously FDA-Approved Multi-Component...

On May 28, 2015, the U.S. District Court for the District of Columbia vacated and remanded the U.S. Food and Drug Administration's (FDA) administrative decision denying five years of new chemical entity exclusivity for Amarin...more

More Biosimilar Q&A’s Released by FDA

After finalizing three key guidance documents on biosimilars at the end of April (reported on our blog here), yesterday FDA released another “Question and Answer” guidance in draft form. The draft guidance is called...more

Republican HELP Committee Members Request FDA to Step Up Finalizing Biosimilars Guidances and Transparency

by McGuireWoods LLP on

On April 30, 2015, Senators on the Health Education Labor and Pensions Committee (HELP) urged FDA to provide additional guidance on “important issues relating to the review and approval of license applications for biosimilar...more

Amgen v. Sandoz: Federal Circuit Grants Injunction Pending Appeal

Yesterday the Federal Circuit granted Amgen’s motion for an injunction pending appeal in Amgen v. Sandoz, the first appeal to squarely address the patent litigation provisions of the Biologics Price Competition and Innovation...more

Recently Finalized FDA Guidance Indicates Some Flexibility for Biosimilars

by Polsinelli on

Earlier this month the Food and Drug Administration ("FDA") published three industry guidances for the Biologics Price Competition and Innovation Act of 2009 ("BPCIA")....more

Otsuka’s Orphan Drug Exclusivity Claims: FDA Rips Off the Band-Aid Early

by McGuireWoods LLP on

On April 20, 2015, FDA filed a brief in Opposition to Plaintiff’s Motion for Temporary Restraining Order (“TRO”) or Preliminary Injunction (“PI”), addressed how Otsuka Pharmaceutical Co., Ltd. Otsuka Pharmaceutical...more

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

by K&L Gates LLP on

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

FDA Approves Biosimilar Agent Zarxio: Dawn of a New Era in Pharmaceutical Therapy and Product Liability Law

by Wilson Elser on

The FDA's approval on March 6, 2015, of Sandoz's Zarxio (filgrastim-sndz) is a momentous occasion for pharmaceutical therapy and product liability law in the United States. Catching up with Europe (where Sandoz's identical...more

Orange Book Patent Listing and Patent Certifications: Key Provisions in FDA’s Proposed Regulations Implementing the Medicare...

by Ropes & Gray LLP on

On February 6, 2015, the United States Food and Drug Administration (FDA) issued long-awaited proposed regulations to implement portions of the Medicare Modernization Act of 2003 (MMA). Consisting of almost one hundred pages...more

ODAC Committee Votes to License Sandoz’s Zarxio®

by K&L Gates LLP on

As noted in our previous client alert, FDA Accepts First Biosimilar Application Filed under Section 351(k) of the Public Health Service Act, Sandoz Inc. (“Sandoz”) filed the first biosimilar application under the Biologics...more

Comments Sought by December 19th on the FDA's Proposed Criteria for "First Generic" Applications

by Katten Muchin Rosenman LLP on

This morning, the Food and Drug Administration (FDA) opened a public docket and requested comments on its proposed criteria for expedited review of "first generic" Abbreviated New Drug Applications (ANDAs). The comment period...more

PGR Report -- The Attack of 35 U.S.C. § 112

Last week, on September 2, 2014, Accord Healthcare, Inc. ("Accord") filed what appears to be the second-ever Post-Grant Review ("PGR") (see Petition). This PGR was for U.S. Patent No. 8,598,219 ("the '219 Patent"), which is...more

Finally, A Biosimilar Application Has Been Accepted By The FDA

In what is thought to be the first application accepted under the new biosimilar pathway created by the Biologics Price Competition and Innovation (BPCI) Act, Sandoz announced last Thursday that the U.S. Food and Drug...more

FDA Draft Guidance Proposes Change to Combination Product Exclusivity Policy

by Morgan Lewis on

New market exclusivity opportunities emerge for pharmaceutical companies. In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more

FDA Intends to Grant Five Years of Market Exclusivity to Fixed-Dose Combination Drugs Containing One New Drug Substance

Fixed-dose combination drug products are becoming increasingly important in the treatment of patients with diabetes, cardiovascular disease, and infectious disease. Within the last two decades, the U.S. Food and Drug...more

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