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Read Intellectual Property Law updates, alerts, news, and legal analysis from leading lawyers and law firms:

Biotech Patent Applications May be Eligible to Receive Benefits From Ongoing USPTO Initiatives

by Knobbe Martens on

A pair of ongoing USPTO initiatives, Patents for Humanity and Patents 4 Patients, offer incentives that certain biotechnology patent applications may be eligible for. Patents for Humanity is open to patents and applications...more

Rx IP Update - October 2017

by Smart & Biggar on

Pfizer obtains orders of prohibition on polymorphic form patent - On September 22, the Federal Court, in a pair of decisions, granted Orders of prohibition under the Patented Medicines (Notice of Compliance) Regulations...more

PTAB Declines Request to Review Method of Treating Lymphoma Claim

A Patent Trial and Appeal Board (PTAB) panel declined to institute an inter partes review (IPR) of a claim directed to a method for treating low grade B-cell non-Hodgkin’s lymphoma. The challenged method required patients to...more

USPTO Finds SureGene Personalized Medicine Treatment Unpatentable Under Mayo

by Foley & Lardner LLP on

In Ex Parte Timothy, the USPTO Patent Trial and Appeal Board (PTAB) affirmed the Examiner’s rejection of personalized medicine treatment claims. This decision highlights the PTAB’s willingness to invalidate claims that it...more

FDA Marketing Exclusivity Periods Limited To Same Active Moiety

by Foley & Lardner LLP on

In Otsuka Pharm. Co., Ltd. v. Price, No. 16-5229 (D.C. Cir. Aug. 29, 2017), the U.S. Court of Appeals for the District of Columbia Circuit affirmed the district court decision upholding FDA’s “same moiety” test for defining...more

Publication of Final Regulations on Patent Linkage and Term Restoration

by Smart & Biggar on

On September 7, 2017, the Government of Canada published final pharmaceutical regulations flowing from CETA. According to an Order in Council, the new regulations will be in force on September 21, 2017....more

Minnesota Patent Litigation Wrap-Up – July 2017

by Fish & Richardson on

This post continues our monthly summary of patent litigation in the District of Minnesota, including short summaries of substantive orders issued in pending cases. In July 2017, there were three notable decisions for...more

Rx IP Update - April 2017

by Smart & Biggar on

Teva awarded section 8 damages regarding pregabalin and olanzapine - On March 30 and April 4, 2017, the Federal Court released two decisions on the merits under section 8 of the Patented Medicines (Notice of...more

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

by Knobbe Martens on

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

by Womble Bond Dickinson on

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

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