Intellectual Property Science, Computers & Technology Administrative Agency

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Amgen Inc. v. Sandoz Inc. Federal Circuit Decision on BPCIA

On July 21, 2015, the United States Court of Appeals for the Federal Circuit issued its decision in Amgen Inc. v. Sandoz Inc., interpreting key provisions in the Biologics Price Competition and Innovation Act (“BPCIA”). In a...more

Biotech-specific Subject Matter Eligibility Materials Delayed

Pursuant to the Notice published in the Federal Register today, the U.S. Patent and Trademark Office provided additional materials related to the Office's interpretation of what does (and what does not) satisfy the subject...more

New Jersey Rulings Allay Personal Jurisdiction Concerns Raised by Daimler and Goodyear

Two judges in the U.S. District Court for the District of New Jersey have denied motions to dismiss for personal jurisdiction in Hatch-Waxman litigations based on the defendants’ compliance with New Jersey’s foreign...more

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

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

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

Submission of Supplemental Evidence in an IPR May Be Submitted After the Due Date - International Business Machines Corp. v....

Addressing the circumstances for submitting supplemental evidence in an inter partes review (IPR), the Patent Trial and Appeal Board (PTAB or Board) allowed the petitioner to submit a responsive declaration after the due date...more

PTAB Issues Dissent for Requested Adverse Judgment - Target Corp. v. Destination Maternity Corp.

In a case with more twists that a Game of Thrones plot, an unexpected dissent issued from an order of the Patent Trial and Appeal Board (PTAB or Board) granting the patent owner’s requested cancelation of the challenged...more

Patent Opposition System - 2014 revision to Japan’s Patent Act introduces new method for challenging patent validity in an...

The 2014 revision of the Japanese Patent Act created an Opposition System to provide a simpler procedure for third parties to challenge patent validity and amended the scope of the existing Invalidation Trial System. This...more

Activities For sNDA and Citizen’s Petition Protected by “Safe Harbor” - Classen Immunotherapies, Inc. v. Elan Pharmaceuticals,...

In a case addressing the “safe harbor” provision of 35 U.S.C. § 271(e)(1), the U.S. Court of Appeals for the Federal Circuit affirmed the district court’s ruling that information submitted to the U.S. Food and Drug...more

Preparing For The Obvious At The PTAB

There is little debate that inter partes reviews have proven to be an effective means of challenging the validity of a patent. During the first two-and-a-half years, more than 73 percent of claims originally challenged in IPR...more

Newsflash, Politico: ‘Patent Death Squad’ Alive and Well

Politico, the popular political journalism publication, recently ran the story “Patent Reform Advocates: PTO Process Not Patent ‘Death Squad.’” The story was based on a blog post by patent reform advocate Unified Patents. ...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

USPTO Pilots Expedited Patent Appeal Program But at What Price?

In a June 15, 2015 Federal Register Notice, the USPTO announced the Expedited Patent Appeal Pilot program, which will run until 2,000 ex parte patent appeals are expedited under the program, or until June 20, 2016, whichever...more

New USPTO Expedited Patent Appeal Pilot Program

On June 15, 2015, the United States Patent and Trademark Office (“USPTO”) issued Notice in the Federal Register announcing a new pilot program, the Expedited Patent Appeal Pilot. Under the program an appellant may have an ex...more

Federal Circuit Issues First Reversal & Remand of an Inter Partes Review in Microsoft Corporation v. Proxyconn, Inc. Addressing...

The Federal Circuit issued its first reversal and remand of a final decision in an inter partes review issued by the Patent Trial and Appeal Board (“PTAB”). In Microsoft Corporation v. Proxyconn, Inc., No. 14-1543, a panel...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

PTAB Grants Fourth Motion to Amend in an IPR Proceeding

For only the fourth time in its history, the Patent Trial and Appeal Board (“PTAB”) has granted a motion to amend in an inter partes review (“IPR”) proceeding, finding all substitute claims proposed by the patent owner...more

Patent Trial and Appeal Board Grants Rare Motion to Amend Claims in Inter Partes Review

On June 5, 2015, a three-judge panel at the Patent Trial and Appeal Board (“PTAB”), granted a motion to amend in an inter partes review (“IPR”) proceeding, ruling that the patentee Neste Oil Oyj (“Neste”) could amend the...more

IP/Unfair Comp. Case Applies Buckman

The very name “intellectual property law” suggests it’s not for us. There are episodes of The Simpsons that seem too complicated for our pretty little heads. Anything deemed “intellectual” scares us away. We usually race...more

Interim Guidance Status Check

As of Tuesday, June 16th, we have been living with the U.S. Patent and Trademark Office's "2014 Interim Guidance on Patent Subject Matter Eligibility" ("Guidance") for six months. Although the USPTO subsequently issued some...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

PTAB to Consider Motion for “Abuse of Process” Sanctions Against Kyle Bass Hedge Fund IPR Petition

In a recent order, the Patent Trial and Appeals Board (PTAB) indicated that it will consider a motion for sanctions based on a claim of “abuse of process” in Inter Partes Review (IPR) proceedings filed by the Coalition for...more

Federal Circuit Oral Arguments in Amgen v. Sandoz

On June 3, the parties in Amgen v. Sandoz presented oral arguments to the Federal Circuit as part of their dispute over the Biologics Price Competition and Innovation Act (BPCIA). The appeal is focused on two questions:...more

Supreme Court Corner: Q2 2015

B&B Hardware, Inc. v. Hargis Industries, Inc. Trademark - Holding: A Trademark Trial and Appeal Board (TTAB) ruling refusing registration on likelihood of confusion grounds can have preclusive effect on a district...more

D.C. Circuit Affirms: FTC Can Change HSR Rules Targeted at Pharmaceutical Patents

In a confluence of IP and antitrust law, a three judge panel for the D.C. Circuit recently affirmed a lower court decision upholding the Federal Trade Commission’s (“FTC”) 2013 modification of regulations under the Hart Scott...more

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