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Split Federal Circuit Upholds Constitutionality of Single PTAB Panels Rendering Both Institution & Final Written Decisions

On January 13, 2016, the Federal Circuit affirmed the decision of the PTAB in Ethicon Endo-Surgery, Inc. v. Covidien LP, IPR2013-00209, that all of the claims of U.S. Patent 8,317,070 are obvious. While the obviousness...more

Just Because You Can, Doesn’t Mean You Should

In Ethicon Endo-Surgery, Inc. v. Covidien LP, [2014-1771](January 13, 2016), the Federal Circuit held that the same panel of the PTAB can make the decision to institute an IPR and the final written decision, and that the PTAB...more

Cuozzo Speed Technologies, LLC v. Lee

The Supreme Court on Friday granted certiorari to review the Federal Circuit's decision that the U.S. Patent and Trademark's Patent Trial and Appeal Board was entitled to perform claim construction in inter partes review...more

USPTO Implementation of AIA Does Not Violate Due Process: Federal Circuit Affirms the PTAB Panel Determining Institution of an IPR...

In Ethicon Endo-Surgery, Inc. v. Covidien LP, a 2-1 panel split of the Federal Circuit held that neither the American Invents Act (“AIA”) nor the Constitution precludes the same panel of the Patent Trial & Appeal Board...more

Living in a Nonmaterial World: Determining IP Rights for Digital Data

The U.S. International Trade Commission (ITC) regulates U.S. trade and oversees Section 337 investigations that address unfair competition based on alleged infringement of intellectual property rights. The ITC has been a...more

Top Stories of 2015: #6 to #10

After reflecting upon the events of the past twelve months, Patent Docs presents its ninth annual list of top patent stories. For 2015, we identified twenty stories that were covered on Patent Docs last year that we believe...more

Knobbe Martens Client STAR Envirotech Wins Affirmance of IPR Decision Finding Patent Valid

On December 31, 2015, the U.S. Court of Appeals for the Federal Circuit affirmed the Patent Trial and Appeal Board’s decision that a STAR Envirotech patent relating to its evaporative emission testing tools is valid and not...more

Inter Partes Review Is Not for Pending Claims - Ford Motor Co. v. Signal IP, Inc.

Addressing the issue of the utility of consolidating an inter partes review (IPR) with an ex parte reexamination proceeding, the U.S. Patent and Trademark Office’s (PTO) Patent Trial and Appeal Board (PTAB or Board) denied a...more

Top Patent Law Stories In 2015

I will try to keep this post as brief as possible, since I posted at length on all of the stories. There was a lot of IP action in 2015 – much involving the Fed. Cir. and Supreme Court’s resolution of cases in progress in...more

ITC Section 337 Update – December 2015

Amendments To Federal Rules Of Civil Procedure Announced – Effective December 1, 2015, the Federal Rules of Civil Procedure (“FRCP”) have been amended with respect to pleading requirements and discovery. Notably, the FRCP do...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

FDA Finalizes Guidance For Formal Meetings Between the FDA and Biosimilars Applicants

On November 17, 2015, the FDA finalized a guidance document, that was first issued as a draft in March 2013, regarding formal meetings between the FDA and biosimilars applicants. Because meetings with biosimilars applicants...more

Apotex Follows the BPCIA “Patent Dance” Again

The first biosimilar makers to file regulatory applications with FDA attempted to bypass all or a subset of the patent litigation provisions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Apotex, the...more

Nearly Two Years After Dismissal of its Declaratory Judgment Action, FDA Accepts for Review Sandoz’s Application for a Biosimilar...

Sandoz Inc. announced on October 2, 2015 that FDA accepted its regulatory application for a proposed biosimilar of Amgen Inc.’s biologic arthritis drug Enbrel for review. The acceptance comes years after Sandoz attempted to...more

ITC Section 337 Update – October 2015

ITC Proposes Extensive Changes To Rules For Adjudicating Section 337 Investigations – On September 24, 2015, the Commission published a Notice of Proposed Rulemaking in the Federal Register announcing proposed changes to its...more

ITC Section 337 Update – September 2015

Judge MaryJoan McNamara Appointed New Administrative Law Judge at U.S. International Trade Commission – On August 17, 2015, the ITC issued a news release announcing that Judge MaryJoan McNamara has been appointed as an ALJ....more

The Federal Circuit's First AIA Reversal

Since the implementation of the inter partes review (IPR) by the America Invents Act on September 16, 2012, IPR proceedings have been viewed as putting one nail in the coffin for patents. In the first two and a half years of...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

Federal Circuit Upholds ITC Interpretation of § 337 to Cover Induced Infringement

Suprema, Inc. and Mentalix Inc. v. Int’l Trade Comm’n, Case No. 12-1170 (Fed. Cir. Aug. 10, 2015) (Reyna, J.) (O’Malley, Proust, Lourie, and Dyk JJ., dissenting). By way of background, appellee Suprema manufactures...more

Riddle Me This: The Federal Circuit Provides a Measure of Clarity to the Enigmatic Biosimilar Approval Pathway

In Amgen Inc. v. Sandoz Inc. (No. 2015-1499), a fractured panel of the Federal Circuit Court of Appeals recently decided two issues of first impression relating to the Biologics Price Competition and Innovation Act of 2009...more

En Banc Federal Circuit Upholds ITC’s Broad Definition of Induced Infringement

Earlier this week, an en banc Federal Circuit interpreted the scope of Section 337 of the Tariff Act (19 U.S.C. § 1337), which proscribes importation of "articles that … infringe" a U.S. patent. (Suprema, Inc. v....more

Bass Opposes Sanctions and Defends His Actions at the PTAB

On July 28, 2015, Celgene filed a motion for sanctions in IPR Nos. 2015-01092 and 2015-01103, proceedings challenging the validity of Celgene patents covering Thalomid®, Revlimid® and Pomalyst®. Celgene specifically...more

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

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