Litigation – Page 9 – IP Law Watch

Federal Circuit Confirms Cuozzo Does Not Disturb § 314(d) Bar on Appellate Review of PTAB Reconsideration of IPR Institutions

Oct 25 2016

The Federal Circuit’s recent decision in Medtronic, Inc. v. Robert Bosch Healthcare Systems, Inc., addressed the effect of the Supreme Court’s decision in Cuozzo Speed Techs., LLC v. Lee, 136 S. Ct. 2131 (2016), on the issue of whether termination of instituted inter partes review (“IPR”) proceedings based on a failure to meet the statutory filing requirements for a petition (namely, to identify all real parties-in-interest) would be barred from review by 35 U.S.C. § 314(d). The Court found that Cuozzo did not disturb Federal Circuit precedent as to the § 314(d) bar on review for reconsiderations of institution decisions.

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By: Rebecca M. Cavin, James (Kwangho) Jang, Jason A. Engel

Practical Implications from the Federal Circuit’s Rare en Banc Reversal in Apple v. Samsung

Oct 12 2016

In a precedential opinion issued en banc on Friday, October 7, 2016, the Federal Circuit overturned a panel decision, affirming and reinstating the district court’s judgment and the jury’s verdict. The majority opinion scrutinized and at times scolded the panel for taking on a role well outside of its appellate function and erroneously relying on extrinsic evidence to modify an agreed to and unappealed claim construction and hold claims invalid for obviousness. The majority characterized the appellate court’s function as “limited” and “requiring appropriate deference be applied to the review of fact findings.”

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By: Jason A. Engel, Rebecca M. Cavin, Gina A. Jenero

Fall Brings a Flurry of Biosimilar Approvals: FDA Approves Biosimilars of Enbrel® and Humira®

Oct 03 2016

The United States biosimilars market is beginning to grow, with two recent approvals for biosimilars: Erelzi^® and Amjevita^®.

On August 30, 2016, the Food & Drug Administration (“FDA”) approved Sandoz’s application for a biosimilar of Enbrel^®. The product is called Erelzi and is the first biosimilar of etanercept to be approved by the FDA. Like Enbrel, Erelzi is administered by injection and is approved to treat moderate to severe rheumatoid arthritis and moderate to severe plaque psoriasis, among other conditions. Erelzi is approved as a biosimilar, not interchangeable, product. It is identified as etanercept-szzs.

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

Sep 21 2016

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 Federal Circuit decided Gilead Sciences Inc. v. Natco Pharma Ltd. [1] Judge Wolf held U.S. Patent No. 6,284,471 (the “’471 patent”) invalid for obviousness-type double patenting over U.S. Patent No. 6,790,444 (the “’444 patent”) because the ’471 patent expired later due to the changes to patent terms under the Uruguay Round Agreements Act (“URAA”), even though both patents claim priority to the same application and the ’471 patent issued years before the ’444 patent. [2]

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By: Margaux L. Nair, Trevor M. Gates, Peter Giunta, Theodore J. Angelis

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

Aug 19 2016

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 regarding Humira® that took place over the past two months: (1) Amgen Inc., which is pursuing a biosimilar version of Humira®, received a recommendation toward approval from the U.S. Food and Drug Administration (“FDA”); (2) AbbVie sued Amgen for patent infringement in the U.S. District Court for the District of Delaware, alleging that Amgen infringed several of its patents by seeking FDA approval of its biosimilar version of Humira®; and (3) the U.S. Patent and Trademark Office instituted inter partes review (“IPR”) of a Humira® patent at the request of Boehringer Ingelheim.

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By: Margaux L. Nair, Trevor M. Gates, Peter Giunta, Theodore J. Angelis

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

Jul 21 2016

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”)[1] and must wait 180 days after giving Amgen post-licensure notice before commercially marketing its FDA-licensed biosimilar product.[2] In affirming the district court’s preliminary injunction against Apotex until the end of the 180-day period, the Federal Circuit followed its previous holding in Amgen v. Sandoz,[3] a split-panel decision. The court reiterated the bright-line rule that a biosimilar applicant must provide notice of commercial marketing to a reference product sponsor after the FDA grants licensure of the biosimilar product and cannot launch its product until 180 days following that post-licensure notice.

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By: Margaux L. Nair, Trevor M. Gates, Peter Giunta, Kenneth C. Liao

Federal Circuit Holds That an Offer to Sell a Drug Product Was a Patent-Invalidating Offer for Sale under Pre-AIA § 102(b) Even Though the Offer Lacked “Safety and Liability Terms”

Jun 07 2016

On May 13, 2016, the Federal Circuit determined that Merck’s crystalline calcium salt of tetrahydrofolic acid (“MTHF”) had been the subject of a commercial offer for sale, and held Merck’s MTHF claim in U.S. Patent No. 6,441,168 is invalid under the on-sale bar provision of pre-AIA § 102(b). Specifically, the Federal Circuit held that Merck made an invalidating offer to sell MTHF when it sent a fax that included price, quantity, and delivery terms, and rejected the district court’s determination that additional, industry standard “safety and liability terms” were required for there to have been an “offer for sale.”

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by Trevor M. Gates, Theodore J. Angelis, Peter Giunta

ANDA Filing May Subject a Pharmaceutical Company to Personal Jurisdiction in Patent Infringement Suits Anywhere in the U.S.

Jun 06 2016

By: Trevor M. Gates, Theodore J. Angelis, and Peter Giunta

The Federal Circuit recently held that filing an abbreviated new drug application with the FDA for a generic drug product, and thus indicating an intention to sell that product in every state (including Delaware), subjected Mylan to specific personal jurisdiction in Delaware.

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What You Need to Know About the Recent Federal Circuit Rule Changes

May 02 2016

By: Devon C. Beane, Jason A. Engel, and Theodore J. Angelis

The U.S. Court of Appeals for the Federal Circuit recently implemented significant amendments to its Rules of Practice. The changes apply to all cases docked on or after April 1, 2016. In large part, the amendments were made to comport existing practices or requirements for electronic case filing with the Rules. Other changes, such as those relating to confidentiality, reflect a wholesale shift in Federal Circuit practice. This alert provides a brief overview of some of the more significant amendments. Please click here to read the full alert.

Roger Maier and Assos of Switzerland SA v ASOS plc and ASOS.com Limited

Apr 02 2015

In a long-anticipated decision, the Court of Appeal of England and Wales (Court of Appeal) on Wednesday held, by 2-1 majority, that use of the ASOS brand by the popular online clothing retailer was defensible under the ‘own name’ defence in Community trade mark law.

The decision, which reversed the findings of the judge at first instance, will be appealed to the Supreme Court (the highest court in England and Wales) by the Claimants, who own the successful ASSOS cycling clothing business and are the proprietors of a Community trade mark for the ASSOS word mark, which has been registered since 2005.

Category:Litigation