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Bevacizumab Biosimilar Update

by Goodwin on

There has been some recent activity regarding proposed biosimilars to Roche’s Avastin (bevacizumab). Avastin is indicated for the treatment of various types of cancers, including colorectal, lung, and kidney cancer....more

Abbvie v. Amgen (Adalimumab) Reassigned to Judge Goldberg

by Goodwin on

Today, the District of Delaware reassigned the AbbVie v. Amgen (adalimumab) litigation from retiring Senior Judge Sue L. Robinson to a visiting judge, Judge Mitchell S. Goldberg of the Eastern District of Pennsylvania. Judge...more

[Webinar] How Far Will Obviousness-Type Double Patenting Go: Considerations and Strategies - August 9th, 10:00 am China, CST

Recent decisions handed down by the U.S. Court of Appeals for the Federal Circuit have expanded the reach of non-obviousness type double patenting, leading to new grounds for rejection before the U.S. Patent and Trademark...more

Federal Circuit Finds Velcade Patent Not Obvious Under Lead Compound Analysis

by Foley & Lardner LLP on

In Millennium Pharmaceuticals, Inc. v. Sandoz, the Federal Circuit reversed the district court decision that invalidated one of the Orange Book-listed patents covering the anti-cancer drug Velcade. In so doing, the court...more

Federal Circuit Thoroughly Reverses District Court Findings of Velcade® Patent Obviousness

On July 17, 2017, the United States Court of Appeals for the Federal Circuit reversed, in a precedential opinion in Millennium Pharmaceuticals, Inc. v. Sandoz, Inc., No. 2015-2066 (Fed. Cir. July 17, 2017), a district court...more

Final Written Decision Not So Final in Eyes of The ITC

by Jones Day on

The ITC recently continued its trend of giving little deference to parallel PTAB IPR proceedings. In Certain Network Devices, Related Software and Components Thereof (II), Inv. No. 337-TA-945, the ITC denied a request to...more

Janssen Biologic Tremfya Secures FDA Approval Following Use of Priority Review Voucher

by Knobbe Martens on

On July 13, 2017, the U.S. Food and Drug Administration approved Tremfya (guselkumab), a biologic manufactured by Janssen Biotech, for the treatment of moderate-to-severe plaque psoriasis patients who are candidates for...more

Fresh From the Bench: Precedential Patent Cases From the Federal Circuit

The Circuit issued only one precedential patent case this week, reversing a determination of obviousness as to a Millennium Pharmaceutical patent covering its blockbuster cancer drug Velcade®, thus extending the life of...more

5 Key Takeaways: Three Years After Octane Fitness – Patent Litigation Fee Fights

Kilpatrick Townsend’s Clay Holloway, a partner in the firm’s Atlanta office, recently participated in a webinar as part of a panel to discuss the issue of attorney fees three years after the U.S. Supreme Court decision in...more

PTAB Life Sciences Report - July 2017 #3

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Pfizer, Inc. v. Biogen, Inc. PTAB Petition: IPR2017-01115; filed March 24, 2017....more

Samsung Bioepis and Merck & Co. Launch Renflexis, A Lower-Priced Competitor to Inflectra

by Goodwin on

Merck & Co. and Samsung Bioepis announced today the U.S. launch of Renflexis (infliximab), a biosimilar of Janssen’s Remicade. Renflexis was approved on April 21 by the FDA for all eligible indications. ...more

Labor & Employment E-Note - July 2017

by Burr & Forman on

Employers who have been anxiously awaiting an answer as to whether the Department of Labor (“DOL”) will continue to defend the Obama Administration’s controversial overtime rule that was temporarily blocked by a federal court...more

Rx IP Update - July 2017

by Smart & Biggar on

Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful - As previously reported, on June 30, 2017, the Supreme Court of Canada granted AstraZeneca’s appeal in the NEXIUM...more

Approved Biosimilar Products Around The world

Please see full chart below for approved biosimilar products around the world. ...more

Third Circuit Rules “McCarthy Test” Determines Ownership of Unregistered Trademarks

The Third Circuit has held that where a manufacturer and its exclusive distributor have no written contract designating which party owns an unregistered trademark, the “McCarthy test,” rather than the “first use test,” should...more

Judge Sleet Denies Defendants’ Motion To Transfer Venue In Patent Infringement Action

by Fox Rothschild LLP on

By Memorandum Opinion entered by The Honorable Gregory M. Sleet in Koniklijke Philips N.V. v. HTC Corp., Civil Action No. 15-1125-GMS (D.Del. July 18, 2017), the Court denied Defendants’ Joint Motion to Transfer Venue which...more

Biosimilar Uptake and Patent Litigation in Japan

Biosimilar uptake in Japan has been a bit mixed, but according to experts the volume shares of biosimilars suggests it could be a key market in years to come. The Pharmaceuticals and Medical Devices Agency (PMDA), which is...more

Pharma and Biologics Disputes in Canada—Big Changes for Big and Small Molecule Litigation

by Bennett Jones LLP on

The patent litigation that propels generic and biosimilar products to market will soon change dramatically. July 15, 2017, marked the release of long-awaited proposed amendments to the Patented Medicines (Notice of...more

Biosimilars in Europe

Europe has led the way globally with respect to biosimilar medicines since 2005. In that year, the European Medicines Agency (EMA) issued regulatory guidelines for the development and assessment of biosimilars....more

Unexpected Results of an Obvious Process are Non-obvious

In Millennium Pharmaceuticals, Inc., v. Sandoz Inc., [2015-2066, 2016-1008, 2016-1009, 2016-1010, 2016-1109, 2016-1110, 2016-1283, 2016-1762] (July 17, 2017), the Federal Circuit reversed the district court, finding that...more

Sandoz Files Two Petitions for IPR of Two AbbVie Patents Related to Humira

by Goodwin on

Sandoz has filed a petition for inter partes review of AbbVie’s U.S. Patent No. 8,802,100 (IPR2017-01823), which claims stable formulations of an anti-TNFa antibody identified in the petition as Humira® (adalimumab). Sandoz...more

Federal Circuit Finds That Fetal Diagnosis Claims Survive Written Description Attacks

by Knobbe Martens on

Stanford University v. The Chinese University of Hong Kong. Federal Circuit Appeal No. 2015-2011. Decided June 27, 2017. In an appeal from the Patent Trial and Appeal Board (PTAB), the Federal Circuit held that claims...more

PILLOW TALK: A Threat to Trade Secrets?

It turns out that, even in romantic relationships, some things are best kept secret. On July 7, 2017, Teva Pharmaceuticals USA, Inc. filed a complaint in the Eastern District of Pennsylvania alleging that a former executive...more

Coherus Challenges One AbbVie Humira Patent In Four PTAB Proceedings

by Foley & Lardner LLP on

I’ve written previously about sequential PTAB challenges to the same patent, but the dispute between Coherus Biosciences Inc. and AbbVie Biotechnology Ltd. has engendered six Inter Partes Review proceedings against the same...more

Is Your Website Accessible to Disabled Users? If Not, Courts Say You Could Be Violating the ADA

by Jaburg Wilk on

Yes, seriously. This is no longer a remote threat cautioned by overzealous lawyers. This is now a real threat that business owners should address now. If you own and/or operate a business, and the business has a website that...more

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