News & Analysis as of

Pharmaceutical Patents

PTAB Grants Rare Rehearing Due To Insufficient Evidence Of Obviousness

by Jones Day on

In Coalition For Affordable Drugs VI, LLC v. Celgene Corp. (2015-01096, -01102, -01103), the PTAB granted Patent Owner Celgene’s request for rehearing of a final written decision that had found the challenged claims invalid...more

Doctrine of Equivalents and Prosecution History Estoppel Around the World

Please see full Doctrine of Equivalents Chart for Countries around the World. ...more

Celgene Notches Rare Win On PTAB Request For Rehearing

by Foley & Lardner LLP on

The recent decisions of the USPTO Patent Trial and Appeal Board (PTAB) granting Celgene’s requests for rehearing in parallel Inter Partes Review proceedings brought by Kyle Bass’s Coalition for Affordable Drugs (CFAD) are...more

District of Delaware “Clips”- Off Venue-Discovery for Medical Device Company but Allows It for Pharmaceutical Company

by Orrick - IP Landscape on

Boston Sci. Corp. v. Cook Grp., Inc., No. 15-980-LPS-CJB, 2017 U.S. Dist. LEXIS 146126, at *2 (D. Del. Sep. 11, 2017); Bristol-Myers Squibb Co. v. Mylan Pharm., Inc., No. 17-379-LPS, 2017 U.S. Dist. LEXIS 146372, at *3 (D....more

A Seismic Shift in UK Patent Infringement Law - Actavis v. Eli Lilly

In a decision that appears to have introduced a doctrine of equivalents for the first time, the UK Supreme Court has shifted the laws on patent infringement in Actavis v. Eli Lilly UK [2017] UKSC 48. While this case...more

District Court Finds Mallinckrodt Patents Claim Unpatentable Natural Phenomena

by Knobbe Martens on

The recent district court ruling in INO Therapeutics LLC et al v. Praxair Distribution, Inc. et al employed the two-step analytical framework of Mayo/Alice to evaluate subject matter eligibility under 35 U.S.C. § 101, and the...more

Recent Trends on the U.S. Doctrine of Equivalents

U.S. courts have long recognized that a product or process which does not literally infringe a patent can nevertheless infringe under the "doctrine of equivalents" if it is equivalent to the claimed invention. The percentage...more

Summary Judgment Motion on Infringement in Immunex v. Sandoz

by Goodwin on

A hearing on summary judgment on infringement of claim 1 of U.S. Patent No. 8,722,631 for the biosimilar version of etanercept has been set for next month before Judge Claire C. Cecchi....more

Sanofi & Regeneron Seek to Assert Inequitable Conduct Defense in Dupilumab Patent Litigation

by Goodwin on

As we previously reported, Immunex sued Sanofi and Regeneron earlier this year in the Central District of California alleging that the sale of Sanofi and Regeneron’s FDA-approved Dupixent® (dupilumab) product would infringe...more

Global Patent Prosecution Newsletter - September 2017

Worldwide Doctrine of Equivalents and Prosecution History Estoppel - The doctrine of equivalents (DOE) arises in the context of a patent infringement action where the accused product or process does not literally infringe...more

Recent IPR Updates

by Goodwin on

The PTAB has been a busy place for biologics patents in the past few weeks. Here are some of the highlights...more

Amgen v. Hospira: Rulings on Motions in Limine

by Goodwin on

We reported earlier this week that the district court in Amgen v. Hospira denied Hospira’s motion for summary judgment of non-infringement of its proposed biosimilar of Epogen®/Procrit® (epoetin alfa) and granted-in-part and...more

Pharmaceutical Company Seeks to Use Tribal Sovereign Immunity to Avoid Inter Partes Review

by Snell & Wilmer on

Allergan announced on September 8, 2017, that it had transferred its patents covering the drug Restasis to the Saint Regis Mohawk Tribe and will pay the tribe $13.75 million. The tribe is also eligible to receive $15 million...more

Framework for Swiss-form claim construction in Australia: Is it really about objective intent?

by FPA Patent Attorneys on

This article looks at the current status of construction of Swiss-style claims in Australia, provides a framework by which construction of Swiss-style claims can be assessed, and concludes that although the position is not...more

The Biosimilars Council Supports Sandoz’s Preemption Position in Federal Circuit Amicus Brief

by Goodwin on

Last week the Biosimilars Council submitted an amicus brief in the Federal Circuit remand proceedings for Amgen v. Sandoz, arguing that Amgen’s state-law claims for Sandoz’s failure to comply with the patent dance’s...more

Pharma and Biologic Disputes in Canada – New Regulations Take Effect September 21, 2017

by Bennett Jones LLP on

Pharma and biologics manufacturers will soon have big decisions to make regarding their pharmaceutical and biological product strategy in Canada. On September 6, 2017, the Governor General in Council, on recommendation of the...more

BI Files Answer to AbbVie’s Complaint in Adalimumab Litigation

by Goodwin on

As we previously reported, last month AbbVie filed a complaint against Boehringer Ingelheim (BI) in the U.S. District Court for the District of Delaware regarding BI’s aBLA for a biosimilar version of AbbVie’s Humira...more

Allergan and the Saint Regis Mohawk Tribe Enter Patent Agreement to Defend Against IPR of RESTASIS® Patents

by Knobbe Martens on

In a creative move to take advantage of recent PTAB decisions regarding Sovereign Immunity, (see e.g., Covidien LP v. University of Florida Research Foundation, IPR2016-01274 and Neochord, Inc. v. University of Maryland,...more

Scheduling Order Entered in Janssen v. Samsung Bioepis

by Goodwin on

This morning, the district court in Janssen v. Samsung Bioepis, which concerns Samsung Bioepis’ Renflexis® (infliximab-abda) biosimilar product, entered a pretrial scheduling order. The scheduling order calls for, among other...more

Pharma Patents Assigned to Indian Tribe to Thwart Inter Partes Review

by Foley & Lardner LLP on

As we have previously reported, sovereign immunity of state universities (who are instruments of state government) has been used to avoid IPRs under the immunity clause of the US Constitution (“Sovereign Immunity of State...more

U.S. Argues Amgen’s State Law Claim Preempted by BPCIA, Supporting Sandoz

by Goodwin on

Yesterday, in the remanded appeal in Amgen v. Sandoz, the United States submitted an amicus brief to the Federal Circuit that generally supports Sandoz’s position that Amgen’s state-law claim for an injunction under...more

FDA re-approves Mylotarg® antibody-drug conjugate seven years after it had been withdrawn from the market

by Knobbe Martens on

Seven years after Mylotarg® (gemtuzumab ozogamicin) was voluntarily withdrawn from the market, the U.S. Food and Drug Administration has re-approved Mylotarg® product....more

Amgen v. Hospira: Litigation Update

by Goodwin on

With the September 18, 2017 trial date fast approaching, the district court in Amgen v. Hospira last week denied Hospira’s motion for summary judgment of non-infringement of its proposed biosimilar of Epogen®/Procrit®...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

Judge Sleet Invalidates Patents-In-Suit After Finding Of Obviousness And Enters Judgment In Favor Of Alleged Infringer In...

by Fox Rothschild LLP on

Following a five-day bench trial in the matter in February 2017 and after having considered the entire record in the case and the applicable law, the Court, through Memorandum, entered by The Honorable Gregory M. Sleet in...more

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