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Federal Circuit Patent Updates - July 2016 #2

WBIP, LLC v. Kohler Co. (No. 2015-1038, -1044, 7/19/16) (Moore, O'Malley, Chen) - Moore, J. Affirming denial of JMOL that patent was invalid as obvious and lacked an adequate written description, affirming finding of...more

Recent Decision in Halo Requires Reconsideration of Summary Judgment Motion on Willfulness

In a multi-district litigation, the district court had previously granted summary judgment in favor of the defendants on the issue of willful infringement. After the Supreme Court's decision in Halo Electronics, Inc. v. Pulse...more

ANDA Update - Volume 2, Number 2

180-Day Notice Period for Biosimilar Approval Is Always Mandatory and Enforceable by Injunction - Amgen Inc., v. Apotex Inc., (Fed. Cir. July 5, 2016) - A year after analyzing the patent dance and notice...more

Janssen Seeks Injunction Against Remicade Biosimilar Based On Cell Culture Patent

In a complaint filed June 14, 2016, Janssen Biotech Inc. seeks a preliminary injunction that would bar Celltrion and Hospira from selling the biosimilar version of Remicade® (infliximab) that received FDA approval April 2016,...more

The Defend Trade Secrets Act: Significant Recent Changes to Intellectual Property Law May Provide New Avenues for Protecting...

On May 11, 2016, President Obama signed into law the Defend Trade Secrets Act (“DTSA”), marking one of largest changes to intellectual property law since the America Invents Act of 2011. This legislation will allow companies...more

Amgen and Hospira Square Off Over BPCIA Private Right of Action After Amgen v. Apotex Ruling

Amgen and Hospira have fired off dueling letters to the court in their litigation over Amgen’s Epogen biosimilar, debating whether the U.S. biosimilar statute, the Biologics Price Competition and Innovation Act of 2009...more

No Exception to Statutory Requirement that a Biosimilar Applicant Provide Notice of Intent to Market its Product

Last week in Amgen Inc. v. Apotex Inc., No. 2016-1308 (Fed. Cir. July 5, 2016), a unanimous Federal Circuit panel ruled that under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), a biosimilar applicant...more

It’s Just Too Much

We’ve blogged before about the long-running appeal in the Polett v. Public Communications litigation. That’s the case where the plaintiff had knee implant surgery that was so successful she agreed to make a promotional video...more

Amgen Inc. v. Apotex Inc. (Fed. Cir. 2016)

Last year, the Federal Circuit described the Biologics Price Competition and Innovation Act ("BPCIA") as "a riddle wrapped in a mystery inside of an enigma" in the Amgen v. Sandoz case. Nevertheless, one of the provisions of...more

Federal Judge Dismisses Target Directors from Data Breached Related Derivative Suit After Special Litigation Committee Recommends...

The hurdles for claims against directors for failed oversight in connection with data breaches continue to increase. On July 7, 2016, District of Minnesota Judge Paul Magnuson released derivative claims against top Target...more

Merck Files DJ Complaint Against Genentech’s Cabilly III Patent

Merck Sharp & Dohme Corp. has challenged Genentech’s U.S. Patent No. 7,923,221 (Cabilly III) with a complaint for declaratory judgment in the Central District of California. The patent relates to methods to produce antibody...more

New Guidance on Mandatory Notice in the Biosimilar ‘Patent Dance’

The Federal Circuit’s recent decision in Amgen Inc. v. Apotex Inc., No. 16-1308, provides new guidance on the timeline of biosimilar approval and the impact to commercial marketing. The ruling weighed in on a key...more

Federal Circuit Requires 180 Day Notice For All Biosimilars, Even After Patent Dance

In Amgen v. Apotex, the Federal Circuit rejected Apotex’s arguments that the 180-day pre-marketing notice requirement does not apply to biosimilar applicants who participated in the “patent dance” process of the Biologics...more

Amgen v. Apotex: Analysis of the Fed. Cir. Opinion

As we posted on July 5, 2016, the Federal Circuit has issued its decision in Amgen v. Apotex, affirming the district court’s (S.D. Fla, J. Cohn) order preliminarily enjoining Apotex from launching its biosimilar version of...more

After Halo, District Court Concludes that Jury's Finding of Willfulness Is Still Appropriate

After a jury trial finding American Technical Ceramics Corp. ("ATC) willfully infringed Presidio Component's ("Presidio") patent, ATC filed a motion for a finding of no willful infringement based on the Supreme Court's...more

Breaking News: CAFC Affirms in Amgen v. Apotex

The Federal Circuit issued its decision in Amgen v. Apotex (re: Apotex’s Neulasta biosimilar) this morning. The Court affirmed the district court, holding that the commercial-marketing provision in 42 U.S.C. § 262(l)(8)(A)...more

6-Month Notice from a Biosimilar Sponsor Always Required — Says Federal Circuit

Our long-time readers know that there are many legal, regulatory, and scientific questions surrounding the Biologics Price Competition and Innovation Act (BPCIA), which was passed as part of the ACA and created a new...more

Apotex—Biosimilars Must Provide 180-Day Marketing Notice after FDA Approval

Apotex—Biosimilars Must Provide 180-Day Marketing Notice after FDA Approval July 06, 2016 According to the Federal Circuit, post-licensure notice 180 days before commercial marketing is mandatory for biosimilars....more

Ask the Public Adjustor: Covering Life with Wisdom*

I’ll come right out and admit it: I was a crasher at last night’s party. Though they helped me bluff my way in, every stitch of clothing I wore was borrowed, and the limo … it’s a long story, but let’s just say Uber. Then I...more

Halo Recognizes that Not All Infringers are Angels

In Halo Electronics, Inc. v. Pulse Electronics, Inc., 579 U.S. — (2016), the Supreme Court rejected the Federal Circuit’s two-step Seagate test for the award of enhanced damages under 35 USC 284, holding that the aware of...more

Federal Circuit Patent Updates - June 2016

Cuozzo Speed Technologies, LLC v. Lee (No. 2015-446, 6/20/16) (Roberts, Kennedy, Thomas, Ginsburg, Breyer, Alito, Sotomayor, Kagan) - June 20, 2016 12:49 PM - Breyer, J. Affirming Federal Circuit decision that the...more

Supreme Court Corner: Q2 2016

Stryker Corp. v. Zimmer, Inc. Halo Electronics, Inc. v. Pulse Electronics, Inc. PATENT – Decided: Jun. 13, 2016 Issue: Whether the Federal Circuit’s two-part test for willful patent infringement, with separate...more

Judge Totenberg Grants Stay of Litigation Pending IPR Proceeding

ETS-Lindgren, Inc. (“ETS”), as the assignee of U.S. Patent No. 8,331,869 ("the '869 patent") pertaining to testing wireless devices, brought an infringement action against MVG, Inc. (“MVG”), on May 28, 2015. MVG petitioned...more

MAG Aerospace Industries, Inc. v. B/E Aerospace, Inc. (Fed. Cir. 2016) - Equitable Assignor Estoppel Doctrine Expanded by Federal...

Arcane aspects of the law are frequently analogized as constituting "traps for the unwary," and patent law seems to have more than its share of minutiae that fall within that characterization. The equitable principle of...more

Amgen v. Sandoz Update -- Supreme Court Seeks Views of United States

In other Supreme Court news from Monday, June 20, 2016, the Court invited the Solicitor General to file briefs in the Sandoz v. Amgen (No. 15-1039) and Amgen v. Sandoz (No. 15-1195) appeals to express the views of the United...more

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