Category:Litigation

1
Coming Home?: Federal Circuit Asked To Immediately Weigh In On Proper Venue Post-TC Heartland
2
The Charging Bull and the Fearless Girl: Moral Rights Protections in Australia and the U.S.
3
Australian Patent and Plant Breeder’s Rights Year in Review
4
Supreme Court Signals Shift in Approach to Damages in Design Patent Infringement Cases
5
Federal Circuit Confirms Cuozzo Does Not Disturb § 314(d) Bar on Appellate Review of PTAB Reconsideration of IPR Institutions
6
Practical Implications from the Federal Circuit’s Rare en Banc Reversal in Apple v. Samsung
7
Fall Brings a Flurry of Biosimilar Approvals: FDA Approves Biosimilars of Enbrel® and Humira®
8
Remicade® Update: Double Patenting Redoubles in Post-Gilead Biosimilar Case
9
Humira® Update: Big Guns Take Aim at Top-Selling Biologic
10
Federal Circuit Confirms Post-Licensure Notice of Commercial Marketing Is Mandatory in Biosimilar Litigation

Coming Home?: Federal Circuit Asked To Immediately Weigh In On Proper Venue Post-TC Heartland

In a case pending in the Eastern District of Virginia, set to start trial on June 12, 2017, the defendants filed a motion to transfer the case to the Eastern District of Tennessee following the Supreme Court’s decision in TC Heartland LLC v. Kraft Foods Group Brands LLC, No. 16-341, 2017 WL 2216934 (U.S. May 22, 2017).  The district court ordered expedited briefing on the issue and ultimately determined that the defendants had waived their right to challenge venue.  In particular, according to the district court, “TC Heartland does not qualify for the intervening law exception to waiver because it merely affirms the viability of Fourco [Glass Co. v. Transmirra Products Corp., 353 U.S. 222, 226 (1957)].” Cobalt Boats, LLC v. Sea Ray Boats, Inc., No. 15-cv-21, Opinion & Order at 6 (E.D. Va. June 7, 2017).

Because trial is just around the corner for these defendants, they filed an emergency motion to stay the district court case with the Federal Circuit to allow time to file a Petition for Writ of Mandamus (“Mandamus Petition”). On June 8, 2017, the Federal Circuit denied the motion without prejudice to refiling if defendants filed the Mandamus Petition.  Interestingly, however, Judge Newman dissented from the denial, stating unequivocally that TC Heartland “was a change in the law of venue.” In re: Sea Ray Boats, Inc., No. 17-124, Dkt. No. 4 at 3 (Fed. Cir. June 8, 2017) (Newman, J., dissenting).  Judge Newman explained that “[t]he processes of law are designed not for the convenience of judges, but as safeguards to litigants and warders of justice.” Id. at 4.  Because the change in law “bring[s] the propriety of the current venue directly into question,” Judge Newman believed a stay of the underlying trial was appropriate. Id.

On the morning of June 9, 2017, the defendants filed their Mandamus Petition and renewed their emergency motion to stay the trial.

Updates to this alert will be provided as they become available.

By: Jason Engel and Devon Curtis Beane

The Charging Bull and the Fearless Girl: Moral Rights Protections in Australia and the U.S.

The Charging Bull has been an iconic New York City landmark since it was placed outside the New York Stock Exchange in December 1989 in an act of guerrilla art.  Despite initially being removed, the statue’s popularity caused it to be relocated to Bowling Green days later, where it has since remained, on loan to the New York City Council.  Earlier this year, on the eve of International Women’s Day, Charging Bull was joined at Bowling Green by a second guerrilla-art installation, sculptor Kristen Visbal’s four foot statue titled Fearless Girl, who stares defiantly at the Charging Bull.

The artist behind the Charging Bull, Artutro Di Modica, claims that the placement of Fearless Girl is an insult to the Charging Bull and that her placement is ‘attacking the bull’.  The competing interests of the artists raise interesting questions in intellectual property law, specifically regarding Di Modica’s ‘moral rights’.  Does the Fearless Girl have reason to fear impending intellectual property litigation? Or will the Charging Bull have to accept the new kid on the block?

Click here to read more.

By: Sophie Taylor

Australian Patent and Plant Breeder’s Rights Year in Review

K&L Gates has prepared the first edition of Patent and Plant Breeder’s Rights Year in Review which examines the significant judgments, development and events effecting patents and plant breeder’s rights in Australia.

The Review looks at a number of cases over the year including the Australian High Court’s decision in D’Arcy v Myriad Genetics Inc in the biotech industry, whether an Australian affiliate of an international pharma company was an exclusive licensee and whether it had standing to sue, and the Productivity Commission’s “IP Arrangements” Inquiry Report plus other updates. Click here for the summary or click here for the ePublication.

By: Simone Mitchell, Veg Tran, Michael Christie, Alex Dunlop, Jillian Lim, Jamie Wolbers and Jessica Mandla

Supreme Court Signals Shift in Approach to Damages in Design Patent Infringement Cases

In its first design patent case in over a century, the Supreme Court on Tuesday, December 6, 2016, reversed a damages award Apple Inc. (“Apple”) had won over Samsung Electronics Co., Ltd. (“Samsung”) in their protracted patent battle.  The design patents at issue were directed to certain elements of Apple’s iPhone.  The Court focused its attention on the meaning of the term “article of manufacture,” suggesting that the Federal Circuit’s definition, which encompassed the entire phone, might be too broad.  Instead, the Court determined that “article of manufacture” could be limited to a particular component of a product, regardless of whether that component is severable (or sold separately) from the product as a whole.  Declining to decide how much money Apple was entitled to under this new interpretation, the Court remanded the case to the Federal Circuit for further proceedings.

Please click here to view the full alert.

By: Jason A. Engel, Gina A. Jenero, Jacob C. Vannette

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

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.

Please click here to view the full alert.

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

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.”

Please click here to view the full alert.

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

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

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.

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

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]

Please click here to view the full alert.

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

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

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.

Please click here to view the alert.

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

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.

Please click here to view the alert.

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

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