Biologics Blog

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Biologics Blog is a source of insights, information and analysis related to biologics, including the legal developments, trends and changing regulation that impact the biotechnology industry. Patterson Belknap represents biotechnology, pharmaceutical and healthcare companies in a broad range of patent litigation matters, including patent infringement cases, PTO trial proceedings, patent licensing and other contractual disputes. Our team includes highly experienced trial attorneys with extensive technical knowledge, many of whom have advanced scientific degrees and industry experience in fields such as molecular biology, biochemistry, chemistry, statistics and nuclear engineering.

Full Federal Circuit Denies En Banc Review of Jurisdictional Decision with Important Implications for BPCIA Litigation

On June 20, 2016, the full Federal Circuit declined to rehear Acorda Therapeutics Inc. v. Mylan Pharms. Inc., 817 F.3d 755 (Fed. Cir. 2016) en banc. Acorda affirmed two District of Delaware decisions finding specific jurisdiction over Mylan Pharms., an out-of-state ANDA filer, based on its plans to sell its proposed generic drugs in Delaware. After the Supreme Court’s decision in Daimler AG v. Bauman, 134 S.Ct. 746 (2014), Mylan has argued that it could only be sued in its home state of West Virginia in ANDA cases since future sales of its proposed generic drugs could not confer specific jurisdiction in Delaware.  The Federal Circuit disagreed.  Under Acorda, plaintiffs in ANDA cases as well as in cases brought under the Biologics Price Competition and Innovation Act (BPCIA) can bring suit in their forum of choice based on future sales of proposed generic or biosimilar products so long as considerations of fairness, such as efficiency or undue burden, do not render jurisdiction in the forum unreasonable.  

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Federal Circuit's Jurisdictional Decision for ANDA Cases Has Important Implications for BPCIA Litigation

The Federal Circuit affirmed two decisions by the District of Delaware to assert personal jurisdiction in ANDA cases over West Virginia-based manufacturer Mylan.  Mylan had argued that it could only be sued in West Virginia in ANDA cases post the Supreme Court's decision in Daimler AG v. Bauman, 134 S.Ct. 746 (2014) because such cases are litigated before actual sales of its generic drug product are made in Delaware (and elsewhere).  The Federal Circuit grounded its rejection of Mylan's approach on Mylan's filing of its ANDAs with the clear intent to market its proposed generic drugs in Delaware upon FDA approval, as well as the injury Mylan would cause in Delaware through such sales.  Under the Federal Circuit's decision, plaintiffs in ANDA and BPCIA cases can obtain jurisdiction over defendants in their forum of choice based on defendants' regulatory filings with the intent to market their proposed products so long as consideration of fairness, such as undue burden on defendants, do not render jurisdiction in the chosen forum unreasonable.

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Update on Personal Jurisdiction for BPCIA Litigants after the Supreme Court’s decision in Daimler

Defendants in Hatch-Waxman cases continue to contest personal jurisdiction outside of their "home" state, in reliance on the Supreme Court's decision in Daimler AG v. Bauman.  Most district courts have rejected such arguments, and found that jurisdiction is proper in the patent owner's preferred forum based on consent-by-registration jurisdiction or specific jurisdiction. Both theories of personal jurisdiction are on appeal before the Federal Circuit, and oral argument is likely to occur early in 2016. The lessons learned in the Hatch-Waxman context will provide guidance for litigation under the BPCIA. 

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First Round of Post-Teva Claim Construction Decisions: Business as Usual?

In Teva v. Sandoz, the Supreme Court held that findings of fact subsidiary to a claim construction decision are entitled to deference on appeal. Teva has the potential to transform claim construction proceedings, but the extent of the impact will depend on how it is applied by the Federal Circuit.  Three recent Federal Circuit decisions give mixed signals about its post-Teva approach to appellate review.  

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Lessons in Personal Jurisdiction for BPCIA Litigants after the Supreme Court’s decision in Daimler

In the wake of the Supreme Court’s decision in Daimler AG v. Bauman, some defendants in Hatch-Waxman litigation have contested personal jurisdiction anywhere outside their “home” state.  District courts have universally rejected such arguments, finding personal jurisdiction in the patent owner’s chosen forum on the basis of consent or specific jurisdiction.    The Federal Circuit will consider two of these cases this summer. The lessons learned will be equally applicable to litigation under the BPCIA.  

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