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 ruling that claims of a patent directed to the Velcade® cancer treatment drug compound were invalid as obvious. The Court held that the District of Delaware clearly erred by finding U.S. Patent No. 6,713,446 (the ‘446 patent) prima facie obvious to one of skill in the art, and by misapplying the secondary indicia of unexpected success and long-unmet need.
Last week the Federal Circuit in Helsinn Healthcare v. Teva Pharmaceuticals clarified the scope of the on-sale bar rule under the America Invents Act (AIA). The on-sale bar in general means that a sale or an offer to sale of an invention more than one year prior to the effective filing date of a patent qualifies as prior art. The Federal Circuit held that 35 U.S.C. § 102 as revised in the AIA does not change the long-settled rule that a sale can invalidate an invention even if the sale does not disclose the details of the invention.
On April 6, 2017, the Federal Circuit reversed-in-part and affirmed-in-part the district court’s judgment of infringement and summary judgment for non-infringement of The Medicines Company’s (“MedCo”) patents-in-suit. See The Medicines Company v. Mylan, Inc., 2015-1113 (Fed. Cir. 2017). The patents-in-suit were U.S. Patent Nos. 7,582,727 (“the ’727 Patent) and 7,598,343 (“the ’343 Patent”). MedCo initiated a suit against Mylan, Inc. (“Mylan”) in response to Mylan submitting an Abbreviated New Drug Application (“ANDA”). Through submitting an ANDA request, Mylan wished to obtain approval from the Food and Drug Administration (“FDA”) for a generic drug that would directly compete against MedCo’s ANGIOMAX® product. To counter Mylan’s ANDA request, and keep their product exclusive, MedCo filed suit alleging that Mylan’s ANDA drug infringed claims in both the ’727 and ’343 Patents.
The district court held on summary judgment that Mylan’s drug did not satisfy the “efficient mixing” limitation of the ’343 Patent; however, following a 6-day bench trial found that Mylan’s drug did infringe the ’727 Patent because the asserted claims did not include an “efficient mixing” limitation. Mylan argued on appeal that the district court erred by not including the “efficient mixing” limitation as part of the “batches” limitation in the ’727 Patent.
On Monday, January 9, 2017, the U.S. Supreme Court denied, without comment, Mylan Pharmaceuticals’ petition for certiorari to reverse an opinion by the Court of Appeals for the Federal Circuit, which affirmed a broad scope of personal jurisdiction over generic ANDA filers in patent infringement suits under the Hatch-Waxman Act.
On Friday, March 18, the Court of Appeals for the Federal Circuit affirmed two District of Delaware rulings that non-resident defendant generic ANDA filer, Mylan, is subject to personal jurisdiction in two Hatch-Waxman suits filed in the state. (See Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., No. 14‐935‐LPS (D. Del. Jan. 14, 2015); AstraZeneca AB v. Mylan Pharmaceuticals Inc., No. 14‐696‐GMS (D. Del. Nov. 5, 2014). For coverage of the oral argument in these appeals, see our prior blog post.) The Federal Circuit found that specific personal jurisdiction exists over Mylan in Delaware because Mylan’s ANDA filings reliably indicate its intent to engage in actions that will harm plaintiffs’ patent rights in the jurisdiction. The court did not reach the issue on appeal of whether Mylan’s compliance with Delaware’s registration statute established consent to general personal jurisdiction in the state, an issue on which the lower court opinions split. However, Judge Kathleen M. O’Malley, concurring in the majority’s judgement, would also have found Mylan consented to general personal jurisdiction in light of Delaware’s interpretation of its registration statute.
Filing an ANDA Satisfies the Minimum Contacts Requirement of Specific Personal Jurisdiction
The court held that “the particular actions Mylan has already taken–its ANDA filings–for the purpose of engaging in that injury-causing and allegedly wrongful marketing conduct in Delaware” satisfy the minimum contacts with Delaware required to establish specific personal jurisdiction. The court began by observing that, if Mylan had already begun the generic drug marketing activities for which it seeks permission by filing an ANDA, “there is no doubt that it could be sued for infringement in Delaware,” and elsewhere that it seeks to market the generic ANDA products. Mylan’s ANDA filings, in turn, are “formal acts that reliably indicate plans to engage in” that same infringing activity. Thus, the ANDA filings, like the contemplated marketing acts they seek approval for, establish personal jurisdiction over Mylan in Delaware.
On Monday, January 4, the Court of Appeals for the Federal Circuit heard oral argument in two appeals that may determine what effect the Supreme Court’s Daimler AG v. Bauman decision will have on the exercise of personal jurisdiction over generic pharmaceutical manufacturers in Hatch-Waxman litigation.
Decisions Below Denying Motions to Dismiss for Lack of Personal Jurisdiction
Generic ANDA filer Mylan appealed from denial of its motion to dismiss in AstraZeneca AB v. Mylan Pharmaceuticals Inc., No. 14‐696‐GMS (D. Del. Nov. 5, 2014). Judge Gregory M. Sleet found specific personal jurisdiction over the foreign corporate defendant in Delaware based on Mylan’s sending a Paragraph IV notice letter to AstraZeneca in Delaware. Judge Sleet also found, citing the Supreme Court’s recent holding in Daimler AG v. Bauman, 134 S. Ct. 746 (U.S. 2014), that Mylan’s registration to do business in Delaware did not constitute consent to personal jurisdiction, and thus general personal jurisdiction, in Delaware.
On Monday Mylan also argued its appeal of the denial of a similar motion to dismiss in Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc., No. 14‐935‐LPS (D. Del. Jan. 14, 2015). In that case, Chief Judge Leonard P. Stark found specific personal jurisdiction exists over Mylan in Delaware based on Mylan’s sending a Paragraph IV notice letter to the Delaware-incorporated Acorda, even though the notice letter was not mailed to Delaware. Judge Stark, unlike Judge Sleet, also found general personal jurisdiction over Mylan because Mylan consented to personal jurisdiction in the state by voluntarily registering to do business there.
On March 12, the United States District Court for the Southern District of Indiana joined the District of Delaware and Eastern District of Texas as the first courts to consider a generic drug manufacturer’s motion to dismiss a Hatch-Waxman patent infringement action for an alleged lack of personal jurisdiction following the Supreme Court’s decision in Daimler AG v. Bauman, 134 S.Ct. 746 (2014). Eli Lilly & Co. v. Mylan Pharmaceuticals, Inc. (S.D. Ind. Mar. 12, 2015). The Eli Lilly court denied generic defendant Mylan’s motion to dismiss, finding specific jurisdiction appropriate in Indiana based on the unique nature of Hatch-Waxman ANDA litigation and the defendant’s forum contacts. Continue Reading Court Denies Generic Drug Manufacturer’s Motion to Dismiss Hatch-Waxman Patent Infringement Action on Jurisdiction Grounds