Justia Patents Opinion SummariesArticles Posted in Consumer Law
ZACHARY SILBERSHER, ET AL V. VALEANT PHARMACEUTICALS INT’L, ET AL
Plaintiff alleged that Valeant fraudulently obtained two sets of patents related to a drug and asserted these patents to stifle competition from generic drugmakers. Plaintiff further alleged that Defendants defrauded the federal government by charging an artificially inflated price for the drug while falsely certifying that its price was fair and reasonable. Dismissing Plaintiff’s action under the False Claims Act’s public disclosure bar, the district court concluded that his allegations had already been publicly disclosed, including in inter partes patent review (“IPR”) before the Patent and Trademark Office. The Ninth Circuit reversed the district court’s dismissal. The panel held that an IPR proceeding in which the Patent and Trademark Office invalidated Valeant’s “‘688” patent was not a channel (i) disclosure because the government was not a party to that proceeding, and it was not a channel (ii) disclosure because its primary function was not investigative. The panel held that, under United States ex rel. Silbersher v. Allergan, 46 F.4th 991 (9th Cir. 2022), the patent prosecution histories of Valeant’s patents were qualifying public disclosures under channel (ii). The panel assumed without deciding that a Law360 article and two published medical studies were channel (iii) disclosures. The panel held that the “substantially the same” prong of the public disclosure bar applies when the publicly disclosed facts are substantially similar to the relator’s allegations or transactions. None of the qualifying public disclosures made a direct claim that Valeant committed fraud, nor did they disclose a combination of facts sufficient to permit a reasonable inference of fraud. View "ZACHARY SILBERSHER, ET AL V. VALEANT PHARMACEUTICALS INT'L, ET AL" on Justia Law
Vermont v. MPHJ Tech. Inv., LLC
The state filed a complaint, alleging that letters mailed by MPHJ to Vermont businesses informing them that they may be infringing certain patents were deceptive and violated the Vermont Consumer Protection Act, 9 V.S.A. 2451. MPHJ is a non-practicing entity incorporated in Delaware that acts through shell corporations incorporated in many states. MPHJ removed the case twice to federal court, once under the original complaint and once under an amended complaint. The district court remanded the case to state court both times. The Federal Circuit affirmed. While 28 U.S.C. 1442(a)(2), provides jurisdiction “in any civil action arising under, or in any civil action in which a party has asserted a compulsory counterclaim arising under, any Act of Congress relating to patents,” the patents at issue were transferred to MPHJ from the original patent owner; they were not directly “derived from a federal officer.” The complaint neither alleged violation of nor sought relief under the Vermont Bad Faith Assertions of Patent Infringement Act so there is no risk that the state court action can affect the validity of federal law. View "Vermont v. MPHJ Tech. Inv., LLC" on Justia Law
King Drug Co of Florence Inc, v. Smithkline Beecham Corp.
In earlier litigation, Teva challenged the validity and enforceability of GSK’s patents on lamotrigine, Lamictal’s active ingredient. Teva was first to file an FDA application, alleging invalidity or nonenforceability, and seeking approval to produce generic lamotrigine tablets and chewable tablets for markets alleged to be annually worth $2 billion and $50 million,. If the patent suit resulted in a determination of invalidity or nonenforceability—or a settlement incorporating such terms—Teva would be statutorily entitled to a 180- day period of market exclusivity, during which time only it and GSK could produce generic lamotrigine tablets. After the judge ruled the patent’s main claim invalid, the companies settled; Teva would end its patent challenge in exchange for early entry into the chewables market and GSK’s commitment not to produce its own, “authorized generic” Lamictal tablets. Plaintiffs, direct purchasers of Lamictal, sued under the Sherman Act, 15 U.S.C. 1 & 2, claiming that the agreement was a “reverse payment” intended to induce Teva to abandon the patent fight and eliminate the risk of competition in the lamotrigine tablet market for longer than the patent would otherwise permit. The district court dismissed. The Third Circuit vacated, citing Supreme Court precedent, holding that unexplained large payments from the holder of a drug patent to an alleged infringer to settle litigation of the patent’s validity or infringement (reverse payment) can violate antitrust laws. View "King Drug Co of Florence Inc, v. Smithkline Beecham Corp." on Justia Law