Articles Posted in Patents

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Spireas earned $40 million in technology license royalties in 2007-2008s. Royalties paid under a license agreement are usually taxed as ordinary income at 35 percent but Spireas claimed capital gains treatment (15 percent) under 26 U.S.C. 1235(a), which applies to money received “in consideration of” “[a] transfer . . . of property consisting of all substantial rights to a patent.” The IRS disagreed and gave Spireas notice of a $5.8 million deficiency for the two tax years. The Tax Court and Third Circuit affirmed. To qualify for automatic capital-gains treatment, income must be paid in exchange for a “transfer of property” that consists of “all substantial rights” to a “patent.” Not every transfer of “rights” qualifies because the statute grants capital gains treatment only to transfers of property. Spireas’s original theory was that he reduced the formulation to practice in 2000, giving him the required property interest, and later assigned his interest. Spireas later abandoned that theory, arguing that he transferred his rights prospectively in 1998. Because that was two years before the invention of the formulation, Spireas’s second position cannot depend on the legal standard of reduction to actual practice to establish that he held a property right at the time of transfer. Spireas’s sole claim on appeal was, therefore, waived. View "Spireas v. Commissioner of Internal Revenue" on Justia Law

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Consolidated appeals involve allegations that the patent-holders for Lipitor and Effexor XR delayed entry into the market by generic versions of those drugs by engaging in a monopolistic scheme that involved fraudulently procuring and enforcing the underlying patents, then entering into a reverse-payment settlement agreement with a generic manufacturer. In 2013, the Supreme Court recognized that reverse payment schemes can violate antitrust laws and that it is normally not necessary to litigate patent validity to answer the antitrust question. The district judge dismissed several claims. The Third Circuit remanded after rejecting an argument that plaintiffs’ allegations required transfer of the appeals to the Federal Circuit, which has exclusive jurisdiction over appeals from civil actions “arising under” patent law, 28 U.S.C. 1295(a)(1). Not all cases presenting questions of patent law necessarily arise under patent law; here, patent law neither creates plaintiffs’ cause of action nor is a necessary element to any of plaintiffs’ claims. Plaintiffs plausibly allege the existence of agreements between the patent holders and the generic manufacturers. The court remanded one of the Lipitor appeals, brought by California pharmacists, and involving claims solely under California law, for determination of whether remand to state court was appropriate. The Lipitor plaintiffs made plausible allegations of fraudulent patent procurement and enforcement, and other related misconduct. View "In re: Lipitor Antitrust Litigation" on Justia Law

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Direct purchasers of Wellbutrin XL, a drug for treating depression, sued, alleging that GSK violated the Sherman Antitrust Act by entering into an unlawful conspiracy with Biovail, GSK’s partner in the development of Wellbutrin XL, to delay the launch of generic versions of the drug. Indirect-purchasers asserted similar theories under state law. The purchasers claim that GSK delayed the launch of generic versions by supporting baseless patent infringement suits and a baseless FDA Citizen Petition aimed at generic drug companies and by entering into an unlawful reverse payment settlement agreement with potential competitors. The district court granted GSK summary judgment, finding insufficient evidence that GSK’s patent litigation was a sham or that the settlement delayed the launch of generic Wellbutrin XL. The court granted GSK’s Daubert motion to exclude the testimony of the purchasers’ economic expert; decertified the indirect-purchaser class for lack of ascertainability; dismissed the indirect-purchaser claims brought under the laws of states that were not the home of a named class representative; and denied Aetna’s motion to intervene. The Third Circuit affirmed. After considering the Supreme Court’s 2013 decision, FTC v. Actavis, the court concluded that the purchasers failed to establish a genuine dispute of fact either as to whether GSK engaged in sham litigation or whether GSK’s actions delayed the launch of generic Wellbutrin XL. View "In re: Wellbutrin XL Antitrust Litigation" on Justia Law

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The consolidated appeals involve allegations that the companies holding the patents for Lipitor and Effexor XR delayed entry into the market by generic versions of those drugs by engaging in an overarching monopolistic scheme that involved fraudulently procuring and enforcing the underlying patents and then entering into a reverse-payment settlement agreement with a generic manufacturer. In 2013, the Supreme Court recognized that reverse payment schemes can violate antitrust laws and that it is normally not necessary to litigate patent validity to answer the antitrust question. The district judge dismissed most of plaintiffs’ claims. The Third Circuit remanded after rejecting an argument that plaintiffs’ allegations required transfer of the appeals to the Federal Circuit, which has exclusive jurisdiction over appeals from civil actions “arising under” patent law, 28 U.S.C. 1295(a)(1). Not all cases presenting questions of patent law necessarily arise under patent law; here, patent law neither creates plaintiffs’ cause of action nor is a necessary element to any of plaintiffs’ well-pleaded claims. The court remanded one of the Lipitor appeals, brought by a group of California pharmacists and involving claims solely under California law, for jurisdictional discovery and determination of whether remand to state court was appropriate. View "In re: Lipitor Antitrust Litigation" on Justia Law

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Arunachalam is a plaintiff in several related patent infringement actions in the U.S. District Court for the District of Delaware. Arunachalam unsuccessfully moved to disqualify the district judge on the basis of the judge’s ownership of mutual funds that have holdings in certain of the defendant corporations. Arunachalam challenged that ruling by seeking a writ of mandamus to order the judge’s disqualification. The Third Circuit concluded that it lacked jurisdiction and directed the Clerk to transfer the case to the United States Court of Appeals for the Federal Circuit. The court stated that it may issue writs of mandamus only “in aid of” its jurisdiction, and it will not possess appellate jurisdiction over the final orders in the patent infringement actions. View "In re: Dr. Lakshmi Arunachalam" on Justia Law

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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

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Jang, a doctor and inventor, sued BSC, the company to which Jang assigned his coronary stent patents, for breach of the patent assignment agreement, which required BSC to share profits from the patents with Jang, including any damages it recovers from third-party infringers. In 2010, BSC settled a claim against Cordis for infringement in combination with anther claim that Cordis had against BSC. BSC made a payment to Cordis, and the parties exchanged several patent licenses. BSC then denied that it had recovered any damages that it was obligated to share with Jang. The Third Circuit reversed judgment on the pleadings in favor of BSC. Two of Jang’s claims are sufficient to survive judgment on the pleadings: that BSC breached the contract because the cash offset qualifies as a “recovery of damages” and that BSC violated the implied covenant of good faith and fair dealing by structuring a settlement to thwart the agreed purpose of the patent assignment. View "Jang v. Boston Scientific SciMed Inc." on Justia Law

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Ethypharm, a French corporation, contracted with Reliant, an American company. Ethypharm would manufacture and provide its drug (Antara®); Reliant would obtain approval and market the drug. Reliant sought FDA approval under 21 U.S.C. 505(b)(2), using data from an approved, fenofibrate drug, TriCor®, developed by Fournier and distributed in the U.S. by Abbott. Antara received approval. Reliant began marketing and sought a declaration of non-infringement or unenforceability of Abbott’s patents. Abbott counterclaimed. In 2006, the companies settled: Abbott and Fournier would license the patents to Reliant and Reliant would pay royaltys. The agreement prohibited Reliant from assigning its rights to or partnering with specific companies. Reliant sold its rights to Oscient, which was not a prohibited purchaser. Losing market share to generic fenofibrate, Oscient discontinued promotion of Antara and filed for bankruptcy. Ethypharm sued Abbott, alleging antitrust and sham litigation under 15 U.S.C. 1, asserting that the settlement agreement was designed to ensure that Antara would be marketed by a company with “limited resources and a relatively small sales force,” so that it could not effectively compete with TriCor and that the royalty payment weakened Antara’s profitability. The district court granted Abbott summary judgment. The Third Circuit vacated, holding that Ethypharm lacked standing under the Sherman Act. View "Ethypharm SA France v. Abbott Labs" on Justia Law

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Schering held a patent on the controlled release coating applied to potassium chloride crystals for treatment of potassium deficiencies. Potential generic manufacturers filed an abbreviated application for approval (ANDA),Hatch-Waxman Act, 21 U.S.C. 301-399, asserting that the Schering patent was invalid or would not be infringed by their new generic drugs. Schering’s subsequent infringement suits were resolved through agreements in which it paid the generic manufacturers to drop patent challenges and refrain from producing a generic drug for a specified period. Congress amended Hatch-Waxman to require pharmaceutical companies who enter into such settlements to file for antitrust review. The FTC filed an antitrust action with respect to Schering’s settlements. Plaintiffs sued on behalf of a class of purchasers of the drug. The Third Circuit affirmed the district court’s certification of the class, but reversed its presumption that Schering’s patent was valid and gave Schering the right to exclude infringing products until the end of its term, including through reverse payment settlements. The court directed use of a “quick look rule of reason analysis” based on economic realities of the settlement rather than labels. The court must treat any payment from a patent holder to a patent challenger who agrees to delay entry into the market as prima facie evidence of unreasonable restraint of trade, rebuttable by showing that the payment was for a purpose other than delayed entry or offers some pro-competitive benefit. View "In Re: K-Dur Antitrust Litigation" on Justia Law