Justia Drugs & Biotech Opinion Summaries

Bard and AngioDynamics both manufacture vascular access ports, devices implanted underneath a patient’s skin that allow the injection of fluid into the patient’s veins on a regular basis without starting an intravenous line each time. Vascular access ports were traditionally used to administer injections at low pressure and flow rates. Certain procedures, like computed tomography (CT) imaging, required the injection of fluids into patients at high pressure and high flow rates (power injection). As of 2005, vascular access ports were not FDA-approved for power injection but certain medical providers were using existing ports for power injection; in some cases, the pressure ruptured the port, seriously injuring the patient. Bard obtained FDA approval for PowerPort as the first vascular access port labeled for power injection and obtained the patents-in-suit. AngioDynamics then obtained FDA approval to market its own vascular access port products as suitable for power injection.Bard sued AngioDynamics for infringement. During the trial, the court granted judgment that the asserted claims were not infringed, were not willfully infringed, and were invalid as directed to printed matter. The Federal Circuit reversed. There was substantial evidence to support a jury finding of infringement and willfulness; the asserted claims are not directed solely to printed matter and are patent-eligible under 35 U.S.C. 101. A genuine dispute of material fact precludes summary judgment as to anticipation. View "C R Bard Inc. v. AngioDynamics, Inc." on Justia Law

The Valeant plaintiffs reside in Japan, Ireland, and Delaware. The defendants are incorporated and have principal places of business in West Virginia, Pennsylvania, and India. The brand-name FDA-approved drug Jublia® has nine patents listed in the Orange Book. Defendant, a generic drug company, executed an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Jublia®, sending the ANDA from its West Virginia office to the FDA in Maryland. Valeant sued for infringement in the District of New Jersey, alleging that the district is a likely destination for the generic solution; each defendant does business in New Jersey and is registered to do so; each defendant has previously submitted to the court's jurisdiction and has a place of business in New Jersey; the generic drug will be “purposefully directed at … New Jersey. The district court dismissed for improper venue, finding that the ANDA was submitted from West Virginia, rendering venue proper there, while acknowledging that MLL, a foreign entity, was subject to venue in every judicial district.The Federal Circuit affirmed in part, citing the 2017 Supreme Court “TC Heartland” holding: the general venue provision in 28 U.S.C. 1391, which provides that a corporation is deemed to “reside” in any judicial district in which it is subject to personal jurisdiction, does not modify the term “resides” in 28 U.S.C. 1400, the specific patent venue statute; “resides” refers only to a corporation’s state of incorporation. A corporation may be sued for patent infringement in districts in the state of its incorporation and those in which it has a regular and established place of business and an act of infringement has occurred. In Hatch-Waxman Act, 35 U.S.C. 271(e)(2)(A) infringement cases, section 1400 “acts of infringement” occur only in districts where actions related to the ANDA submission occur, not in all locations where future distributions of the products specified in the ANDA is contemplated. The court remanded the dismissal of the foreign defendant. View "Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc." on Justia Law

The Snyders patent describes and claims an artificial heart valve and a system for inserting the valve. In 2017, St. Jude filed two petitions under 35 U.S.C. 311–19, seeking inter partes reviews (IPR) of claims 1, 2, 4–8, 10–13, 17–19, 21, 22, and 25–30. The Patent Trial and Appeal Board instituted two reviews, each addressing all the challenged claims. In IPR-105, the Board ruled that St. Jude failed to establish unpatentability of any of the challenged claims, rejecting the contention that all the challenged claims were anticipated by the Leonhardt patent and would have been obvious over Leonhardt plus either the Anderson patent or the Johnson and Imachi patents. In IPR-106, the Board found claims 1, 2, 6, and 8 anticipated by the Bessler patent, but it rejected St. Jude’s contentions as to all other claims, finding that St. Jude had not proved, as to all but claims 1, 2, 6, and 8, anticipation by Bessler or obviousness over Bessler combined with either Anderson or Johnson and Imachi. The Federal Circuit affirmed the decision in IPR-105; reversed the finding in IPR-106 that Bessler anticipated claims 1, 2, 6, and 8; did not reach the anticipation argument as to claim 28; and affirmed the obviousness rejection in IPR-106. View "St. Jude Medical, LLC v. Snyders Heart Valve LLC" on Justia Law

Immunex’s 487 patent is directed to antibodies that bind to the human interleukin-4 receptor, the resulting inhibition of which is significant for treating various inflammatory disorders, such as arthritis, dermatitis, and asthma. Amid infringement litigation, Sanofi filed three inter partes review (IPR) petitions challenging claims 1–17 of the patent. Two were instituted. In one final written decision, the Board concluded that claims 1–17 were unpatentable as obvious over two prior references. Immunex appealed, contesting the construction of the claim term “human antibodies.” In the other IPR, involving a subset of the same claims, the Board did not invalidate the patents for reasons of inventorship. Sanofi contested the Board’s inventorship determination. In consolidated appeals, the Federal Circuit upheld the Board’s claim construction, affirming the invalidity decision, leaving valid no claims at issue in the inventorship appeal. View "Immunex Corp v. Sanofi-Aventis U.S. LLC" on Justia Law

GSK’s 067 patent for “carvedilol” issued in 1985. The FDA initially approved carvedilol for treating hypertension; the product was marketed with the brand name Coreg®. Scientists continued to study carvedilol. In 1997, the FDA approved carvedilol for the additional treatment of congestive heart failure. GSK’s 069 patent issued in 1998, describing and claiming treatment with a combination of carvedilol and an angiotensin-converting enzyme (ACE) inhibitor, a diuretic, and digoxin. The patent was listed in the FDA’s Orange Book. In 2003, the FDA approved this Coreg® combination for use by patients suffering from left ventricular dysfunction following myocardial infarction. In 2002, Teva applied for FDA approval of generic carvedilol, certifying in the ANDA that its product would not be launched until the 067 patent expired and that the 069 patent was “invalid, unenforceable, or not infringed.” Teva received FDA tentative approval “for treatment of heart failure and hypertension,” to become effective in 2007. GSK, in 2003, sought reissue of the 069 patent, 35 U.S.C. 251. The 000 patent issued in 2008. In 2011 the FDA required Teva to amend its carvedilol label to be “identical in content to the approved [GSK Coreg®] labeling.GSK sued for infringement.A jury found the 000 patent valid and infringed, assessed damages, and found the infringement willful. The district court granted Teva judgment of non-infringement as a matter of law. The Federal Circuit reinstated the jury verdicts as supported by substantial evidence. View "GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc." on Justia Law

AndroGel is a testosterone replacement therapy that generated billions of dollars in sales. The Federal Trade Commission sued under Section 13(b) of the Federal Trade Commission Act, alleging that AndroGel’s patent owners filed sham patent infringement suits against Teva and Perrigo and entered into an anticompetitive reverse-payment agreement with Teva. The FTC accused the patent owners of trying to monopolize and restrain trade over AndroGel. The District Court dismissed the FTC’s claims to the extent they relied on a reverse-payment theory but found the owners liable for monopolization on a sham-litigation theory and ordered disgorgement of $448 million in ill-gotten profits. The court denied the FTC’s request for an injunction.The Third Circuit reversed in part, holding that the district court erred by rejecting the reverse-payment theory and in concluding the owners’ litigation against Teva was a sham. The court erred by ordering disgorgement because that remedy is unavailable under Section 13(b) of the FTC Act. The court affirmed in part. The district court correctly concluded that the Perrigo litigation was a sham and that the owners had monopoly power in the relevant market but did not show the monopolization entitles the FTC to any remedy. The court did not abuse its discretion in denying injunctive relief. View "Federal Trade Commission v. AbbVie Inc" on Justia Law

Biogen’s patent is directed to a method of treating a viral condition, a viral disease, cancers, or tumors, by the administration of a pharmaceutically effective amount of a recombinant polypeptide related to human interferon-β (IFN-β). Biogen sued Serono, alleging contributory and induced infringement of the patent by the sale and marketing in the U.S. of Rebif, a recombinant IFN-β product used for the treatment of Multiple Sclerosis. A jury found that the patent claims were anticipated by two references teaching the use of native IFN-β to treat viral diseases; that the asserted claims not invalid for lack of enablement or written description, or for obviousness; that patients and prescribers directly infringed the asserted claims; and that Serono contributorily infringed the claims but did not induce infringement thereof. The district court granted judgment as a matter of law of no anticipation in favor of Biogen and conditionally granted a new trial on anticipation; sustained the jury’s verdict of no invalidity based on written description or enablement; overturned the verdict of no induced infringement; sustained the verdict of contributory infringement; and held that the claims were not patent ineligible.The Federal Circuit reversed with respect to anticipation and the conditional grant of a new trial. A reasonable jury could find the claims of the patent anticipated on the record presented. The court remanded with instructions to reinstate the verdict of anticipation. View "Biogen MA Inc. v. EMD Serono, Inc." on Justia Law

Baxalta sued Genentech, asserting that Genentech’s Hemlibra® product used to treat the blood clotting disorder hemophilia infringes claims of its 590 patent. The 590 patent relates to preparations used to treat hemophilia patients who have developed factor VIII inhibitors. After the district court issued a claim construction order, construing the terms “antibody” and “antibody fragment,” the parties stipulated to non-infringement of the asserted claims. The Federal Circuit vacated, finding that the district court erred in construing the terms by selecting a narrower construction, which is inconsistent with the written description and the plain language of the claim. View "Baxalta Inc. v. Genentech, Inc." on Justia Law

Bio-Rad’s patents are directed to systems and methods for forming microscopic droplets (plugs) of fluids to perform biochemical reactions. Microfluidic systems—often called “labs-on-a-chip”—allow scientists to conduct microscale chemical and biological reactions. For example, the technology allows scientists to analyze and compare DNA, RNA, and proteins within large numbers of individual cells. This technology has applications in medical diagnostics and high-throughput screening. In an infringement suit, the jury found all three patents valid and willfully infringed and awarded damages of $23,930,716. The court granted Bio-Rad’s motion for a permanent injunction. The Federal Circuit affirmed the judgment of infringement of one patent (which covers all six accused products) and the entire damages award. Prosecution history estoppel does not apply and 10X’s challenges concerning the infringement under the doctrine of equivalents fail. The court reversed the district court’s construction of the asserted claims of two patents, vacated the judgment of infringement of those patents, and remanded for a new trial on the issue of whether 10X’s accused products infringe those patents under the proper claim construction. The court also vacated the injunction with respect to 10X’s Linked-Reads and CNV product lines. View "Bio-Rad Laboratories, Inc. v. 10X Genomics Inc." on Justia Law

Takeda sued Mylan for patent infringement based on Mylan’s Abbreviated New Drug Application (ANDA) for a generic version of Takeda’s Colcrys® version of the drug colchicine. The parties settled, entering into a License Agreement that allows Mylan to sell a generic colchicine product on a specified date or under circumstances defined in Section 1.2, which refers the date of a final court decision holding that all unexpired claims of the licensed patents that were asserted and adjudicated against a third party are not infringed, invalid, or unenforceable. The parties stipulated that Mylar's breach of Section 1.2 “would cause Takeda irreparable harm.”Takeda also sued Hikma based on Hikma’s FDA-approved colchicine product Mitigare®. The district court granted summary judgment of non-infringement. After Mylan launched its product, Takeda sued, alleging breach of contract and patent infringement.The Federal Circuit affirmed the denial of a preliminary injunction. Takeda failed to show it is likely to succeed on the merits or that it will suffer irreparable harm. Section 1.2(d) was triggered by the third-party litigation; all unexpired claims of the three patents that were “asserted and adjudicated” were held to be not infringed. An objective, reasonable third party would not read Section 1.2(d) to be limited to generic equivalents of Colcrys® excluding section 505(b)(2) products like Mitigare®. Because Takeda had not established that Mylan breached the Agreement, the irreparable harm stipulation did not apply. Money damages would remedy any harm Takeda would suffer as a result of Mylan launching its generic product. View "Takeda Pharmaceuticals U.S.A. v. Mylan Pharmaceuticals, Inc." on Justia Law