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Qui tam relator failed to satisfy the False Claims Act’s materiality requirement in alleging that the manufacturer of a widely-prescribed cancer drug, Avastin, suppressed data that caused doctors to certify incorrectly that Avastin was “reasonable and necessary” for certain at-risk Medicare patients. Avastin is FDA-approved and has accounted for $1.13 billion a year in Medicare reimbursements. The relator, formerly the head of healthcare data analytics for the manufacturer, claimed the company ignored and suppressed data that would have shown that Avastin’s side effects for certain patients were more common and severe than reported and that such analyses would have required the company to file adverse event reports with the FDA, and could have resulted in changes to Avastin’s FDA label. He claimed the company caused physicians to submit Medicare claims that were not “reasonable and necessary.” The Third Circuit affirmed dismissal of the claim, stating the allegations may be true but a False Claims Act suit is not the appropriate way to address them. The manufacturer followed all pertinent statutes and regulations. If those laws and regulations are inadequate to protect patients, it falls to the other branches of government to reform them. View "Petratos v. Genentech Inc" on Justia Law

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The Leahy-Smith America Invents Act did not change the statutory meaning of “on sale” under 35 U.S.C. 102, in a case involving patents that were ready for patenting and subject to an invalidating contract for sale prior to the critical date of January 30, 2002. Teva had invoked the provision as a defense in a suit charging infringement based on Teva’s filing of an Abbreviated New Drug Application (ANDA). The district court upheld, as valid, Helsinn’s patents, directed to intravenous formulations of palonosetron for reducing chemotherapy-induced nausea and vomiting, and rejected Teva’s “on sale” defense. In reversing, the Federal Circuit noted that the invention worked for its intended purpose, that the evidence that the formulation was ready for patenting was “overwhelming,” and that there was no tenable argument that, before the critical date, Helsinn was unable to file a patent application that met the requirements of 35 U.S.C. 112. The district court clearly erred by applying too demanding a standard. The completion of Phase III studies and final FDA approval are not pre-requisites for the invention here to be ready for patenting. View "Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc." on Justia Law

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Serena Kwan appealed the dismissal of her second amended complaint for failing to state a claim upon which relief can be granted. In 2014, Kwan, On Behalf of Herself and All Others Similarly Situated, filed a class action against Defendants-Appellees, SanMedica International, LLC (“SanMedica”), and Sierra Research Group, LLC (“Sierra”), alleging violations of California’s Unfair Competition Law (“UCL”) and California’s Consumers Legal Remedies Act (“CLRA”). The complaint was based on an allegation that the defendants falsely represented that their product, SeroVital, provided a 682% mean increase in Human Growth Hormone (“HGH”) levels, that it was clinically tested, and that “peak growth hormone levels” were associated with “youthful skin integrity, lean musculature, elevated energy production, [and] adipose tissue distribution." The Ninth Circuit concluded the district court correctly concluded that California law did not provide for a private cause of action to enforce the substantiation requirements of California’s unfair competition and consumer protection laws. Further, the district court did not err in concluding that Kwan’s second amended complaint failed to allege facts that would support a finding that SanMedica International’s claims regarding its product, SeroVital, were actually false. Accordingly, the Court affirmed dismissal. View "Kwan v. Sanmedica Int'l" 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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Navartis’s 283 patent relates to a solid pharmaceutical composition suitable for oral administration, comprising a sphingosine-1 phosphate (S1P) receptor agonist and a sugar alcohol, which the patent explains is useful for the treatment of certain autoimmune diseases such as multiple sclerosis. According to the specification, S1P receptor agonists generally exhibit properties that make formulations suitable for oral administration of a solid composition difficult to create. However, “solid compositions comprising a sugar alcohol provide formulations which are particularly well suited to the oral administration of S1P receptor agonists." They also “provide a convenient means of systemic administration of S1P receptor agonists, do not suffer from the disadvantages of liquid formulations for injection or oral use, and have good physiocochemical and storage properties.” On inter partes review, the Patent Trial and Appeal Board found all original claims of the 283 patent and proposed substitute claims unpatentable as obvious. The Federal Circuit affirmed. The Board discussed independent grounds supporting the motivation to combine prior art, fingolimod and mannitol, in a solid oral composition. View "Novartis AG v. Torrent Pharmaceuticals, Limited" on Justia Law

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Zafgen Inc.’s investors (Investors) brought a securities fraud class action suit against Zafgen and its Chief Executive Officer (collectively, Defendants) following a significant drop in the share price of the company. Specifically, Investors alleged that the Defendants made several misleading statements regarding Zafgen’s anti-obesity drug Beloranib. The district court granted Defendants’ motion to dismiss, concluding that the complaint did not contain facts giving rise to a “cogent and compelling” inference of scienter as required under the Private Securities Litigation Reform Act. The First Circuit affirmed, holding that the district court properly dismissed Investors’ claims because the complaint, considered as a whole, did not present allegations giving rise to a cogent and compelling inference of scienter. View "Brennan v. Zafgen, Inc." on Justia Law

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Bivalirudin is a synthetic peptide used to prevent blood clotting in patients undergoing cardiac catheterization. Bivalirudin’s pharmacological properties were known before the filing of Medicines’ 727 and 343 patents and were covered by Medicines’ 404 patent, which expired in 2015. The claimed inventions of the 727 and 343 patents are directed to minimizing impurities in batches of bivalirudin, an active ingredient, typically distributed as a dry powder that must be compounded with a base before being administered to a patient as an intravenous injection. Medicines received FDA approval to market a base-compounded bivalirudin drug product in 2000, and has sold the approved product since 2001 under the tradename ANGIOMAX®, before the critical date of the 727-343 patents. Mylan submitted an Abbreviated New Drug Application, seeking to market a generic version of ANGIOMAX. The district court held that the 343 patent was not infringed because Mylan did not satisfy the “efficient mixing” limitation of asserted claims and that the 727 patent was infringed because its asserted claims did not include an “efficient mixing” limitation. Without addressing the validity of the patents, the Federal Circuit reversed as to the 727 patent and affirmed as to the 343 patent. Both include a “batches” limitation that requires batch consistency, which, according to the patents, is achieved through efficient mixing. Efficient mixing is required by the asserted claims of both patents. View "The Medicines Co. v. Mylan, Inc." on Justia Law

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The 631 application, entitled “Glenoid Implant for Minimally Invasive Shoulder Replacement Surgery,” describes an invention related to “rotator cuff sparing procedures and associated devices for shoulder replacement surgery.” The application improves on the prior art by offering “simple and less invasive perpendicular access to the humeral and glenoid joint surfaces,” which “spares the rotator cuff tendons and allows for a quicker and more functional recovery.” The surgery described in the application involves two main steps. First, the surgeon removes “a minimal amount of bone from the peripheral surface of the glenoid”—a process called reaming. Second, the surgeon places an implant in the reamed cavity. The Patent Trial and Appeal Board concluded that several claims were anticipated by prior art, 35 U.S.C. 102(b). The Federal Circuit reversed; the finding of anticipation was not supported by substantial evidence. View "In re: Chudik" on Justia Law

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Hundreds of plaintiffs sued the drug manufacturer Merck, alleging that the osteoporosis drug Fosamax caused them to suffer serious thigh bone fractures. Each brought a state-law tort claim alleging that Merck failed to add an adequate warning of the risk to Fosamax’s FDA-approved drug label. Many also brought claims including defective design, negligence, and breach of warranty. Plaintiffs’ suits were consolidated in multi-district litigation in the District of New Jersey. Following discovery and a bellwether trial, the court granted Merck summary judgment, based on the Supreme Court’s holding in Wyeth v. Levine, that state-law failure-to-warn claims are preempted when there is “clear evidence” that the FDA would not have approved the warning that plaintiffs claim was necessary. The Third Circuit vacated. Preemption is an affirmative defense; Merck did not carry its burden to prove that it is entitled to that defense. The Wyeth “clear evidence” standard is demanding and fact-sensitive. It requires a court sitting in summary judgment to anticipate the range of conclusions that a reasonable juror might reach and the certainty with which the juror would reach them. Here, plaintiffs produced sufficient evidence for a reasonable jury to conclude that the FDA would have approved a properly-worded warning about the risk of thigh fractures—or to conclude that the odds of FDA rejection were less than highly probable. View "In Re: Fosamax Products Liability Litigation" on Justia Law

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Amphastar Pharmaceuticals Inc. and its wholly owned subsidiary (collectively, Amphastar) and Sandoz Inc. were competitors in the U.S. market for generic enoxaparin, an anticoagulant. Momenta Pharmaceuticals Inc. served as Sandoz’s contract laboratory. Amphastar filed a complaint alleging antitrust violations by Sandoz and Momenta based on Defendants’ alleged misrepresentations to the United States Pharmacopeial Convention, a private standard-setting organization charged with ensuring the quality of drugs. Defendants brought an infringement suit against Amphastar, resulting in a temporary restraining order (TRO) and preliminary injunction prohibiting Amphastar from selling enoxaparin. The preliminary injunction was later vacated, but it did prevent Amphastar from selling its generic enoxaparin for approximately three months. Amphastar then filed this suit under the Sherman Act seeking damages for lost profits during the pendency of the TRO and injunction. The district court dismissed the complaint under the Noerr-Pennington doctrine, which immunizes good-faith petition of government entities from antitrust liability. The First Circuit reversed, holding that the district court erred in applying Noerr-Pennington. Remanded for the district court to consider Defendants’ other arguments in the first instance. View "Amphastar Pharmaceuticals, Inc v. Momenta Pharmaceuticals, Inc." on Justia Law