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Defendants manufacture and distribute FDA-approved prescription eye drop medications for treating conditions such as glaucoma. Bottles are pre-packaged with a fixed volume of medication; labeling does not indicate how many doses or days of treatment a patient can extract from the bottle. The dimensions of the bottle’s dropper tip dictate the size of the drop dispensed. Scientific research indicates that a normal adult’s inferior fornix – the area between the eye and the lower eyelid – has a capacity of approximately 7-10 microliters (µLs) of fluid. If a drop exceeding that capacity is placed into an eye, excess medication is expelled, providing no pharmaceutical benefit to the patient. Expelled medication also may flow into a patient’s tear ducts and move into his bloodstream, increasing the risk of certain harmful side effects. These studies conclude that eye drops should be 5-15 µLs. Defendants’ products emit drops that are considerably larger so that at least half of every drop goes to waste. The Third Circuit reversed dismissal of a putative class action (Class Action Fairness Act, 28 U.S.C. 1332) under state consumer protection statutes. The consumers’ allegations of injury were sufficient to confer standing. Plaintiffs claim economic interests in the money they spent on medication that was impossible for them to use; their concrete and particularized injury claims fit comfortably in categories of “legally protected interests” readily recognized by federal courts. View "Cottrell v. Alcon Laboratories" on Justia Law

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The FDA approved Depakote for treating seizures, migraine headaches, and conditions associated with bipolar disorder. Physicians may prescribe it for other "off-label" uses, but a drug’s manufacturer can promote it only as suitable for uses the FDA has found safe and effective. Abbott, which makes Depakote, encouraged intermediaries to promote Depakote’s off-label uses for ADHD, schizophrenia, and dementia, hiding its own involvement. Abbott pleaded guilty to unlawful promotion and paid $1.6 billion to resolve the criminal case and False Claims Act suits, 31 U.S.C. 3729–33. Welfare-benefit plans that paid for Depakote’s off-label uses sought treble damages under the Racketeer Influenced and Corrupt Organizations Act, 18 U.S.C. 1964, for a class comprising all third-party payors. Following a remand, the court dismissed the suit on the ground that the plaintiffs could not show proximate causation, a RICO requirement. The Seventh Circuit affirmed, reasoning that the Payors are not the most directly, injured parties. Patients suffer if they take Depakote when it is useless and may be harmful and costly. Physicians also may lose, though less directly. Because some off-label uses of Depakote may be beneficial to patients, it is hard to treat all off-label prescriptions as injurious to the Payors; if they did not pay for Depakote they would have paid for some other drug. In addition, some physicians were apt to write off-label prescriptions whether or not Abbott promoted such uses. Calculation of damages would require determining the volume of off-label prescriptions that would have occurred absent Abbott’s unlawful activity. View "Sidney Hillman Health Center of Rochester v. Abbott Laboratories, Inc." on Justia Law

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Amgen’s patents relate to antibodies that help reduce low-density lipoprotein cholesterol (LDLC), or “bad cholesterol.” Typically, high LDL-C is treated using small molecules (statins), which sometimes have adverse side effects or cannot reduce a patient’s LDL-C to a healthy level, requiring an alternative treatment, such as a PCSK9 inhibitor. PCSK9 is a naturally occurring protein that binds to and causes the destruction of liver cell receptors (LDL-Rs) that are responsible for extracting LDLC from the bloodstream. Amgen began studying PCSK9 in 2005 and developed the drug Repatha™ with the active ingredient “evolocumab,” a monoclonal antibody that targets PCSK9 to prevent it from destroying LDL-R proteins.The FDA approved Repatha in 2015. In 2007, Appellants started exploring antibodies targeting PCSK9, resulting in the development of Praluent. Praluent's active ingredient is a monoclonal antibody that targets PCSK9 to prevent it from binding to and destroying LDL-R proteins. The LDL-R proteins then extract LDL-C, lowering overall LDL-C levels. In 2011, Appellants obtained a patent that claimed Praluent by its amino acid sequence. The FDA approved Praluent in 2015. Amgen sued Appellants. Appellants stipulated to infringement. The district court enjoined the sale of Praluent. The Federal Circuit reversed in part. The district court erred by excluding Appellants’ evidence regarding post-priority-date evidence of enablement and improperly instructed the jury on written description. View "Amgen Inc. v. Sanofi" on Justia Law

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Dr. David Jang, M.D., is the named inventor of the patent, which is directed to a coronary stent. Jang assigned the patent to BSC. BSC agreed to pay a royalty if it ever produced a product that would infringe the patent. Jang sued, based on BSC’s “Express stent.” BSC sought ex parte reexamination, then sought to include invalidity defenses in Jang’s suit. The district court denied the motion, deeming invalidity defenses “irrelevant” as to whether BSC owed royalties for past sales. The Patent and Trademark Office subsequently cancelled the asserted claims as unpatentable. The court denied BSC’s motion in limine to preclude Jang from presenting a doctrine of equivalents theory, finding that Jang’s experts sufficiently explained his doctrine of equivalents theory in their expert reports. The jury ultimately found no literal infringement, but found infringement under the doctrine of equivalents. Following through on its earlier decision, the district court conducted an evidentiary hearing on ensnarement. Concluding that Jang did not meet his burden of persuasion, which includes providing a proper hypothetical claim that does not ensnare the prior art, the district court vacated the jury verdict and entered judgment of non-infringement. The Federal Circuit affirmed the entry of judgment of non-infringement. View "Jang v. Boston Scientific Corp." on Justia Law

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The Fifth Circuit affirmed defendant's sentence for methamphetamine-related offenses. The court held that the district court did not clearly err by denying a mitigating-role adjustment under USSG 3B1.2 where defendant certainly understood that she was illegally transporting contraband into the United States and that she was being paid for her participation. The court also held that the district court did not impermissibly rely on her integral role to the exclusion of all else, and remand was not warranted where the district court need not weigh each USSG 3B1.2 factor on the record. View "United States v. Bello-Sanchez" on Justia Law

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The Fifth Circuit affirmed the district court's grant of summary judgment to Solvay on relators' False Claims Act (FCA) claims. The court held that relators failed to produce sufficient evidence to survive summary judgment on any of their briefed claims where the public disclosure bar applied to relators' AndroGel claims; at bottom, the probative value of relators' off-label marketing causation evidence was primarily based on conjecture and speculation and was insufficient to create a genuine issue of material fact for trial; and summary judgment was appropriate as to relators' claim that Solvay unduly influenced P&T committees to place Solvay's drugs on preferred drug lists and as to relators' FCA retaliation claims. Finally, the court affirmed the district court's ruling that partly granted court costs to Solvay. View "King v. Solvay Pharmaceuticals, Inc." on Justia Law

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This appeal involved two antipsychotic drugs primarily used to treat schizophrenia and bipolar disorder: Abilify Maitena, manufactured by Otsuka; and Aristada, manufactured by Alkermes. Otsuka sought judicial review, contending that the FDA's same-moiety limitation on the scope of a drug's marketing exclusivity conflicted with the Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. 355(a). The DC Circuit affirmed the district court's grant of summary judgment for the FDA and Alkermes, holding that the FDA's same-moiety test was a reasonable construction of the statute and was consistent with the agency’s regulations. View "Otsuka Pharmaceutical Co. v. Price" on Justia Law

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The First Circuit affirmed the district court’s finding, in this securities fraud class action against Sarepta Therapeutics, Inc. and former and current Sarepta executives, that Plaintiffs, several shareholders, failed to allege facts creating a strong inference that Defendants intentionally or recklessly deceived the investing public in the months before the Food and Drug Administration deemed premature Sarepta’s application for approval of a novel gene therapy. The price of the publicly traded securities issued by Sarepta dropped sixty-four percent after the FDA judged Sarepta’s filing premature. Plaintiffs allegedly that Defendants overstated the significance of certain data and exaggerated the likelihood that the FDA would accept a new drug application for filing, thereby deceiving the investing public and causing the purchase of Sarepta securities at inflated prices. The First Circuit affirmed the district court’s dismissal of this action, holding that Plaintiffs failed to satisfy the requisite pleadings standards. View "Corban v. Sarepta Therapeutics, Inc." 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