Justia Drugs & Biotech Opinion Summaries

Plaintiff owns a patent on an FDA-approved (21 U.S.C. 355(b)(2) ) pharmaceutical nasal spray Fortical, used to treat osteoporsis, with the active ingredient salmon calcitonin. In its FDA filing, plaintiff identified the drug as bioidentical to Miacalcin. Defendant filed an Abbreviated New Drug Application with the FDA, stating intent to make, use, offer to sell, sell, and/or import a generic version of Fortical product before the expiration of plaintiff's patent. Plaintiff claimed infringement. Defendant alleged invalidity under 35 U.S.C. 101, 102, 103,and 112, noninfringement and inequitable conduct in failure to disclose an allegedly material piece of prior art and making allegedly misleading statements during patent prosecution. The district court found that the patent would not have been obvious at the time of invention, denied defendant's motion to breach the attorney-client privilege under the crime-fraud exception, and determined that defendant had waived several counter-claims. The Federal Circuit affirmed. Even accepting that there was a design need and market pressure to develop a pharmaceutical formulation bioequivalent to Miacalcin, there was no evidence that the claim would be an obvious solution to those motivations.View "Unigene Labs, Inc. v. Apotex, Inc." on Justia Law

The FTC sued Lundbeck, Inc., alleging that its acquisition of the drug NeoProfen violated the Federal Trade Commission Act, 15 U.S.C. 41 et seq., the Sherman Act, 15 U.S.C. 1-7, the Clayton Act, 15 U.S.C. 12-27, the Minnesota Antitrust Law of 1971, and unjustly enriched Lundbeck. At issue was whether the district court properly determined that the FTC failed to identify a relevant market where the FTC did not meet its burden of proving that the drugs Indocin IV and Neoprofen were in the same product market. The court held that the district court's finding was not clearly erroneous and affirmed the judgment. View "Federal Trade Commission v. Lundbeck, Inc." on Justia Law

The Mississippi Public Employees' Retirement System filed a class action, claiming that senior management of a publicly traded manufacturer of medical devices in which it invested, withheld material information and made misleading statements about devices for treating coronary artery disease, in violation of the Securities Exchange Act of 1934, 15 U.S.C. 78j(b), 78t(a), and Securities Exchange Commission Rule 10b-5, 17 C.F.R. 240.10b-5. In an earlier opinion, the First Circuit reversed dismissal, finding that the inference of scienter advanced by the plaintiff was at least as cogent and compelling as the contrary inference, satisfying the "strong inference" pleading standard of the Private Securities Litigation Reform Act. After discovery, the district court entered summary judgment in favor of defendants. The First Circuit affirmed, finding that plaintiff did not produce evidence that would support a reasonable inference of scienter. Given the statements and disclosures that defendants did make concerning the devices, they had no obligation to disclose the fact that they were working on an improvement that would reduce the very small number of no-deflate complaints that they received, and of which the market was aware. View "MS Pub.Emps. Ret. Sys. v. Boston Scientific Corp." on Justia Law

Shortly after Plaintiff Mark Rimbert's father began taking Prozac, he killed his wife and himself. Plaintiff brought a wrongful death action against Defendant Eli Lilly, the manufacturer of Prozac. Defendant moved for summary judgment on various grounds and to exclude the testimony of Plaintiff's sole expert witness on the question of causation. The motions were denied by the district judge initially assigned the case. Once the case was reassigned, Defendant moved for reconsideration. The second district judge granted Defendant's motion to exclude Plaintiff's expert witness. The court then entered summary judgment for Defendant, concluding that without the expert's testimony, Plaintiff had no case. Plaintiff brought this appeal to the Tenth Circuit, arguing that the district court erred by excluding the testimony of his expert. Upon review, the Tenth Circuit affirmed the district court's order excluding the testimony, but reversed the order granting summary judgment. The Court remanded the case for further proceedings. View "Rimbert v. Eli Lilly & Co." on Justia Law

Wife, suing on behalf of her deceased husband, (plaintiff) filed tort claims and a breach of warranty claim against pharmaceutical companies, alleging that the prescription Mirapex that husband used to treat his Parkinson's disease lead him to compulsively gamble. At issue was whether the district court properly granted summary judgment to defendants because plaintiff's claims were time-barred. The court held that the district court correctly determined that plaintiff's claim accrued more than two years before he brought his suit and thus was time-barred. The court also held that because husband became aware of the effect of the Mirapex more than two years before he filed suit, the continuing tort doctrine did not save his claim; that the open courts provision did not operate to save plaintiff's claim; that the district court did not err in determining that the facts were sufficiently developed to establish a concrete injury in 2006 for the purpose of determining ripeness; that the affidavits at issue did not raise a genuine issue of fact as to whether husband's behavioral problems and side effects were so severe as to render him legally incompetent and therefore, the tolling provisions of section 16.0001 of the Texas Civil Practice and Remedies Code were unavailable; and that plaintiff had not satisfied the requirement that purchasers gave notice of a breach of warranty claim prior to filing suit and therefore, the district court did not err in granting summary judgment to defendant on that claim. Accordingly, the judgment was affirmed. View "Gazal v. Boehringer Ingelheim Pharmaceuticals, et al." on Justia Law

Plaintiff, a pharmaceutical company, owns a patent that claims conjugated estrogen pharmaceutical compositions for use in hormone replacement therapies. Plaintiff alleged infringement of the patent based on defendant's Abbreviated New Drug Application for a generic version of plaintiff's hormone replacement therapy product, arguing the doctrine of equivalents. The district court entered summary judgment for defendant. The Federal Circuit affirmed. Plaintiff failed to rebut the presumption of prosecution history estoppel based on unforeseeability. The doctrine of prosecution history estoppel prevents a patent owner from recapturing, through the doctrine of equivalents, subject matter surrendered to acquire the patent. Because plaintiff narrowed the scope of the patent's claims in response to a prior art rejection, a presumption of prosecution history estoppel applies. View "Duramed Pharm., Inc. v. Paddock Labs, Inc." on Justia Law

These consolidated lawsuits involved state tort law claims based on certain drug manufacturers' alleged failure to provide adequate warning labels for the generic drug metoclopramide. State tort law required a manufacturer that was, or should be, aware of its drug's danger to label it in a way that rendered it reasonably safe. On the other hand, federal drug regulations, as interpreted by the FDA, prevented the manufacturers from independently changing their generic drug safety labels. At issue was whether such federal drug regulations applicable to generic drug manufacturers directly conflicted with, and thus preempted, the state law claims. The Court concluded that the federal drug regulations preempted the state law claims because, if manufacturers had independently changed their labels to satisfy their state law duty to attach a safer label to their generic metoclopramide, they would have violated the federal requirement that generic drug labels be the same as the corresponding brand-name drug labels. Thus, it was impossible for the manufacturers to comply with federal and state law. Even if the manufacturers had fulfilled their federal duty to ask for FDA help in strengthening the corresponding brand-name labels, assuming such a duty existed, they would not have satisfied their state tort law duty. State law demanded a safer label, it did not require communication with the FDA about the possibility of a safer label. Therefore, the Court held that when a party could not satisfy its state duties without the Federal Government's special permission and assistance, which was dependent on the exercise of judgment by a federal agency, that party could not independently satisfy those state duties for preemption purposes. The Court also noted that Congress and the FDA retained authority to change the law and regulations if they so desired. Accordingly, the case was reversed and remanded for further proceedings. View "PLIVA, Inc., et al. v. Mensing; Actavis Elizabeth, LLC v. Mensing; Actavis, Inc., v. Demahy" on Justia Law

Vermont's Prescription Confidentiality Law, Vt. Stat. Ann., Tit. 18, 4631(d), restricted the sale, disclosure, and use of pharmacy records that revealed the prescribing practices of individual doctors. Respondents, Vermont data miners and an association of brand-name drug manufacturers, sought declaratory and injunctive relief against state officials, contending that section 4631(d) violated their rights under the Free Speech Clause of the First Amendment. At issue was whether section 4631(d) must be tested by heightened judicial scrutiny and, if so, whether Vermont could justify the law. The Court held that the Vermont Statute, which imposed content-based and speaker-based burdens on protected expression, was subject to heightened judicial scrutiny. The Court also held that Vermont's justifications for section 4631(d) did not withstand such heightened scrutiny and therefore, affirmed the Second Circuit's judgment that section 4631(d) unconstitutionally burdened the speech of pharmaceutical marketers and data miners without adequate justification. View "Sorrell, et al. v. IMS Health Inc., et al." on Justia Law

A citizen of Illinois brought suit against several non-Illinois companies and one Illinois company, alleging failure to warn with respect to side effects of Yazmin birth control pills. The defendants removed to federal court, claiming improper joinder. The district court dismissed the Illinois pharmacy owner, restoring diversity, and dismissed the suit after the plaintiff abandoned the case. The Seventh Circuit affirmed, applying the "learned intermediary doctrine" and reasoning that the pharmacy had no duty to warn, absent knowledge of a particular susceptibility. The "common defense" exception does not serve as a basis for remand because the plaintiff alleged that the other defendants concealed information.

Plaintiffs, two scientists, brought a suit to enjoin the National Institutes of Health ("NIH") from funding research using human embryonic stem cells ("ESCs") pursuant to the NIH's 2009 Guidelines ("Guidelines"). At issue was whether the preliminary injunction was properly granted where the district court concluded that plaintiffs were likely to succeed in showing that the Guidelines violated the Dickey-Wicker Amendment, an appropriations rider that barred federal funding for research in which a human embryo was destroyed. The court vacated the preliminary injunction and held that plaintiffs were unlikely to prevail because Dickey-Wicker was ambiguous and the NIH seemed reasonably to have concluded that, although Dickey-Wicker barred funding for the destructive act of deriving an ESC from an embryo, it did not prohibit funding a research project in which an ESC would be used.