Drugs & Biotech Case Summaries
[08/26] Ferring Pharmaceuticals, Inc. v. Watson Pharmaceuticals, Inc.
Denial of plaintiff’s motion for a preliminary injunction against defendant, brought pursuant to a Lanham Act claim, is affirmed where: 1) in light of the Supreme Court’s decisions in eBay, Inc. v. MercExchange, L.L.C and Winter v. Natural Resources Defense Council, Inc., a party bringing a claim under the Lanham Act is not entitled to a presumption of irreparable harm when seeking a preliminary injunction and must demonstrate that irreparable harm is likely; and 2) plaintiff failed to demonstrate that irreparable harm was likely.
[08/22] Ferring B.V. v. Watson Laboratories, Inc.
Dismissal of plaintiff’s claims alleging that defendant infringed each and every claim of the patents-in-suit by filing an Abbreviated New Drug Application (ANDA) is affirmed, where defendant’s amendment to its ANDA rendered it non-infringing.
[08/06] TYCO Healthcare Group v. Mutual Pharmaceutical Co.
Summary judgment in favor of plaintiffs holding that they did not violate the antitrust laws by filing suit against defendant or by filing a “citizen petition” with the Food and Drug Administration (FDA) seeking to bar defendant from obtaining FDA permission to market its generic version of one of plaintiffs’ drugs is: 1) vacated in part, where the district court should determine whether plaintiffs’ factual theory of infringement is objectively baseless; 2) affirmed in part, where defendant has not met its burden to establish that plaintiffs’ validity arguments were objectively baseless; and 3) vacated in part and remanded, where the district court erred in granting summary judgment against defendant on the citizen petition issue.
[08/06] ScriptPro, LLC v. Innovation Associates
In an infringement action involving plaintiff’s patent for a unit and system that that automatically fills and labels pill bottles or other prescription containers, summary judgment for defendant, holding that plaintiff’s asserted claims were invalid under 35 U.S.C. section 112 for lack of an adequate written description, is reversed and remanded, where a trier of fact could find that a skilled artisan would understand the specification to disclose a system that relies on the computer memory, without sensors, to fulfill the central purpose of keeping track of slot use by particular customers and slot availability, with sensors optionally providing confirmation only.
[07/30] Bristol-Myers Squibb v. Superior Court (Anderson)
In an action alleging defects in Plavix, a drug petitioner manufactures and sells throughout the country, a petition for writ of mandate challenging the trial court’s finding of jurisdiction over petitioner with regard to non-California resident plaintiffs is denied, where: 1) California does not have general jurisdiction over petitioner based upon the facts of this case; but 2) petitioner has engaged in substantial, continuous economic activity in California, including the sale of more than a billion dollars of Plavix to Californians; 3) that activity is substantially connected to the non-resident plaintiffs’ claims, which are based on the same alleged wrongs as those alleged by the California resident plaintiffs; 4) petitioner does not establish it would be unreasonable to assert jurisdiction over it; and therefore, 5) it is consistent with due process to require petitioner to defend the non-resident plaintiffs’ claims before the trial court in coordination with the claims of the California resident plaintiffs.
[07/29] Merck Eprova AG v. Gnosis S.p.A.
Judgment in favor of plaintiff on its Lanham Act false advertising and contributory false advertising claims is affirmed, where: 1) when, as here, the parties operate in the context of a two‐player market and literal falsity and deliberate deception has been proved, it is appropriate to utilize legal presumptions of consumer confusion and injury for the purposes of finding liability in a false advertising case brought under the Lanham Act; and 2) in a case where willful deception is proved, a presumption of injury may be used to award a plaintiff damages in the form of defendant’s profits, and may, in circumstances such as those present here, warrant enhanced damages.
[07/24] NRDC v. US FDA
In an action seeking to force the defendant Food and Drug Administration (FDA) to prohibit the use of certain antibiotics in animal feed, summary judgment in favor of plaintiffs is reversed and remanded, where: 1) Congress has not required the FDA to hold hearings whenever FDA officials have scientific concerns about the safety of animal drug usage; 2) the FDA retains the discretion to institute or terminate proceedings to withdraw approval of animal drugs; 3) the statutory mandate contained in 21 U.S.C. section 360b(e)(1) applies to limit the FDA’s remedial discretion by requiring withdrawal of approval of animal drugs or particular uses of such drugs only when the FDA has made a final determination, after notice and hearing, that the drug could pose a threat to human health and safety; and 4) the decision whether to institute or terminate a hearing process that may lead to a finding requiring withdrawal of approval for an animal drug is a discretionary determination left to the prudent choice of the FDA.
[07/14] Medisim LTD v. BestMed, LLC
The district court’s grant of judgment as a matter of law (JMOL) that plaintiff’s ‘668 patent is anticipated by its own prior art thermometer and in favor of defendant on plaintiff’s unjust enrichment claim is: 1) vacated in part and remanded, where defendant failed to preserve its right to JMOL on anticipation; but 2) affirmed in part with regard to the unjust enrichment claim and its conditional grant of a new trial on anticipation.
[07/07] Retractable Technologies, Inc. v. Becton Dickinson and Co.
The district court’s denial of defendant’s motion to modify the district court’s damages award following the partially successful appeal of the patent infringement judgment on which the award was based, is affirmed, where the mandate rule forecloses the relief that defendant seeks.
[06/27] State of CA v. Superior Court (Bristol-Myers Squibb Co.)
In a qui tam action alleging that defendant violated the Insurance Fraud Prevention Act (IFPA) by employing runners and cappers to induce physicians to prescribe its drugs to their patients, the trial court’s summary adjudication order in favor of defendant is reversed and the petition for writ of mandate is granted, where: 1) for the assessment of monetary penalties (but not the imposition of other available remedies), Insurance Code section 1871.7 requires proof of resulting claims that are in some manner deceitful, though not necessarily containing express misstatements of fact; and 2) causation may be established under the standard substantial-factor test, not the but-for test.
[06/19] Hardin v. PDX, Inc.
In an action alleging that defendant PDX intentionally modified its software to allow defendant Safeway to distribute abbreviated drug monographs that automatically omitted warnings of serious risks, the trial court did not err when it denied defendant’s motion to strike plaintiff’s negligence and product liability action as a Strategic Lawsuit Against Public Participation under Code of Civil Procedure section 425.16, where plaintiff demonstrated a probability she may prevail on her claim.
[06/12] Bristoll-Myers Squibb Co. v. Teva Pharms. USA, Inc.
In a patent infringement case concerning a drug for the treatment of hepatitis B, the district court’s finding of a claim 8 invalid for obviousness, is affirmed where Teva proved by clear and convincing evidence that claim 8 would have been obvious.
[06/10] Allergan, Inc. v. Apotex Inc.
The district court’s judgment finding that defendants had infringed claims of plaintiffs’ ‘029 patent for a topical application of compounds to treat hair loss, and ‘404 patent for the treatment of eyelash hair loss through topical application of bimatoprostand, and had failed to establish they were invalid, is reversed as to the findings with respect to the validity of each patent.
[06/09] Louisiana Wholesale Drug Co. v. Shire LLC
In an action brought by plaintiffs, wholesale dealers in pharmaceutical products, alleging that defendant drug manufacturers violated the Sherman Act by breaching their contracts to supply competing manufacturers with an unbranded version of defendants’ widely prescribed patented drug, dismissal of the suit is affirmed, where plaintiff has failed to allege facts that would place this case outside the “long recognized right of a trader or manufacturer engaged in an entirely private business, freely to exercise his own independent discretion as to parties with whom he will deal.”
[06/06] City of Edinburgh Council v. Pfizer, Inc.
Dismissal of a private securities fraud class action under the Private Securities Litigation Reform Act of 1995 (PSLRA), in which plaintiff-institutional investors allege that defendant and its executives made materially false and misleading statements in violation of the Securities Exchange Act of 1934 (Exchange Act) regarding interim clinical trial data related to the development of an experimental Alzheimer’s drug, is affirmed, where: 1) the district court correctly concluded that plaintiffs have not adequately alleged that defendants made a material misrepresentation or omission; 2) the district court correctly concluded that defendants were under no duty to disclose the allegedly omitted information; and 3) the district court correctly dismissed the control person liability and insider trading claims for failure to adequately plead a predicate Exchange Act violation.
[06/04] Consumer Watchdog v. Wisconsin Alumni Research Foundation
Plaintiff’s appeal from the Patent Trial and Appeal Board’s decision affirming the patentability of claims 1–4 of defendant’s ‘913 patent, which is generally directed to human embryonic stem cell cultures, is dismissed, where plaintiff has not established an injury in fact sufficient to confer Article III standing.
[06/03] Planned Parenthood Arizona v. Humble
In an action seeking to enjoin enforcement of an Arizona statute and its implementing regulation, which restrict the manner in which certain medications may be used to perform abortions, the district court’s denial of plaintiffs’ motion for a preliminary injunction is reversed and remanded, where: 1) plaintiffs introduced uncontroverted evidence that the Arizona law substantially burdened women’s access to abortion services; 2) Arizona introduced no evidence that the law advanced in any way Arizona’s interest in women’s health; 3) on the record here, the burden imposed by the Arizona law was undue within the meaning of Planned Parenthood of Se. Penn. v. Casey, 505 U.S. 833, 876 (1992), and Gonzales v. Carhart, 550 U.S. 124 (2007); and therefore, 4) the district court abused its discretion when it held that plaintiffs were unlikely to succeed on the merits of their undue burden claim.
[06/02] Nautilus, Inc. v. Biosig Instruments, Inc.
In a patent infringement suit alleging that defendant, without obtaining a license, sold exercise machines containing plaintiff’s patented technology for a heart-rate monitor used with exercise equipment, the Federal Circuit Court of Appeals erred in concluding that plaintiff’s patent survived indefiniteness review under its articulated standard, where: 1) a patent is invalid for indefiniteness if its claims, read in light of the patent’s specification and prosecution history, fail to inform, with reasonable certainty, those skilled in the art about the scope of the invention; 2) definiteness is to be evaluated from the perspective of a person skilled in the relevant art, claims are to be read in light of the patent’s specification and prosecution history, and definiteness is to be measured as of the time of the patent application; 3) the Federal Circuit’s standard that a patent claim passes the threshold so long as the claim is “amenable to construction,” and the claim, as construed, is not “insolubly ambiguous,” does not satisfy the Patent Act’s definiteness requirement; and 4) the matter must be remanded so that the Federal Circuit can reconsider, under the proper standard, whether the relevant claims in the subject patent are sufficiently definite.
[05/27] K/S HIMPP v. Hear-Wear Technologies, LLC
The decision of the United States Patent and Trademark Office (PTO) Board of Patent Appeals and Interferences (Board) in an inter partes reexamination affirming the Examiner’s decision not to reject claims 3 and 9 of the ‘512 patent, which is directed to a hearing aid with three parts, is affirmed, where the objector failed to identify the factual evidence necessary to support its contention that the claims would have been obvious.
[05/19] Tobinick v. Olmarker
In an interference proceeding before the Patent Trial and Appeal Board at the United States Patent and Trademark Office (PTO) relating to drug treatments for spinal nerve injuries, dismissal of claimant’s patent application is reversed, where: 1) the Board did not err in its claim construction; but 2) the Board’s finding of lack of adequate written description is not supported by substantial evidence.
[04/30] In re: Fosamax Products Liability Litigation (No. II)
In an action involving product liability claims against defendant drug manufacturers by plaintiffs who allegedly suffered bone fractures because they took Fosamax or the generic equivalent of that drug, the district court’s judgment on the pleadings in favor of the Generic defendants is affirmed, where: 1) plaintiffs waived any arguments regarding negligence-based design-defect claims against the Generic defendants by raising them for the first time in their reply brief; and 2) plaintiffs’ strict-liability design-defect claims against the Generic defendants are preempted by federal law.