Justia Drugs & Biotech Opinion Summaries

Eilise was born in 1996 and had problems with gross motor skills and language development. After therapy, Eilise showed dramatic improvement. In 2001, Eilise received three vaccinations, including her second dose of the measles, mumps, and rubella vaccine. Five days later, Eilise’s brother witnessed her arching her back, thrusting her head back, rolling her eyes, and jerking. He did not know what was happening. Her parents, who did not witness the seizure, noted that Eilise was feverish and lethargic. Eilise had a grand mal seizure at school. She was taken to a hospital. She had another seizure there. Eilise’s MRI results were generally normal, but her EEG results were “consistent with a clinical diagnosis of epilepsy.” She continued to suffer seizures until she started a ketogenic diet. Her parents filed suit under the National Childhood Vaccine Injury Compensation Program, 42 U.S.C. 300aa, alleging that Eilise suffered from autism as a result of her vaccinations; they later amended to allege, instead, that Eilise suffered from a “seizure disorder and encephalopathy.” The Claims Court affirmed denial of her petition. The Federal Circuit vacated: in certain cases, a petitioner can prove a logical sequence of cause and effect between a vaccination and the injury with a physician’s opinion where the petitioner has proved that the vaccination can cause the injury and that the vaccination and injury have a close temporal proximity. View "Moriarty v. Sec'y of Health & Human Servs." on Justia Law

BBC, owner of the FLANAX trademark in Mexico, and its sister company, Bayer, filed suit against Belmora, owner of the FLANAX trademark in the United States, contending that Belmora used the FLANAX mark to deliberately deceive Mexican-American consumers into thinking they were purchasing BCC’s product. The court concluded that the Lanham Act’s, 15 U.S.C. 1125, plain language contains no unstated requirement that a section 43(a) plaintiff have used a U.S. trademark in U.S. commerce to bring a Lanham Act unfair competition claim; the Supreme Court’s guidance in Lexmark International, Inc. v. Static Control Components, Inc. does not allude to one, and the court's prior cases either only assumed or articulated as dicta that such a requirement existed; and therefore, the district court erred in imposing such a condition precedent upon Bayer’s claims. The court also concluded that BCC has adequately pled a section 43(a) false association claim for purposes of the zone of interests prong; BCC's allegations reflect the claim furthers the section 45 purpose of preventing the deceptive and misleading use of marks in commerce within the control of Congress; and BCC has also alleged injuries that are proximately caused by Belmora’s violations of the false association statute. Therefore, the court held that BCC has sufficiently pled a section 43(a) false association claim to survive Belmora’s Rule 12(b)(6) motion. Because these statements are linked to Belmora’s alleged deceptive use of the FLANAX mark, the court is satisfied that BCC’s false advertising claim, like its false association claim, comes within the Act’s zone of interests. The court inferred that the alleged advertisements contributed to the lost border sales pled by BCC, and that the claim also satisfies Lexmark’s proximate cause prong. Further, the court agreed with Bayer that the district court erred in overturning the TTAB’s section 14(3) decision because it read a use requirement into the section that is simply not there. Accordingly, the court vacated and remanded. View "Belmora LLC v. Bayer Consumer Care AG" on Justia Law

In consolidated cases, patent-holder plaintiffs market drugs and have patents in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations publication (Orange Book), 21 U.S.C. 355(b)(1). Mylan filed Abbreviated New Drug Applications (ANDA), 21 U.S.C. 355(j), seeking FDA approval to market generic versions of the drugs, certifying that the Orange Book patents are invalid or would not be infringed by the proposed drugs. The plaintiffs sued in Delaware under 35 U.S.C. 271(e)(2)(A). Mylan is incorporated in, and has its principal place of business in, West Virginia and submitted its ANDAs in Maryland; it intends to direct sales into Delaware, among other places, once it has FDA approval. Mylan sent notices to the plaintiffs in New York, Ireland, Delaware and Sweden. One plaintiff is incorporated in Delaware, the U.S. subsidiary of another has its principal place of business in Delaware. Both have sued others for infringement in Delaware. Each district court concluded that Delaware had sufficient contacts related to the subject of these cases to exercise specific personal jurisdiction over Mylan. The judges disagreed about whether Delaware could exercise general personal jurisdiction (independent of suit-related contacts) on the ground that Mylan consented to jurisdiction in registering to do business. Each declined to dismiss. The Federal Circuit affirmed on the issue of specific jurisdiction, declining to address general personal jurisdiction. View "Acorda Therapeutics, Inc. v. Mylan Pharma., Inc." on Justia Law

The People filed a complaint charging defendants with causing, aiding, and abetting the illegal delivery of marijuana. The trial court granted an injunction barring defendants from further developing or marketing their marijuana delivery app. At issue on appeal is whether Proposition D, L.A. Mun. Code, 45.19.6, which City voters enacted in 2013 to regulate medical marijuana businesses, generally prohibits the delivery of marijuana by vehicles. The court concluded that the City established a likelihood of proving defendants’ app caused, aided, or abetted the violation of Proposition D because, outside of the narrow exception for designated primary caregivers, it prohibits the vehicular delivery of medical marijuana to qualified participants, identification card holders, or primary caregivers in the City. Further, defendants’ opposition to the City’s unfair competition allegations necessarily fails because the City has demonstrated a likelihood of success on its claim that defendants facilitated a violation of Proposition D. In this case, defendants made no showing at all concerning the balance of hardships, much less that the balance tipped sharply in their favor. Accordingly, the court affirmed the trial court's judgment. View "People v. Nestdrop, LLC" on Justia Law

Plaintiffs filed suit under federal securities laws and state blue sky laws, alleging that Sanofi made materially false or misleading statements regarding its breakthrough drug, Lemtrada, designed to treat multiple sclerosis. The district court granted defendants' motion to dismiss for failure to state a claim. The court agreed with the district court's reasoning and holding. The court writes principally to examine the impact of the Supreme Court’s decision in Omnicare, Inc. v. Laborers District Council Construction Industry Pension Fund, decided after the district court rendered its decision. Given the sophistication of the investors here, the FDA’s public preference for double‐blind studies, and the absence of a conflict between defendants’ statements and the FDA’s comments, the court concluded that no reasonable investor would have been misled by defendants’ optimistic statements regarding the approval and launch of Lemtrada. Issuers must be forthright with their investors, but securities law does not impose on them an obligation to disclose every piece of information in their possession. As Omnicare instructs, issuers need not disclose a piece of information merely because it cuts against their projections. Accordingly, the court affirmed the judgment. View "In re Sanofi Sec. Litig." on Justia Law

The underlying coverage dispute arose from the supplying of a defective ingredient for incorporation into Wisconsin Pharmacal Company (Pharmacal) probiotic supplement tablets. Pharmacal brought this action against Jeneil Biotech, Inc. and Nebraska Cultures of California, Inc. (the Insureds) and the Netherlands Insurance Company and Evanston Insurance Company (the Insurers), alleging numerous tort and contract claims. The Insurers moved for summary judgment, arguing that their respective insurance policies did not cover any damages that arose out of the causes of action against the Insureds. The circuit court granted the Insurers’ motions for summary judgment, determining that the facts of this case did not trigger the Insurers’ duties to defend. The court of appeals reversed, concluding that the policies provided coverage. The Supreme Court reversed, holding that there was no “property damage” caused by an “occurrence” in this case, and even if there were, certain exclusions in both policies applied to negate coverage. View "Wis. Pharmacal Co., LLC v. Neb. Cultures of Cal., Inc." on Justia Law

Warner Chilcott, a brand-name drug manufacturer that owns the patent covering Loestrin 24 Fe, and Watson Pharmaceuticals, Inc., which sought to introduce a generic version of Loestrin 24, entered into a settlement agreement wherein Watson agreed to delay entry of its generic version of Loestrin 24 in exchange for favorable side deals. Thereafter, Lupin Pharmaceuticals, Inc. announced that it would introduce a generic version of Loestrin 24. Warner and Lupin settled on terms similar to those between Warner and Watson. Two putative classes of plaintiffs brought antitrust claims that the settlement agreements were violations of the Sherman Act and constituted illegal restrains on trade under FTC v. Actavis. At issue in this case was whether such settlement agreements are subject to federal antitrust scrutiny where they do not involve reverse payments in pure cash form. The district court dismissed, concluding that Actavis applies only to monetary reverse payments and that Plaintiffs had alleged the existence of non-cash reverse payments only. The First Circuit vacated and remanded, holding that the district court erred in determining that non-monetary reverse payments do not fall under the scope of Actavis. Remanded. View "In re Loestrin 24 FE Antitrust Litig." on Justia Law

OWW owns patents directed to cushioning devices that fit over the residual stumps of amputated limbs to make the use of prosthetics more comfortable. OWW has asserted its patents against Alps in several actions, including one filed in 2004 concerning devices consisting of stretchable synthetic fabric, coated with a gel on only the side touching the body, to reduce skin irritation, while the dry side allows free interaction with the prosthesis. After the court issued a claim construction order, Alps filed two successive ex parte reexamination proceedings before the Patent and Trademark Office. The examiner rejected the claims of the patent for obviousness. The Board of Patent Appeals and Interferences reversed, but the court granted Alps summary judgment of invalidity as to all asserted claims. The Federal Circuit remanded. Following remand, the Federal Circuit affirmed findings of inequitable conduct in the second reexamination, but not in the first. OWW executive Colvin was aware that OWW’s reexamination counsel represented to the Board that testimony by Alps’s witness (Comtesse) was uncorroborated; that Colvin was aware of materials that corroborated Comtesse’s testimony; and that Colvin failed to correct counsel’s misrepresentations. Based on that inequitable conduct finding, the patent is unenforceable and the case was exceptional, justifying a fee award against OWW. View "Ohio Willow Wood Co. v. Alps S., LLC" on Justia Law

AngioScore sells angioplasty balloon catheters (AngioSculpt), designed to open arterial blockages. Three AngioScore patents each list three inventors, but none lists Lotan as an inventor. TriReme is a competitor of AngioScore. Apparently concerned that AngioScore might charge TriReme with infringement, TriReme sought to acquire an interest in the AngioScore patents from Dr. Lotan, who performed consulting services for AngioScore. Lotan granted TriReme an exclusive license to “any and all legal and equitable rights” he held in the AngioScore patents. Lotan claimed that his inventive contribution arose from his work in connection with the development of the AngioSculpt catheters in 2003, which is reflected in the AngioScore patents. AngioScore’s defense was based on a 2003 consulting contract between AngioScore and Lotan. AngioScore asserts that it acquired rights to all inventive work completed by Lotan. TriReme brought suit for correction of inventorship, 35 U.S.C. 256. The district court dismissed, finding that TriReme lacked standing. The Federal Circuit reversed and remanded for consideration of whether Lotan’s continued work on AngioSculpt after the contract’s effective date came within the contract’s language. View "TriReme Med., LLC v. Angioscore, Inc." on Justia Law

Samuel’s 575 patent, filed in 1997, claims inventions in the field of intraluminal stent technology. One type of intraluminal stent is a vascular stent. Vascular stents are used to treat medical conditions wherein a vascular wall is unduly constricted, as in the case of vascular stenosis, or unduly enlarged, as in the case of aneurysm. Either of these medical conditions poses an unacceptable risk of insufficient blood flow or vascular rupture. The 575 patent generally claims intraluminal stents that can be affixed to a vascular wall via the use of “an inflatable and deflatable cuff” without penetrating the vessel wall. In a 2013 infringement suit, defendant TriVascular filed a petition for inter partes review. The Patent Trial and Appeal Board found that TriVascular failed to demonstrate that the challenged claims were unpatentable over the applied art; adopted Samuels’ construction of “inflatable protrusions,” as “protrusions that are themselves inflatable, i.e., expandable by being filled with fluid;” and concluded that the 575 patent’s “inflatable protrusions” were not disclosed by the prior art. The Federal Circuit affirmed. View "Trivascular, Inc. v. Samuels" on Justia Law