Justia Drugs & Biotech Opinion Summaries

Elan marketed metaxalone, a muscle relaxant, under the brand-name Skelaxin. Years after Skelaxin’s approval, Elan learned that another company conducted in vivo bioequivalence fasting studies and in vitro dissolution tests on metaxalone and that, based on the results, the FDA proposed to change the designation of metaxalone from “non bioproblem” to “bioproblem.” Elan initiated a study and observed a significant effect of food on bioavailability. Elan petitioned the FDA to require both fed and fasting data for any abbreviated new drug application for a generic version of Skelaxin and to revise its product label. The FDA granted both. Elan obtained patents based on its bioavailability data, which were later invalidated in light of prior art. Classen’s 472 patent is directed to a method for accessing and analyzing data on a commercially available drug to identify a new use of that drug, and commercializing that new use. Classen alleged that Elan infringed that patent when it studied the effect of food on Skelaxin’s bioavailability, used the data to identify a new use, and commercialized that use. The court entered summary judgment of noninfringement, finding Elan protected by the safe harbor provision of 35 U.S.C. 271(e)(1), for activities “reasonably related to the submission of information” under the Federal Food, Drug, and Cosmetic Act. During ex parte reexamination of the 472 patent, the PTO cancelled 107 of the 137 originally issued claims. The Federal Circuit affirmed with respect to the 271(e)(1) exemption, but remanded an allegation that activities that occurred after the FDA submissions infringed the 472 patent and were not exempt. View "Classen Immunotherapies, Inc. v. Elan Pharma., Inc." on Justia Law

Takeda owns several asserted patents that cover several methods of administering colchicine products to treat gout. Colchicine itself, which has been used for centuries, is not covered by Takeda’s patents. Takeda has patents directed to treating acute gout flares and others directed to methods for administering colchicine for prophylaxis of gout in patients who are concomitantly taking certain drug inhibitors known as “CYP3A4” and “P-gp” inhibitors. In 2010, Hikma sought FDA approval of a colchicine product for prophylaxis of gout flares. It submitted an New Drug Application under the Hatch Waxman Act, 21 U.S.C. 355(b)(2). In 2014, the FDA granted Hikma approval to market its Mitigare colchicine capsule. Hikma launched Mitigare, and Takeda filed suit, asserting induced infringement under 35 U.S.C. 271(b) based on Hikma’s labeling of the Mitigare product. Hikma planned on launching an authorized generic version of Mitigare in October 2014. The district court granted Takeda’s request for a temporary restraining order, but later denied a preliminary injunction. The Federal Circuit affirmed. Takeda acknowledged that evidence of mere knowledge of infringing uses is not sufficient and did not establish a probability of success on the issue of infringement. View "Takeda Pharma., U.S.A. v. Hikma Am., Inc." on Justia Law

Madel sued the Department of Justice and Drug Enforcement Administration for a response to Freedom of Information Act, 5 U.S.C. 552, requests that sought information on oxycodone transactions in Georgia by five private companies. DEA withheld some documents as confidential commercial information. The district court granted summary judgment to DEA, finding it produced all non-exempt information. The court denied declaratory and injunctive relief and attorney fees. The Eighth Circuit reversed and remanded. Rejecting a claim that DEA did not justify withholding the five documents under FOIA Exemption 4, the court concluded that DEA showed that substantial competitive harm was likely. DEA did not make “barren assertions” that the documents were exempt, but linked each document to identifiable competitive harms. The court remanded for consideration of FOIA’s segregability requirement. DEA did not show “with reasonable specificity why documents withheld pursuant to a valid exemption cannot be further segregated.” Its Declaration does not address how disclosure of the data from, for example, 2007, leads to the proffered substantial competitive harms of a competitor “target[ing] specific markets” or “forecast[ing] potential business of new locations.” View "Madel v. Dep't of Justice" on Justia Law

When Samantha Reckis was seven years old, she developed toxic epidermal necrolysis, a life-threatening skin disorder, after receiving multiple doses of Children’s Motrin, an over-the-counter medication with ibuprofen as its active ingredient. Plaintiffs, Samantha and her parents, sued the manufacturer and marketer of Children’s Motrin and its parent company, alleging that Samantha developed TEN as a result of being exposed to ibuprofen in the Children’s Motrin and that the warning label on the medication’s bottle rendered the product defective because it failed to warn consumers about the serious risk of developing a life-threatening disease from it. A jury found in favor of Plaintiffs and awarded Samantha a total of $50 million in compensatory damages and each of Samantha’s parents $6.5 million for loss of consortium. The Supreme Judicial Court affirmed, holding (1) Plaintiffs’ claim of failure to warn was not preempted by the Federal Food, Drug, and Cosmetic Act; (2) a pharmacologist who offered the causation evidence essential to Plaintiffs’ case was qualified to testify as to specific medical causation, and the testimony was reliable and admissible; and (3) the damages awarded to each of the plaintiffs were not grossly excessive or unsupported by the record. View "Reckis v. Johnson & Johnson" on Justia Law

From 1998 to 2012 Abbott marketed the anticonvulsant medication Depakote for applications that had not been FDA-approved (off-label uses). Physicians may prescribe drugs for off-label uses, but pharmaceutical companies are generally prohibited from marketing drugs for those same applications. Qui tam actions were filed under the False Claims Act. In 2009, Abbott disclosed in an SEC filing that the Department of Justice was investigating its marketing. Abbott pleaded guilty to illegally promoting Depakote from 2001 through 2006 and agreed to pay $1.6 billion to settle the criminal and qui tam actions. Employee benefits funds filed suit 15 months later, alleging that Abbott misrepresented Depakote’s safety and efficacy for off-label uses, paid kickbacks to physicians, established and funded intermediary entities to promote the drug for off-label uses, and concealed its role in these activities, in violation of the Racketeer Influenced and Corrupt Organizations Act. The district court dismissed, finding that the statute of limitations for the RICO claim began to run in 1998, when the funds initially reimbursed a prescription for off-label use. The court refused to toll the limitations period until the guilty plea, finding that Abbott’s concealment efforts were not designed to hinder potential lawsuits. The Seventh Circuit reversed, finding that dismissal was premature without an opportunity for discovery into when a reasonable fund should have known about its injuries from off-label marketing. View "Sidney Hillman Health Ctr. of Rochester v. Abbott Labs., Inc." on Justia Law

Pfizer’s patent discloses methods of treating eye infections by topical administration of azithromycin to the eye and states that before the invention, azithromycin was commonly administered orally for the treatment of antibacterial infections, but was not known to be effective when topically administered to the eye. Insite owns three patents. Inspire is the licensee of all four patents and markets the FDA-approved topical azithromycin solution, “Azasite®.” The FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations lists the four patents. Sandoz filed an Abbreviated New Drug Application for its generic version of Azasite® with a certification under 21 U.S.C. 355(j)(2)(A)(vii)(IV) that the patents were invalid or not infringed. The patent holders sued under 35 U.S.C. 271(e). After claim construction, Sandoz stipulated to infringement. The district court ruled that Sandoz failed to show that the asserted claims would have been obvious to a person of ordinary skill in the art and upheld the validity of the patents under 35 U.S.C. 103(a). The Federal Circuit affirmed, rejecting an argument that the court “misframed” the inquiry relating to development of “improved topical treatments for ocular infections,” rather than the narrower problem of topically administering azithromycin to treat conjunctivitis. View "Insite Vision, Inc. v. Sandoz, Inc." on Justia Law

The patents relate to pharmaceutical formulations containing omeprazole, the active ingredient in Astra’s prescription drug, Prilosec, which is effective in treating acid-related gastrointestinal disorders. The omeprazole molecule can be unstable. To protect it from stomach acid, formulators have used an enteric coating. Enteric coatings contain acidic compounds, which can cause the omeprazole to decompose. To enhance storage stability, alkaline reacting compounds must be added, which can compromise a conventional enteric coating. The inventors of the patents at issue added a water-soluble, inert subcoating, separating the alkaline material from the enteric coating. The resulting formulation provides a dosage form of omeprazole with good storage stability, sufficient gastric acid resistance, and rapid release. After a finding of infringement, the district court awarded $76,021,994.50 plus prejudgment interest on a reasonable royalty theory of recovery. The Federal Circuit rejected challenges to the evidentiary analysis and conclusion that a 50 percent royalty rate constituted fair compensation under the reasonable royalty theory; upheld a finding that there was no reason to exclude the value of the active ingredient when calculating damages and refusal to discount the value of Astra’s patents based on the existence of alternatives to the infringing formulation that Apotex actually used; and reversed the award relating to the pediatric exclusivity period. View "Astrazeneca AB v. Apotex Corp." on Justia Law

Enzo’s 767 patent involves the use of nucleotide probes that allow a scientist to detect, monitor, localize, or isolate nucleic acids when present in extremely small quantities, as is necessary for the sequencing of deoxyribonucleic acid (DNA). A jury found that Applera directly infringed all of the asserted claims, that Applera induced its customers to infringe all of the asserted claims, and that the claims at issue were not proven by clear and convincing evidence to lack enablement or written description. The Federal Circuit vacated the judgment of infringement and remanded, finding error in the district court’s claim construction, which construed the claims at issue to cover both direct and indirect detection of a signalling moiety. View "Enzo Biochem, Inc. v. Applera Corp." on Justia Law

Daiichi markets Benicar® for treating hypertension. In seeking FDA approval, Daiichi listed, in the Approved Drug Products with Therapeutic Equivalence Evaluations publication, (Orange Book), the 599 patent covering the drug’s active ingredient, olmesartan medoxomil, which expires in 2016, and the 703 patent covering methods of treatment, which expires in 2021. After Mylan filed an Abbreviated New Drug Application in 2006, Daiichi disclaimed the 703 patent, 35 U.S.C. 253. The district court upheld the validity of the 599 patent. Apotex filed an ANDA for generic olmesartan medoxomil, acknowledging that the 599 patent is valid, barring an effective date of FDA approval earlier than 2016. Daiichi did not sue Apotex for infringing the 703 patent. The FDA has not removed the patent from the Orange Book, despite Daiichi’s request. Apotex sought a declaratory judgment that it will not infringe that patent, to enable it to receive FDA marketing approval. The district court dismissed for lack of a case or controversy. The Federal Circuit reversed. Apotex has a concrete, potentially high-value stake in obtaining a judgment; Daiichi has a concrete, potentially high-value stake in denying Apotex that judgment and delaying Apotex’s market entry, as does Mylan, the first applicant for approval of a generic. View "Apotex, Inc. v. Daiichi Sankyo, Inc." on Justia Law

Cadence’s patents are directed to aqueous phenol formulations— particularly acetaminophen (sometimes referred to as “paracetamol”). The 222 patent, issued in 2000, explains that in aqueous solutions, acetaminophen decomposes into potentially toxic products and is directed at avoiding this decomposition by adding a free-radical capturing agent and a buffer. The 218 patent claims priority to a 2000 French application and discloses a method for obtaining stable acetaminophen formulations by deoxygenating solutions with an inert gas to achieve oxygen concentrations below 2 parts-per-million. Cadence’s FDA-approved injectable acetaminophen product is distributed under the name Ofirmev®. The FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) lists the patents in connection with Ofirmev®. Exela filed an FDA Abbreviated New Drug Application, seeking approval of a generic equivalent of Ofirmev®. The ANDA included a certification under 21 U.S.C. 355(j)(2)(A)(vii)(IV) (Paragraph IV certification) stating that the 222 and 218 patents were invalid and not infringed. Cadence sued Exela for infringement under 35 U.S.C. 271(e)(2)). The district court found the 222 patent not invalid and literally infringed and the 218 patent not invalid and infringed under the doctrine of equivalents. The Federal Circuit affirmed, upholding the constructions of “buffering agent” and “vacuum stoppering step.” View "Cadence Pharma, Inc. v. Exela Pharma Sciences, LLC" on Justia Law