Justia Drugs & Biotech Opinion Summaries

Schering held a patent on the controlled release coating applied to potassium chloride crystals for treatment of potassium deficiencies. Potential generic manufacturers filed an abbreviated application for approval (ANDA),Hatch-Waxman Act, 21 U.S.C. 301-399, asserting that the Schering patent was invalid or would not be infringed by their new generic drugs. Schering’s subsequent infringement suits were resolved through agreements in which it paid the generic manufacturers to drop patent challenges and refrain from producing a generic drug for a specified period. Congress amended Hatch-Waxman to require pharmaceutical companies who enter into such settlements to file for antitrust review. The FTC filed an antitrust action with respect to Schering’s settlements. Plaintiffs sued on behalf of a class of purchasers of the drug. The Third Circuit affirmed the district court’s certification of the class, but reversed its presumption that Schering’s patent was valid and gave Schering the right to exclude infringing products until the end of its term, including through reverse payment settlements. The court directed use of a “quick look rule of reason analysis” based on economic realities of the settlement rather than labels. The court must treat any payment from a patent holder to a patent challenger who agrees to delay entry into the market as prima facie evidence of unreasonable restraint of trade, rebuttable by showing that the payment was for a purpose other than delayed entry or offers some pro-competitive benefit. View "In Re: K-Dur Antitrust Litigation" on Justia Law

Lupin submitted an Abbreviated New Drug Application (ANDA) to the Food and Drug Administration seeking approval to market a generic version of Fortamet, an extended-release tablet of metaformin hydrochloride. Shionogi, which markets Fortamet, sued Lupin for patent infringement under 35 U.S.C. 271(e)(2)(A) asserting, among others, the 866 patent), which is listed in the Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) entry for Fortamet. Lupin attempted to launch its generic Fortamet “at risk,”( without a final judgment on the merits in the litigation). Shionogi obtained a preliminary injunction. The Federal Circuit vacated and remanded. The district court incorrectly concluded that Lupin failed to raise a substantial question of validity regarding the asserted claims of the 866 patent, an abused its discretion by issuing a preliminary injunction. View "Sciele Pharma Inc. v. Lupin, Ltd." on Justia Law

The patents involve topical compositions for protecting pets from fleas and ticks. The 940 patent, now expired, claimed fipronil for pest control by direct toxicity. Merial, as exclusive licensee, developed compositions sold as Frontline. Merial also devised compositions, covered by the 329 patent, combining fipronil with an insect growth regulator, sold as Frontline Plus, the leading flea and tick treatment. In 2007 Merial sued Cipla and other internet retailers, alleging infringement. No defendant responded. The district court found that the patents were not invalid, that Cipla had infringed each patent, and entered a permanent injunction barring Cipla from directly or indirectly infringing the patents. In 2008 Cipla filed an informal communication, not intended to constitute an appearance, denying infringing or having any presence in the U.S., and requesting dismissal. The district court entered final judgment. Velcera, led by former Merial executives, engaged with Cipla to develop, test, manufacture, and distribute products to compete with Merial. Both Velcera and Cipla entered into development and supply agreements with various companies. In 2011, they began selling PetArmor Plus. The district court held Velcera and Cipla in contempt. The Federal Circuit affirmed, rejecting challenges to jurisdiction and to the contempt order’s application to Velcera. View "Merial, Ltd. v. Cipla, Ltd." on Justia Law

The patent is entitled “Ultra High Molecular Weight Polyethylene Molded Article for Artificial Joints and Method of Preparing the Same.” The examiner rejected a reissue application as obvious, finding that it would have been obvious to a person of ordinary skill in the art to use cross-linked UHMWPE in the method of making the UHMWPE products disclosed by a reference, given the teaching of another reference that cross-linking prior to compression deformation results in improved transparency, an increased melting point, and excellent dimensional stability. The examiner further found that one of ordinary skill in the art would have had a reasonable expectation of success in obtaining those enhanced properties by combining the techniques taught by the two references. The Board affirmed, rejecting an argument that there would have been no motivation to combine the teachings because the references are directed to different products. The Federal Circuit affirmed. View "In Re: Hyon" on Justia Law

Montgomery filed the 824 application in 2005, claiming priority to United Kingdom applications 9722026.3 (October 1997) and 9810855.8 (May 1998). The application is directed to inhibitors of the renin-angiotensin system (RAS), important in control of blood pressure and regulation of salt and water metabolism. The claims recite administering RAS inhibitors to patients diagnosed as in need of stroke treatment or prevention. The examiner rejected these claims as anticipated by each of prior art references. The Board of Patent Appeals and Interferences affirmed. The Federal Circuit affirmed. The contested claim elements were administration of ramipril, a known RAS inhibitor, to a patient diagnosed as in need of stroke treatment or prevention, where such administration is for treatment or prevention of stroke or its recurrence. Prior art discloses both requirements. View "In Re Montgomery" on Justia Law

The FDA last approved a typical antipsychotic in 1975. Despite drawbacks, typical antipsychotics are still used to treat schizophrenia. In the early 1960s, researchers discovered clozapine, the first "atypical" antipsychotic, useful for treating both positive and negative symptoms. Clozapine had serious potential side effects and was withdrawn from clinical trials. The FDA approved no new antipsychotic drugs between 1976 and 1989, finally approving clozapine in 1990, only for certain patients, subject to blood testing. The FDA approved risperidone, an atypical antipsychotic, in 1994, and, since then, has approved seven other atypical antipsychotics, including aripiprazole. These are as effective as typical antipsychotics for treating positive symptoms, while also treating negative symptoms and causing fewer side effects than clozapine. Every approved atypical antipsychotic has chemical structure related either to clozapine or risperidone, except aripiprazole, the active ingredient in "Abilify," marketed by plaintiff for treatment of schizophrenia, bipolar disorder, irritability associated with pediatric autistic disorder, and as add-on treatment for depression. Anticipating expiration of the patent, companies submitted FDA Abbreviated New Drug Applications for approval of generic aripiprazole. The district court ruled in favor of plaintiff on patent infringement, 35 U.S.C. 103. The Federal Circuit affirmed, rejecting claims of obviousness and of nonstatutory double patenting. View "Otsuka Pharm. Co., Ltd. v. Sandoz, Inc." on Justia Law

This case involved a type of patent litigation settlement known as a "pay for delay" or "reverse payment" agreement. In this type of settlement, a patent holder paid the allegedly infringing generic drug company to delay entering the market until a specified date, thereby protecting the patent monopoly against a judgment that the patent was invalid or would not be infringed by the generic competitor. This case began when the FTC filed a complaint in district court alleging that the reverse payment settlements between the holder of a drug patent and two generic manufacturers of the drug were unfair restraints on trade that violated federal antitrust laws. The court's precedent established the rule that, absent sham litigation or fraud in obtaining the patent, a reverse payment settlement was immune from antitrust attack so long as its anticompetitive effects fell within the scope of the exclusionary potential of the patent. The court rejected the FTC's claims to the contrary and affirmed the judgment. View "FTC v. Watson Pharmaceuticals, Inc., et al." on Justia Law

Once the FDA has approved a brand manufacturer's drug, another company could seek permission to market a generic version pursuant to legislation known as the Hatch-Waxman Amendments. See Drug Price Competition and Patent Term Restoration Act of 1984, 98 Stat. 1585. The relevant statute at issue in this case provided that a generic company "may assert a counterclaim seeking an order requiring the [brand manufacturer] to correct or delete the patent information [it] submitted... under [two statutory subsections] on the ground that the patent does not claim... an approved method of using the drug." 117 Stat. 2452, 21 U.S.C. 355(j)(5)(C)(ii)(I). At issue in this case was whether Congress had authorized a generic company to challenge a use code's accuracy by bringing a counterclaim against the brand manufacturer in a patent infringement suit. The Court held that a generic manufacturer could employ this provision to force correction of a use code that inaccurately described the brand's patent as covering a particular method of using the drug in question. Therefore, the Court reversed the judgment of the Federal Circuit. View "Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S" on Justia Law

A drug manufacturer can obtain FDA permission to market a generic version of an approved drug by Abbreviated New Drug Application (ANDA), rather than full New Drug Application (NDA). It is an act of infringement to file an ANDA for a drug or use of the drug claimed in a patent, 35 U.S.C. 271(e)(2)(A). Every NDA must identify every patent that could reasonably be asserted in an infringement action, 21 U.S.C. 355(b)(1), for publication in the Orange Book. An ANDA for a generic drug must address each patent in the Orange Book that relates to that drug. For patents that will not expire prior to proposed marketing, the applicant can include a statement that the applicant is not seeking approval for the method of use claimed in the patent or can certify that the patent is invalid or will not be infringed. Bayer markets Yasmin, an oral contraceptive, approved by NDA in 2001. Defendants filed ANDAs to market generic versions and certified that three patents would not be infringed, arguing that their ANDAs related only to contraceptive use and not to claimed methods for treating hirsutism or acne or reducing water retention. The district court entered judgment of noninfringement. The Federal Circuit affirmed.View "Bayer Schering Pharma, AG v. Lupin, Ltd." on Justia Law

A brand-name company seeking FDA new drug approval must submit information about patents for which a claim of infringement could reasonably be asserted, 21 U.S.C. 355(b)(1), for publication in the Orange Book. A generic company may seek FDA approval using abbreviated new drug application (ANDA), including, for each patent in the Orange Book, certification that approval is not sought until the patent expires or paragraph IV certification that such patent is invalid or will not be infringed. If an ANDA contains only paragraph IV certifications, it may be approved unless the holder sues for patent infringement within 45 days. The first generic company to file an ANDA containing paragraph IV certification receives a 180-day exclusivity period from the date of its first commercial marketing. The period can be forfeited by failure to launch after final judgment of noninfringement or invalidity. An ANDA filer, not sued within 45 days, can seek declaratory judgment under 28 U.S.C. 2201. Plaintiffs obtained declaratory judgment that a generic pharmaceutical did not infringe defendant's patent. The Federal Circuit affirmed, rejecting a challenge to the district court’s jurisdiction, based on a covenant not to sue contained in an earlier settlement between the parties.View "Dey Pharma, LP v. Sunovion Pharm., Inc." on Justia Law