by
The Biologics Price Competition and Innovation Act, 42 U.S.C. 262, establishes a scheme for adjudicating claims of patent infringement in the FDA's approval of “biological products.” To obtain FDA approval, the sponsor of a new biological product must demonstrate that it is “safe, pure, and potent.” For a “biosimilar” product based on an approved “reference” product, a party may submit an abbreviated “subsection (k)” application that “piggybacks” on the showing made for an approved reference product but must provide the reference product's sponsor with its subsection (k) application and information that describes the manufacturing process. The parties then collaborate to identify patents for immediate litigation. The second phase is triggered by the applicant’s notice of commercial marketing and involves any patents that were included on the lists but not previously litigated. Hospira's subsection (k) application sought approval of a biosimilar of EPOGEN®, Amgen’s FDA-approved product, Although Amgen asserted that Hospira failed to disclose the composition of the cell-culture medium used during manufacturing, the parties began identifying patents. Amgen claimed that it could not assess the reasonableness of asserting infringement claims concerning other patents for culturing cells and moved to compel discovery on the composition of Hospira’s cell-culture medium in its suit on listed patents. The court denied Amgen’s motion, stating that the information had no relevance to the asserted patents. Amgen appealed that interlocutory order. The Federal Circuit dismissed, holding that it lacked jurisdiction under the collateral order doctrine and that Amgen failed to satisfy the prerequisites for mandamus. View "Amgen, Inc.. v. Hospira, Inc.." on Justia Law

by
In this action brought by two individuals (Relators) under the False Claims Act (FCA) and various state analogues, the First Circuit affirmed in part and reversed in part the district court’s dismissal of the complaint. The district court concluded that Relators failed to plead false claims under either the FCA or the state-law versions of the FCA with the particularity required by Fed. R. Civ. P. 9(b). The First Circuit held (1) the complaint was correctly dismissed to the extent it relied on the alleged falsity of statements made by the product manufacturer in securing approval from the FDA to market a hip-replacement device; but (2) the district court erred in dismissing the complaint to the extent to rested on allegations that the manufacturer sold latently defective versions of its FDA-approved product on unsuspecting doctors who sought government reimbursement for defective products, as Relators’ complaint was sufficient to survive a Rule 9(b) motion to dismiss. View "Nargol v. DePuy Orthopaedics, Inc." on Justia Law

by
The specifications of the three Soft Gel patents describe a method for dissolving CoQ10. The patented inventions include a composition, a soft gelatin capsule, and a method of making such a soft gelatin capsule, each involving a solution of CoQ10 dissolved in a monoterpene. CoQ10, also called ubiquinone, is a coenzyme, i.e., a chemical compound that is required for the biological activity of certain proteins and is necessary for certain metabolic processes and for the production of cellular energy; it has a secondary role as an antioxidant. In clinical trials, CoQ10 has been shown to be effective in regulating blood pressure and cholesterol levels, improving cardiovascular health, and “thwarting various diseases such as certain types of cancers.” It is “sparingly soluble in hydrophilic solvents such as water.” According to the patents, at the time of the inventions, most solvents that were used to administer CoQ10 in liquid form could dissolve, at most, only about 5 to 10 percent of the CoQ10. Jarrow requested inter partes reexaminations of the three Soft Gel patents. The Patent Board invalidated several claims. The Federal Circuit affirmed, finding the claims invalid as obvious in light of prior references, 35 U.S.C. 103(a). View "Soft Gel Technologies, Inc. v. Jarrow Formulas, Inc." on Justia Law

by
Millennium developed the patented product for the treatment of oncology diseases, particularly multiple myeloma and mantle cell lymphoma. The product has the brand name Velcade®. Sandoz and others filed abbreviated new drug applications (ANDAs), admitting infringement and seeking to invalidate various claims of the 446 Patent. The district courts held that certain claims were invalid as obvious, 35 U.S.C. 103. In consolidated appeals, the Federal Circuit concluded that the district court erred and that invalidity was not established. Sandoz identified no reference or combination of references that show or suggest a reason to make the claimed compound. The district court clearly erred in its examination of the objective indicia of unexpected results and long-felt need. View "Millenium Pharmaceuticals, Inc. v. Sandoz, Inc." on Justia Law

by
Plaintiff filed a products liability suit against McNeil and its corporate parent, Johnson & Johnson, after he suffered a severe reaction after taking Motrin. The Court of Appeal held that the jury's verdict finding McNeil liable for negligent failure to warn must be reversed because it was fatally inconsistent with the verdict finding McNeil not liable for strict liability failure to warn; the negligent failure to warn special verdict was also defective because of the failure to include the necessary question whether a reasonable manufacturer under the same or similar circumstances would have warned of the danger; the verdicts against McNeil for negligent and strict liability design defect, as well as against Johnson & Johnson for strict liability design defect, must be reversed, because the design defect claims were based on a theory—failure to sell dexibuprofen—that was impliedly preempted; the strict liability design defect verdicts must also be reversed because the jury found McNeil and Johnson & Johnson liable solely under the consumer expectation test, but that test did not apply when, as here, the question of design defect involved complex questions of feasibility, practicality, risk, and benefit beyond the common knowledge of jurors; and none of plaintiffs' design defect claims could be retried. View "Trejo v. Johnson & Johnson" on Justia Law

by
Masters filed suit challenging the DEA's 2014 decision to revoke the company's certificate of registration, without which it cannot sell controlled substances. The DC Circuit denied the petition for review, holding that the Administrator's conclusions -- that whenever an order for controlled substances was held by the SOMS Computer Program, that order was presumptively "suspicious" under 21 C.F.R. 1301.74(b), and Masters' employees rarely undertook the investigation required to dispel the suspicion surrounding held orders -- were well founded. The court held that Masters failed to identify any prejudicial errors in the Administrator's decision. View "Masters Pharmaceutical, Inc. v. DEA" on Justia Law

by
The State of New Hampshire moved to enforce administrative subpoenas served on defendants Actavis Pharma, Inc., Endo Pharmaceuticals, Inc., Janssen Pharmaceuticals, Inc., Purdue Pharma L.P., and Teva Pharmaceuticals USA, Inc. The State was investigating defendants’ role in allegedly causing health care providers to prescribe opioids to treat chronic pain. Defendants resisted, arguing the Office of the Attorney General’s (OAG) engagement of outside counsel was unlawful. In addition, defendants moved for a protective order, seeking to “bar the Attorney General from engaging contingent fee counsel to: (a) participate in or assume responsibility for any aspect of the State’s investigation of alleged violations of the Consumer Protection Act . . . ; or (b) participate in or assume responsibility for any subsequent enforcement action pertaining to alleged CPA violations.” Defendants argued that the OAG’s fee agreements with the firm Cohen Milstein: (1) violated RSA 21-G:22 and :23 (2012) (amended 2016); (2) violated New Hampshire common law; (3) were ultra vires because the OAG did not comply with RSA 7:12 (2013) (amended 2016) or :6-f (Supp. 2016); (4) violated the doctrine of separation of powers; (5) violated the New Hampshire Rules of Professional Conduct; and (6) violated due process under the New Hampshire and United States Constitutions. The State replied that an objection to the Attorney General’s use of outside counsel was not appropriate justification for refusing to comply with lawful subpoenas, and that defendants lacked standing to raise that complaint. The trial court denied the State’s motion to enforce the subpoenas and granted the defendants’ motion for a protective order “to the extent that the OAG and Cohen Milstein’s contingency fee agreement is invalid.” The trial court determined that the defendants had demonstrated standing to bring their claims, that the fee agreement was void, and therefore denied the State’s motion to enforce the subpoenas on that basis. The New Hampshire Supreme Court concluded defendants lacked standing to challenge the outside counsel agreement. It reversed and remanded the matter for further proceedings. View "New Hampshire v. Actavis Pharma, Inc." on Justia Law

by
The Fourth Corner Credit Union applied for a master account from the Federal Reserve Bank of Kansas City. The Reserve Bank denied the application, effectively crippling the Credit Union’s business operations. The Credit Union sought an injunction requiring the Reserve Bank to issue it a master account. The district court dismissed the action, ruling that the Credit Union’s stated purpose, providing banking services to marijuana-related businesses, violated the Controlled Substances Act. The Tenth Circuit vacated the district court’s order and remanded with instructions to dismiss the amended complaint without prejudice. By remanding with instructions to dismiss the amended complaint without prejudice, the Court’s disposition effectuated the judgment of two of three panel members who would allow the Fourth Corner Credit Union to proceed with its claims. The Court denied the Federal Reserve Bank of Kansas City’s motion to strike the Fourth Corner Credit Union’s reply-brief addenda. View "Fourth Corner Credit Union v. Federal Reserve Bank of Kansas" on Justia Law

by
The claims at issue involve testing methods for fetal aneuploidies, conditions in which a fetus either has an abnormally high number of chromosomes (e.g., Down’s syndrome) or an abnormally low number (e.g., Turner’s syndrome). Previously, physicians diagnosed fetal aneuploidies using invasive amniocentesis or chorionic villus sampling or less invasive methods, such as ultrasonography and biochemical marker detection that had suboptimal accuracy. In three interference proceedings between Stanford and Chinese University, the Patent Trial and Appeal Board found that Stanford’s claims were unpatentable for lack of written description. The Federal Circuit vacated, finding that the Board relied on improper evidence and did not cite other substantial evidence to support its key findings. Whether a patent claim satisfies the written description requirement, 35 U.S.C. 112, depends on whether the description clearly allows persons of ordinary skill in the art to recognize that the inventor invented what is claimed. On remand, the Board should examine whether a person of ordinary skill would have understood that the patent’s specification disclosed random MPS sequencing and would have known, as of the priority date, that the specification’s reference to Illumina products meant random MPS sequencing as recited in the claims, by examining the record evidence as to pre-filing date art-related facts on Illumina products. View "Stanford University v. Chinese University of Hong Kong" on Justia Law

by
When an artery is damaged or inflamed, the body releases the enzyme myeloperoxidase (MPO). Prior art taught that MPO could be detected in an atherosclerotic plaque or lesion that required a surgically invasive method; could be indirectly detected in blood; or could be detected in blood with results that were not predictive of cardiovascular disease. Cleveland Clinic purportedly discovered how to “see” MPO in blood and correlate that to the risk of cardiovascular disease. True Health, a diagnostic laboratory, purchased the assets of Diagnostics, which had contracted with Cleveland Clinic to perform MPO testing. Rather than continue that relationship, True Health performed its own MPO testing. Cleveland Clinic sued, asserting infringement of the patents. The district court found all the claims patent-ineligible under 35 U.S.C. 101; dismissed the contributory and induced infringement claims of the 260 patent; denied leave to amend; and held that it was proper to consider section 101 at the motion to dismiss stage.. The court found that the claims were directed to a law of nature, with no saving inventive concept. The Federal Circuit affirmed. Cleveland Clinic provided no proposed construction of any terms or proposed expert testimony that would change the analysis. The claims, whether considered limitation-by-limitation or as a whole, do not sufficiently transform the natural existence of MPO in a bodily sample and its correlation to cardiovascular risk into a patentable invention. View "Cleveland Clinic Foundation v. True Health Diagnostics. LLC" on Justia Law