Justia Drugs & Biotech Opinion Summaries

The Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Act), 21 U.S.C. 355(j)(2)(A)(vii)(IV) established procedures for identifying and resolving patent disputes between brand-name and generic drug manufacturers. One procedure requires a prospective generic manufacturer to certify to the FDA that any listed, relevant patent is invalid or will not be infringed by the manufacture, use, or sale of the generic drug (paragraph IV). Generic manufacturers filed paragraph IV applications for generic drugs modeled after Solvay’s FDA-approved, patented drug AndroGel. Solvay claimed patent infringement, 35 U.S.C. 271(e)(2)(A). The FDA approved the generic product, but the generic companies entered into “reverse payment” settlements, agreeing not to bring the generic to market for a number of years and to promote AndroGel to doctors in exchange for millions of dollars. The FTC sued, alleging violation of section 5 of the Federal Trade Commission Act by agreeing to abandon patent challenges, to refrain from launching low-cost generic drugs, and to share in Solvay’s monopoly profits. The district court dismissed. The Eleventh Circuit affirmed. The Supreme Court reversed and remanded, calling for application of a “rule of reason” approach rather than a “quick look.” Although the anti-competitive effects of the reverse settlement might fall within the exclusionary potential of Solvay’s patent, the agreement is not immune from antitrust attack. It would be incongruous to determine antitrust legality by looking only at patent law policy, and not at antitrust policies. The Court noted the Hatch-Waxman Act’s general pro-competitive thrust, facilitating challenges to a patent’s validity and requiring parties to a paragraph IV dispute to report settlement terms to antitrust regulators. Payment for staying out of the market keeps prices at patentee-set levels and divides the benefit between the patentee and the challenger, while the consumer loses. That a large, unjustified reverse payment risks antitrust liability does not prevent parties from settling their lawsuits; they may settle in other ways, e.g., by allowing the generic to enter the market before the patent expires without payment to stay out prior to that point. View "Fed. Trade Comm'n v. Actavis, Inc." on Justia Law

Myriad obtained patents after discovering the precise location and sequence of the BRCA1 and BRCA2 genes, mutations of which can dramatically increase the risk of breast and ovarian cancer. The discovery enabled Myriad to develop medical tests for detecting mutations for assessing cancer risk. Myriad’s patents would give it the exclusive rights to isolate an individual’s BRCA1 and BRCA2 genes and to synthetically create BRCA composite DNA. The district court entered summary judgment, finding the patents invalid under 35 U.S.C. 101 because they covered products of nature. On remand following the Supreme Court’s decision, Mayo Collaborative Servs. v. Prometheus Labs, Inc., the Federal Circuit found both isolated DNA and composite DNA patent-eligible. The Supreme Court affirmed in part and reversed in part, noting that the case did not involve “method claims” for new applications of knowledge about the genes or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. A naturally-occurring DNA segment is not patent-eligible merely because it has been isolated, but composite DNA is patent-eligible because it is not naturally-occurring. Myriad did not create or alter the genetic information encoded in the genes or the genetic structure of the DNA. Even brilliant discovery does not alone satisfy the section 101 inquiry. Myriad’s claims are not saved by the fact that isolating DNA from the human genome severs chemical bonds that bind gene molecules together. The claims are not expressed in terms of chemical composition, nor do they rely on the chemical changes resulting from the isolation of a particular DNA section. Composite DNA, however, is not a “product of nature;” a lab technician unquestionably creates something new when introns are removed from a DNA sequence to make composite DNA. View "Assoc. for Molecular Pathology v. Myriad Genetics, Inc." on Justia Law

The University of Minnesota owns the 281 and 291 patents, which are directed to “septal occluders,” medical devices for repairing holes in the septum of the heart, using a catheter threaded through a vein. The University accused AGA of infringing both patents. AGA’s accused septal occluders are one-piece devices made from tubes of wire mesh. After claim construction, the district court granted summary judgment that the 291 patent was not infringed and that the asserted claims of the 281 patent were invalid as anticipated. The Federal Circuit affirmed. The district court properly construed the terms “affixed” and “conjoint” to conclude that the 291 patent requires two physically separate disks. View "Regents of the Univ. of MN v. AGA Med.Corp." on Justia Law

Piperidine derivatives are commonly used as active ingredients in antihistamines. D’Ambra, AMRI’s president, found the prior art processes for making piperidine derivatives inefficient and overcame the deficiencies by synthesizing piperidine derivatives using piperidine and cyclopropylketone (CPK) intermediates at an earlier stage in the reaction. The processes developed by Dr. D’Ambra have the stated advantage of more readily separating out a substantially pure piperidine derivative end product, if desired. Sanofi-Aventis, the exclusive licensee of AMRI’s 703 patent, uses the processes to produce large quantities of fexofenadine, which is the active ingredient in its antihistamines marketed under the brand name Allegra® and Allegra-D® 24 Hour. The parties stipulated to a noninfringement judgment following the district court’s Markman opinion, which consolidated numerous patent infringement cases and construed terms of the 703 patent, among others. The Federal Circuit reversed and remanded, holding that the district court erred in construing “substantially pure.” View "Aventis Pharma, Inc. v. Amino Chem., Ltd." on Justia Law

Sunovion and Dey plaintiffs were simultaneously developing pharmaceutical products to treat chronic obstructive pulmonary disease by storing the compound formoterol in an aqueous solution and administering it through a nebulizer. Sunovion filed a patent application, followed by an application to test its products in human subjects. It then received a patent and held clinical trials, before ultimately releasing a commercial product. Dey likewise filed a series of patent applications, received several patents, ran human subject trials, and released a commercial product. Dey’s patent applications were filed after Sunovion’s, and its patents were issued after consideration of Sunovion’s patent. When Dey sued Sunovion for patent infringement, the district court held that some of Dey’s patents were invalid because a Sunovion clinical trial in which Sunovion tested its own product constituted anticipated Dey’s inventions and a prior public use within the meaning of 35 U.S.C. 102(b). The Federal Circuit reversed. Sunovion has not shown that it is entitled to summary judgment based on its assertion that its use of formulations meeting the limitations of Dey’s later-issued patents constituted a public use of Dey’s inventions within the meaning of section 102(b). View "Dey,L.P. v. Sunovion Pharma, Inc." on Justia Law

The National Childhood Vaccine Injury Act of 1986 established a no-fault compensation system to stabilize the vaccine market and expedite compensation to injured parties. Under the Act, a proceeding for compensation is “initiated” by service upon the Secretary of Health and Human Services and “the filing of a petition containing” specified documentation with the clerk of the Court of Federal Claims, who forwards the petition for assignment to a special master. 42 U. S. C. 300aa–11(a)(1). An attorney may not charge a fee for services in connection with such a petition, but a court may award attorney’s fees and costs incurred by a claimant in any proceeding on an unsuccessful petition, if that petition was brought in good faith. In 1997, shortly after receiving her third Hepatitis-B vaccine, Cloer began to experience symptoms that led to a multiple sclerosis (MS) diagnosis in 2003. In 2004, she learned of a link between MS and the Hepatitis-B vaccine, and in 2005, she filed a NCVIA claim. The special master concluded that Cloer’s claim was untimely because the Act’s 36-month limitations period began to run when she had her first MS symptoms in 1997.The Federal Circuit agreed. Cloer then sought attorney’s fees and costs. The Federal Circuit ruled in Cloer’s favor. The Supreme Court affirmed. Nothing in the attorney’s fees provision suggests that the reason for the subsequent dismissal of a petition, such as untimeliness, nullifies the initial filing. An NCVIA petition delivered to the court clerk, forwarded for processing, and adjudicated before a special master is a “petition filed under section 300aa–11.” The government’s contrary position is inconsistent with the fees provision’s purpose, which was to avoid limiting petitioners’ ability to obtain qualified assistance by making awards available for “non-prevailing, good-faith claims.” View "Sebelius v. Cloer" on Justia Law

In 1985, Behringwerke filed a U.S. patent application directed to the use of DNA sequences (enhancers) identified in human cytomegalovirus. An enhancer, when introduced into a cell that produces a drug, can enable the cell to produce the drug at a much higher rate. In 1992, Behringwerke and Genentech entered into a licensing agreement related to enhancers that matured into the patents-in-suit; for fixed annual payments, Genentech could practice the patents for research purposes. Genentech was to pay a royalty on sales of commercially marketable goods incorporating a “Licensed Product.” The Agreement, governed by German law, required that disputes be settled by arbitration. Behringwerke sold its pharmaceutical business to Sanofi, but the Agreement and patent rights stayed with Hoechst; both are German entities. In 2008, Sanofi sued Genentech for infringement based on sales of the allegedly infringing drugs Rituxan and Avastin, which Genentech had not identified as licensed products. Hoechst demanded arbitration before a European arbitrator. The district court found no infringement. The Federal Circuit affirmed. Arbitration continued. On remand, Genentech sought to enjoin Sanofi from continuing the foreign arbitration. The district court denied the motion, finding that Hoechst is a party to the arbitration, but not a party to the litigation and that an injunction would frustrate policies favoring enforcement of forum selection clauses, and would not be in the interest of international comity. The arbitrator determined that German substantive law, not U.S. patent law, would be used, that a drug could be a licensed article even though it did not contain the patented enhancers, if those enhancers were used in its manufacture, and that Genentech was liable for damages. The Federal Circuit affirmed that Genentech was not entitled to an injunction. View "Sanofi-Aventis Deutschland, GMBH v. Genentech, Inc." on Justia Law

Plaintiffs commenced this putative class action alleging that defendants participated in a global Internet conspiracy to sell illegal prescription drugs, in violation of the laws of the United States and Virginia. At issue on appeal was whether the district court erred in dismissing the complaint against four foreign banks for lack of personal jurisdiction. The court concluded that Rule 4(k)(2) did not justify the exercise of personal jurisdiction over the banks because exercising jurisdiction over them would not, in the circumstances here, be consistent with the United States Constitution and laws. Subjecting the banks to the coercive power of the court in the United States, in the absence of minimum contacts, would constitute a violation of the Due Process Clause. Accordingly, the court affirmed the district court's orders dismissing the complaint against the banks. View "Unspam Technologies v. Chernuk" on Justia Law

Combigan®, used to treat glaucoma, is a combination of the well-known alpha2-agonist Alphagan® and the well-known beta-blocker Timoptic® and contains the preservative benzalkonium chloride, which is widely-used in ophthalmic formulations. Allergan holds four patents related to Combigan®. The asserted claims are directed to a composition of 0.2% brimonidine and 0.5% timolol, expressed in different ways, some claims are directed to a fixed combination, others are directed to a method of treatment by administering the composition twice daily, and others are directed to packaging material indicating that twice daily administration of the composition is useful for treating glaucoma or ocular hypertension. Defendants submitted to the U.S. Food and Drug Administration an Abbreviated New Drug Application, seeking approval to market a generic version of Combigan®. Allergan sued under 35 U.S.C. 271(e)(2)(A), claiming infringement of Allergan’s four Orange Book-listed patents. Prior to trial, but after claim construction, the district court granted summary judgment of non-infringement as to certain claims, the court then found each asserted claim not invalid. The Federal Circuit affirmed in part and reversed in part, finding the district court erred in finding certain claims not invalid as obvious. Defendants, however, failed to prove that another claim would have been obvious. View "Allergan, Inc. v. Sandoz, Inc." on Justia Law

Figueroa received the flu vaccine in 2008. Within 20 days, he developed numbness in his face, impaired speech, and weakness. He was diagnosed with Guillain-Barré Syndrome, a sometimes fatal nervous system disorder. Because GBS is not listed on the Vaccine Injury Table, 42 U.S.C. 300aa-14(a), it requires proof of causation, although flu vaccine GBS cases have been compensated under the National Childhood Vaccine Injury Act. Figueroa had 36 months from the onset of symptoms to file a petition under the Act (until November, 2011), but, in 2010, he died of pancreatic cancer. His widow timely sought compensation for the vaccine-related neurological injuries suffered prior to his death. A special master dismissed, reasoning that because Figueroa had died of pancreatic cancer, a non-vaccine-related cause, Ms. Figueroa lacked standing to seek injury compensation. The Court of Federal Claims affirmed. The Federal Circuit reversed, interpreting a section that provides: “any person who has sustained a vaccine-related injury, the legal representative of such person if such person is a minor or is disabled, or the legal representative of any person who died as the result of the administration of a vaccine ... may ... file a petition for compensation,” 42 U.S.C. 300aa-11(b)(1)(A) View "Figueroa v. Sec'y of Health & Human Servs." on Justia Law