Articles Posted in Drugs & Biotech

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Amgen’s patents relate to antibodies that help reduce low-density lipoprotein cholesterol (LDLC), or “bad cholesterol.” Typically, high LDL-C is treated using small molecules (statins), which sometimes have adverse side effects or cannot reduce a patient’s LDL-C to a healthy level, requiring an alternative treatment, such as a PCSK9 inhibitor. PCSK9 is a naturally occurring protein that binds to and causes the destruction of liver cell receptors (LDL-Rs) that are responsible for extracting LDLC from the bloodstream. Amgen began studying PCSK9 in 2005 and developed the drug Repatha™ with the active ingredient “evolocumab,” a monoclonal antibody that targets PCSK9 to prevent it from destroying LDL-R proteins.The FDA approved Repatha in 2015. In 2007, Appellants started exploring antibodies targeting PCSK9, resulting in the development of Praluent. Praluent's active ingredient is a monoclonal antibody that targets PCSK9 to prevent it from binding to and destroying LDL-R proteins. The LDL-R proteins then extract LDL-C, lowering overall LDL-C levels. In 2011, Appellants obtained a patent that claimed Praluent by its amino acid sequence. The FDA approved Praluent in 2015. Amgen sued Appellants. Appellants stipulated to infringement. The district court enjoined the sale of Praluent. The Federal Circuit reversed in part. The district court erred by excluding Appellants’ evidence regarding post-priority-date evidence of enablement and improperly instructed the jury on written description. View "Amgen Inc. v. Sanofi" on Justia Law

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Dr. David Jang, M.D., is the named inventor of the patent, which is directed to a coronary stent. Jang assigned the patent to BSC. BSC agreed to pay a royalty if it ever produced a product that would infringe the patent. Jang sued, based on BSC’s “Express stent.” BSC sought ex parte reexamination, then sought to include invalidity defenses in Jang’s suit. The district court denied the motion, deeming invalidity defenses “irrelevant” as to whether BSC owed royalties for past sales. The Patent and Trademark Office subsequently cancelled the asserted claims as unpatentable. The court denied BSC’s motion in limine to preclude Jang from presenting a doctrine of equivalents theory, finding that Jang’s experts sufficiently explained his doctrine of equivalents theory in their expert reports. The jury ultimately found no literal infringement, but found infringement under the doctrine of equivalents. Following through on its earlier decision, the district court conducted an evidentiary hearing on ensnarement. Concluding that Jang did not meet his burden of persuasion, which includes providing a proper hypothetical claim that does not ensnare the prior art, the district court vacated the jury verdict and entered judgment of non-infringement. The Federal Circuit affirmed the entry of judgment of non-infringement. View "Jang v. Boston Scientific Corp." on Justia Law

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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

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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

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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

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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

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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

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Apicore owns, and Mylan Is the exclusive licensee of, the 992, 616, and 050 patents, which relate to isosulfan blue (ISB), a triarylmethane dye used to map lymph nodes. The 992 and 616 patents (together, “the process patents”) are directed to a process for preparing ISB by reacting isoleuco acid with silver oxide in a polar solvent, followed by reaction with a sodium solution. In response to Aurobindo’s FDA application to market a generic version of Myland’s drug, Lymphazurin®, Apricore and Myland obtained a preliminary injunction precluding Aurobindo from making, using, selling, offering to sell, and importing the accused ISB product that allegedly infringes the patents. The Federal Circuit affirmed. While the district court’s “equivalents analysis” was deficient and there remains a substantial question concerning infringement, so that the court’s grant of a preliminary injunction based on the process patents constituted an abuse of discretion, the injunction stands under the 050 patent. View "Mylan Institutional LLC v. Aurobindo Pharma Ltd." on Justia Law

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The Leahy-Smith America Invents Act did not change the statutory meaning of “on sale” under 35 U.S.C. 102, in a case involving patents that were ready for patenting and subject to an invalidating contract for sale prior to the critical date of January 30, 2002. Teva had invoked the provision as a defense in a suit charging infringement based on Teva’s filing of an Abbreviated New Drug Application (ANDA). The district court upheld, as valid, Helsinn’s patents, directed to intravenous formulations of palonosetron for reducing chemotherapy-induced nausea and vomiting, and rejected Teva’s “on sale” defense. In reversing, the Federal Circuit noted that the invention worked for its intended purpose, that the evidence that the formulation was ready for patenting was “overwhelming,” and that there was no tenable argument that, before the critical date, Helsinn was unable to file a patent application that met the requirements of 35 U.S.C. 112. The district court clearly erred by applying too demanding a standard. The completion of Phase III studies and final FDA approval are not pre-requisites for the invention here to be ready for patenting. View "Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc." on Justia Law

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Navartis’s 283 patent relates to a solid pharmaceutical composition suitable for oral administration, comprising a sphingosine-1 phosphate (S1P) receptor agonist and a sugar alcohol, which the patent explains is useful for the treatment of certain autoimmune diseases such as multiple sclerosis. According to the specification, S1P receptor agonists generally exhibit properties that make formulations suitable for oral administration of a solid composition difficult to create. However, “solid compositions comprising a sugar alcohol provide formulations which are particularly well suited to the oral administration of S1P receptor agonists." They also “provide a convenient means of systemic administration of S1P receptor agonists, do not suffer from the disadvantages of liquid formulations for injection or oral use, and have good physiocochemical and storage properties.” On inter partes review, the Patent Trial and Appeal Board found all original claims of the 283 patent and proposed substitute claims unpatentable as obvious. The Federal Circuit affirmed. The Board discussed independent grounds supporting the motivation to combine prior art, fingolimod and mannitol, in a solid oral composition. View "Novartis AG v. Torrent Pharmaceuticals, Limited" on Justia Law