Articles Posted in Drugs & Biotech

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Sanofi’s patents describe and claim compositions and uses of the cardiovascular (antiarrhythmic) drug dronedarone. The 800 patent, which expires in 2019, claims pharmaceutical compositions containing dronedarone. The 167 patent, which expires in 2029, claims methods of reducing hospitalization by administering dronedarone to patients having specified characteristics. In 2009, Sanofii received New Drug Application approval for 400 mg tablets of dronedarone, sold as Multaq®. Both patents are listed in the FDA publication Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) as patents claiming either Multaq® or a method of using Multaq®. Defendants, hoping to market generic versions of Multaq®, filed abbreviated new drug applications with the FDA, certifying under 21 U.S.C. 355(j)(2)(A)(vii)(IV), their beliefs that both patents were invalid and/or that the manufacture, use, and sale of the proposed generic drugs would not infringe either patent. Sanofi sued for infringement under 35 U.S.C. 271(e)(2)(A). The district court ruled, and the Federal Circuit affirmed, that as to the 167 patent, Sanofi proved that sale of the proposed generic drugs, with the proposed labels, would induce physicians to infringe, and defendants did not prove that any asserted claims were invalid for obviousness. As to the 800 patent, the courts rejected the non-infringement argument. View "Sanofi v. Watson Laboratories Inc." on Justia Law

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In 2003, the FDA granted Bayer approval to market vardenafil hydrochloride trihydrate to treat erectile dysfunction (ED) under the name Levitra. Vardenafil belongs to a class of ED drugs called phosphodiesterase inhibitors. When the FDA approved Levitra, two other phosphodiesterase inhibitors were already on the market: Pfizer launched Viagra in 1998, and Eli Lilly launched Cialis in 2003. Each is formulated as immediate-release tablets that are swallowed whole. Bayer’s 950 patent issued in 2013, claiming priority to 2005; it is directed to a formulation of vardenafil as “an uncoated tablet which disintegrates rapidly in the mouth,” vardenafil ODT, which Bayer markets as Staxyn. Watson filed an FDA Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Staxyn. Bayer alleged infringement. The Federal Circuit reversed the district court’s holding Watson failed to prove by clear and convincing evidence that two claims would have been obvious, 35 U.S.C. 103. The district court clearly erred in finding a skilled artisan would not have been motivated to use the claim elements to formulate an ED drug as a fast-dissolving tablet; the claims would have been obvious. View "Bayer Pharma AG v. Watson Laboratories, Inc." on Justia Law

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Merck owns the 150 patent, which is directed to a process for preparing a stable formulation of ertapenem, an antibiotic compound, and claims a manufacturing process for a final formulation of the antibiotic that purportedly minimizes both dimerization and hydrolysis degradation pathways. Hospira notified Merck that it had filed an abbreviated new drug application, seeking FDA approval to engage in the commercial manufacture, use, or sale of generic versions of Merck’s Invanz® product, the principal component of which is the carbon dioxide adduct of ertapenem. Merck sued Hospira for infringement of two patents—the 150 patent and the 323 patent. The Federal Circuit affirmed a holding that certain claims of the 150 patent are invalid under 35 U.S.C. 103, for obviousness. It was reasonable for the district court to deduce from the evidence that the order and detail of the steps, if not already known, would have been discovered by routine experimentation while implementing known principles. View "Merck Sharp & Dohme Corp. v. Hospira, Inc." on Justia Law

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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