In an appeal characterized as “unusual,” the Federal Circuit affirmed the grant of a preliminary injunction, holding it likely that plaintiff patent holder would succeed on the merits its claim of infringement of a patent claiming a purified chemical compound, but reversed a finding of infringement under the doctrine of equivalents of related chemical process patents. Mylan Institutional LLC v Aurobindo Pharma Ltd., 2017-1645 (May 19, 2017 Fed. Cir.). The decision is an interesting read because, as the court admitted, “of the sparse and confusing case law concerning equivalents, particularly the paucity of chemical equivalents case law, and the difficulty of applying the legal concepts to the facts.” Slip Op at 12. Continue reading this entry
Personalized medicine will change how health care is delivered and disease is prevented and treated. But first, how disease and health is defined, as well as the clinical development and adoption of new therapies must align with current theories of disease and treatment. Continue reading this entry
Of the many business, operational, legal, regulatory and clinical obstacles standing in the way of widespread delivery of personalized medicine, the single greatest challenge may lie in solving the reimbursement puzzle. Advocates of personalized medicine contend that it results in better care for the patient, as therapy is targeted specific to an individual, and that it should result in cost savings as treatment that is unlikely to work for that patient is avoided.
The advent of big data has helped enable the growth of personalized medicine. But if machine learning and analytics are to truly help transform health care, it won’t be through bigger data, but through harmonized, smarter data.
Despite regulations, litigation, and significant draft guidance, the future of regulation of HCT/Ps remains up in the air. Learn what you need to know quickly with these seven questions and answers.