A regulatory perspective on in vitro diagnostics

Article Abstract:

The Food and Drug Administration (FDA) is developing a guidance document that will outline the approach for concurrent development of both a new drug and a corresponding in Vitro Diagnostic device (IVD) for use in decision-making about drug selection for patients in clinical practice. The development of a cooperative framework among regulators, product sponsors and technology experts would be required for revolutionary promise that these platforms caould have on the evolution of drug development, regulatory science, the practice of medicine and public health.

Product development, Medical Instruments and Supplies, Medical Equipment and Supplies Manufacturing, Medical Instruments & Supplies, Medical equipment and supplies industry, Medical equipment industry, United States. Food and Drug Administration, Diagnostic equipment (Medical), Medical test kit industry, Toxicity testing, In vitro tests

No room for experiment: the federal circuit's narrow construction of the experimental use defense

Article Abstract:

American educational and research institutions have deflected suggestions that their research activities run afoul of in-force patents by pointing to the so-called experimental use doctrine. The doctrine established by court decisions held that activities undertaken without any intent to derive profits or practical advantage do not constitute patent infringement.

Support (Domestic relations), Patent infringement, American Educational Research Association

Proposed changed to patent codes loom over biotech industry

Article Abstract:

The US District Court for the Eastern District of Virginia issued an order against the suggested changes to the US patent code after London-based GlaxoSmithKline (GSK) filed a suit against the US Patent and Trademark Office (USPTO).

Pharmaceutical preparations, Patents & copyrights, Patent Owners & Lessors, Lessors of Nonfinancial Intangible Assets (except Copyrighted Works), Patent owners and lessors, United Kingdom, Company legal issue, Cases, Pharmaceutical industry, Intellectual property, Patent licenses, Patent licensing, Powers and duties, United States. Patent and Trademark Office, GlaxoSmithKline PLC, Patent licencing