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Claiming Metabolites: Federal Circuit Poses New Challenges to Patent Applicants
After they are administered, or taken by the patient, many drugs are converted into other chemical compounds or other physical forms, as the drugs are processed within the body of the patient. Often these compounds, known as metabolites, are the “active ingredient” that is responsible for the desired result, such as lowering blood pressure or cholesterol levels. The Court of Appeals for the Federal Circuit has also long recognized this effect and has held that the ingested form of a drug or its “metabolites” can be patented. Thus, an optimal patent strategy would require an inventor to patent both the pre-ingested form of the drug and its new physical forms or metabolites, as formed in the body (“in vivo“). However, the in vivo fate of the drug may not be learned until long after the “parent” drug has been tested and patented.
Two recent Federal Circuit decisions, Novartis Pharm. v. Eon Labs, 363 F.3d 1306 (Fed. Cir. 2004) and Schering Corp. v. Geneva Pharmaceuticals, Inc., 339 F.3d 1373 (Fed. Cir. 2003) will make it much more difficult for holders of “metabolite patents” to enforce them against accused infringers. In Novartis, the patent on the immunosuppression drug, cyclosporin, had expired, but Novartis had obtained a patent on an injectable “hydrosol” formulation of the drug. A hydrosol is a fine suspension, or colloid, of solid particles in a water-alcohol solution.
The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
Use of Deferred Prosecution Agreements In White Collar Investigations
This article discusses the practical and policy reasons for the use of DPAs and NPAs in white-collar criminal investigations, and considers the NDAA's new reporting provision and its relationship with other efforts to enhance transparency in DOJ decision-making.
How AI Has Affected PR
When we consider how the use of AI affects legal PR and communications, we have to look at it as an industrywide global phenomenon. A recent online conference provided an overview of the latest AI trends in public relations, and specifically, the impact of AI on communications. Here are some of the key points and takeaways from several of the speakers, who provided current best practices, tips, concerns and case studies.
The DOJ's New Parameters for Evaluating Corporate Compliance Programs
The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.