BioLaw will be reporting live all week from the Biotechnology Industry Organization International Conference ("BIO 2008") in San Diego. BioLaw wishes to thank BIO 2008 for granting it official press status, and for providing excellent facilities in the Press Room.
BioLaw will report on every interesting biolaw issue it can during the week. However, BioLaw expects four issues in particular to attract disproportionate attention at presentations and among attendees at BIO 2008:
Follow-on biologics. Drug and patent law are both currently grappling with how to foster and effectively regulate a market for generic versions of biotechnological therapeutics. The existing model of generic pharmaceuticals may be useful, but the issues involved in more complex biologics tend to be more complicated.
Food and Drug Admistration ("FDA"). The past year has offered an unfortunate cornucopeia of regulatory disasters relating to food and drugs. Inadequate funding, ineffective management, political interference, and global trade have all been offered up as culprits responsible for such problems as tainted pet food, Salmonella tomatos, and unsafe pharmaceuticals.
Healthcare costs. Spending on healthcare and drugs by both government and consumers is reaching new heights. Presidential hopefuls, the Prescription Drug User Fee Act ("PDUFA"), the Medicare Modernization Act of 2003 ("MMA"), generic drugs, and follow-on biologics could each have significant effects on whether the escalating trajectory of healthcare costs can be altered.
Biotechnology patent law. The combined effects of KSR, Quanta, Seagate, and the trilogy of mental steps appeals considered by the Court of Appeals for the Federal Circuit will influence biotechnology patent law for years to come. Add to these cases both the continuing efforts in Congress to rewrite the Patent Act and the Patent and Trademark Office's proposed patent rule changes, and biotechnology patent law is undergoing considerable - perhaps even unprecedented - flux.
Stay tuned for regular biolaw updates from BIO 2008.