ACI, the nation’s premier provider of life sciences intellectual property conferences, is pleased to bring the third west coast installment of its renowned Hatch-Waxman Series back to San Diego.
2011 brought the enactment of the America Invents Act and 2012 marked the release of the FDA Draft Guidance on Biosimilars. Understand how this will impact the Hatch-Waxman arena.
Now in its third year, Hatch-Waxman Boot Camp – San Diego Edition has become the gathering place of the Southern California life sciences IP Bar. With the precedential regulatory changes in the IP regulatory arena there will clearly be impacts to Hatch-Waxman. Attend this essential event to understand the interplay of IP and FDA regulation relative to pharma/biotech patents vis-à-vis Hatch-Waxman and recently released biosimilars guidance and ensure that you are aware of the intersection of the newly promulgated America Invents Act with Hatch-Waxman. It is vital to understand how all these components work together and that both will influence the Hatch-Waxman rubric.
A thorough understanding of Hatch-Waxman is absolutely essential to anyone working in the biopharmaceutical area. This knowledge sets the foundation for the protection of small molecules and small proteins and provides the tools to ponder an IP and regulatory framework for what lies beyond the realm of traditional pharmaceuticals. The highly regulated nature of the products which the pharmaceutical and biotechnology industries manufacture dictates that the patenting of these products be closely tied to regulatory approval by the FDA. Anyone who works in the life sciences industry – and who even remotely deals with its IP – must be well versed in the regulatory components and IP subtleties that play such an integral role in the patenting of its products.
You cannot afford to be left in the dark regarding the interconnection of IP and FDA regulation in these industries.
Gain the competitive edge – boost your life sciences IP and regulatory IQ.
ACI’s Hatch-Waxman Boot Camp has been designed to give counsel and advisors to brand name and generic drug companies and biopharmas – critical insights into commercialization and the pre-approval process, and also provide you an in-depth review of Hatch-Waxman and other IP basics relative to small molecules and biologics. This conference will lay the necessary foundation for you to thoroughly comprehend the dynamics of the applicable patent life cycles for pharmaceutical and biopharmaceutical products and business development plans.
Master the intricacies of the patent and regulatory framework for drugs and biologics.
A faculty of top-notch IP and regulatory counsel all having a wealth of experience through working for brand names and generics as well as biopharmas – will share their knowledge on:
- The organization, jurisdiction of the FDA and the PTO and their interplay in the patenting of drugs and biologics
- How the approval process for drugs and biologics is connected to the patenting of these products
- Pre-patent considerations relative to R&D and patent portfolio and patent life cycle management
- How the Hatch-Waxman Act established the paradigm for market entry of generic small molecule drugs – and how biosimilar
- Products are adding a new dimension to this schematic
- The relationship between patent and non-patent exclusivity
- The importance of patenting bioequivalence characteristics in certain drug products
- The ins and outs of patent term extension under 35 U.S.C. § 156 and 37 CFR 1.710 – 1.791