Last week, I attended PLI’s Advanced Patent Prosecution Workshop 2011 in New York where an esteemed panel of experts offered hands-on claim drafting and amendment writing techniques.  The program was organized into four technological sections: Biotechnology, Chemical/Pharmaceutical, Electrochemical and Electronics/Computers. I attended the Chemical/Pharmaceutical segment where Michael Davitz, Partner at Axinn, Veltrop & Harkrider and Practice Center Contributor, discussed Chemical and Pharmaceutical Claim Drafting.  Here are some highlights from his presentation….

• Development of a Patent Portfolio – patent portfolio is developed in the context of a business plan and where in the life cycle the product is.
• Generic Player – differentiate product from innovator and create difficulty for competitors, other generics.
• Innovator – at what stage is the development? Integrate FDA and patent filing strategies and develop patents with an eye towards forcing infringement.
• Strategies for Early-stage and Late-stage Products
• Developing a Portfolio of both Listed and Unlistable Patents
• Start with the end-game and plan backwards
• Planning considerations from start to finish – improve prosecution, prosecute with an eye towards litigation, plan beyond prosecution and litigation (settlements, 180-day exclusivity, authorized generics, patent reform)
• Patent filing strategies – invention disclosure, clearance search; file provisional application with full description (21 years term) prior to any publication; if prior disclosure file PCT application within 6 months of disclosure to maximize foreign grace periods; file both US and PCT application at anniversary; decide foreign filings based on markets, manufacturing, and licensing; coordinate international prosecution
• KSR v. Teleflex – a combination that has “obvious to try” could mean that it was obvious but “obvious to try” does not automatically mean that it was obvious
• Post-KSR Obviousness Decisions – Aventis v. Lupin, Sanofi v. Apotex, Forest v. Ivax, Ortho-McNeil v. Mylan, Takeda v. Alphapharm, In re Kubin
• While theoretically, KSR lowered the bar to obviousness by allowing consideration of obvious to try, obviousness-based patent attacks have met with little success
• Claims and patents covering chemical compounds of a particular structure remain strong
• Consider a narrow claim to particular compounds of interest
• Evaluate your arsenal of secondary considerations to understand the strength/weakness of your claim
• Obviousness-Type Double Patenting – a later claim that isn’t patentability distinct from an earlier claim is invalid for obvious-type double patenting; the earlier patent’s specification may be used to determine the meaning and scope of the patent claims
• Implications in Patent Portfolio Management – consider the desired contours of IP protection prior to prosecution; a later filed method of preparation patent may hold up but a later filed method of use patent (for use already disclosed in an earlier patent/application) may not
• The analysis in obviousness type double patenting requires an analysis of obviousness. KSR and post-KSR obviousness case law applies
• Written Description Requirement – objective inquiry into the four corners of the specification from the perspective of a person of ordinary skill in the art
• Enablement Requirement – is enough instruction to the person of ordinary skill in the art so that he/she is able to practice the invention without undue experimentation (undue experimentation is evaluated by the Wand factors)
• The written description/enablement battle is being waged in the biologics context rather than the small molecule context.  Understand the field of the invention. For written description – is there enough in the specification to show the inventor had possession of the claimed invention? For enablement – the less developed the technology, the more you need to disclose.

Tags: biochemical patents, Claim Drafting, generics, KSR, obviousness, patent infringement, patent portfolio, pharmaceuitcal patents, Provisional application

This entry was posted on Monday, July 18th, 2011 at 15:21 and is filed under biotechnology patents, Claim Construction and Markman Hearings, posts. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.