PLI Developments in Pharmaceutical and Biotech Patent Law Seminar

Practising Law Institute (PLI) will be holding a seminar on Developments in Pharmaceutical and Biotech Patent Law on September 17, 2009 in New York, NY and on October 14, 2009 in San Francisco, CA.  Groupcasts of the New York session will also be held in Boston, MA; Philadelphia, PA; Pittsburgh, PA; and New Brunswick, NJ.  The conference will offer presentations on the following topics:

• Patentability of pharmaceutical products in view of KSR

• The development of the "lead compound" analysis for determining obviousness of drug compounds;
• Patentability issues affecting chemical compounds, stereoisomers, and pharmaceutical salts;
• Review of significant post-KSR Federal Circuit pharma cases, including:  Takeda v. AlphaPharm (Actos®), Ortho-McNeill v. Mylan (Topomax®), Eisai v. Dr. Reddy's (AcipHex®), and Sanofi v. Apotex (Plavix®).

• Inequitable conduct in biotechnology and pharmaceutical patent cases

• Whether the "plague" rages on or is becoming more contained; and
• Recent developments at the Federal Circuit and the Supreme Court, along with patent reform legislation.

• Developments in § 112 law:  The enablement and written description requirements as applied to pharma and biotech patents

• How have the USPTO's Written Description Guidelines developed and what has been their impact on pharma and biotech patents in litigation?
• Are there special rules that apply to patents directed to nucleic acid sequences?
• Explore the relationship between written description and the utility requirement for biotech patents.

• Cutting edge issues impacting pharma and biotech prosecution

• What has been the impact of KSR on the examination of pharmaceutical and biotech patent applications in the USPTO?
• How have the revised Written Description Guidelines affected prosecution in the pharmaceutical and biotech arts?
• How has the USPTO been dealing with nucleotide and amino acid sequence claims in terms of written description and utility?
• What rule changes are being considered that may impact pharma and biotech practice before the USPTO?

• Patent misuse and other issues in pharmaceutical and biotech licensing

• What is patent misuse:  When does it matter and why?
• Can patent misuse be cured and what does that mean when analyzing the potential for patent misuse?
• When and how does monetizing research tool patents risk patent misuse?
• Arbitration and Most Favored Nation clauses in patent licenses; and
• Effect of corporate transactions on existing patent licenses.

• Antitrust issues impacting pharma and biotech patent cases

• What kinds of unique antitrust issues arise in litigation over pharma and biotech patents?
• What strategies should be used to avoid antitrust liability in bringing and maintaining Hatch-Waxman litigation?
• What constraints affect settlement?
• What issues do authorized generics raise?
• How have recent decisions by the courts and actions by the FTC altered the landscape?

A full program for the Developments in Pharmaceutical and Biotech Patent Law seminar can be found here (New York) and here (San Francisco).  The registration fee for the seminar is $1,495. Those interested in registering for the conference can do so here (New York) or here (San Francisco).  Those interested in registering for the Groupcasts can do so here (Boston, MA), here (Philadelphia, PA), here (Pittsburgh, PA), or here (New Brunswick, NJ).