Nostrum Laboratories, Inc.

Dr. Berks is Corporate Counsel for Intellectual Property at Nostrum Laboratories, Inc. in New York.His presentation will discuss pharmaceutical patent law from an inhouse counsel perspective.

Chem. and pharmaceutical companies invest enormous amounts of money and inventor hours to discover and develop new materials such as drugs and processes for making them, as well as other inventions.Such companies also attempt to protect their inventions by securing patents.The success of these inventions in the marketplace depends on a number of factors, the foremost of which being the strength of the patents obtained to protect them.These patents are expected to protect the vast investment of money and time in creating these inventions, and the product market share, for the next nearly twenty years.However, competitors will try to undermine the value of the inventions by challenging the strength of the patents, including their validity and coverage by the patent claims of their own products, in a court of law.Recently, many seemingly strong and valuable patents have been invalidated or narrowly viewed and found not infringed.Recent court decisions reinforce the axiom that every word that goes into describing the invention in a patent application must be chosen with extreme care.This session will provide insights into how to reduce the chances of losing in a patent battle against an infringer, including practical pointers on how to write winning patent applications.This session will also analyze recent Federal Circuit court decisions that have invalidated such patents or found them not infringed, as real world examples of what can go right or wrong years after a patent is granted.

In March 2010, Congress enacted the "Biologics Price Competition and Innovation Act of 2009," which sets out a new legal procedure for the approval of "biosimilar" biol. products, such as antibodies, vaccines, and protein drugs.This procedure is analogous in many ways to the procedure for the approval of generic drugs under the Hatch-Waxman Act, but there are significant differences.The biosimilar pathway requires a showing of "biosimilarity" and interchangeability.The Act also provides a patent challenge procedure.This Act may present important new com. opportunities for pharmaceutical companies.This poster will highlight important elements of the Act.