Claim Construction: A Key to Success in Filing Paragraph IV

Patent claims are the part of a patent or patent application that defines the scope of protection granted by the patent. A Paragraph IV filing is considered to be a technical act of patent infringement and gives the innovator company the right to initiate a patent infringement suit. The Abbreviated New Drug Application (ANDA) applicant must notify the owner of the New Drug Application (NDA) and the owner of any listed patent for which a Paragraph IV certification was made that the ANDA and certification have been filed. The notice must be accompanied by a detailed statement of the factual and legal bases for the applicant’s opinion that the patent is invalid, is unenforceable or has not been infringed. If the owner of a listed patent sues for patent infringement within 45 days of receipt of notice, the FDA is barred from approving the ANDA for 30 months. The availability of this automatic stay provides an incentive for the patent owner to litigate.

Conversely, Waxman-Hatch also provides an incentive to challenge invalid or unenforceable patents or patents that would not be infringed by marketing of the generic drug by rewarding the first ANDA applicant to file a Paragraph IV certification with an extremely valuable 180 days of generic exclusivity if the first filer prevails in litigation.

Claim construction – the process of determining the precise meaning of the claim terms and therefore of the overall claims – is sometimes performed at a relatively early stage in the process in a so-called “Markman hearing”. In many cases, the court’s construction of the claims is dispositive of the issue of patent infringement or validity and is therefore often the pivotal factor in determining whether an ANDA applicant will be allowed to commercialise its product.

It is therefore very important to understand the technical issues involved in claim construction both from infringement and validity determination perspective.

In this Webinar participants will:

• Receive an overview of U.S. claim construction
• Learn from developments in claim construction theory and standard practice
• Understand the technical issues involved in claim construction both from infringement and validity determination perspective
• Hear from the case studies which are driving interpretation and future IP strategies

Presenters:

Alpesh Pathak
Head-API Patent Cell
Alembic Research Center