Step 3: Fact Discovery (RFPs, ROGs, RFAs, Depos, Subpoenas) Scope of Discovery The US legal system allows for extensive pre-trial discovery. Generally, a party is entitled to any information relevant to a claim or defense in the lawsuit. Documents or information falling within certain privileges, such as the attorney-client privilege or the attorney work product immunity, are immune from discovery. Discovery: Requests for Production (RFPs) No limit to the number of RFPs. Often exceed 100 per side. Patent litigation often involves the exchange of hundreds of thousands of pages. When patent litigation involves large corporations or many issues, document production surpassing 1 million pages is notRead More →

Patent Infringement Litigation Overview   Step 1: The Pleadings (Complaint, Answer, Reply) The Complaint: Pre Suit Investigation A patentee must form a reasonable basis for bringing an infringement action. Failure to do so can lead to sanctions, including expenses and attorney fees. Patentees should obtain a prelitigation opinion that analyzes the strengths and weaknesses of alleged infringement and examines: Whether the competitor’s product or method infringes the patent (analyzes claim construction issues, tests the accused products and compares the construed claims to the device or process). Whether there are issues that cast doubt on the validity and enforceability of the patent. The Complaint: Parties Plaintiff(s)Read More →

Recent Developments in Pharma and Biologics IP Law: A Discussion of Recent Cases Affecting Pharma and Biologics IP Law Topic 1: Cases Interpreting the Biologics Price Competition and Innovation Act (BPCIA) BPCIA – The Patent Dance Purple Book does not list patents. Instead, Biosimilars Act contemplates an initial exchange of information prior to potential patent litigation: Within 20 days of notice of FDA acceptance, a biosimilar applicant “shall” provide a copy of its aBLA and information describing the manufacturing process. Within 60 days later, the reference product sponsor “shall” provide a list of patents and identify patents it will license. • Within 60 days later,Read More →