If a patent has been infringed, the patent owner may bring a civil action in federal court seeking damages. This article discusses two key questions for both the company launching a new product and patent owners.Information on patents and suitability petitions that impact the availability of generic drugs. Pharmaceutical patent disputes are subject to certain specialized procedures under the HatchWaxman Act and the. Claims for patent infringement can only prevail when a 503A is compounding a drug that is "essentially a copy" of a commercially available drug. Having a basic understanding of patent law is more important to those in the medical device and diagnostics industry now than it has ever been. When received in the U.S. Patent Office, the application package is assigned to an examiner who specializes in the field relevant to the invention. A pioneer drug owner who receives notice of a Paragraph IV certification has 45 days to initiate a patent infringement suit against the applicant. With counterclaims of patent infringement. Though typically addressed through litigation related to patent validity (i.e.