Third-party patents present a significant threat to parties seeking to enter the pharmaceuticals market. Often, such challenges may be addressed by undertaking searches to identify specific threats and, where such threats exist, taking action to design around the patent(s); seeking confirmation from the patentee (or a court) that the product or process in question does not infringe; or, if necessary, clearing the way by initiating opposition and/or revocation proceedings against patents of questionable validity.