Any patent practitioner knows that §101 challenges are filed as a matter of course in patent infringement cases involving software and business methods. On the other hand, challenges under §101 are rarely used in cases. In fact, of the 490 ANDA cases filed since the Supreme Court’s decision in Alice Corp. Pty. v. CLS Bank Int’l 134 S.Ct. 2347 (2014), only six appear to address §101 (Alice) challenges. By utilizing §101 motions less than 2 percent of the time, generics are not fully availing themselves of the Supreme Court’s decisions in Alice, Mayo, and Myriad. As an example, and without providing an exhaustive list, generic pharmaceutical companies should, at a minimum, consider filing §101 motions in cases involving method of treatment, pK profiles, or polymorph patents.
Section 101: Interpretation and Applications
35 U.S.C. §101 provides that a patent may be granted to “[w]hoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof[.]”
