Definiteness and the Medicines Co. and Forest Labs. Decisions


Dr. Brian Trinque
Lathrop Gage LLP, Boston MA


256th ACS National Meeting - Boston
Monday, August 20, 2018, 9AM
"Developments in Pharmaceutical Patent Law"


Pharmaceutical patent practitioners implement IP strategies for medicines well beyond the granting of a basic composition-of-matter patent. Novel formulations, combination therapies, dosing strategies, and patient stratifications are just a few examples of the discoveries arising from clinical development that can inspire new patent applications, which will protect these inventions, and, importantly, extend patent protection for a product. Practitioners must often strike a balance between the trifecta of the examples, which illustrate the discovery and serve as a building block for the filing; the specification, which provides an invention narrative that advocates for successful patenting; and, finally, claim breadth, which one hopes to maximize, but is grounded by the realities of novelty, obviousness, written description, and enablement. The Forest Labs., Inc. v. Teva Pharms. USA, Inc., decision, which was released at the end of 2017, and The Medicines Co. v. Mylan decision before it, are important reminders that claim definiteness must be given equal weight when preparing applications directed toward such “second generation” pharmaceutical discoveries. In particular, these decisions show that our definiteness requirements can impact patent prosecution, as well as claim interpretation and validity during an infringement action.