In a recent case, United Therapeutics Corporation v. Liquidia Technologies, Inc., there was a discussion by the Federal Circuit on July 24 concerning the necessity for safety and efficacy within pharmaceutical method claims to be sufficiently enabled and backed by written description. This case was sparked when Liquidia Technologies filed a new Drug Application for a dry powder inhalation formulation of treprostinil meant for the treatment of pulmonary hypertension. United Therapeutics, the proprietor of U.S. Patent 10,716,793, brought legal action against Liquidia in response to this.
This transpired within the District Court under Fitch, Even, Tabin & Flannery LLP. The law firm handled the litigation proceedings, aiming to clarify the extent to which safety and efficacy should be considered when policing pharmaceutical patent claims. The decision here can have serious implications for patent litigation going forward, particular within the pharmaceutical industry. This paints a picture of a potential paradigm change in how patent suits are interpreted, particularly in the pharmaceutical landscape.
One aspect to note regarding this court case is the extent of its potential impact on the pharmaceutical industry’s development process. In essence, it could impose an increased burden on pharmaceutical companies looking to file patents, since they might need to provide more in-depth detail upfront to sufficiently support their claims. This could slow down the filing process and potentially even discourage innovation if the hurdles become too high to overcome.
Here lies the tightrope between the legal and pharmaceutical fields that must be treaded carefully. By making patent applications harder, there is potential to discourage malicious or low-quality patents. On the other hand, putting up too many barriers could damp the spirit of progress within pharmaceutical development. It will be interesting to see the rippling consequences of this case and how it could potentially reshape standards and expectations within patent filings.
Read more about the case proceedings on the JD Supra website.