Liquidia Corporation, a biopharmaceutical company developing innovative therapies for patients with rare cardiopulmonary diseases, announced today that the United States District Court for the District of New Jersey (District Court) has found that the interference by United Therapeutics Corporation (United Therapeutics) with the launch of generic Treprostinil Injection caused losses in excess of $137M. Treprostinil Injection is manufactured by Sandoz Inc. (Sandoz) and was launched as the first-to-file, fully-substitutable generic treprostinil for parenteral administration in March 2019. Liquidia PAH, LLC (formerly known as RareGen), a wholly owned subsidiary of Liquidia (Liquidia PAH), partnered with Sandoz in August 2018 on an exclusive basis to market and commercialize Treprostinil Injection.

The decision arises from the lawsuit filed in April 2019 by Liquidia PAH and Sandoz against United Therapeutics and another party in the District Court of New Jersey (Case No. No. 3:19 cv 10170), in which Liquidia PAH and Sandoz alleged that United Therapeutics violated the Sherman Antitrust Act of 1890, state law antitrust statutes, unfair competition statutes and a prior settlement agreement between Sandoz and United Therapeutics by taking calculated steps to restrict and interfere with the launch of generic Treprostinil Injection. Specifically, Liquidia PAH and Sandoz alleged that United Therapeutics and another party entered into anticompetitive agreements whereby restrictions were placed on the cartridges necessary for the subcutaneous administration of treprostinil such that they could not be used for generic Treprostinil Injection.

In March 2022, the District Court issued an order granting partial summary judgment to United Therapeutics with respect to the antitrust and unfair competition claims and granting partial summary judgment to Sandoz with respect to the breach of contract claim. After a trial, the District Court determined the damages caused by the breach of contract by United Therapeutics. Although the losses were determined by the District Court to be in excess of $137 million, the final damage award has yet to be determined by the District Court and will be offset by amounts that the District Court has ruled were costs avoided by Sandoz as a result of the breach, including amounts that would have been paid to Liquidia. The District Court’s decisions can be appealed by any of the parties to the proceeding.

The Impact on Liquidia

The court's decision is a significant victory for Liquidia and Sandoz. It sends a strong message that companies will be held accountable for interfering with the launch of generic drugs. This is important because generic drugs play a crucial role in making healthcare more affordable. The decision is also likely to have a positive impact on Liquidia's stock price.

How the Case Unfolded

The case dates back to April 2019 when Liquidia PAH and Sandoz filed a lawsuit against United Therapeutics and another party in the District Court of New Jersey. In the lawsuit, Liquidia PAH and Sandoz alleged that United Therapeutics violated the Sherman Antitrust Act of 1890, state law antitrust statutes, unfair competition statutes, and a prior settlement agreement by taking calculated steps to restrict and interfere with the launch of generic Treprostinil Injection.

In March 2022, the District Court issued an order granting partial summary judgment to United Therapeutics with respect to the antitrust and unfair competition claims and granting partial summary judgment to Sandoz with respect to the breach of contract claim. After a trial, the District Court determined the damages caused by the breach of contract by United Therapeutics. Although the losses were determined by the District Court to be in excess of $137 million, the final damage award has yet to be determined by the District Court and will be offset by amounts that the District Court has ruled were costs avoided by Sandoz as a result of the breach, including amounts that would have been paid to Liquidia.

What's Next for United Therapeutics

United Therapeutics has not yet commented on the court's decision. However, the company is likely to appeal the decision. This could lead to a lengthy legal battle. In the meantime, the decision is likely to have a negative impact on United Therapeutics' stock price.

The Future of Generic Treprostinil Injection

The court's decision is a major victory for the generic drug industry. It shows that companies will be held accountable for interfering with the launch of generic drugs. This is important because generic drugs play a crucial role in making healthcare more affordable. The decision is also likely to lead to more competition in the market for Treprostinil Injection, which could benefit patients.

Implications of the Decision

The decision in the Liquidia-Sandoz case has significant implications for the pharmaceutical industry. It underscores the importance of competition in the pharmaceutical market and the need to protect the rights of generic drug manufacturers. The decision is also a reminder that companies can be held accountable for engaging in anticompetitive behavior.

The Importance of Generic Drugs

Generic drugs are essential to keeping healthcare costs low. They are typically much cheaper than brand-name drugs, but they have the same active ingredients and work in the same way. The availability of generic drugs allows more people to afford the medications they need. The decision in the Liquidia-Sandoz case is a reminder of the important role that generic drugs play in the healthcare system.

Closing Thoughts: A New Era for Generic Medications

The court’s decision in Liquidia Corp. v. United Therapeutics is a landmark victory for the generic pharmaceutical industry and a powerful statement in support of a competitive marketplace. This decision is expected to have a far-reaching impact, motivating generic drug manufacturers and pushing the industry towards a more balanced and equitable landscape. The future of healthcare accessibility and affordability depends on promoting a robust generic market, and this decision serves as a crucial step in that direction.