United States Patent 10,716,793: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
The United States Patent 10,716,793, owned by United Therapeutics Corporation (UTC), has been at the center of a significant patent dispute involving UTC and Liquidia Technologies, Inc. This patent pertains to methods of treating pulmonary hypertension through the inhalation of treprostinil. Here, we delve into the scope, claims, and the evolving patent landscape surrounding this patent.
Background of the Patent
The '793 patent is directed to methods of treating pulmonary hypertension by inhaling treprostinil. The patent includes several claims, with Claim 1 being the only independent claim. This claim specifically outlines the method of treating pulmonary hypertension using a therapeutically effective dose of treprostinil[2][4].
Claims and Scope
Claim 1 and Dependent Claims
Claim 1 of the '793 patent describes a method for treating pulmonary hypertension by administering a therapeutically effective dose of treprostinil via inhalation. The dependent claims (claims 2-8) further specify various aspects of this method, including the dosage, administration route, and patient groups[2].
Enablement and Written Description
A crucial aspect of the patent is whether the claims are enabled and supported by an adequate written description. The Federal Circuit affirmed that the specification of the '793 patent sufficiently enables the scope of the claims and provides adequate written description support. This means that a skilled artisan would not need to engage in undue experimentation to practice the full scope of the claimed treatment[3][4].
Patent Validity and Infringement
District Court Rulings
In the district court, it was determined that claims 1, 4, and 6-8 of the '793 patent were not invalid and were infringed by Liquidia Technologies. However, the court also found that claims 1-3 of another UTC patent (U.S. Patent 9,593,066) were invalid as anticipated, although they were otherwise infringed by Liquidia[3][4].
Federal Circuit Appeals
Liquidia Technologies appealed the district court's decision, raising several issues, including the construction of claim limitations and the validity of the '793 patent claims. The Federal Circuit rejected Liquidia's arguments, affirming that the district court did not clearly err in finding the asserted claims of the '793 patent to be adequately enabled and supported by an adequate written description[3][4].
Inter Partes Review (IPR) and PTAB Decisions
PTAB Findings
In an inter partes review (IPR) initiated by Liquidia, the Patent Trial and Appeal Board (PTAB) found all claims of the '793 patent to be unpatentable as obvious over prior art. The PTAB concluded that a person of ordinary skill in the art would have been motivated to combine prior art references to arrive at the claimed invention[2][5].
Federal Circuit Affirmation
The Federal Circuit affirmed the PTAB's decision, upholding the finding that all claims of the '793 patent are unpatentable as obvious. This affirmation was despite UTC's arguments and evidence of objective indicia of nonobviousness, such as unexpected results and long-felt and unmet needs[2][5].
Supreme Court Denial
In a recent development, the United States Supreme Court denied United Therapeutics' petition to appeal the rulings that found all claims of the '793 patent invalid. This decision solidifies the Federal Circuit's affirmation of the PTAB's findings[1].
Anticipation of Product-by-Process Claims
The Federal Circuit also clarified that product-by-process claims, such as those in the '066 patent, can be anticipated by a prior art disclosure of the claimed product, regardless of the process by which the product is made. This principle was applied in invalidating certain claims of the '066 patent[3].
Safety and Efficacy Considerations
The Federal Circuit reiterated that absent specific limitations related to safety and efficacy in the claims, such concerns do not fall under the purview of the court. This means that the claims of the '793 patent do not inherently include safety and efficacy requirements, even though they involve treating pulmonary hypertension[3].
Impact on Patent Landscape
The invalidation of the '793 patent claims has significant implications for the patent landscape in the field of pulmonary hypertension treatment. It opens up the market for other companies, including Liquidia Technologies, to develop and market similar treatments without the encumbrance of UTC's patent claims.
Key Takeaways
- The '793 patent, owned by United Therapeutics, pertains to methods of treating pulmonary hypertension via inhalation of treprostinil.
- Claims 1, 4, and 6-8 were initially found valid and infringed by Liquidia, but later all claims were found unpatentable as obvious by the PTAB and affirmed by the Federal Circuit.
- The Supreme Court denied UTC's petition to appeal, solidifying the invalidation of the patent claims.
- The decision clarifies that product-by-process claims can be anticipated by prior art disclosures of the product, regardless of the process.
- Safety and efficacy concerns are not inherently included in the claims unless specifically stated.
FAQs
What is the '793 patent about?
The '793 patent is about methods for treating pulmonary hypertension by inhaling treprostinil.
Why were the claims of the '793 patent invalidated?
The claims were invalidated because the PTAB and the Federal Circuit found them to be unpatentable as obvious over prior art.
What was the role of the Supreme Court in this case?
The Supreme Court denied United Therapeutics' petition to appeal the rulings that found all claims of the '793 patent invalid.
How does this decision affect other companies in the field?
The decision opens up the market for other companies to develop and market similar treatments for pulmonary hypertension without the encumbrance of UTC's patent claims.
What is the significance of the Federal Circuit's ruling on product-by-process claims?
The Federal Circuit's ruling clarifies that product-by-process claims can be anticipated by prior art disclosures of the claimed product, regardless of the process by which the product is made.
Cited Sources:
- United States Supreme Court Declines to Review Rulings that Invalidate United Therapeutics’ Patent - Liquidia.
- UNITED THERAPEUTICS CORPORATION v. LIQUIDIA TECHNOLOGIES, INC. - U.S. Court of Appeals for the Federal Circuit.
- Takeaways From United Therapeutics Corporation v. Liquidia Technologies, Incorporated - Haug Partners.
- United Therapeutics Corporation v. Liquidia Technologies, Inc. - U.S. Court of Appeals for the Federal Circuit.
- U.S. Federal Circuit Affirms Earlier PTAB Decision to Invalidate All Claims of United Therapeutics Patent No. 10,716,793 ('793 Patent) - GlobeNewswire.
