AbbVie Inc. has intensified its legal campaign to protect its endometriosis treatment franchise by filing a new patent infringement lawsuit against Hetero Labs Ltd., targeting what appears to be the last remaining generic challenger to its Orilissa medication.
The lawsuit, filed Monday in the US District Court for the District of Delaware, alleges that Hetero's proposed generic versions of Orilissa infringe on US Patent No. 12,102,637. This patent, just issued on October 1 and licensed from Neurocrine Biosciences Inc., provides protection for the drug until 2036 - a significant 13-year exclusivity window.
Patent Details and Infringement Claims
AbbVie's complaint specifically targets Hetero's plans to produce generic 150-milligram and 200-milligram tablets containing elagolix sodium, the active pharmaceutical ingredient in Orilissa. The timing of the lawsuit is notable, as it comes shortly after the new patent was issued, demonstrating AbbVie's aggressive approach to defending its intellectual property.
The newly issued patent appears to be a key component of AbbVie's strategy to extend market exclusivity for Orilissa beyond earlier patents. By licensing this intellectual property from development partner Neurocrine Biosciences, AbbVie has strengthened its patent portfolio around the medication.
Strategic Importance of Orilissa
Orilissa represents an important asset in AbbVie's women's health portfolio. Approved by the FDA in 2018, it was the first oral gonadotropin-releasing hormone (GnRH) antagonist specifically developed for women with moderate to severe endometriosis pain. The drug works by reducing the production of estrogen, which helps alleviate the painful symptoms associated with endometriosis.
Endometriosis affects approximately 1 in 10 women of reproductive age worldwide, causing debilitating pain and potential fertility issues. Prior to Orilissa's approval, treatment options were limited primarily to hormonal contraceptives, pain medications, and surgical interventions.
Broader Patent Protection Strategy
This lawsuit against Hetero Labs appears to be part of a comprehensive strategy by AbbVie to block all potential generic competitors from entering the market. The complaint describes Hetero as the "last holdout" in AbbVie's efforts to protect Orilissa from generic competition.
The pharmaceutical industry routinely uses patent litigation as a mechanism to protect revenue streams from successful medications. For drugs like Orilissa that address significant unmet medical needs, maintaining market exclusivity can represent billions in potential revenue over the extended patent life.
Implications for Patient Access
The outcome of this litigation will have significant implications for patients with endometriosis. Generic competition typically drives down prices substantially, potentially increasing accessibility for patients who struggle with the cost of brand-name medications.
However, pharmaceutical companies argue that patent protection is essential to recoup research and development investments and fund future innovation. AbbVie likely invested hundreds of millions in the development and commercialization of Orilissa.
What's Next in the Legal Process
The case will now proceed through the federal court system, with Hetero Labs likely to mount a defense challenging either the validity of the patent or arguing that their formulation does not infringe upon it. Such pharmaceutical patent cases often take years to resolve, potentially delaying generic entry regardless of the ultimate outcome.
Neither AbbVie nor Hetero Labs has publicly commented on the specifics of the case beyond the court filings. The pharmaceutical industry will be watching closely as this case could set precedents for similar patent protection strategies involving recently issued patents.
