LG Chem's subsidiary Aveo Pharmaceuticals has initiated legal action against Indian pharmaceutical company Hetero Labs Ltd., seeking to block the production of generic versions of its kidney cancer medication Fotivda (tivozanib hydrochloride). The lawsuit, filed Friday in the US District Court for the District of Delaware, alleges that Hetero's proposed generic formulations would infringe on Aveo's intellectual property rights.
Patent Infringement Claims
According to court documents, Aveo claims that Hetero's generic 0.89- and 1.34-milligram tablets of tivozanib hydrochloride would infringe US Patent No. 11,504,365. This patent specifically covers specialized dosing methods for patients with liver impairment, a critical consideration in cancer treatment where many patients may have compromised liver function.
The lawsuit represents a standard pharmaceutical industry practice to protect market exclusivity for branded medications when generic manufacturers attempt to enter the market. Under the Hatch-Waxman framework, brand-name drug companies can file patent infringement suits that automatically trigger a 30-month stay on FDA approval of generic applications, unless the court rules earlier.
About Fotivda
Fotivda (tivozanib) is an oral, once-daily, vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) approved for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) who have received two or more prior systemic therapies. The drug works by blocking the VEGFR pathway, which plays a crucial role in tumor angiogenesis – the formation of new blood vessels that supply tumors with nutrients and oxygen.
The FDA approved Fotivda in March 2021 based on clinical trials demonstrating improved progression-free survival compared to sorafenib in patients with heavily pretreated advanced RCC. The approval addressed an important unmet need for patients with limited treatment options after multiple lines of therapy.
Market Implications
For LG Chem and its Aveo subsidiary, protecting Fotivda's market exclusivity is strategically important. Kidney cancer treatments represent a significant market segment within oncology, with renal cell carcinoma accounting for approximately 90% of all kidney cancers. In the United States alone, an estimated 79,000 new cases of kidney cancer are diagnosed annually.
Generic competition would likely substantially reduce Fotivda's market share and price point. By filing this patent infringement lawsuit, Aveo aims to maintain its exclusive position in this specialized treatment area for the duration of its patent protection.
Specialized Dosing Considerations
The patent at the center of this dispute highlights the importance of specialized dosing regimens for patients with compromised liver function. Cancer patients, particularly those with advanced disease who have undergone multiple treatments, often experience hepatic impairment that can significantly affect drug metabolism and clearance.
Developing appropriate dosing guidelines for these vulnerable patient populations requires substantial research and clinical validation. Pharmaceutical companies typically seek patent protection for such innovations to recoup research investments and fund future drug development efforts.
Industry Context
This case represents a common scenario in the pharmaceutical industry, where innovator companies defend their intellectual property against generic manufacturers seeking market entry. The outcome will depend on the court's interpretation of Aveo's patent claims and Hetero's arguments regarding patent validity or non-infringement.
For patients with advanced kidney cancer, the case has implications for future treatment access and affordability. While branded medications like Fotivda provide important treatment options, generic alternatives eventually help reduce costs and expand access to effective therapies.
