Analysis of patent litigation, PTAB practice, prosecution and pharma IP, written on the data behind LexDana.
Tagged pharma · clear
In the realm of pharmaceuticals, the approval process for generic and brand-name drugs holds significant importance. The Hatch-Waxman Act, a pivotal piece of legislation, governs these processes, ensuring a delicate balance between innovation,…
British drugmaker GlaxoSmithKline (GSK) has taken American pharmaceutical giant Pfizer to court, alleging a violation of its patent rights in the creation of Pfizer's RSV vaccine. The lawsuit filed in Delaware District Court, has cast a shadow over a…
When it comes to generic medications, the Abbreviated New Drug Application (ANDA) process plays a crucial role in bringing affordable alternatives to brand-name drugs to the market. At the heart of ANDA approval lies the significance of bioequivalence…
The landscape of patent litigation is ever-evolving, and the first half of 2023 has been no exception. The dynamics of patent litigation are complex, and its trends can be influenced by various elements that interact with each other. Factors such as…
When it comes to preparing an Abbreviated New Drug Application (ANDA), there are several common pitfalls that applicants often encounter. These pitfalls can significantly impact the approval process and delay the launch of a generic drug in the market.…
The Abbreviated New Drug Application (ANDA) process plays a vital role in the pharmaceutical industry, enabling generic drug manufacturers to bring affordable alternatives to market while respecting patent owner rights. Balancing the interests of patent…
Promosome LLC, a biotech firm represented by law firm Susman Godfrey, has just filed a patent infringement lawsuits against Moderna, Pfizer, and BioNTech. The lawsuits claim that the mRNA-based COVID-19 vaccines produced by these companies violate…
The Hatch-Waxman Act, officially known as the Drug Price Competition and Patent Term Restoration Act, revolutionized the pharmaceutical industry by balancing the interests of brand-name drug manufacturers and generic drug manufacturers. It introduced the…
In the world of pharmaceuticals, the Abbreviated New Drug Application (ANDA) process plays a critical role in the approval and market entry of generic drugs. However, the intersection of patents and generic drug approvals can be a complex and challenging…
In late August, we published our third annual ANDA Litigation Intelligence Report. We evaluated the stakeholders for Hatch-Waxman cases filed between July 1, 2017, and June 30, 2022. This report's major highlights have been covered in our previous…
In late August, we published our third annual ANDA Litigation Intelligence Report, covering important statistics and evaluating all stakeholders in Hatch-Waxman litigation, including attorneys, local counsel, law firms, generic and brand pharmaceutical…
Last August, we published our third annual ANDA Litigation Intelligence Report. The report covered the ANDA litigation landscape and focused on cases filed during the past five years. We provided different statistics related to the Hatch-Waxman litigation…
