Analysis of patent litigation, PTAB practice, prosecution and pharma IP, written on the data behind LexDana.
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Abbreviated New Drug Application (ANDA) litigation stands at the crossroads of pharmaceutical innovation and legal prowess. As generic drug companies seek to enter the market while facing patent challenges from brand-name giants, the role of skilled…
In the world of pharmaceuticals, access to affordable generic drugs is crucial for ensuring cost-effective healthcare solutions. The Drug Price Competition and Patent Term Restoration Act, commonly known as the Hatch-Waxman Act, plays a pivotal role in…
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…
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…
Most of the community involved in life science litigation and pharmaceutical companies, thought they saw the end of the long-fought battle between Amgen and Sanofi in 2021 with the CAFC decision . As a result, at the time, it was said that the attorney…
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…
