This post explores how drug manufacturers leverage secondary patents to manage the patent cliff and maintain exclusivity. A detailed analysis of Entresto’s patent timeline and Indian legal context is provided.
Read more about Profiting from the Patent Cliff: What Drug Manufacturers Need to Know about Secondary PatentsTag: Generic drugs
A Patently Generic Win
The US Supreme Court’s decision in Caraco vs. Novo Nordisk clarifies the rights of generic drug manufacturers to challenge overly broad patent claims. This case marks a significant development for generic competition and FDA approval processes.
Read more about A Patently Generic WinRestricting ‘Pay-for-Delay’ Agreements
This post discusses recent fines imposed on pharmaceutical companies for pay-for-delay agreements and examines their impact on market competition and drug pricing. It analyses regulatory measures and the ongoing debate over the balance between innovation and consumer interests.
Read more about Restricting ‘Pay-for-Delay’ AgreementsDemystifying the Evergreen myth
This post explores evergreening in pharmaceutical patents and how Section 3d of the Indian Patent Act limits patentability for incremental inventions. It discusses the implications for innovation, generic competition, and the evolving legal landscape in India.
Read more about Demystifying the Evergreen mythCompulsory License for “Not working”
This post discusses the legal grounds for granting compulsory licenses when patented drugs are not locally worked in India, as revealed through recent Form 27 compliance issues. It analyses relevant sections of the Indian Patent Act and the implications for innovator pharmaceutical companies.
Read more about Compulsory License for “Not working”Patent Suit over Viagra
Pfizer has sued Watson Laboratories to delay generic Viagra, leveraging the Hatch-Waxman Act and its patents. This case examines Pfizer’s legal strategy and the implications for generic competition in the pharmaceutical market.
Read more about Patent Suit over ViagraGenerication of Public Interest
This article explores how public interest has guided Indian patent law, often supporting generic drug companies over innovators. It argues for a balanced approach to public interest that considers both affordability and pharmaceutical innovation.
Read more about Generication of Public InterestPharmaceutical Business Strategy – A Brand Name Perspective
The post explores how brand name drug companies exploit regulatory provisions to maintain market dominance during generic drug challenges. It details the legal and procedural mechanisms involved, focusing on the strategic use of the 30 month stay period under the Hatch Waxman Act.
Read more about Pharmaceutical Business Strategy – A Brand Name PerspectiveUNDP Issues Guidelines For Pharmaceutical Patent Examination
The UNDP has issued new guidelines aimed at strengthening pharmaceutical patent examination with an emphasis on public health. The guidelines advocate for stricter standards and the use of TRIPS flexibilities to curb evergreening and improve access to medicines.
Read more about UNDP Issues Guidelines For Pharmaceutical Patent ExaminationLee and BDR decision – the End of Compulsory Licenses?!
The Lee and BDR decisions signal a shift in the landscape of compulsory licensing in India. This post examines the legal and policy developments leading to these outcomes, highlighting their implications for the Indian pharmaceutical industry.
Read more about Lee and BDR decision – the End of Compulsory Licenses?!