The Potential To Harmonize Best Practices in China, India and Globally (Part 2 of 2)
By: Leslie A. Platt, Jason Schwartz, Reza Zarghamee, and Vladimir Chechik, Pillsbury Winthrop Shaw Pittman LLP, Washington, D.C.
The first part of this two-part column explored the remarkable potential for outsourcing clinical trials to China, India and other developing nations, as well as the challenges that worldwide governments face when establishing and enforcing best practices for such outsourced clinical research. This second part focuses on potential methods for benchmarking outsourced clinical research to internationally-recognized performance standards.
Continue reading "Insider Analysis: Can Outsourced Clinical Trials Also Be The Best?" »
The Potential To Harmonize Best Practices in China, India and Globally (Part 1 of 2)
By: Leslie A. Platt, Jason Schwartz, Reza Zarghamee, and Vladimir Chechik, Pillsbury Winthrop Shaw Pittman LLP, Washington, D.C.
Continue reading "Insider Analysis: Can Outsourced Clinical Trials Also Be The Best?" »
By: Tony Chen, Jones Day, Shanghai
From its genesis in 1984, patent protection in China has evolved by leaps and bounds as China’s economy has become integrated with the rest of the world. Recent statistics show that China has the world’s third busiest patent office (after Japan and the United States) in annual patent filings. Significantly, more patent infringement lawsuits were filed in China than in the United States in 2005 and 2006 – most of them between Chinese parties. This phenomenon has emerged despite a lack of formal discovery and the low level of damages granted by Chinese courts.[1]
Continue reading "Insider Analysis: Defending IP in China Lends Vigor to Patent Process, Viagra Case Demonstrates" »
By: Shamnad Basheer
Indian patent law recently landed itself in the eye of a “TRIPS” storm on account of the rejection of a patent application covering Novartis’s famed anticancer drug, Glivec (imatinib mesylate). The rejection stemmed, inter-alia from a unique section in the Indian patent regime (section 3(d)) that prohibits the patenting of new forms of existing pharmaceutical substances that do not demonstrate significantly enhanced “efficacy.”
Continue reading "Insider Analysis: The Glivec Patent Saga – Effectuating “Efficacious” Patent Norms In India" »