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Insider Analysis: Can Outsourced Clinical Trials Also Be The Best?

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.

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.

Insider Analysis: Defending IP in China Lends Vigor to Patent Process, Viagra Case Demonstrates

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]

Insider Analysis: The Glivec Patent Saga – Effectuating “Efficacious” Patent Norms In India

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.”

Insider Analysis: Pharmaceutical Outsourcing To China – Some Legal Issues

By: Susan Finder, Heller Ehrman, Hong Kong

Insider Analysis: India’s Indecision – How To Provide Pharma Companies With Clinical Trial Data Exclusivity

By: Nathan A. Evans and Seth I. Heller, Finnegan, Henderson, Washington, D.C.

Insider Analysis: China’s New Drug and Device Measures – Real Politics

By: Chen Yang, Sidley Austin LLP, Beijing & Scott Bass, Sidley Austin LLP, Washington, D.C.

Insider Analysis: Establishing Pharmaceutical R&D Centers in China/Legal Issues

By Simon Luk, Susan Finder and Peter Luan
Heller Ehrman, Hong Kong

Guest Column: China Commercial Bribery Laws and Life Sciences Enterprises

By Tang Zhengyu Sidley Austin LLP, Shanghai

By Tang Zhengyu Sidley Austin LLP, Shanghai

By Tang Zhengyu Sidley Austin LLP, Shanghai