With a special focus on the pharmaceutical industry, the November 2018 edition of Asia IP discusses the legal and regulatory landscape for life sciences companies across Asia. In a section of the feature focused on how best to prevent litigation, the magazine includes extensive commentary from two members of the Tilleke & Gibbins team—Alan Adcock, Partner and Deputy Director, Intellectual Property, and Alec Wheatley, Consultant.
As the starting point for protection, Alan emphasizes the importance of securing intellectual property within a company’s own walls first and foremost. “[C]ompanies operating in this space must first secure their IP in-house before seeking patent registration and moving to market,” he said. “[I]t is paramount to require all employees and contractors to sign strong employment agreements that include provisions on IP assignment, ownership, and confidentiality obligations.”
The focus of the article then turns toward the topic of generic drugs, which typically benefit from lower overall costs because they are not required to conduct full clinical trials or devote large budgets to marketing. But Alec states that this cost advantage does not necessarily place generics producers at a competitive advantage against pharmaceutical innovators: “Patented products will continue to benefit from the limited monopoly granted by patent registration for development of innovative, new drugs. This enables patent owners to build up sizable public awareness of their drugs under the brand names, which continues to inure to their benefit long past the expiration of the patent.”
To help prevent litigation between innovators and generics manufacturers, Alan proposes that regulators should require applicants of generics to disclose all related pharmaceutical patents as part of their application process with the Food and Drug Administration (FDA): “Currently, Thailand does not have this requirement for generics—but surprisingly, it does for new drugs. This compulsory disclosure would provide greater clarity to the reviewing officer at the FDA, and could result in a reduction in the number of infringing generics granted approval in non-Bolar exemption jurisdictions,” Alan explains. “In turn, this would see a corresponding reduction in the overall potential for litigation by patent owners obliged to monitor both FDA databases for granted generic approvals and the market for infringing commercial activities.”
To read the full article, please visit the Asia IP website (subscription required).