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Table 2 Types of TRIPS-Plus IP provisions common in recent regional trade agreements

From: Analyzing the impact of trade and investment agreements on pharmaceutical policy: provisions, pathways and potential impacts

Type of provision

Mechanism for prolonging exclusivity

Requirement to grant patents for new uses of known products, new methods of using known products, or new processes of using known products

Enables firms to obtain additional patent protection for new forms or uses of existing products, which may reduce the use of equivalent versions after the expiry of primary patents on original molecules.

Patent term adjustments to compensate for delays in granting patents and/or in marketing approval processes

Extends the length of patent terms.

Data protection for new pharmaceutical products including biologics (an alternative pathway for maintaining monopoly control based on the clinical trial data submitted to regulators in order to gain marketing approval)

Can add to the length of exclusivity if the period of data protection extends beyond the expiration of relevant patents.

Can provide monopoly protection for drugs or biologics that are not protected by patents (e.g., where a drug or biologic is not eligible for a patent or where the key patent has been invalidated).

Provides a time-limited but absolute monopoly which cannot be challenged in court (as in the case of a patent) and may prevent or delay marketing approval of generics produced under a compulsory or government use license.

Additional data protection for new indications/formulations/methods of administration or for combination products containing a chemical entity that has not previously been approved

New and/or longer periods of data protection or market exclusivity for biologic products;a

Patent linkage mechanisms (linking patent status with marketing approval of generics);

Can extend periods of exclusivity if marketing approval is denied due to patents of questionable validity, patents that are not being infringed by the generic product or patents for changes that have no direct therapeutic applications.

Trade secrets protection

Unlike a patent, trade secret protection does not provide a time-limited monopoly, so it can potentially exclude competition indefinitely.b

TRIPS-Plus provisions for the enforcement of intellectual property rights

Strict enforcement of, and penalties for, suspected violations of intellectual property rights, including seizure of suspected counterfeit goods at the border (i.e., goods suspected of violating IP rules rather than being of deliberately inferior quality), excessive damages, provisional measures, and criminal enforcement of patent infringement.

  1. aBiologic products are a new class of medicines which are derived from living cells using biotechnological processes and that need to be delivered by injection or intravenously. These include many expensive treatments for cancer and autoimmune diseases, and account for a growing share of the global pharmaceutical market and of pharmaceutical expenditure in many countries. [21]. IMS Institute for Healthcare Informatics. The Global Use of Medicines: Outlook through 2017. IMS Health, 2013
  2. bProtection of trade secrets is likely to play an increasing role in excluding competition due to the growing dominance of biologics and the emergence of personalized medicine. The manufacturing processes for developing these newer treatments are very complex, and may make it essentially impossible to create a biosimilar that is identical to the reference product. [22]. Lyman GH, Zon R, Harvey RD, Schilsky RL. Rationale, opportunities, and reality of biosimilar medications. New England Journal of Medicine 2018;378:2036–2044
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Globalization and Health

ISSN: 1744-8603