This is a guest post from Susan K Finston, President of Finston Consulting. Do you have a response to Susan’s post? Respond in the comments section below.
In what can only be described as a slow news period for pharma IP policy, the arcane yet important issue of patent linkage has resurfaced in not once but twice in the last week – relating to the recently completed EU/Canada FTA and in the ongoing cut and thrust of Indian pharma IP policies. These mentions – in both cases implying that the policy unfairly prejudices generic producers – shed more heat than light on a topic critical to the innovative bio-pharma industry. So this posting will attempt to clarify the concept of patent linkage: what it is, why it matters as an IP norm, and how patent linkage has been implemented across regions.
First to define patent linkage: when a company receives a patent for a pharmaceutical invention that is found to be novel, non-obvious and to have a commercial application, the conventional bundle of rights that goes along with the patent includes the right to exclude others from commercializing the patented invention. To ensure that outcome for highly regulated products requiring marketing approval by government agencies, patent linkage connects the marketing approval process for a product to its patent status, ensuring return on investment by preventing entry of infringing products during the limited patent period.
In effect, without patent linkage, the grant of patents for pharmaceutical products cannot assure any exclusivity in the market, and so advanced developing and developed countries with well-functioning patent systems have also made an effort to implement patent linkage.
Among the BRICS, perhaps the most predictable system is found in South Africa, where the Medicines Control Council (MCC) accepts generic manufacturing applications prior to the expiration of patent protection, consistent with the country’s ‘early working’ exception to patent protection that does not permit manufacturing or warehousing of products for launch of infringing generic products during the period of patent protection. At the time of WTO accession, Russia also committed to providing notifications to innovators of generic applications for marketing approval, for any subsequent applications lodged during the six-year period of data exclusivity in force in the Russian Federation. (Implementation of the Russian policy remains to be seen, however.) Although similar in design to the US approach, the Chinese Patent Linkage policy has been characterized by information gaps relating to registration applications and patent databases, so it has been helpful at times, yet inconsistent. While there is no formal patent linkage in Brazil, injunctive relief for patent holders is widely available in the country’s judicial system. Accordingly, stakeholders have opportunities for redressal through access to the courts, either before or after the entry into the market of infringing products, though still suffering substantial injury from patent infringement in the process. India famously has neither a patent linkage system nor a work-around in terms of timely access to the courts to prevent market entry for openly infringing product.
The US Patent Linkage system seeks to promote a high level of transparency through publicly accessible online databases that list existing patents. The system also requires that marketing approval applications include a declaration relating to the patent status to the patent holder to enable timely private enforcement of patent rights. The US Food and Drug Administration (FDA) maintains an online database of pharmaceutical products under patents – Approved Drug Products with Therapeutic Evaluation Equivalents, known familiarly as “the Orange Book.” (The Electronic Orange Book is available via the internet at: http://www.fda.gov/cder/ob/)
The EU also provides a very high degree of predictability for right holders through the effective operation of up to 11 years of data exclusivity that provides patent linkage by proxy across the EU. Both early working and expanded data exclusivity periods were introduced under the Future of Medicines Law (FML), where the 10 – 11 year data exclusivity term may be co-extensive with the remaining patent protection period at the time of product launch. Accordingly, data exclusivity operates as a proxy for formal patent linkage for patent holders, and innovators enjoy effective protection against registration of potentially infringing pharmaceutical products during the patent period.
Canada’s Patent Register, generally equivalent to the U.S. “Orange Book,” lists patents relevant to approved pharmaceutical products. Under the Patented Medicines (Notice of Compliance) Regulations, Health Canada requires that applicants seeking marketing authorization for a generic product address the status of all listed patents for that particular product, and provides an expeditious legal process for review of claims of potential infringement. In addition, following Canada’s loss before the tribunal in the 2000 WTO dispute settlement panel decision barring advance manufacturing and ‘stockpiling’ of generic versions of patent-protected products, Canada amended its patent law to bar commercial scale manufacturing of any generic product during the period of patent protection, providing another safety valve to prevent infringement of innovative products during the period of patent protection.
All in all, patent linkage has become an IP norm, adopted in one fashion or another by most of the BRICS, the US, EU and Canada, among others. Given its fundamental importance to prevent routine infringement of patent rights, and the validation by the WTO’s 2000 panel ruling against Canada (stockpiling), how weird is that?
About the author:
President of Finston Consulting LLC since 2005, Susan works with innovative biotechnology and other clients ranging from start-up to Fortune-100, providing support for legal, transactional, policy and “doing business” issues. Susan has extensive background and special expertise relating to intellectual property and knowledge-economy issues in advanced developing countries including India and South Asia, Latin America and the Middle East North Africa (MENA) region. She also works with governments, and NGOs on capacity building and related educational programs through BayhDole25. Together with biotechnology pioneer Ananda Chakrabarty, she also is co-founder of Amrita Therapeutics Ltd., an emerging biopharmaceutical company based in India with cancer peptide drugs entering in vivo research. Previous experience includes 11 years in the U.S Foreign Service with overseas tours in London, Tel Aviv, and Manila and at the Department of State in Washington DC. For more information on latest presentations and publications please visit finstonconsulting.com.