Posts Tagged: "TRIPS"

I happened to be listening to NPR yesterday morning, and caught an interview on BBC Newshour between the BBC’s Razia Iqbal and a representative of the African Union, Dr. Ayoade Olatunbosun-Alakija, who is also co-chair of the African Union COVID-19 Africa Vaccine Delivery Alliance. The discussion was somewhat unique in that the BBC host was at several points defending patent rights and pushing her guest to explain precisely how patents are the problem with respect to the undeniable crisis of insufficient vaccine access in the world’s poorest countries. An excerpted and slightly edited transcript of the interview follows

Bloomberg first reported today that U.S. Trade Representative Katherine Tai said that the United States will back a proposal by India and South Africa last year to waive intellectual property protections under the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement. The proposal calls for the suspension of international protections for patents, copyrights, industrial designs, trade secrets and proprietary materials, “in relation to the prevention, containment, or treatment of COVID-19 until widespread vaccination is in place globally and the majority of the world’s population has developed immunity.” Tai reportedly said “We are for the waiver at the WTO, we are for what the proponents of the waiver are trying to accomplish, which is better access, more manufacturing capability, more shots in arms.”

Never more than in this past year has reflection and introspection been important to cope with the isolation and stress brought by a raging pandemic. As I look back at World IP Day last year, I immediately recognize how much we have learned and evolved since the beginning of this aggressive and deadly disease. In little more than a year, the outlook is significantly more positive: vaccines are being rolled out in vast quantities, their effect in curbing infections and deaths starts to be recognized, the economy is showing signs of recovery, schools are reopening and there is finally more optimism.

Though it is not over, it seems that the end of the Covid-19 pandemic may be in sight. A select group of countries has managed to bring vaccines to the market in record time. Take the United States, for example. At the time of this writing, three U.S. companies have managed to produce vaccines that received approval from the U.S. Food and Drug Administration (FDA). The intellectual property that underlies these products quite literally has life-saving potential. This achievement no doubt represents a significant feat in human ingenuity, but it also presents a ripe issue in the intellectual property space — namely, compulsory licensing and intellectual property (IP) waivers. Some feel that the cost of sharing this information represents a bold degradation of the intellectual property system. In developing countries, however, the lack of vaccine availability is proving particularly difficult to manage.

On March 25, 2020, the Indian government declared lockdown throughout the country, and we could not have anticipated the number of issues across all sectors that would surface in such a short time. Copyright infringement through social media turned out to be one such issue. At a time when so many industries are facing losses both in terms of work and revenue, the newspaper industry in India has not been spared. The newspaper companies have lost a large number of subscribers to their physical newspapers due to fear of the spread of COVID-19. Recently, a national Indian daily newspaper published a news article stating that sharing PDF copies of an e-newspaper on messaging apps is illegal and that group admins and individuals can be held liable for unauthorized circulation.

In the wake of COVID-19, government officials around the world face unprecedented decisions about when and to what extent they should reopen their respective societies before effective anti-viral medications or vaccines have been developed, necessary regulatory approvals obtained, and those solutions are manufactured for public use. Fundamentally, such decisions will require a delicate balance between protecting public health and facilitating economic growth, which, as we have all been reminded this year, are deeply intertwined.

As governments around the globe fight the COVID-19 outbreak, pharmaceutical companies race to develop a vaccine and potentially secure a patent for it. To speed the process, much of that effort builds on known drugs for other diseases. The World Economic Forum reports that 70 potential vaccines are currently in development around the world. According to a BBC report, research is in progress on more than 150 additional drugs globally, with many pre-existing drugs being trialed for potential usefulness in combatting COVID-19. Those which can are giving it their best shot—for people as well as profit. In the wake of this COVID-19 vaccine and patent sprint, questions arise concerning affordable and universal access: will governments, especially poorer ones, be able to secure affordable access to a vaccine if and when one becomes available? Can a patent owner actually be forced to license a COVID-19 vaccine for the benefit of the greater good? The answers are likely yes to both, depending where you are.

In withdrawing the 2013 statement, the new 2019 guidance by the DOJ, NIST and the USPTO states the obvious, i.e. that there is no difference in the law between F/RAND assured standard essential patents and all other patents. While some would have perhaps liked to break the unitarity approach of the patent system so as to weaken remedies against the infringement of essential patents, a legal system that would apply a different standard to standard essential patents as opposed to other patents would violate U.S. trade obligations.

In 2002, India’s Patent Act 1970 [“the Act”] was amended to include Section 107A. This provision says that any act of making, using, selling or importing a patented invention solely for uses reasonably related to the development and submission of information required under any law in India, or in a country other than India, shall not be considered as infringement of patent rights.  This provision also outlines India’s Bolar exemption. As per the “Bolar doctrine,” which arose out of the U.S. case of Roche Products v. Bolar Pharmaceuticals (1984), it is permissible for third parties to carry out research and development on patented products (especially drugs) for the purposes of submitting information as required by regulatory authorities. The purpose of this provision is to ensure that third parties can conduct research and development and obtain prior regulatory approvals, enabling them to launch the patented products on the market as soon as the patent term expires. This ensures that patent holders do not get a de facto monopoly on their inventions after expiration of their patent term. Further, it ensures that the public has access to cheaper generic versions of the drugs immediately after expiration of the patent term. In India, the scope of this provision has been controversial for some time now, leading to a slew of litigation between major international pharmaceutical companies and Indian generic manufacturers claiming the Bolar exemption. In the recent combined decision in the matters of Bayer Corporation v. Union of India & Ors. LPA No. 359/2017 and Bayer Intellectual Property GMBH & Anr. v. Alembic Pharmaceuticals Ltd. RFA(OS)(COMM) 6/2017 (March 22, 2019), the Division Bench of the Delhi High Court laid these controversies to rest by deciding the question of whether export is permissible under this provision.

The United States is on the brink of making changes to the U.S. patent law that would be modeled on India’s Patent Law. At a Senate Judiciary Committee markup scheduled for tomorrow, June 27, Senator Lindsey Graham (R-SC) plans to offer language as an amendment in the form of the No Combination Drug Patents Act. The language of the bill would prohibit the patenting of new forms, new uses and new methods of administration of new medicines unless the patent applicant can show “a statistically significant increase in efficacy”. This language is oddly similar to India’s Section 3(d), something the Trump Administration’s U.S. Trade Representative has complained “restricts patent eligible subject matter in a way that poses a major obstacle to innovators” (see here, page 49). Other Senators have also weighed in against “a generally deteriorating environment for intellectual property” in India (see here), including Judiciary Committee ranking member Dianne Feinstein (D-CA) and Judiciary Committee members Mike Crapo (R-ID), Amy Klobuchar(D-MN)and Chris Coons (D-CT).

Earlier this year, the Supreme Court of India set aside an order of the division bench of the Delhi High Court that revoked a patent granted on genetically modified cotton, holding that the single bench of the High Court should assess the patentability of the invention after hearing arguments from both sides. The Indian Patent Office granted Patent No. 214436 to Monsanto Technology LLP on genetically modified cotton. In 2016, Monsanto filed a suit before the single judge bench of the Delhi High Court [Civil Suit (Comm) No. 132 of 2016] alleging infringement by Nuziveedu Seeds Ltd., which responded with a counterclaim for invalidity of the patent, among other claims. The single judge ruled in favor of the petitioner and granted an injunction. On appeal, the division bench of the Delhi High Court vacated the injunction and invalidated the patent. That decision was set aside by the Supreme Court, which held that the matter at hand was the injunction and that patentability issues must be dealt with separately by the High Court. This suggests a changing mindset by the Indian courts regarding patentability of genetically modified living organisms. India may now be set to join the league of various other nations that respect biotechnological inventions.

In 1994, the United States was winding up the Uruguay Round of trade negotiations leading to the establishment of the World Trade Organization (WTO). Tucked in among the toothbrush and rice tariffs was the Agreement on Trade-Related Aspects of Intellectual Property. The TRIPS Agreement was seen as a breakthrough, setting common standards for protecting IP, including provisions on trade secrets that closely aligned with U.S. law. Twenty years later, I visited a friend at the WTO to find out what had actually been happening as a result of TRIPS. I was especially interested in what countries had done since 1994 to bring their national laws into harmony with the trade secret requirements. Because each member of the WTO was supposed to submit reports on its compliance, I asked about them. Yes, we have them, my friend told me. They were in boxes in the next room. But no one had ever read them. Just months before my visit, the European Commission had received an industry report lamenting the legal chaos facing companies that tried to enforce their trade secret rights in Europe. Although every one of the 27 member states of the EU was also a signatory to the TRIPS agreement, virtually none of them was in compliance. In response, the Commission issued a “Directive,” instructing all member states to (finally) harmonize some basic aspects of their trade secret laws.

Australia’s Tobacco Plain Packaging Act (TPPA) was enacted in 2011 and prohibits all use of trademarks (other than word marks) on tobacco product packaging. The law seemingly created a domino effect around the world, with countries including Hungary, Ireland, New Zealand, Norway, and the UK having enacted similar laws since, and many other countries presently considering various approaches to restricting tobacco and other products, including alcohol, snack foods and soda. Most recently, Canada enacted the Tobacco and Vaping Products Act, which places certain restrictions on tobacco products, and is still considering broader plain packaging regulations. Complaints about the law have been pending with the World Trade Organization (WTO) for some time, and, on January 14, the International Trademark Association (INTA) submitted a brief opining in the latest stage of that case.

ACTION for Trade asks Lighthizer to consider advocating for strong IP protections and robust enforcement to benefit a diverse group of industries, including digital content producers and distributors, biopharmaceutical firms and software developers… Along with strong patent policy, ACTION for Trade calls for the establishment of regulatory data protection (RDP) provisions which are consistent with U.S. law, especially where medical innovations are concerned. The letter to USTR Lighthizer notes that U.S. law recognizes a 12-year period of RDP for biologic treatments and a 5-year period of RDP for small molecule treatments. Such provisions would allow the original innovators of novel medicines to submit data on the safety and efficacy of medicines while shielding that data from others who might produce generics based on the data.

The Brazilian Government is considering the adoption of an emergency measure to eliminate the Patent Office chronic backlog problem by automatically granting, without examination, 230,000 pending applications until 2020. The emergency measure has been labelled by the Government as an “extraordinary solution” and a draft of the plan was introduced for public discussion. Companies may soon need to deploy a strategy within a time-frame as short as 90 days to take full advantage of the new system while minimizing potential risks… For the past 15 years, Brazil has been enduring one of the world’s most severe patent backlogs. The problem has grown considerably after the enactment of the 1996 Patent Statute, which was adopted to make the country TRIPS compliant.