Posts Tagged: "World Trade Organization"

The horrific second wave of COVID-19 in India has compelled the government to introduce an expedited vaccination drive from May 1, 2021, where all citizens above the age of 18 (and not just priority groups) will be eligible to register. The program also came with the promise of an introduction to several new vaccines in the market. A majority of the states also decided to roll out the vaccine for free. Unfortunately, reports that stock had run out followed shortly in several states. States like Maharashtra and Delhi had to keep the drive on hold. Bengaluru also faced supply problems ahead of the drive. A popular proposition is that patent restrictions and exclusivity of “know-how” are a barrier to adequate production of vaccines.

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.

Intellectual property protection has played an important role in this pandemic. As some have pointed out, without legal protection for innovative ideas, there may not have been such a rapid response to the pandemic – both in terms of testing/ treatment and, most recently, vaccines. Companies like Moderna, in conjunction with research and funding from the National Institutes of Health (NIH), have spent a decade developing key technology that enabled quicker vaccine development than ever before. Without some intellectual property protections in place that provide strong financial incentives to invest in new ideas, innovation like this may never have come to light. Nevertheless, India and South Africa initiated a proposal in October that is gaining traction among like-minded World Trade Organization (WTO) members. This proposal would temporarily suspend certain provisions of the Agreement on Trade-Related Aspects of Intellectual Property (TRIPS Agreement) for products related to COVID-19, including vaccines. What began with a handful of nations has now reached a majority, with 57 national sponsors of the proposal, and over 60 WTO members who are in support.

India and South Africa recently urged the World Trade Organization to suspend intellectual property protections for COVID-19 vaccines and treatments. The claim is that this would allow developing countries to manufacture “cheap” COVID-19 therapeutics and vaccines, hastening the end to the pandemic—at least, that’s what proponents claim. They’re wrong. Dangerously wrong. Gutting IP protections won’t make COVID-19 medications more readily available but it will set a terrible precedent that will chill future medical innovation.

While coronavirus spent the majority of 2020 wreaking havoc on earth, pharmaceutical companies have been busy at work trying to invent a vaccine to combat it. Several companies, such as Pfizer, Moderna and AstraZeneca, have competed neck and neck to be the first to deliver a cure to the world. Renowned pharmaceutical companies have been successful in developing the vaccine, which will be protected under the Trade-Related Aspects of Intellectual Property Rights Agreement (TRIPS).

The biggest vaccination effort in the history of medicine is underway to eradicate the global pandemic, with several strong prospects appearing poised for regulatory approval. As of December 2020, data from the World Health Organization showed over 50 vaccine candidates in clinical research, and 163 more in the preclinical stage. The wait could soon be over. Two separate vaccines – one from Pfizer and BioNTech and one from Moderna – are pending emergency use authorization from the U.S. Food and Drug Administration. The former is already being administered for the first time outside of clinical trials following its approval by the UK government. That’s why recent calls to strip away intellectual property protections are so dangerous. Specifically, some nations have asked the World Trade Organization (WTO) to waive intellectual property protections related to COVID-19 – including not only vaccines, treatments, diagnostics, and medical technologies, but all forms of IP – until the majority of the world’s population has developed immunity. They argue that the current global intellectual property system is a barrier to accessing said COVID-19 vaccines, treatments, diagnostics, and medical technologies.

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.

Founded in 2006 by the governments of France, the United Kingdom and several others, and financed by a combination of a tax on airline tickets and government grants, Unitaid is one of the lesser known players in the crowded world of global health. Unitaid’s most distinctive contribution is its Medicines Patent Pool (MPP), now approaching its tenth year of operation. It is a “one-stop shop” for patented medicines owned by different companies and available for voluntary licensing in low- and middle-income countries, so generic versions can be manufactured cheaply. At the moment, it focuses on medicines for HIV, malaria, tuberculosis and Hepatitis C. Respecting existing intellectual property rights (IPRs) for new medicines is key to the success of the MPP, as it allows rights-holders of innovative medicines to widen access to their medicines in lower-income markets without compromising their markets in wealthier parts of the world from where they derive the majority of their profits. This in turn ensures the funds for the research and development that drives medical progress. Despite demonstrating how the market-based system of IPRs can be used to promote access to medicines, Unitaid has also started to pursue energetically what it describes as a “complementary” strategy of encouraging middle-income countries to undermine and attack IP rights.

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.

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.

A number of organizations, including Ericsson, Nokia, Philips, Qualcomm, the Innovation Alliance and the Licensing Executives Society, have sent two separate letters to U.S. Attorney General William Barr, USPTO Director Andrei Iancu, and Secretary of Commerce Wilbur Ross stating their support for the United States’ decision to withdraw the Department of Justice, Antitrust Division’s assent to the 2013 joint DOJ-U.S. Patent and Trademark Office “Policy Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments” (the 2013 Joint Policy Statement). The letter sent by Ericsson, Nokia, Philips, and Qualcomm begins by explaining that those signing the letters collectively spend many billions of dollars annually to “the development of cutting-edge that substantially contribute to the social welfare and quality of life of U.S. consumers,” and “and employ tens of thousands of people in the U.S.” The letter goes on to explain that injunctions are necessary to address the widespread patent infringement that has occurred in recent years; infringement that risks innovators’ ability to continue to innovate and create next generation technologies. Without property protections it is economically irrational to invest the billions of dollars required to create cutting-edge technologies.

While a preliminary trade deal seems to have been struck between China and the United States over tariffs, the two sides have yet to seriously address the toughest and perhaps most economically crucial issues on the table: China clinging to a tech policy based on systematic theft of U.S. intellectual property (IP), forced technology transfer, and cybertheft.President Trump has paid lip service to the need for any deal to include IP protections, and China responded on March 14 by rushing a law that would, according to CNBC, “prohibit the forced transfer of technology from foreign-invested businesses in China, step up protection of intellectual property and claim to give the companies equal footing with domestic players.”  Nevertheless, China watchers are skeptical that these commitments remain cosmetic, while it remains clear that Trump has focused his negotiators chiefly on those things nearest and dearest to his heart: physical goods and tariffs. As talks move forward, the question remains—how will U.S. Trade Representative (USTR) Robert Lighthizer resolve these challenges for the benefit of IP holders?

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.

Enforcement of trademark rights in China is an ongoing issue faced by numerous corporations.  Invalidating or canceling a trademark registration in the Chinese market is time-consuming and costly.  The best way to defend your company’s valuable intellectual property assets is to put in place as many protections as possible.  If your company owns a creative design mark, consider going beyond the standard trademark registration and getting the “super trademark” by obtaining copyright registration for this artistic design element.