Is there a conflict between drug patents and public health?
The outbreak of COVID-19 has caused consternation not only in China but also among the international community. As combating the virus has entered a critical phase, the public’s primary attention goes to how to treat and cure those infected. Undoubtedly, antiviral medicine is of great significance to the treatment of the patients. Yet, it is a pity that there is still not a drug that has a special effect against the epidemic. However, relevant authorities, scientific institutions and biotech companies are working day and night to discover effective drugs and invent vaccines.
Just as we know, drugs are a special kind of product, relying heavily on patent protection due to the vast investment, high risk and prolonged research period. Thus, most countries grant the pharmaceutical enterprise patent protection for their newly developed original drugs by offering them a limited monopoly under the patent protective term in order to make sure they can recover their cost, make a slight profit, and have an incentive to create new drugs to cure diseases that people suffer from. This is the underlying ground for patent protection of pharmaceutical products and has proved useful and practical. However, the side effect is the high price of brand-name drugs during their patent protective terms and the availability, which triggers a widespread debate on the conflict between the pharmaceutical patent and public health.
Actually, during the pandemic, the patent issue has been brought into the spotlight since last month. When a local virology institute filed a patent application to the National Intellectual Property Office regarding the use of Remdesivir against COVID-19, there was a considerable discussion on whether the patent application could undergo the scrutiny of the validity process and whether it was appropriate for any entity to patent a viable drug in such a special situation.
Basically, there are mainly three types of patents with respect to pharmaceutical products according to Chinese Patent Law: chemical compounds, preparation methods and new applications. What the institute claimed belongs to the new application category, and as long as it conforms to the patentable standard of novelty and creativity, the National Patent Administration is likely to approve the institute’s patent application. Notably, chemical compound patents and new application patents are not contradictory. Although the rights holder of the core patent regarding Remdesivir, namely the chemical compound, is the American biotech corporation Gilead, it cannot keep anyone from applying for new application patents for the drug based on research statistics and clinical tests. A typical case in point is Viagra. The producer’s initial intention of inventing this drug was to cure stenocardia, but later it was found to be more effective in treating sexual impotence. And the latter was granted a new application patent. Nevertheless, even though the institute’s application was successful, it still has to try to negotiate a cross license with Gilead, in order to manufacture the drug in massive quantity and for commercial use from a legal standpoint.
That’s why many people expressed their concern about the conflict between drug patents and public health. It is equivalent to answer the question regarding the appropriateness of the patent application during this emergent time. Actually, though the institute did it in this way, it seems more like a kind of defensive application. It is just like the declaration given out by the institute, saying that they would not enforce the patent right in case of a domestic emergency, yet the primary reason for them to apply is to prevent others from squatting on such a patent of great importance at present. What’s more, the chemical compound company has also turned out to be very cooperative, and, according to some reports, Gilead explicitly expressed unwillingness to get involved in the patent battle and was willing to provide any necessary convenience.
In addition, where public interests are concerned, eligible entities are entitled to apply for compulsory licenses to exploit a pharmaceutical patent according to Article 49 of Chinese Patent Law. Although such a compulsory license is subject to certain conditions and specific procedures, it has played an essential role in balancing the patent regime and public health in pharmaceutical field. And it has long been recognized as an international legal doctrine. The TRIPS agreement, as the common standard for international IP protection, includes a similar exception to the exclusive right of a patent rights holder in situations of national emergency. As the World Health Organization has declared the outbreak of COVID-19 as a public health emergency of international concern, relevant authorities have the power to grant compulsory licenses upon an eligible entity’s application if any patent rights holder would be antagonistic.
However, in practice, such a compulsory license has never been implemented since the promulgation of Chinese Patent Law. On one hand, the government only uses it as a bargaining chip, and almost all pharmaceutical companies are definitely cooperative to an open license of their patents in many cases. On the other hand, we need the pharmaceutical giants’ help and coordination during such a health emergency, as their experience and expertise are of great value. For even if a compulsory license was granted and the drug patent information disclosed, most generic drug manufacturing enterprises are still not capable of producing drugs of the same effect of the original ones -- and, in most cases, there is a huge discount in terms of the drug's effect. Owing to the drug making process as being highly scientific and technology intense, sometimes just following the information contained in the patent is not enough. Given the status quo of our pharmaceutical market and the availability of high-quality drugs, we still need the patent system to spur innovation in the marketplace to push forward the research and discovery of the antidote to the epidemic. And in coordination with joint efforts by relevant authorities and scientific institutions, we have confidence in the final victory in the fight against COVID-19.
The author is an assistant judge of the Beijing Intellectual Property Court.
The opinions expressed here are those of the writer and do not represent the views of China Daily and China Daily website.
