Exclusive rights to an innovative drug, will probably belong to companies that are engaged in their development, says Director of the healthcare practice at Pepeliaev Group Alexander Panov. It is not excluded that the right to a patent will belong to several companies involved in the creation of the drug. The inventors likely will not become a patent. “The important affiliation registration certificate. The owner determines the regulatory fate of this drug, is responsible for its security, has the right to withdraw the lot or batch”, – said Panov.
With an appeal not to grant patents and not to cash in on the medications, tests or vaccines used to fight the pandemic COVID-19, was organized by the international medical humanitarian organization “Doctors without borders”. The organization called on governments “to prepare for the suspension and cancellation of validity of patents and other measures such as price regulation, to ensure the availability of medication, including financial, and to save more lives.” As explained by the lords, the specifics of the pharmaceutical business is that innovative drugs appear mainly in publicly funded areas. Therefore, if interest groups can convince the state to invest in new segments therapy, society will benefit. Thus, must act with a bunch of “patient community, the medical community and pharmaceutical companies state”.
Payment of works on creation of vaccines is one incentive for the pharmaceutical industry. Often this work is funded by grants. “More important, however, the prospect of receiving exclusive rights to the invention and, accordingly, the possibility to commercialize this right, for example by providing licences. Appropriate opportunities are defined by the Civil code of the Russian Federation,” explained gentry.
State-selfish
Some countries in the period of a pandemic can be national selfishness and to restrict the export of vaccines. Now the main mechanism of pressure – this is the compulsory license, which the authorities impose on national level in the administrative order. It can also be granted by the court, explains the head of intellectual property practice, Pepeliaev Group, lecturer at Digital IP Valentina Orlova.
“It is in the vast majority of cases, the conflict mechanism, and not always it is possible to quickly organize the production, – the expert warns. – In addition to the patent for the active ingredient can be a many more know-how in the production process and other aspects of technology transfer, which the donor will not give a reason. Can help urgently withcreated global centers of technology transfer, where the terms “world” compulsory license left action and the right to additional intellectual property. While such a mechanism does not exist. It is important that the company had the opportunity not to lose all their intellectual property because of her guilt in the specific limitations, most likely, no.”
Because the use cases of the object of the patent right without the permission of the copyright holder and the license agreement defined by law, to speak about discredit of the Institute of intellectual property (IP) enforcement measures exceptions and limitations to exclusive rights is unlikely, the expert continued. Moreover, this approach is consistent with the provisions of the Agreement on trade-related aspects of intellectual property rights (trips).
however, in the current situation with the pandemic should pay attention to the following. Among the extraordinary circumstances in which the use of a protected IP object will not be considered a violation of the law in parentheses refers only to natural disasters, catastrophes and accidents. It is not clear, emphasizes, this is an exhaustive list of such circumstances or exceptional cases.
“on April 1 entered into force the Law № 98-FZ “On amendments to certain legislative acts of the Russian Federation for prevention and liquidation of emergency situations”, which appears to be quite clearly separates the two modes – the mode of high alert and emergency mode, explained Valentina Orlova. – However, the question of what exactly should be attributed to extraordinary circumstances, remains open. This may allow to interpret existing rules in favor of patent holders. But still, if a clear distinction between the threat of an emergency very emergency, in order to protect the interests of patent holders can speak about the absence of emergency, if such a regime was not officially entered.”
Barriers to vaccine
There are other obstacles in the development of the drug. If the first vaccine will be able to obtain and to patent a particular state, the product becomes a lever of pressure on the opponent, says patent attorney Rebecca Harasimowicz, whose opinion results in the publication The National Law Review.
however, according to the head of the Department of bioethics and medical law international UNESCO rnsmu. N. I. Pirogov Evgeny Taratukhin, international law in General, is ready to consolidate the efforts of different countries to find a vaccine. Declaration of human rights and other inter-state agreements explain that we must act for the benefit of all mankind. “Decisions will be made at the level of individual th��of oudart and supranational associations. Leverage on countries that are more successful in developing a vaccine against COVID-19, if will be applied, then immediately acquire political significance. But, in my opinion, unity of the scientific community in the world directly or indirectly will help to avoid a situation in which one producer will benefit from the woes of all mankind.”
Treat the agreement
In April, the UN General Assembly proposed to consider the future of the vaccine in the public domain. With this initiative and the Government of the Russian Federation, pointing.
in the state Duma a draft Federal law “On amendments to Chapter 72 of part IV of the Civil code of the Russian Federation”. The document proposes to give the Cabinet the right to “allow the use of the invention in the manufacture in territory of the Russian Federation of medicines for export of pharmaceuticals without the consent of the patent owner notifying him about it as soon as possible and by paying him commensurate compensation”.
In the explanatory note to the draft contains a link to an article 31bis of the Agreement on trade-related aspects of intellectual property rights (trips). It follows that WTO members can obtain compulsory licenses for production of medicines for export. In addition, WTO members that lack resources for the production of drugs can refer to other members of the organization for help in providing States with drugs. Using article 31bis, the Russian authorities can organize the production of medicines for deliveries abroad at an affordable price in order to combat epidemics, stated in the explanatory note of the bill.
