The COVID-19 pandemic: are drug patents at risk?

It is still too early to determine when a vaccine against new coronavirus will be available. Even if renowned research centers and pharmaceutical companies could put their best efforts into developing a vaccine against COVID-19, it is obviously necessary to follow the correct clinical protocols to launch a safe and effective product in the market. Specialists say that it will take at least 18 months, which is an extremely optimistic prediction.

At the same time, alternative treatments are being used in an attempt to help patients, especially those based on medicaments useful for treating other diseases. Hydroxychloroquine, which is used to treat malaria, lupus erythematosus, and rheumatoid arthritis, is one of these drugs, although there is no clinical proof that the use of this substance is safe and effective against coronavirus.

Another example of medication that is being tested on COVID-19 patients is the combination of antiretroviral drugs lopinavir and ritonavir. Such combination is currently marketed worldwide by US company Abbvie Inc. under trade name Kaletra for treating HIV patients.

Although there is no scientific evidence on the use of lopinavir + ritonavir to treat COVID-19 patients, some governments are taking measures to guarantee the supply of this medication to their populations. In this sense, Israel’s Attorney General announced on March 19, 2020 the compulsory licensing of the patent covering Kaletra’s formulation, which will only expire in 2024. By doing so, the Israeli government intends to purchase a generic version of Kaletra from India, where there is no valid patent for the combination of lopinavir and ritonavir. It is worth mentioning that the compulsory license applies only for use in the treatment of COVID-19, which means that the generic product imported from India cannot be used in the treatment of HIV.

In response to Israel’s compulsory license, Abbvie decided not to enforce its patent rights related to Kaletra patents all over the world. This means that even in countries where there is one or more valid patent covering Kaletra, the rights provided by these patents can now be explored by the local government regardless of a compulsory license grant. This is probably the reason why no other country has yet announced any measure similar to Israel.

In Brazil, Articles 68 to 74 of the Brazilian Industrial Property Law regulate compulsory licenses for patents. A compulsory license may be granted in Brazil if the applicant exercises the rights provided by a patent in an abusive manner or practices an abuse of economic power. In addition, a patent can be compulsorily licensed in the following situations: (a) if after three years from the patent grant, its subject matter has not been explored due to lack of manufacture or incomplete manufacture of the product, or if there is lack of complete use of a patented process; or (b) in the event that the commercialization does not meet the market needs. The compulsory license can only be requested by a third-party with a legitimate interest, which must prove the technical and economic capacity to carry out the efficient exploitation of the patent.

Moreover, the Brazilian government may request a compulsory license specifically in the case of a national emergency or for the public interest. The compulsory license of Efavirenz, which is an antiretroviral medication used to treat HIV, was the only one effectively granted based on the public interest/national emergency criteria in Brazil. The Brazilian government was close to the declaration of compulsory license for other products, but before the license was granted, the patent holders/manufacturers were able to come to an agreement with the government. One example is the above-mentioned medication Kaletra, for which the Brazilian government issued a Declaration of Public Interest on June 24, 2005. However, less than three months after the issuance of the Declaration, the patentee and the Brazilian government came to an agreement and the compulsory license request was disregarded.

For now, there is a lot of uncertainty in all matters related to COVID-19 and the scenario is no different from the patent perspective. Patent holders may have rights over drugs that can be crucial for treating coronavirus patients and saving lives. On the other hand, is it fair to issue compulsory licenses on drugs that have not been clinically proven to treat COVID-19? The Kaletra case leaves the door open to other governments to take the same measures as Israel if any clinical evidence points to the use of other patented drugs against coronavirus. Apart from the financial loss for pharmaceutical companies, this type of measure may encourage some countries to keep rejecting pharmaceutical patent applications and then benefit from selling generic drugs to other countries where a compulsory license is granted.

Source: Lexology - https://www.lexology.com/library/detail.aspx?g=b0defd2f-dba7-4769-ae5b-f938c0430db3