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GILEAD DEFENDS THEIR SOFOSBUVIR PATENT SUCCESSFULLY

GILEAD DEFENDS THEIR SOFOSBUVIR PATENT SUCCESSFULLY

Sofusbovir is a substance from the group of nucleotide prodrugs, which has been successfully marketed by the US pharmaceutical company Gilead since 2013 as a medicament under the brand name „SOVALDI“.

Sofosbuvir inhibits the RNA-dependent enzyme NS5B polymerase, which plays an important role in the replication of specific viruses. Thus, the substance is effective against chronic hepatitis C, of which, according to the WHO, around 400,000 people die each year, and another 100,000 in other complications such as liver cancer or liver cirrhosis. Worldwide, the number of diseases is over 70 million.

 

As Spiegel, referring to “Ärzte ohne Grenzen” (comp. Doctors Without Borders), recently reported, 90% of hepatitis C patients treated with the substance could be cured within 12 weeks. The medicament, however, is so expensive in the countries where Gilead has patent protection that it would be referred to as a „1000 dollar pill“. Specifically, for a 12-week treatment in patent-protected states, costs of 43,000 EUR would be incurred. In patent-free countries, the costs would be just around 50 (!) EUR. The patent-driven high costs would mean that health insurers would pay for this medicament only in cases in which the disease is already well advanced and death would otherwise be expected.

No fewer than ten parties, including “Ärzte ohne Grenzen”, lodged an opposition against the granting of Gilead patent EP 2203462 B1 in 2016 and were thus inferior already in first instance. In the appeal proceedings, which just took place on September 13, 2018, Gilead could also defend her patent to a limited extent.

Unfortunately, given that the limitations in the claims do not provide enough space for a generics company to fill, it is unlikely that Gilead will change its pricing policy in the foreseeable future to the detriment of patients.

Of course, it is opportune for pharmaceutical companies to recoup their high development costs – which must also take into account the many unsuccessful attempts – over the price and also make a profit. It is also not objectionable that they must protect their development successes from free imitation by third parties through the instrument of patent protection. But where the price policy is at the expense of the health of people, the limits are reached. Arguments, such as that patent protection is so late anyway, are not caught. Through skilful life cycle management, today every pharmaceutical company is able to extend the patent protection for its blockbusters by successor patents de facto to 25 to 30 years; supplementary protection certificates do the rest.

In the present case, one cannot help feeling that Gilead wants to make money only with the help of patent protection. However, once the means of opposition has failed to materialize, chances for successful resistance are far from exhausted. Antitrust considerations, for example, can be considered by competitors, as there is a suspicion that a competitive position is being exploited here.

In particular, reference is made to § 24 of the German Patent Law, whose title is „compulsory license“. A case from last year, in which the X. Civil Senate of the Federal Court of Justice (BGH) awarded Merck the right to continue selling its AIDS medicament „ISENTRESS“ on the German market, although it holds patents of third parties, shows that this can be an effective instrument. The judges found that the patients’ protection enjoys priority (judgment of 11.07.2017, Az. X ZB 2/17).

Even emerging economies such as Brazil, Thailand and India have already demonstrated how exorbitant price expectations of patent holders in the pharmaceutical sector can be successfully combated by forcibly granting licenses to generics manufacturers.

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