European Patent Office Amends Gilead’s Patent Claims on Sovaldi

gilead-sciences-inc-faces-challenges-for-high-prices-of-sovaldi-in-europeIn a major victory for public health, the European Patent Office (EPO) has amended Gilead’s patent claims on Sofosbuvir (branded as Sovaldi), used for the treatment of Hepatitis C. Ruling in an opposition proceeding filed by Medecins du Monde (MdM), the EPO held that Gilead’s patent claims extended beyond the content of the patent application as filed”.

A spokesperson for the EPO told Statnews that some of the patent claims were no longer admissible, and had been changed in scope. The EPO reportedly also issued a statement that “[Sovaldi] as claimed in the version of the patent granted was no longer contained in this form of the patent”. Gilead however stressed that the EPO ruling did not invalidate the patent as a whole, as the EPO had “found that claims covering [Sovaldi] within the patent were valid…and believed that these claims were novel and inventive”. While further information on the order is not available at this time, we shall bring you a more detailed post once the decision is made available.[Update: GIlead sent us a statement on the decision, read it here].

This partial revocation shortens the patent protection enjoyed by Gilead by four years, now subsisting only until 2024, rather that the previously expected 2028. EPO procedure provides the mechanism for an appeal, which means that this ruling may not be final. Should it not be appealed, the order would entitle generic manufacturers to begin production a whole four years earlier than was expected. Sovaldi patents have already been rejected in China, Ukraine and Egypt, but the loss of protection in the high income region that is Europe will be sorely felt by Gilead.

As far as Sovaldi’s patent in India is concerned, it was upheld, albeit shakily by the Indian Patent Office (IPO) in May 2016. Soon after, the US-based Initiative for Medicines, Access and Knowledge (I-MAK) and the Delhi Network of Positive People (DNP+) filed an appeal in the Delhi High Court against the order. Arguing mainly that the decision is contrary to public interest, they contended that the IPO had failed to assess the full scientific and legal evidence presented, and ignored Indian Patent Law and judicial precedent. While there is no news on the status of the appeal as of yet, do read Prof. Basheer’s and Rahul’s posts on the legal infirmities of the decision. Our previous coverage on the Sovaldi controversy can be found here.

According to Tahir Amin, who heads intellectual property at I-MAK – Sovaldi is the basis for future treatments and will factor into other compounds that are developed. He therefore states that the invalidation of some of its patent protection opens up the market as well as removes an obstacle to fundamental treatment of Hepatitis C.

Gilead faces trouble on other continents as well, with the United States Food and Drug Administration (FDA) having recently issued a ‘black box warning’ for certain medicines used for the treatment of Hepatitis C; a list on which Gilead’s Sovaldi and Epclusa feature. This warning highlights the risk of reactivating Hepatitis B in patients by prescribing the named drugs for the treatment of Hepatitis C.

While Intellectual Property Watch reports on the EPO order based on a statement released by MdM on the 5th of October, 2016; they note that the EPO has issued a contrary statement, which we will bring to you as soon as we receive more news. The decision is yet to be made public, and could take a while as there were as many as ten opponents. But do expect a detailed post from us on this soon!

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