Teva and generics in SPC win against MSD


Teva and generics in SPC win against MSD

Photo: Courtesy of Teva

The English High Court has ruled that a supplementary protection certificate (SPC) owned by Merck Sharp & Dohme (MSD) is invalid because it didn’t comply with European regulations. 

In a decision handed down on Tuesday, March 21, Mr Justice Arnold backed generic makers Teva, Mylan and Accord Healthcare. 

SPCs are national rights in Europe that extend patent protection for medicinal and plant protection products. 

Teva and the other generic makers challenged the validity of MSD’s SPC for Atripla, an anti-retroviral medication. 

The drug is a combination product consisting of three active ingredients: efavirenz, tenofovir in the form of the disoproxil fumarate, and emtricitabine in a single, fixed dose tablet.

The generic makers claimed that the SPC didn’t comply with article 3(a) or (c) of Regulation (EC) No. 469/2009.

According to Teva, the SPC didn’t comply with article 3(a) because the drug is not protected by European patent (UK) number 0,582,455, which MSD relied on as the basic patent for the SPC. 

Teva also argued that the SPC didn’t comply with article 3(c) because MSD had previously obtained an SPC for efavirenz based on the patent, SPC/GB00/35, which expired on November 19, 2013. 

“Accordingly, the claimants say that the product has already been the subject of a certificate within the meaning of article 3(c), which compensated Merck for the delay in exploiting the invention in the patent as a result of the need to obtain a marketing authorisation for efavirenz,” said the High Court. 

The only claim at issue was claim 16, “a combination of the compound of claim 12 or a pharmaceutically acceptable salt thereof with a nucleoside analog having biological activity against HIV reverse transcriptase”.

Under article 3(a), Arnold said, the scope of protection of claim 16 extends to a combination of efavirenz and tenofovir or to a combination of efavirenz and emtricitabine, but not to a combination of all three.

Since the minimum requirement for a product to be protected by a basic patent is that the product falls within the extent of protection of at least one claim, it follows that the product was not protected, Arnold said. 

Arnold added that based on article 3(c), there was nothing in the patent to suggest that claim 16 represented a distinct invention. 

“Given the need for a simple and transparent system for the grant of SPCs, it seems to me that that should ordinarily be the end of the matter and that it should not be necessary to adduce expert evidence on this question,” he said. 

He concluded that the SPC was invalid because it didn’t comply with either article 3(a) or (c). 

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Teva, Mylan, Accord Healthcare, Merck Sharp & Dohme, SPC, supplementary protection certificate, English High Court, HIV, generics

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