(1) Teva UK Limited, (2) Accord Healthcare Limited, (3) Generics (UK) Limited trading as Mylan v Merck Sharp & Dohme Corporation

Arnold J held that Merck Sharp & Dohme Corporation’s (“MSD”) SPC was invalid as it did not comply with either Article 3(a) or Article 3(c) of the SPC Regulation.

The SPC in issue was for a product described as “A combination of efavirenz, emtricitabine or a pharmaceutically acceptable salt or ester thereof, and tenofovir or a pharmaceutically acceptable prodrug, salt or ester thereof, particularly tenofovir disoproxil, especially tenofovir disoproxil fumarate” (the “Product”).  The SPC covered the HIV triple combination product marketed as Atripla, which combines efavirenz, emtricitabine and tenofovir into a single fixed-dose tablet.

Although originally MSD had obtained the SPC by relying on claim 17 of its patent (EP 0 582 455 (the “Patent”)), which had been added after an amendment, at trial MSD solely relied on claim 16.  Claim 16 is to: “A combination of the compound of claim 12 [efavirenz] or a pharmaceutically acceptable salt thereof with a nucleoside analog having biological activity against HIV reverse transcriptase.” (emphasis added)

Article 3(a)
Article 3(a) of the SPC Regulation provides that an SPC is only available where the product is protected by a basic patent in force.  In order to determine whether the Product was protected by a basic patent in force, Arnold J first had to construe claim 16 (being the claim relied upon as protecting the Product).  In doing so, two constructions issues arose.

The first issue was whether tenofovir was a “nucleoside analog”.  Arnold J relied on the expert evidence and held that a skilled reader’s understanding of a “nucleoside anlaog” in the context of the patent would include tenofovir.
The second issue was whether “a nucleoside analog” meant a single nucleoside analog only (limiting claim 16 to double combinations) or at least one nucleoside analog (meaning claim 16 would also cover triple combinations and above).  Applying the ordinary rules of construction, Arnold J preferred the Claimant’s view that “a nucleoside analog” meant a single nucleoside analog only.

Having construed claim 16 in this way, Arnold J held that the scope of protection of claim 16 included a combination of efavirenz and the nucleoside analog tenofovir, OR a combination of efavirenz and the nucleoside analog emtricitabine, but not to a combination of the three.  Accordingly the triple combination product was not protected by the Patent and the SPC was invalid for failure to comply with Article 3(a).

Article 3(c)
Article 3(c) of the SPC Regulation provides that an SPC is only available where the product has not already been the subject of an SPC.  Here, MSD had previously obtained an SPC for efavirenz based on the same patent.
After considering the case law surrounding Article 3(c), Arnold J held that it was clear that Article 3(c) “precludes the grant of an SPC for a combination of active ingredients where one of those active ingredients embodies the “core inventive advance” or “sole subject-matter of the invention” of the basic patent and has already been the subject of an SPC based on that patent even if the patent contains one or more claims which protect the combination”.

He went on to say, however, that if the combination represents a distinct invention protected by the patent, then the grant of an SPC for a combination of active ingredients is permissible (at [34]).
Accordingly, Article 3(c) would only be satisfied in these circumstances if claim 16 represented a distinct invention over efavirenz itself.  Arnold J held that it did not.

In reaching this decision, Arnold J stated that it should not be necessary to rely on expert evidence.  If, however, expert evidence is appropriate, he considered that the evidence established that it would have been obvious to the skilled person to try, with a fair expectation of success, to combine efavirenz with one or more nucleoside analogues.  When answering this question, the skilled person is taken to know of the invention covered by the first SPC, in this case efavirenz and its efficacy in treating HIV, in addition to the CGK at the priority date.

As the combination product embodied in claim 16 was not a distinct invention from the single product (efavirenz) that was subject of an earlier SPC, the requirements of Article 3(c) were not met and the SPC was invalid.

Exchange of evidence
A final note on procedure: in this case the parties agreed to the sequential service of expert’s reports, starting with MSD’s expert.  This was met with approval from Arnold J, who thought that the procedure worked well.

A copy of the judgment can be read here.

Headnote: Scott Parker, Simmons & Simmons