SPCs – Combination product must be a “distinct invention”

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

This is one of three recent cases from the Patents Court concerning supplementary protection certificates (SPCs) for combination products. An SPC offers an extension of up to five years in patent protection for pharmaceutical and plant protection products and is intended to compensate the patent owner for time “lost” due to the length of time taken to obtain market authorisation for these highly regulated products.

This decision sheds light on the issues concerning SPCs for combination products.  In particular, the decision confirms that a combination product including an active ingredient for which an SPC has already been granted must be a “distinct invention” in order for a further SPC to be granted for that combination.

The case concerns Merck Sharp and Dohme Corporation’s (“MSD”) supplementary protection certificate SPC/GB08/022 (“the SPC”) for a combination product of efavirenz, emtricitabine and tenofovir. The SPC covered the anti-retroviral medication ATRIPLA used for treatment of HIV.

Teva challenged the validity of MSD’s SPC on the ground that it did not comply with Article 3(a) or (c) of European Regulation 469/2009/EC (the SPC Regulation). This was on the grounds that the product was not protected by the basic patent (European Patent (UK) No. 0582455), as required by Article 3(a), and because MSD had previously obtained an expired SPC for efavirenz, such that the product had already been the subject of a certificate within the meaning of Article 3(c).

Article 3(a)

The relevant claim of the basic patent (Claim 16) required a combination of efavirenz (a non-nucleoside reverse transcriptase inhibitor, NNRTI) with a nucleoside analogue having biological activity against HIV reverse transcriptase (NRTI).

In construing Claim 16, the judge held based on the expert evidence that tenofovir was a nucleoside analogue. He also held that “a” nucleoside analogue meant that only a single nucleoside analogue was present. In reaching the latter conclusion he distinguished from the use elsewhere in the patent of “one or more” and references therein to double and triple combinations. He commented that MSD’s arguments to the contrary were “exactly the sort of meticulous verbal analysis deprecated in the authorities”.

Based on this construction, the judge held that Claim 16 did not cover a combination of all three active ingredients, so that the product was not protected by a basic patent. Thus, the SPC was invalid under Article 3(a).

Article 3(c)

The judge reviewed the case law on the interpretation of Article 3(c) and held that:

In my judgment it is clear from this case law 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. On the other hand, it does not preclude the grant of an SPC for a combination of active ingredients, even if one of those active ingredients is protected by the basic patent and has already been the subject of an SPC, if the combination represents a distinct invention protected by the patent. If the combination is a distinct invention, it should not matter whether it is protected by the same patent or by a different patent.

The judge considered expert and documentary evidence and concluded that the skilled person would have considered that there was a reasonable likelihood that a combination of a NRTI and a NNRTI would be either synergistic or additive in vitro.

Contrary to the conclusion reached on Article 3(a), the judge assumed for the purposes of assessing the Article 3(c) case that Claim 16 of the patent covered the product.

He formulated and answered the question to be decided as follows:

Counsel for the Claimants submitted that it should be assumed for this purpose that the skilled person had efavirenz and its activity against HIV reverse transcriptase disclosed to them at the priority date. Although counsel for MSD took issue with this, I consider that it is correct. The question to be considered is not the conventional one of whether a claim is invalid over a particular item of prior art read in the light of the common general knowledge, but whether, given the invention of efavirenz, claim 16 represents a distinct invention such that it could in principle form the subject-matter of a separate patent.

Considered in that way, I consider that claim 16 is not independently valid over the claims which protect efavirenz and does not represent a distinct invention. There is nothing in the Patent to suggest that claim 16 represents 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.

If it is appropriate to have regard to the expert evidence, however, I consider that the evidence establishes that, given efavirenz, it would have been obvious to combine it with a NRTI in vitro because that would have been an obvious thing to try and the skilled person would have had a fair expectation of success.

Thus, the SPC was also invalid under Article 3(c).