Yesterday the CJEU delivered yet another decision on the interpretation of the SPC Regulation in Actavis v Boehringer (C-577/13). Just over a year ago, the CJEU provided the clarification that it is,
Yesterday the CJEU delivered yet another decision on the interpretation of the SPC Regulation in Actavis v Boehringer (C-577/13). Just over a year ago, the CJEU provided the clarification that it is, in principle, possible to obtain two SPCs from the same basic patent in Georgetown University v Octrooicentrum Nederland (C-617/12) but it did not provide a test of general application to determine the circumstances in which this might possible Yesterday, the CJEU provided further guidance limiting the circumstances when it might be possible to obtain two SPCs from the same basic patent.
In this case, Boehringer already had an SPC covering a product for the single active ingredient, telmisartan under the brand name Micardis, but this SPC expired in December 2013. Boehringer also sells a combination product consisting of telmisartan and, another active ingredient, hydrochlorothiazide (HCT) for which it has a combination SPC. Actavis wishes to market this combination and is seeking to invalidate Boehringer's combination SPC. One of the grounds of invalidity is that the second SPC was based on a patent claim that was amended to specifically include the combination and this amendment was only made after the grant of the marketing authorisation for the combination product.
The CJEU ruled that: "where a basic patent includes a claim to a product comprising an active ingredient which constitutes the sole subject-matter of the invention, for which the holder of that patent has already obtained a supplementary protection certificate, as well as a subsequent claim to a product comprising a combination of that active ingredient and another substance, that provision precludes the holder from obtaining a second supplementary protection certificate for that combination".
The IP industry was hoping for guidance from the CJEU as to the circumstances in which a patent may be amended post-grant to ensure that the patent complies with the conditions in the SPC Regulation. Mr Justice Birss referred four detailed and specific questions to the CJEU and the CJEU chose to skirt the post-grant amendment issue altogether by focusing, instead, on the issue of whether the combination of the two active ingredients was a distinct and separate invention from that of the single active ingredient.
The CJEU asserts at paragraph 26 of the Judgment that "it is common ground in the main proceedings that, in that combination, telmisartan, which is the innovative active ingredient of Boehringer's basic patent, is the sole subject-matter of the invention". This concession from Boehringer is not included in the Judgment of Mr Justice Birss referring the case to the CJEU. Indeed, at paragraph 12 of that Judgment an indication is given that a trial of the case would be needed to determine whether the combination is a "separate inventive advance". The concession from Boehringer could have been made during the course of the CJEU proceedings but the author cannot confirm this as the general public is not privy to the Written Submissions of the parties or to the oral hearing.
If the CJEU is correct as to its understanding of the common ground between the parties, then Boehringer's combination SPC should be invalidated in light of the CJEU's decision. If the CJEU's understanding is incorrect, a trial would be needed to determine whether telmisartan is the sole subject-matter of the invention. Assuming Boehringer were to be successful in that trial to establish that the combination of telmisartan and HCT is a separate inventive advance, then a further reference would be needed on the issue of whether post-grant amendments to patents may or may not preclude the grant of a second SPC, all because of another wasted opportunity from the CJEU.
In this case, Boehringer already had an SPC covering a product for the single active ingredient, telmisartan under the brand name Micardis, but this SPC expired in December 2013. Boehringer also sells a combination product consisting of telmisartan and, another active ingredient, hydrochlorothiazide (HCT) for which it has a combination SPC. Actavis wishes to market this combination and is seeking to invalidate Boehringer's combination SPC. One of the grounds of invalidity is that the second SPC was based on a patent claim that was amended to specifically include the combination and this amendment was only made after the grant of the marketing authorisation for the combination product.
The CJEU ruled that: "where a basic patent includes a claim to a product comprising an active ingredient which constitutes the sole subject-matter of the invention, for which the holder of that patent has already obtained a supplementary protection certificate, as well as a subsequent claim to a product comprising a combination of that active ingredient and another substance, that provision precludes the holder from obtaining a second supplementary protection certificate for that combination".
The IP industry was hoping for guidance from the CJEU as to the circumstances in which a patent may be amended post-grant to ensure that the patent complies with the conditions in the SPC Regulation. Mr Justice Birss referred four detailed and specific questions to the CJEU and the CJEU chose to skirt the post-grant amendment issue altogether by focusing, instead, on the issue of whether the combination of the two active ingredients was a distinct and separate invention from that of the single active ingredient.
The CJEU asserts at paragraph 26 of the Judgment that "it is common ground in the main proceedings that, in that combination, telmisartan, which is the innovative active ingredient of Boehringer's basic patent, is the sole subject-matter of the invention". This concession from Boehringer is not included in the Judgment of Mr Justice Birss referring the case to the CJEU. Indeed, at paragraph 12 of that Judgment an indication is given that a trial of the case would be needed to determine whether the combination is a "separate inventive advance". The concession from Boehringer could have been made during the course of the CJEU proceedings but the author cannot confirm this as the general public is not privy to the Written Submissions of the parties or to the oral hearing.
If the CJEU is correct as to its understanding of the common ground between the parties, then Boehringer's combination SPC should be invalidated in light of the CJEU's decision. If the CJEU's understanding is incorrect, a trial would be needed to determine whether telmisartan is the sole subject-matter of the invention. Assuming Boehringer were to be successful in that trial to establish that the combination of telmisartan and HCT is a separate inventive advance, then a further reference would be needed on the issue of whether post-grant amendments to patents may or may not preclude the grant of a second SPC, all because of another wasted opportunity from the CJEU.