Unpicking the SPC decisions

On December 12, 2013 the Court of Justice of the European Union (CJEU) delivered rulings for three cases relating to the issue of supplementary protection certificates (SPCs) which, it was hoped, would introduce some clarity on how to interpret some rules of the regulation.

SPCs extend the protection of a patented active ingredient or combination of active ingredients in a pharmaceutical product after the patent has expired.

They are intended to compensate the innovator for time of the patent term that may be lost while waiting for regulatory approval, and can add up to five-and-a-half years of protection after a patent’s expiry date.

The Medeva case of 2011 raised a few questions  about when SPCs should be issued; to what extent an active ingredient, or combination of active ingredients should be defined in the patent claims in order to be deemed protected; and whether more than one SPC can be granted for the same patent.

December’s decisions went some way toward answering these questions, though as WIPR finds, some uncertainties remain.

Georgetown University v Octrooicentrum Nederland

In 2007, Georgetown University filed eight SPC applications with the Netherlands Patent Office (OCN), each in relation to its patent covering a cervical cancer vaccine.

One application was rejected by the OCN, initially because the marketing authorisation (MA) for Sanofi’s drug Gardasil that was relied on in support of the SPC application related to a medicinal product that contained active ingredients that were not covered by the applications.

Georgetown appealed against the decision, and the referring court said that in light of the answers provided by the court in Medeva and Georgetown University and Others, it is not possible to refuse to grant an SPC for the active ingredient individually. As a result, the OCN’s decision should be annulled, the court said.

OCN said that the decision not to award to the SPC could be based on Article 3(c) of Regulation 469/2009 that provides that only one SPC can be awarded for each basic patent, while Georgetown had already been granted two SPCs based on the same patent.

The Rechtbank’s-Gravenhage court referred five questions to the CJEU, the answers to the latter four hinging on whether the first question was answered in the affirmative. One question asked whether the regulation could preclude the holder of a basic patent from being granted certificates for multiple products, if the patent protects several products.

The court decided that if the patent holder already has an SPC for a combination of active ingredients based on a basic patent and an MA for a medicinal product, it may also obtain an SPC for one of those active ingredients that is individually protected “as such” by that patent.

Actavis Group v Sanofi

The UK Court asked the same question of multiple certificates for multiple medicinal products in its referral to the CJEU.

Sanofi makes and markets antihypertensive drug Aprovel (irbesartan), which was first authorised as a single product. It later started marketing CoAprovel, a fixed-dose combination drug that combines irbesartan with diuretic hydrochlorothiazide (HCTZ).

Sanofi held the patent covering irbesartan, which included a claim covering it in combination with a diuretic.

Wishing to make generic versions of Aprovel and CoAprovel, Actavis challenged Sanofi’s SPC covering the latter at the UK High Court. It argued that the second SPC is invalid as the specific combination of irbesartan and HCTZ is not claimed in the wording of the basic patent. It also contended that the second SPC is invalid as it relates to a product that has already been the subject of an SPC.

As well as asking for clarity on the multiple certificates per patent, the court asked for criteria for deciding whether “the product is protected by a basic patent in force” as laid out in Article 3(a) of the regulation.

The court decided that where the patent holder has already obtained an SPC for an active ingredient based on a basic patent covering that ingredient and an MA for a medicinal product containing that ingredient “as the single active ingredient”, the patent holder is entitled to oppose the use of that active ingredient either alone or in combination with other active ingredients.

It said that the regulation must be interpreted as precluding the patent holder from obtaining a second SPC relating to that combination of active ingredients, “on the basis of that same patent but a subsequent MA for a different medicinal product containing that active ingredient in conjunction with another active ingredient which is not protected as such by the patent”.

To that effect, the court decided that the second SPC may not be granted to Sanofi for the combination of irbesartan and HCTZ, “irrespective of whether that combination was protected as such by the basic patent within the meaning of [the regulation]”.

Eli Lilly v Human Genome Sciences

Human Genome Sciences (HGS) holds a European patent covering a protein, Neutrokine-α, and the antibodies that bind specifically to it. Its lupus drug Benlysta (belimumab) is formulated with the Neutrokine-α antibodies.

Eli Lilly sought to market a product for the treatment of autoimmune diseases, using the same antibodies as its active ingredient.

It brought an action seeking declaration that any SPC relying on HGS’s patent would be invalid, arguing that the antibody is not covered by a basic patent, and one of the claims in the patent is “too broadly drafted for it to be possible for that antibody to be regarded as being ‘specified’, for the purpose of the test set out in … Medeva.”

"The second SPC may not be granted to Sanofi for the combination of irbesartan and HCTZ, 'irrespective of whether that combination was protected as such by the basic patent'"

Because the claim is so broadly worded, Eli Lilly said, in order for an SPC to be granted, the patent would have to contain a structural definition of the active ingredients “and the claims would have to be significantly more specific”.

The court observed that in HGS’s patent the antibody is defined functionally, not structurally, and so covers “an unknown number of otherwise unspecified antibodies”. This is the broadest way of claiming an antibody, it added.

The UK High Court referred three questions to the CJEU.

The first asked what the criteria are for deciding whether a product is protected by a basic patent, as seen in Actavis, and the second concerned whether those criteria are different if the product is not a combination product. The third related to how to define antibodies in patent claims.

“Is it sufficient that the antibody or antibodies are defined in terms of their binding characteristics to a target protein, or is it necessary to provide a structural definition for the antibody or antibodies, and if so, how much?” it asked.

The court considered the three questions together. It said that for an active ingredient to be regarded as protected by a basic patent, it is not necessary for it to be identified in the claims of the patent by a structural formula.

It added that if the active ingredient is covered by a functional formula in the claims of a patent, the regulation does not preclude the grant of an SPC for that active ingredient, on the condition that it is possible to determine that the claims relate to the active ingredient in question.

Conclusions

Edward Oates, partner at Carpmaels & Ransford LLP in London, said that while the December decisions had clarified the first question of whether more than one SPC may be granted per basic patent—“we now know there’s no blanket one-SPC-per-patent rule,” he said—a greater number of uncertainties has arisen in their place. “It’s raised more questions than answers,” he said.

“Broadly speaking, questions about two uncertainties were referred to the CJEU.  However, we are now left with at least four areas of uncertainty. For example, it now seems necessary to examine functionally defined claims differently from structurally defined claims, and that dichotomy had never previously existed.”

He continued: “There’s uncertainty over what tests to apply when you have a functionally defined claim.”

The patent offices will now sometimes have to consider whether a patent covers a “totally separate innovation”, as laid out in Actavis v Sanofi, he said.

In Actavis, the court found that if a combination product—consisting of an innovative active ingredient (already covered by an SPC) and another active ingredient that is not protected as such by the patent in question—is the subject of a new basic patent, the combination would be entitled to an SPC as long as the patent covered a “totally separate innovation”.

He said this terminology, which has no basis in the SPC regulations was based on a test put forth by Justice Arnold in the UK High Court case, and built upon by the CJEU.

“It was surprising seeing that gain traction before Arnold,” he said.

“Some thought this test would be far too complicated for the CJEU to pick up and run with, but that they did, and it’s now something that we have to contend with.”

He said it will create more confusion: “No one knows exactly what is meant by ‘a totally separate innovation’, let alone how to assess whether one exists, so patent offices are going to be left scratching their heads. It’s going to lead to a lot of argument,” he adds.

“Some cases clearly pass that test, but others will struggle.”

He suggests that patent offices may have to impose new patentability-type tests to ask whether one invention is innovative over another. “This will create many difficulties,” he said.

“The confusion and uncertainty that these cases cause is going to be detrimental for most companies, particularly companies that have claimed broadly.”

He also said it was not clear why Georgetown was allowed multiple SPCs per patent, while Sanofi was not: “It’s not clear quite which factors swung the result Georgetown’s way but not Sanofi’s way,” he said.

Jaap Mannaerts, partner at Nederlandsch Octrooibureau in The Hague, said that the decisions answered some questions left over from the Biogen case as well as Medeva.

He said that the Article 3(a) question of whether a certificate may be granted for more than one basic patent is becoming more of a subjective criterion: “The CJEU has now explained that it does not have to be a literal disclosure.

“It should be clear that the invention concerns the active ingredient in question so there’s still a lot of room for interpretations.

“I would be surprised if it answers each and every future case conceivable,” he said.

Mannaerts added that the CJEU’s decisions have made it more difficult to obtain SPCs for simple variations in the small molecule area.

He observed that the Medeva and Georgetown and Others decisions from 2011 concerned biological products, while the underlying difficulties in these cases related to combination products, which are more often seen in the small molecule area.

“All the criteria that originated from Medeva—that the active ingredient had to be specified in the wording of the claims—was particularly bothersome for the companies involved in biotech, which is what I saw in practice,” he said, though added that the court’s decision on the Eli Lilly case has “made life for those biotech companies a little easier.”