Combination products: one lump or two?

Following on from last Sunday's post on Actavis Group PTC EHF & another v Sanofi Pharma Bristol-Myers Squibb SNC, "Combination SPCs: more hypertension for the Court of Justice?" (here) our distinguished reader Herwig von Morze provides the following comment:

I believe a distinction must be made between the treatment of novel and inventive products (for example two distinct antibodies or active ingredients) and a combination product where the invention solely resides in one active ingredient, e.g., irbesartan, which is combined with HCT or a diuretic in general. In the first case. In the first case it should be possible to secure SPCs for each active ingredient. It is a pity that the question before the CJEU lumps the two types of "products" together. In case of a non-inventive combination, it could be said that you are only dealing with one product (for example, irbesartan), whether it is irbesartan alone or in combination with a diuretic.

Do readers agree with this sentiment? It presumably isn't too late to amend the questions which are being referred to the Court of Justice for a preliminary ruling but which, so far as one can tell from the Curia website, have not yet been received by the Court.

Combination SPCs: more hypertension for the Court of Justice?

Last week Mr Justice Arnold gave judgment in the Patents Court, England and Wales, in Actavis Group PTC EHF & another v Sanofi Pharma Bristol-Myers Squibb SNC [2012] EWHC 2545 (Pat). In this action Sanofi was granted a second SPC in respect of European Patent (UK) No 0 454 511, "N-substituted heterocycle derivatives, their preparation, compositions containing them" (this being antihypertensive drug known by its international non-proprietary name of irbesartan).  The first SPC, for the single product irbesartan, expired on 14 August of this year.  The second SPC, granted in December 1999 and with an expiry date of 14 October 2013, is for a combination of irbesartan and hydrochlorothiazide sold under the trade mark CoAprovel.  Actavis challenged this grant and the judge has decided to refer two questions to the Court of Justice of the European Union (CJEU) for a preliminary ruling

The first question for reference relates to Article 3(a) of the SPC Regulation, which states that an SPC shall be granted in respect of a patent when, on the date of the application for it, "the product is protected by a basic patent in force". Arnold J's first question to the CJEU, at [74], is this:

"What are the criteria for deciding whether 'the product is protected by a basic patent in force' in Article 3(a) of the Regulation?"

The second question is found at [92], where Arnold J states:

"It appears ... that the Dutch Patent Office has adopted the opposite interpretation of [the CJEU's ruling in Case C-322] Medeva to that adopted by the UK Intellectual Property Office, namely that it prohibits the grant of more than one SPC per patent regardless of the number of products claimed in the basic patent. In Case AWB 10/4769 Georgetown University v Octrooicentrum Nederland (11 July 2012), which is a parallel case to the Georgetown case in this country, the Rechtbank 'S-Gravenhage (Judge van Walderveen) held that the correct interpretation of Article 3(c) was unclear and decided to refer a question to the CJEU provisionally worded as follows:

"Does [the Regulation], more specifically Article 3(c), in the situation in which multiple products are protected by (the claims) of a basic patent, preclude the proprietor of the basic patent being issued a certificate for each of the products protected?" ...

Arnold J has provisionally decided to ask this question too.

Italian u-turn on latanoprost abuse of dominant position dispute

The SPC Blog is very pleased to thank Micaela Modiano (Modiano & Partners) and Anna Maria Stein (Franzosi Dal Negro Setti),for the following item of news from Italy:

"Recently we reported  he decision of the Italian Antitrust Authority in the latanoprost case. In that decision, the Authority found that Pfizer abused its dominant position as a result of a combination of activities including filing a divisional, validating it only in a part of the designated states, filing an SPC and a paediatric extension based on it and Pfizer's involvement in related litigation in Italy.

Pfizer filed an appeal against this decision. On 3 September 2012 the Italian administrative court competent for this appeal issued its decision on Pfizer's appeal. The appeal decision is very interesting because, while the Italian Antitrust Authority had held that Pfizer's behaviour represented an abuse of dominant position, the Italian administrative court has now decided that this finding is entirely incorrect. In particular, the most noteworthy points of the administrative court decision are -- as regards the issue of abuse of dominant position -- that:

* Pfizer's divisional does not amount to an abusively excluding activity, since it was filed several years before the anticipated market entry of generic companies (i.e. not simultaneously with it), 

* the filing of Pfizer's divisional does not amount to an abusively excluding activity just because it took place when Pfizer realized the more limited protection conferred by the parent patent, 

* contrary to what happened in the AstraZeneca case, Pfizer did not provide the EPO with elusive information when pursuing its divisional, 

* Pfizer's litigation activity was not an abusively excluding activity, given that in most of the relevant litigation Pfizer was actually the defendant rather than the plaintiff, 

* Pfizer's warning letters sent prior to the litigation were not an abusively excluding activity, given that they were sent on the basis of Pfizer objectively having obtained an SPC for Italy; 

* the Antitrust Authority finding is altogether flawed as it appears to be based on the fact that, at the time of the Authority's decision, the divisional patent had been revoked by the EPO Opposition Division, while ignoring that the revocation could be (and was indeed) appealed. That is to say, it was not final at the time, and was indeed overturned by the EPO Board of Appeal.

Thus, while the Italian Antitrust Authority had held that a number of activities which are based on the provisions of the EPC and of the EC SPC and paediatric extension regulations allegedly represented, taken together and in the way in which Pfizer had carried them out, constituted an abuse of Pfizer's dominant position, the Italian administrative court has now held that Pfizer legitimately and non-abusively relied on such provisions simply to obtain the IP rights to which it was entitled.

The new Italian administrative court decision is therefore important as it appears to take away some of the very negative light shed in a blanket-like manner by the Italian Antitrust Authority on divisionals, SPCs and paediatric extensions. The new decision does not necessarily say that one can always and under any circumstance file a divisional, SPC or paediatric extension or sending warning letters or be involved in litigation without ever incurring in anticompetitive behaviour, but it surely says that in this particular case Pfizer merely relied on the available legal provisions to obtain certain rights it was entitled to.

We now wait to discover whether the administrative court decision will now be appealed by the Antitrust Authority"..

For those readers who are actually Italian or read Italian, the original decision is here.  Micaela and Anna Maria are seeing what they can do to get us all an English translation. Thanks!

Paediatric poser: an answer

Earlier today this weblog published a paediatric poser concerning plans for paediatric extensions in Switzerland and asked if any reader could assist. Kilian Schärli, (a Rechtsanwalt with meyerlustenberger lachenal) has kindly obliged with the following information:

"Switzerland is indeed planning to introduce paediatric extensions to its SPC (new Art. 140n PatG) along the same lines as the EU’s legislation with the Ordinary Revision of the Therapeutic Products Act (stage 2). 

Here's the Explanatory Report (p. 98 f.) and the Results of the Consultation concerning the Ordinary Revision of the Therapeutic Products Act (p. 72 ff.). Unfortunately, both documents are not yet available in English. 

The Federal Office of Public Health (FOPH) is in charge for the Ordinary Revision of the Therapeutic Products Act. According to FOPH’s webpage the following persons should be able to provide up-to-date information regarding the expected date for its entry into force: Matthias Enderle / Amedeo Cianci Tel: +41 31 324 50 41 / +41 31 322 63 19; email matthias.enderle@bag.admin.ch; website www.bag.admin.ch  

In this regard, it is worth to mention that the Swiss Federal Institute of Intellectual Property has changed its practice (sic! 6/2012, p. 419 f.) regarding the grant of SPC with a negative term of protection – effective as of now – based on the decision in Case C-125/10  Merck in June 2012".

The SPC Blog has tried, so far without success, to email its personal gratitude to Kilian, so for the time being all we can say is a very public "thank-you!"

Paediatric poser: can you help?

One of these is a device for
achieving Swiss paediatric
extensions -- but which is it?

A reader has emailed The SPC Blog to ask the following question:

"Does anyone have any up-to-date information on the possibility of Switzerland introducing paediatric extensions to its SPC system? The last I heard was there was draft legislation along the same lines as the EU’s legislation --  but is there an expected date for its entry into force yet? And do we know what transitional provisions there will be for obtaining extensions of SPCs that are close to expiry (e.g. the extension request must be filed at least 6 months before expiry, as was originally the case in the EU)?"

It would be much appreciated if one of our better-informed readers (of which we have many) could set our reader right.

Casualty of Law: will SPC legislation be the next victim after Neurim?

After Neurim many
people view sheep
in a completely
different light ...

Following on from their article published in Life Science IP Review relating to the Opinion of the Advocate-General, Mike Snodin and Michael Pears (Potter Clarkson LLP) have published another article in the September edition of Scrip Regulatory Affairs on the ruling  of the Court of Justice of the European Union (CJEU) in Case C-130/11 Neurim Pharmaceuticals.

Mike and Michael's article, "Neurim wins the battle but not (yet) the war for innovators", notes that the Court of Justice's decision 

"significantly diverges from the opinion of the Advocate-General in a way that, through (arguably) focusing upon the need for a new therapeutic application / indication of an active substance, may just avoid some of the undesirable side-effects that could have arisen from strict adherence to the proposals in that opinion".

Nevertheless, Mike and Michael highlight the difficulties that national patent offices and courts are likely to have in interpreting the CJEU's decision, and especially in understanding how it fits in with its own earlier case law, such as Pharmacia Italia (C-31/03) and Yissum (C-202/05).  They also note the uncertainty for the pharmaceutical industry that arises from these interpretive difficulties.

In this respect, the article concludes with the following comments. 

"Various further questions from national courts are now almost certain to be referred to the CJEU, if only to obtain clarification as to what the decision in Neurim actually means.  In this respect, although the Neurim decision has improved the situation for the innovative pharmaceutical industry, the war is still far from won. The hardest battle yet to be faced relates to how to the CJEU can reach a clear and consistent interpretation of the SPC legislation that provides an appropriate reward for innovators. Although the current SPC legislation has survived the battle in Neurim, it is still perfectly possible that the legislation itself may become a casualty of future battles, especially if the CJEU fails to square the circle between Neurim and earlier case law such as Yissum".

A copy of the full article can be viewed here.