Post-Medeva analysis: the dialogue continues

A fortnight ago, Dorothea von Renesse and Norbert Schwenk (König, Syznka, Tilman, von Renesse, Düsseldorf) wrote a thoughtful article (here) in response to The SPC Blog's call for comments on Paul Inman's and Herwig von Morze's comments the previous week on Medeva and the interpretation of EU law. Dorothea's and Norbert's article is to be published in the September issue of the Mitteilung der deutschen Patentanwälte.

Herwig con Morze has now kindly produced a detailed response to Dorothea's and Norbert's article, which we reproduce here:

"While I agree with a number of statements in the article written by Dorothea von Renesse and Norbert Schwenk, some statements relating to the abuse of the SPC system must be challenged. In addition, the AG’s Opinion is rather problematic. 

Fundamentally, Article 1(b) of Regulation 469/2009 treats a combination of active ingredients of a medicinal product as a product different from a single active ingredient of a medicinal product (this is a clear difference to the law in the United States). To make it even clearer: the combination A + B is a product different from single active ingredient A or single active ingredient B. Therefore, their fates of supporting an SPC should not be tied to each other, unless special circumstances apply. The AG does not appear to grasp when special circumstances apply requiring tying of SPC eligibility of the active ingredient with that of a combination and when not. In other words, one has to distinguish two scenarios: 

1. The basic patent is limited to active ingredient A, but the first approved product is A + B. According to the AG in Medeva an SPC could issue for the product A. Later on, a second product obtains approval directed to the single active ingredient A. Because previously an SPC already issued for A on the basis of the marketing authorization for A + B, no further SPC can issue for A (Art. 3(c) of the Regulation), but the SPC already issued for A covers also A as single active ingredient (Art. 4 of Regulation 469/2009). Beyond the bar of Art. 3(c), the further extension of A’s exclusivity could result in an abuse of the SPC system, as the duration of its exclusivity could exceed the 15-year maximum term. 

2. The basic patent has two claims, one directed to A, the other one directed to A + B. Assume again, the first approved product is A + B. Here, the SPC does not require any adjustment like in Medeva. The subject of the marketing authorization is identical with the product A + B, the subject of a patent claim. Later on, a second product obtains approval directed to the single active ingredient A. Because A + B is a product different from single active ingredient A, an SPC directed to A can issue. In other words, in this situation the possibility of securing an SPC for A has not been consumed by the earlier marketing authorization for A + B or the earlier SPC directed to A + B. Articles 3(c) and 3(d) do not apply. Because of the clear distinction between a combination of active ingredients and a single active ingredient from this combination pursuant to Art. 1(b), SPCs with different duration may result. A legitimate extension beyond the 15-year exclusivity maximum may result not for a single active ingredient but for the totality of products containing this ingredient in accordance with current practice. This outcome does not amount to an abuse of the SPC system. 

3. This legitimate extension beyond the 15-year term cannot be limited to the situation where the combination of active ingredients is the subject matter of a separate patent in which the combination is specifically claimed, and this combination patent is the basic patent of the SPC request, as argued by Dorothea von Renesse and Norbert Schwenk (No. 17). Otherwise, the existence of an additional basic patent would create a legitimate use of the SPC system, which in the absence of this additional patent would be considered an abuse of the SPC system. Both situations could have the same effect of producing an extension beyond the 15-year exclusivity for the totality of products A and A + B. 

4. In summary, the prevention of abuse of the SPC system has to be tied to a scenario where the facts of Medeva prevail: the product authorized for marketing includes more active ingredients than what is the subject of the patent. The AG failed to recognize the distinction between a set of circumstances akin to Medeva and the more common circumstance where the active ingredients of the approved product coincide with the product claimed in the patent. On a fundamental level the AG did not understand the mandate of Art. 1(b) to distinguish between individual active ingredients and a combination of these individual active ingredients. In sum, you cannot have a second SPC for the same active ingredient (Article 3(c)) but you can have two SPCs for two different products even if the two products have an active ingredient in common but are different with respect to their other active ingredient(s). 

5. The AG’s Opinion would be acceptable to the extent it is directed to the Medeva scenario, albeit the infringement test would have been much cleaner and less tortuous and achieve the same result. However, as the AG ventures outside the boundary conditions of Medeva, her views are rather troublesome for the biochemical and pharmaceutical industry. She appears to sweep a number of previously accepted practices under the “abuse of the SPC system” carpet. Let’s hope that her carpet will not fly at the ECJ".

Memantine: the Bundesgerichtshof speaks

From Cordula Tellmann (Freshfields Bruckhaus Deringer LLP, Düsseldorf) comes some helpful information concerning a judgment by the Bundesgerichtshof -- the German Federal Supreme Court -- regarding the supplementary protection certificate for memantine. The judgment was delivered in proceedings between Merz, as the owner of the SPC, against an entire bevy of companies which maintained that the SPC was invalid because the underlying patent was itself invalid: Neuraxpharm, Teva, Synthon, Pliva and Chemo Ibérica.

The Bundesgerichtshof held that the SPC was invalid, since the underlying basic patent was invalid for lack of novelty.

Cordula has kindly provided this weblog with a copy of the German original of the judgment. While the decision was issued following an oral hearing on 9 June 2011, it is only now that the written decision has been published only now.

According to Cordula, the Court held that the discovery that a certain active ingredient (here memantine) is effective against a pathological situation in a specific illness (in this case Alzheimer's disease) does not lead to a novel teaching if it was known in the state of the art that patients with this illness were treated with this active ingredient to alleviate such symptoms and if the patent does not teach a new way of dosage or a new group of patients which previously did not receive such treatment.

The decision must be read in the context of the decision of the Court of Justice of the European Union in Case C-195/09 Synthon on 28 July 2011 (noted by The SPC Blog here) regarding the validity of SPCs where there has been a pre-65/65 authorizations. In the German case, the Bundesgerichtshof did not have to address this question as the SPC was already invalid due to the invalidity of the basic patent.

Matrix tablets and scope of protection: a reader asks

One of our readers has a problem for which no information or case law could be found.  The SPC Blog wonders whether any of our other readers might be able to offer some information -- or at least their opinions -- for which our reader would be most grateful.  The problem runs like this:

"The basic patent concerned covers in claim 1 an oral formulation which releases the active ingredient in a specific amount, which may exist in specific embodiments (a) to (g).  (a) is a matrix tablet not specifying the excipients, while (b) to (g) are other forms such as a coated tablet, a pulsatile dosage form etc.

The SPC is based on a matrix tablet. The title reads: "Pharmaceutical formulations comprising (the active ingredient) X"

As far as reported in textbooks and commentaries, the scope of protection of an SPC is that of the basic patent, but restricted to the specific authorized product. This means that, if the basic patent claims a generally defined formula, the SPC is restricted to the specific active ingredient which is present in the authorized product. If the patent claims a use, then the scope of the SPC is restricted to this use of the authorized product. If the patent claims a process for obtaining the active ingredient, the SPC is restricted to the process for obtaining the active ingredient present in the authorized product.

My questions now are:

1: Is the scope of protection of the SPC restricted to the embodiment (a), that is, to a matrix tablet, and are the other embodiments (b) to (g) not covered by the SPC any more?

Or, even more narrowly:

2. Is the scope of protection SPC even restricted to the specific excipients used in the authorized products, and can other excipients be used without infringing the SPC literally? (Equivalency would have to be considered separately)".

If you have any bright ideas or comments, do let us know!

German Escitalopram ruling in English: now we know why there's no ECJ reference

The deckchair is empty:
we're all at work!

Last Wednesday The SPC Blog posted here a note on the recent Escitalopram SPC decision from Germany. The text of this decision was kindly supplied by Chris Hayes (Lundbeck), who offered us sight of an English translation once it became available. This afternoon, some ten minutes ago in fact, this member of the blogging team found the English translation sitting in his in-box. He has lost no time in uploading it here for the benefit of anyone who finds the original German text too difficult. As mentioned in last week's post, the German Patent Court declined to make a further reference to the Court of Justice for a preliminary ruling. Said the Court:

"The present legal dispute does not raise any questions not yet clarified as to the interpretation of Regulation (EC) 469/2009, and this is why the Board has not followed the suggestion of Plaintiff to stay the proceedings in accordance with Art. 267 Treaty on the Functioning of the European Union (TFEU) and to refer the questions Plaintiff has formulated to the European Court of Justice as part of proceedings for a request for preliminary ruling. Such a referral is only possible if questions need to be decided regarding Community law, which cannot be answered either on the basis of legal sources nor have been sufficiently clarified in the case law of the European Court of Justice. Plaintiff was not able to formulate such a question of the law nor is such a question otherwise apparent. In the present nullity proceedings, the question is, on the contrary, decisively the subsumtion of the specific facts under the legal rules pertinent in this regard. The question that is of major significance in this case is whether escitalopram has its own medicinal effect and thus must be considered to be a different active ingredient than is citalopram. However, the Board cannot present the European Court of Justice with this factual question. The viewpoint in connection with this of whether the authorization for a medicinal product that contains as active ingredient a chemical compound as racemate that bars the grant of an SPC for a medicinal product that contains as active ingredient an enantiomer of the racemic compound and is the subject matter of a later marketing authorization as well as its own substance patent, also does not raise any legal questions requiring clarification. The purpose of Art. 3 (d) Regulation (EC) 469/2009 as a regulation lies in the objective to not prolong the overall term of protection granted by an SPC for a product in that several subsequent certificates can be granted for one and the same product (cf. German Federal Court of Justice decision “Escitalopram” in GRUR 1010, at 123, no. 76). Since, however, it must be assumed – as presented – for lack of any convincing, contradictory reference points that escitalopram is, within the terms of Art. 1(b) Regulation (EC) 469/2009, a different product than is citalopram, this viewpoint does not bar the grant of the SPC. That no other conclusion could be derived from the decision of the German Federal Court of Justice of 14 October 2008 (“Doxorubici-Sulfat”, X ZB 4/08, in GRUR 2009, at 41) was already specifically clarified by the Federal Court of Justice in its “Escitalopram” decision (see Federal Court of Justice “Escitalopram” decision in GRUR 2010, at 123, no. 77).

None of the other disputed questions decisive for the present nullity proceedings reveals an abstract, not-clarified legal question which would require an interpretation by the European Court of Justice. For these reasons, the Board did not order a stay of the proceedings pursuant to Art. 267 TFEU nor did it refer the case, in accordance with the suggestion made by Plaintiff as an auxiliary motion, to the European Court of Justice. The Board believes that its opinion is confirmed by the evaluation voiced by the Federal Court of Justice in its “Escitalopram” decision which insofar was also based on an “acte claire” (see Federal Court of Justice “Escitalopram” decision in GRUR 2010, at 123, no. 78)".

More comments to the AG opinion in Medeva

Dorothea von Renesse and Norbert Schwenk (König, Syznka, Tilman, von Renesse, Düsseldorf) have kindly provided their input (here) to The SPC Blog's call for thoughts to Paul Inman's and Herwig von Morze's comments last week on Medeva and the interpretation of EU law.

Dorothea and Norbert's comments are strongly influenced by the German perspective about the meaning of the "subject matter of the patent" and will be published in the September issue of the Mitteilung der deutschen Patentanwälte.

Uncertainty and disharmony: an overview

In an article, "Uncertainty and Disharmony Plague Patent Term Extensions in Europe" (published today by Genetic Engineering & Biotechnology News), Andrew Sharples discusses the problems created by insufficiently specific and variously-implemented EU legislation which was intended to harmonise the law and practice relating to patent term extensions. He gives a short overview of the issues currently awaiting decision by the Court of Justice of the European Union, as well as the issues surrounding the controversial 'infringement test'.

Escitalopram decision from Germany -- but no ECJ reference this time

From Chris Hayes (Lundbeck) comes news of another Escitalopram SPC decision, this time from the German Patent Court (you can download it here). An English translation has been promised in due course. Chris explains:

"The case was heard earlier this year, but we have only just received the full reasons for judgment. This was an attack on the SPC only, and the Patent Court's decision is in alignment with the earlier decision of the German Supreme Court on the validity of the basic patent and the SPC.

A reference to the ECJ was refused, as the Court decided that this was a purely factual dispute. The Court decided that foreign regulatory proceedings had no bearing on the validity of the SPC;, nor did decisions of the German pricing authorities".

Thanks so much, Chris, for this judgment.

The fight for atorvastatin: further news

According to a recent piece in Dispensing Doctor, "Teva and Pfizer set the date for Lipitor patent battle: Asda strikes no-involvement deal", by Ailsa Colquhoun, a date in late November has been mooted for the Lipitor patent validity trial due to take place at the High Court of Justice in London [on earlier proceedings in this dispute see here]. If Teva's challenge succeeds, it will be legally entitled to release the generic atorvastatin stock currently held by wholesalers. According to the news item:

"The trial takes place some six months before the scheduled expiry of the current UK patent supplementary protection certificate (SPC) for Lipitor. ...

In the meantime, Pfizer has shown no sign of abating the legal pressure on dispensers.  On Friday, July 22, Pfizer announced that it had struck a deal in the High Court to exclude Asda from the ongoing legal action against Teva and other wholesalers, in return for a promise not to deal or dispense generic atorvastatin. However, at the same hearing, Pfizer named Day Lewis in its ongoing action against Teva and others, and has signalled its intention to pursue an injunction and full financial recompense from the chain".

Medeva and the interpretation of EU law: literal or teleological?

Earlier this week The SPC Blog posted "The holiday is over: a close reading of the Opinion in Medeva", in which Paul Inman expressed some bewilderment as to what precisely the Advocate General was advising the Court of Justice. It seems that Paul is not alone, since the blog has now received a further admission from a reader that this Opinion has caused confusion, this coming from International Patent Consultant Herwig von Morze. Writes Herwig:

"I share Paul Inman's confusion regarding paras 67-69 of the Advocate General's Opinion in Medeva, in particular since Art.1(c) uses the word "protects". May I add a confusion of my own? I am confused by the fact that the AG uses a literal interpretation for the purpose of rejecting the infringement test as the basis for the assessment of Art. 3(a). However, thereafter in the paras starting with 75, she rejects the literal interpretation essentially of the same articles as in conflict with the aims of the regulation. 

I haven't read any ECJ decision or AG Opinion which vacillates between literal interpretation for arriving at one conclusion and teleological interpretation to support the aims of a regulation. Such a selective approach seems arbitrary to me. Perhaps somebody with more ECJ experience can help and set me straight?"

My personal recollection is that the ECJ seems to favour starting from the teleological approach in intellectual property references even when its application contradicts the clear and unambiguous literal meaning of plainly expressed words (see eg Case C-292/00 Davidoff v Gofkid).  However, as a common lawyer I have no problem with inconsistency between the two approaches since I was brought up to believe that they were complementary rather than in conflict: one started with the literal interpretation and applied it -- unless (i) there was an ambiguity as to how it should be applied or (ii) its application produced a result that was clearly nonsensical, in which case one moved straight away to a teleological approach. The ECJ's approach is fortified by the availability of considerable material that is prepared for the purpose of aiding interpretation of Directives and Regulations, particularly in the form of the recitals in the preamble, whereas domestic statutory interpretation in the United Kingdom does not have such useful guidance, especially in the case of older statutes. However, the Court of Appeal for England and Wales in Neurim must have been wearing teleological spectacles when it viewed the law on SPCs and questuined whether it was "fit for purpose"

Readers' thoughts on Herwig's and Paul's comments are very welcome.

SPC Event 2011 Slides and Videos

Following the successful SPC Blog event in June, we're now able to provide you with embedded videos of the presentations and the Q+A session and a downloadable link to the slidepack (also embedded). This is the first time that we have attempted this, so please let us know if any of the links do not work (the videos may require Internet Explorer to function)!




Introduction video - Robert Stephen


Medeva and All Things Combination: Nicole Jadeja, Rouse


SPC Case Law in Belgium: Patricia Cappuyns, Olswang


SPCs in Spain: Javier Huarte, Grau and Angelo

C-130/11Neurim: Hugh Goodfellow and Ed Oates, Carpmaels and Ransford


Q+ A Session

"Déjà vu at the ECJ?": a note on Neurim

"Déjà vu at the ECJ?" is a Current Intelligence note by patent attorneys Mike Snodin and John Miles (Potter Clarkson LLP, United Kingdom) on Neurim Pharmaceuticals (1991) Ltd v The Comptroller-General of Patents [2011] EWCA Civ 228, 3 February 2011 (on which see The SPC Blog here and here).  This note is published in the Journal of Intellectual Property Law & Practice (2011) 6 (8): 513-515.  Its salient points are reproduced here:

"The Court of Appeal for England and Wales (CA) has referred questions to the Court of Justice of the European Union (ECJ) on whether a supplementary protection certificate (SPC) can be obtained for active ingredients which have previously been authorized for a different use. Although the ECJ may well feel that it has considered this issue previously, the case again highlights weaknesses of the legislation governing SPCs, and has even prompted the CA to question whether it is fit for purpose.
...

The precise questions referred by the CA have not previously been considered by the ECJ. However, similar factual situations have been the background to earlier references to the ECJ in respect of Pharmacia Italia, MIT and Yissum cases (cases C-31/03, C-431/04 and C-202/05, respectively).

In particular, the Pharmacia Italia case led to the ECJ deciding that an earlier veterinary MA for a formulation containing cabergoline was prejudicial to the grant of a SPC based upon the first MA for a human use of cabergoline. Although the decision in Pharmacia Italia related specifically to the transitional provisions of the legislation (Article 19(1) of Regulation 1768/92), another ECJ decision (case C-127/00, Hässle) has made it clear that the words “first marketing authorisation” must take the same interpretation for all provisions of the SPC legislation.
...

Underlying referral of questions in Neurim appears to be the CA’s perception that there is an injustice in not awarding an SPC to the holder of a patent for a new (and non-obvious) use of a previously authorized substance which is the subject of a new MA. In this respect, it will be interesting to see how the ECJ answers the questions referred. To date, the ECJ has interpreted Article 3(d) in a manner that takes no account of the perceived injustices outlined by the CA. Instead, it has simply adopted a ‘one bite of the cherry’ approach, in which the availability and term of all SPC protection for an active agent is based upon the first MA issued for that active agent (for any human or veterinary use).
....

If Neurim succeeds in persuading the ECJ that Article 4 should be taken into account when interpreting the term ‘first marketing authorization’ in Article 3(d) of Regulation 469/2009, this would significantly increase the number of patents to (approved) second medical uses that might qualify for SPC protection.

Success for Neurim based only on its potentially most persuasive arguments (relating to the regulatory burden faced by those seeking the first ever authorization for a human use of an active agent) would have a more limited impact: the relevance of the decision might be restricted to only those factual situations where the existence of one or more earlier MAs for certain uses does not in any way reduce the regulatory burden for the sponsor of (pre-)clinical trials for a different, separately patented use.

However, it is far from certain that Neurim will succeed in relation to any of its arguments. Success depends upon persuading the ECJ to depart completely from the logic applied in previous ECJ decisions relating to Article 3(d).

In any event, the case will be watched closely by SPC aficionados, as a decision completely adverse to Neurim could lead to questioning whether the legislation is fit for purpose, or even to calls for its complete overhaul".

The holiday is over: a close reading of the Opinion in Medeva

Will our correspondent be applying
for a Supplementary Holiday
Certificate ...?

Paul Inman (Partner, Wragge & Co LLP) has been taking a close look at the recently-delivered Opinion of the Advocate General in Joined Cases C‑322/10 Medeva BV v Comptroller-General of Patents, Designs and Trade Marks and C‑422/10 Georgetown University, University of Rochester and Loyola University of Chicago v Comptroller-General of Patents, Designs and Trade Marks (noted here by The SPC Blog, with further comments here). He writes (and the comments in square brackets are his asides, not our additions):

"Dear SPC Blog

Sorry for harking back to the Medeva AG opinion (but its holiday season and some of us have been away!)

As regards the first question in this reference - what is meant by "the product is protected by a basic patent in force", it seems to me (unless I have missed something) that the AG has -- in rather an off-hand manner -- answered this in passing somewhere around the late 60s (paras).

• In para 67 she makes reference to the "subject matter" of a patent when she states that the subject matter of each of the three categories of patent referred to in Art 1(c) (i.e. product, process and use) is always the "active" [not sure if this is correct -- but anyway]. 

• In para 68, she then appears simply to proclaim that "the subject matter" of a patent equates to the "extent of protection" of that patent. [So there we have her answer: "protected by a basic patent" = "the subject matter of a basic patent"]. Somewhat bizarrely, she then differentiates this concept of "extent of protection" from "the protective effect" of the basic patent (despite the obvious link in the word "protect" in both phrases). Whilst there may indeed be a distinction between these two concepts, there appears to me to be no reasoning behind her proclamation that "extent of protection" equates to "the subject matter". [and anyway -- what does that mean?] 

• In para 69 she fortifies her position by stating "The decisive consideration in that context is the fact that the definition of the basic patent in Art 1(c) of [the Regulation] takes as its basis the subject matter of the patent, and not its protective effect." (emphasis in original). Again, there seems to be no basis for this statement, despite the fact that Art. 1(c) uses the word "protects" and not "subject matter". Nevertheless, the entire remainder of the Opinion is built on this "rock" of principle - that "protects" in Article 1(c) actually means "is the subject matter of", and "protected by" in Art. 3(a) actually means "the subject matter of".

Looking at this from a wider perspective of the legislation - what does Art. 4 now mean?

• That article is entitled "Subject matter of protection". Should this be construed (in the context of this Regulation) as "Subject matter of subject matter"? 

• The substance of Art. 4 states: "Within the limits of protection conferred by the basic patent …". Does this therefore mean "Within the subject matter of the basic patent"? 

• Art. 4 goes on: "the protection conferred by a certificate shall extend only to the product …". Does this mean "the subject matter of the certificate shall extend only to the product …"? If that is the case, how does her inference that SPCs for active(s) forming only part of multi-active medicinal products will protect those multi-active medicinal products stack up?

Finally, does this mean we now have to refer to this Regulation as the 'Supplementary Subject Matter Certificate Regulation'?

Back from Holiday and Confused".

As ever, readers' thoughts and comments are invited.

Non-payment of Cetrorelix fee on time fatal for SPC

On 20 July 2010 the United Kingdom's Intellectual Property Office issued a decision in Case BL0/252/11 The Administrators of the Tulane Education Fund, on the consequences of the non-payment of the fee for bringing an SPC into effect. The official note of the case describes this decision thus:

"The applicant failed to pay the prescribed fee for bringing supplementary protection certificate SPC/GB/99/033 into effect within the prescribed period or within the period of six months following the end of the prescribed period. The applicant argued that a late payment of the fee should be allowed either as a correction of an irregularity under rule 107 [of the Patents Rules 2007], a reinstatement under section 20A [of the Patents Act 1977], or a restoration under section 28. The hearing officer found that there was no error, default or omission on the part of the Office that resulted in the failure to pay the SPC fee in time in order to bring the SPC into effect and therefore rule 107 did not give the comptroller discretion to allow the late payment. He also found that neither section 20A nor section 28 applied in the present circumstances. The SPC could not therefore be brought into effect".

The SPC in this instance was for “Cetrorelix and pharmaceutically acceptable salts thereof, including cetrorelixacetate”, protected by basic patent EP (UK) 0299402 entitled “LHRH antagonists, their manufacture and pharmaceutical compositions thereof”. The circumstances in which the applicant failed to make payment on time are explained in the decision of Mr B. Micklewright.