A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Sunday 30 October 2011

Medeva and Georgetown rulings: save the date!

Some readers may not have seen the news, but the Curia diary shows that the Court of Justice will be giving its rulings in Case C-322/10 Medeva and C-422/10 Georgetown University and others in less than a month from now:

Thursday 24/11/2011
Approximation of laws
Court of Justice - Fourth Chamber

Thursday 24/11/2011
Approximation of laws
Georgetown University and Others
Court of Justice - Fourth Chamber

The SPC Blog will do its best to bring speedy coverage.

Medeva and the role of the Advocate General: a call for more communication

Regular reader and occasional commentator Paul Inman (Wragge & Co. LLP) has been giving some further thought to the role of the Advocate General in shaping and applying legal policy where issues have been referred to the Court of Justice of the European Union for a preliminary ruling. He writes:
"One (of many) of the causes of consternation arising from Advocate-General Trstenjak’s Opinion in the Medeva reference (discussed many times  in earlier posts on this weblog) was her contention (in para 102) that:
“according to the Court’s case-law, only one supplementary protection certificate may be granted for each basic patent”.
This has caused more than a few squawks of concern by commentators across the continent (and indeed beyond), not least on this blog.

A-G Trstenjak attributes this “case-law” to paragraph 28 of the ECJ Judgment in the Biogen case, from which she has taken a literal quote of the final words of that paragraph. As the world and his wife have since pointed out, however, this is not consistent with past and current practice around Europe (and many examples of multiple SPCs based on single patents have been brought forward).

Of course, the ECJ judgment in Biogen was founded on, and came to very much the same conclusion as that reached by Advocate-General Fennelly in that case. I was struck, therefore, while perusing A-G Fennelly’s opinion in Biogen (as one does on a Friday evening) with paragraph 53 of his opinion, which closes with the words:
“It is nowhere stated that a patent can be the subject of only one certificate, or of a certificate only in respect of one medicinal product, as the same patent may be used for widely differing medicinal products.”
Hurrumph! Don’t these Advocates-General talk to each other? Perhaps Angela Merkel is right – perhaps peace in Europe should not be taken for granted".

Monday 24 October 2011

Shoot the phoenix, count the cost!

Gently chiding The SPC Blog for the symbolism of its phoenix logo, our good friend Sophie Miller (Legal Adviser, Association of the British Pharmaceutical Industry, ABPI) kindly reminds us that an SPC is not a resurrection of an expired patent, but rather an agreed continuation of a patent term for an inventive pharmaceutical medicine, in accordance with EU Regulation.  She continues:
"Even with an SPC extension, a recent study by the ABPI IPEN with data supplied by UK IPO has found that the actual years of valuable patent life that a pharmaceutical patent that a company can actually use with a product on the market tends to last no longer than a total of between 10 and 12 years (even with the maximum 5 year SPC granted on top of the 20 years from the date of the patent application).

Even once a marketing authorisation has been granted by MHRA or EMA (National or European routes), companies need then to persuade governments (who are the sole purchasers of medicines through their national health services) to purchase new medicines for which companies need to prove increased efficiency over the existing drugs on the market through the Health Technology Appraisal (run in England through the lovely acronymed NICE, the National Institute for Healthcare and Clinical Excellence) , even before you can start to educate the doctors about the innovative new medicine and how it can help patients who are not responding to current treatments on the market. We’ve all heard of postcode prescribing. Well, the NHS is pretty reluctant to allow doctors to prescribe innovative new medicines that may have cost up to about £1.3bn to produce… unless all other avenues have failed with a particular patient first, and even then the local NHS PCT has to agree that the doctor is allowed to spend the money on the patient before treatment can start.

This makes pharmaceutical patents rather unique in that they become more valuable the closer to the end of the patent term you reach – so much so that pharmaceutical companies can find it worth while spending millions on patent litigation to protect weeks worth of SPC (see the Merck negative–term SPC cases in which in order to gain a handful of weeks of a 6 month SPC for paediatric study, Merck spent a lot of money trying to persuade the IPO and other patent offices around Europe to grant a negative term SPC (ie less than zero term) so that they could obtain the promised extra few months of the maximum 6 month extension allowed by the paediatric regulation.)

Compare this with the patents granted in the world say of mobile phones, where you have product almost immediately available on the market as soon as the invention is made to keep up with your cutting edge. They manage to squeeze the most of the full 20 years of market control available from the patent term …

I’d say the pharmaceutical industry as a result gets a pretty rough deal! (Noting also that any profits reported on the share market actually get ploughed back into the process of inventing the next new drug… and they don’t go into the pockets of the share holders at all.) And with the science getting more difficult and personalised (smaller sections of society benefiting from resulting innovation, now that genetically related “lock and key” mechanisms are being investigated) there is less and less money to pay for the next “big thing” through sales of resulting medicines before the generic market gets a look in (who can also use the same clinical data submitted by the innovator patentee to prove their significantly cheaper to produce generic manufacture-only costs medicine is safe to go on the market..). Since none of the profits of the generic industry gets ploughed back into the reimbursement of costs of development of the new medicines by innovator companies, we need all the protection we can get!

So less of the phoenix rising, and more on funding the costs of getting innovation from bench to bedside please!

I attach a handy graphic of information (reproduced below) on the R&D lifecycle we publish in our “Did you Know” booklet about the pharmaceutical industry. 
© Association of the British Pharmaceutical Industry from “Did you know?” Jan 2011 www.apbi.org.uk
This shows the process timeline and average cost of bringing a new medicine to market – even once the basic scientific invention costs are done. It also shows how and why pharmaceutical companies need SPCs".
Knowing how broadly this weblog's readership is spread between the proprietary and generic manufacturers, private practitioners, administrators, investors and academics, I suspect that there may be some interesting responses to Sophie's position. All opinions are welcome on The SPC Blog's moderated comment service.

Sunday 23 October 2011

Quetiapine and Bulgaria's transitional ruling

From our colleague Dimitar Batakliev comes news of a decision of the Bulgarian Supreme Court which interprets the transitional provisions of the SPC Regulation, in particular Art.19a(k) of Regulation 1768/92. The case is AstraZeneca Pharmaceuticals LP v Bulgarian Patent Office, in an action which followed the refusal of the Office to issue an SPC for Quetiapine. The main question is whether the Supreme Court has correctly applied the principle of supremacy of the EU law in national legislation. Dimitar explains as follows:
"In 1997 a patent, BG 61365 for Thiazepine compounds, was granted to AstraZeneca Pharmaceuticals LP as a pipeline patent on the basis of EP 240228. The national legislation at that time allowed granting of such patents for medicinal and other compounds, applied for or protected by patents abroad before entry into force of the Bulgarian Patent Act. The law required that, at the time of applying for the patent, the product must not have been marketed on the territory of Bulgaria, that no certificate of authorship had been issued for the same subject-matter, and that the applicant or the patentee had a serious commercial enterprise in the country of origin of the invention.

The national legislation further provided that the term of protection of such patents should expire with the expiration of the foreign parent patent. Consequently, due to an SPC issued in UK for Quetiapine based on EP 240228, the protection of BG 61365 was extended beyond the regular 20-year period until 24.03.2012.

In 2007, the accession of Bulgaria to the European Union was also accompanied by a reform in the patent legislation. A new provision stated that the pipeline patents with extended term of protection should be deemed to have expired at the 20th year following the filing date of the parent patent. Instead, the patent holders were entitled to file an SPC application under Regulation 1768/92, which had just entered into force for Bulgaria. The SPC applications had to be filed within a transitional 6-month period from the accession of Bulgaria to the EU.

The patentee applied for an SPC and furnished a marketing authorisation for Quetiapine, issued in 1999 in UK, which was the first marketing authorisation for the product in the Community. The Bulgarian Patent Office rejected the application for failure to comply with the requirements of Art. 19a(k) of Regulation 1768/92. That provision stated that an SPC should be granted only if the first marketing authorisation for the product was issued after 01.01.2000.

On the appeal against the decision of the Patent Office, the Administrative Court revoked it and held that the requirement for the date of issue of the first marketing authorisation did not apply to the case. According to the court, there was not such requirement in the national provisions that entitle the former holders of pipeline patents to apply for SPCs.

The Bulgarian Patent Office appealed the decision before the Supreme Administrative Court. It also requested a reference for preliminary ruling, asking whether Art. 19a(k) of Regulation 1768/92 allowed for derogation in the national legislation from the requirement for the date of issue of the first marketing authorisation after 01.01.2000 in favour of SPC applications, based on the former pipeline patents. The Supreme Court confirmed the decision of the court of first instance and upheld all of that court's arguments. It refused to refer the case for a preliminary ruling, stating that Art. 19a(k) of Regulation 1768/92 did not have any significance for the correct decision of the case".
The full text of the decision in Bulgarian can be read here.

Thank you, Dimitar, for this information.

Monday 17 October 2011

Every day counts -- but how do we count them?

Every day counts: why pharmaceutical companies in the EU need to make sure they get the right SPC term” is the title of an article by Mike Snodin (Potter Clarkson) which has just been published in the October 2011 edition of Scrip Regulatory Affairs. Mike's article addresses the calculation of SPC term (and the deadline for applying for an SPC) in circumstances where the relevant marketing authorisation has been issued by the European Commission (under the centralised procedure).

Mike notes that, when the first marketing authorisation in the EEA for a medicinal product is obtained via the centralised procedure, the standard practice of many patent offices in Europe (including the offices of Germany, France, the UK, Italy, Ireland, Sweden, the Czech Republic and the Netherlands) has been to set the SPC term based on the date that the European Commission decided to issue the centralised authorisation.

In his new article, Mike argues that the standard practice of many patent offices is incorrect, and that the term of SPCs should (where relevant) instead be calculated using the date of notification to the applicant of the European Commission decision to authorise the medicinal product.

The date of notification is typically two to four days later than the date of the Commission's decision. For this reason, Mike argues that a correspondingly longer SPC term should be available where:
(i) a medicinal product is first authorised in the EEA by way of the centralised procedure;(ii) that authorisation represents the first authorisation in the EEA for a "product" that represents the (combination of) active ingredient(s) present in the medicinal product; and(iii) less than 10 years has elapsed between the date of filing of a patent that protects the "product" and the date that the European Commission decided to issue the centralised authorisation.
If Mike's theory is correct, then in these circumstances the duration of the SPC may be a few days (e.g. 2 to 4 days) longer than has previously been thought to be the case. Of course, for successful medicines, even a few extra days' protection will be valuable.

Moreover, Mike points out that Article 17(2) and Recital 17 of Regulation 1610/96 together make it possible for an SPC holder to file an appeal aimed at correcting the term of a granted SPC.  This means that, provided the SPC in question has not expired, it may not be too late for a proprietor to take action to correct the official registers of those patent offices that have incorrectly calculated the term of the SPC.

You can read Mike's article in full here.

Rivastigmine ruling: judgment now available

Last Monday, in "Rivastigmine patent, SPC held invalid" (here), The SPC Blog reported on a 30 September 2011 decision of Mr Justice Floyd in the Patents Court, England and Wales. The decision had not yet been posted on BAILII and the blog's news item was based on a LexisNexis note.

A check today revealed that the decision had still not been posted on BAILII, but Alison Hall, the very helpful Clerk to Mr Justice Floyd, has circulated an approved copy of the judgment, which you can read in full here.

Sunday 16 October 2011

Daiichi: SPC validity not an issue

The SPC Blog reported a few days ago that Case C-414/11 Daiichi Sankyo Co. Ltd, currently before the Court of Justice of the European Union, concerned among other things a supplementary protection certificate, this being the Greek SPC for levofloxacin hemihydrate, and its infringement by the Greek generics company Demo AEVE.

We have since heard from Constantinos Kilimiris (Patrinos & Kilimiris, Athens) that the litigation in question does not involve any objections to the validity of the SPC. He explains
"As the patent on which the SPC was based was granted in 1986, Demo had argued that the product claims contained in the patent cannot be enforced because of the prohibition of patenting pharmaceutical products per se, which was in force in Greece at the time of filing. 
We had argued, on behalf of Daiichi, that the provisions of Articles 27 and 70.2 of TRIPS prevail over the relevant legislation and that full protection should be available based on the product claims. 
The court found that there is a matter of interpretation of Articles 27 and 70 of TRIPS, which constitute an integral part of community law and decided to refer three questions to the Court of Justice of the European Union.

I would be happy to provide more information if anyone is interested".
Many thanks, Constantinos, for your clarification.

Valsartan: now it's Austria's turn

From Dr Ernst Tremmel (Partner, Wiltschek Rechtsanwälte, Vienna) comes new that, in the recent past, an Austrian first instance court has delivered its judgment in the main proceedings, holding that a Valsartan/HCTZ product infringes the mono SPC for Valsartan. He tells us that, though the judgment is not yet final, he thought it might be of interest both for us at The SPC Blog and for our readers, so he has kindly furnished us with (i) a short English-language summary of the decision and (ii) the anonymised German-language version of the judgment. It is is hope that, within the next few days, he will be able to send us also an unofficial English translation.

Thanks, so much Ernst, both for this information and for your offer to deal with any questions arising out of these attachments.

Wednesday 12 October 2011

Escitalopram again, this time in Belgium

Escitalopram is in the news again. The Belgian District Court has very recently given judgment in Ratiopharm, Tiefenbacher v Lundbeck, an action which is of great interest in Benelux circles on account of the parallel proceedings in which a decision is currently keenly awaited.

On 3 October the Belgian District Court invalidated the contested SPC, since the marketing authorization for escitalopram referred to in Lundbeck’s SPC application was not the first marketing authorization for the product under Article 3(d) of the SPC Regulation. According to the court, the SPC should have designated the marketing authorization for citalopram, not the marketing authorization for escitalopram. The court additionally found that a previous SPC had been granted for the same product (Article 3(c) of the same Regulation).

The District Court took the view, with reference to the Court of Justice ruling in Case C-431/04 MIT, that in the racemic mixture citalopram, only the S-enantiomer (es-citalopram) had "a therapeutic effect of its own". Accordingly the active substance (or "product") in citalopram and es-citalopram is the same, namely: es-citalopram. The court refers, inter alia, to the decision of the CBG (the Dutch MEB), which had decided that there were no cliniacally relevant differences between citalopram and es-citalopram and that es-citalopram was to be considered a line extension of citalopram. The court also explicitly deviated from the earlier decision of the German Federal Supreme Court (which had held the SPC valid) because, in its view, the German decision was not in line with the SPC case law of the Court of Justice -- in particular, its understanding of the word “product”.

An English translation of the Belgian District Court has been kindly provided by an anonymous benefactor. you can read it here.

Tuesday 11 October 2011

TRIPS case heading for the ECJ has an SPC in the underlying dispute

Readers of The SPC Blog may be aware of Case C-414/11 Daiichi Sankyo Company Limited, Sanofi-Aventis Deutschland GmbH v DEMO Anonimos Viomikhaniki kai Emporiki Etairia Farmakon, a reference for a preliminary ruling on certain TRIPS-related matters from the Polimeles Protodikio Athinon (Greece).

From information posted on the IPKat today it can be seen that the underlying dispute involves a patent and a supplementary protection certificate for levofloxacin hemihydrate, an active ingredient of a product sold under the trade mark TAVANIC.

Monday 10 October 2011

Paediatrics and transitional periods: a reader writes

The SPC Blog has received this question from a concerned reader who would like to draw upon the collective brain-power of this weblog. He asks:
"According to Regulation 469/2009, Article 7(4) my understanding is that the transitional period of six months prior to the SPC expiry will rise to two years from 27 January 2012. The implication would appear to be that the six months transition will only exist for current and granted SPCs up to that date. The day after it will change to two years. So, if you are a company working on a paediatric extension using the six months transition, you will have to make sure your application is filed by 27 January 2012. Failure to comply, even by one day, could mean that the application for the paediatric extension will not be allowed. This is bound to cause some problems, a concern shared by the UK Patent Office. The wording in the Regulation has obviously not been constructed to deal with this anomaly.

Also it is not absolutely clear, when the two year transition period comes into force, how SPCs with less than two years duration will be treated. I have been informally advised by the UK Intellectual Property Office that, in such instances, applications for the SPC and any subsequent paediatric extension will have to be filed concurrently".

Rivastigmine patent, SPC held invalid

Via a LexisNexis update (since it's not yet available on BAILII) comes news of Generics (UK) Ltd (t/a Mylan) v Novartis AG [2011 EWHC 2403 (Pat), a 30 September 2011 decision of the Patents Court, England and Wales, by Mr Justice Floyd.

In brief it appears that Generics applied for declarations of invalidity in respect of Novartis's SPC GB9B/038 as well as its underlying patent, UK patent 2 203 040, which covered rivastigmine (sold as Exelon), a drug for the symptomatic treatment of Alzheimer's disease of which Generics sought to market a generic version.

Back in 1985 a team of scientists led by Marta Weinstock had made and tested a compound, RA7, which was the unresolved racemic compound of which rivastigmine was the (-) enantiomer. RA7 was one of a number of compounds she proposed for treating Alzheimer's, but her publications made no mention of resolving it into its individual enantiomers. Generics contended that the patent lacked inventive step. Novartis counterclaimed that Generics' threatened marketing of a generic version of rivastigmine would infringe the SPC and sought appropriate relief.

In these proceedings the sole issue was whether a relevantly skilled pharmaceutical development team, without knowledge of Novartis's patent, would have found it obvious in the light of the Weinstock publications to resolve the racemic mixture of RA7 into its individual enantiomers.

Floyd J allowed the claim and dismissed the counterclaim, holding both the SPC and the patent invalid.

In his view the correct analysis was that a pharmaceutical composition for treatment of Alzheimer's comprising rivastigmine was conceptually obvious in the light of Weinstock and would immediately occur to the skilled team: the team would consider that resolving R A7 would be a worthwhile step to take for good technical reasons, finding the chemistry involved to be trivial. Accordingly there was no doubt that the inventive concept was obvious in the light of Weinstock.

At first blush this looks like a pure and simple invalidity case. Once the judgment is available we will be able to see if anything of note was said about the SPC.

Monday 3 October 2011

Valsartan in France: a clarification -- and an apology

In last week's post on the decision of the Cour d'appel de Paris, France, in the Valsartan case, the text of that post -- kindly supplied by Tougane Loumeau and Grégoire Triet (Gide Loyrette Nouel A.A.R.P.I.) --  read, in relevant part:
"On three occasions, French courts had ruled that an SPC confers exactly the same protection scope as a patent so that a product A+ B was considered as infringing an SPC on A. 
Now for the first time, the Cour d'appel has had a chance to consider the issue".
As Laëtitia Bénard and David Por (Allen & Overy LLP) were swift to tell us, this is not in fact the case:
"The Paris Court of Appeals indeed rendered a previous decision on 15 March 2011, in E.I. Du Pont De Nemours And Company and Laboratoires Merck Sharp & Dohme-Chibret v. Mylan SAS and Qualimed SAS, in relation to the losartan SPC which was reported on this blog. In the losartan case, the Paris Court of Appeals ruled the opposite way, confirming the preliminary injunction ordered in first instance and stating the following:

"An SPC, which aims at supporting innovation in the field of health, grants a protection to a product as a medicament under all the forms that fall within the protection of the basic patent.

Consequently, in the case at hand, the certificate which has been extended grants the same rights as those of the basic patent covering losartan, and the protection granted by this certificate concerns the product covered by the MA for any use of this product as a medicament that has been authorised prior to the expiry of the certificate. Consequently, the protection encompasses any use of losartan as a medicament".
Further research into the matter has revealed that both sets of lawyers are right and that the fault lies with this blogger.  In editing the original piece for publication and forgetting the existence of the earlier post, I had taken the words "Now for the first time" as meaning that it was the first time the Cour d'appel had ruled at all, whereas those words were intended to indicate that it was the first time the Cour d'appel had the opportunity to rule in the opposite direction to that taken in the earlier decision of 15 March.

I offer my apologies to both sets of lawyers -- and my thanks to them for assisting me in sorting this problem out.