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
Tuesday, 30 December 2014
As regular readers of this blog will know, the questions referred by the Oberlandesgericht Wien in Seattle Genetics relate to the issue of whether longer term should be awarded to certain SPCs by relying upon the date of notification of a “centralised” Marketing Authorisation instead of the (earlier) date of the European Commission’s decision to issue the Authorisation.
Mike’s article discusses and analyses the questions referred to the CJEU and highlights potential problems with regard to the framing of those questions. In an attempt to clear away any confusion that could be caused by the manner in which the questions referred have been framed, Mike presents an alternative question that is more precisely adapted to the facts underlying Seattle Genetics. He concludes by expressing the hope that the CJEU decides to answer such an alternative question, and by outlining reasons why, in his view, that alternative question should be answered in favour of using the date of notification for “centralised” MAs.
Wednesday, 3 December 2014
Monday, 24 November 2014
CJ case: C-471/14: SEATTLE GENETICSThe UKIPO provides further information about its solicitation of comments:
We have received notification of a new case referred to the Court of Justice of the European Union (CJEU): C-471/14: A request for a preliminary ruling concerning the supplementary protection certificate for medicinal products.
The questions referred to the Court of Justice (CJ) for a preliminary ruling are:
1. Is the date for the first authorisation to place the product on the market, pursuant to Article 13(1) of Regulation 469/2009 concerning the supplementary protection certificate for medicinal products determined according to Community law, or does that provision refer to the date on which the authorisation takes effect in the law of the Member State in question?This case and the questions referred to the Court can also be viewed on our website at:
2. If the Court determines that the answer is that the date is determined by Community law, is this the date of authorisation or the date of notification?
If you would like to comment on this case please e-mail email@example.com by 01 December 2014.
We understand how difficult it is to provide detailed comments in the time available. The IPO has tight time limits in which to consider and provide advice to ministers on CJ cases. In order to help us provide the right advice, we just need a short email by the deadline stating whether you think the UK should intervene and some general points about how you think we should answer the questions.
You are welcome to follow this email up with more detailed comments after the deadline, which can be taken into consideration if we have chosen to submit observations or if we decide to attend a hearing.
If you are aware of any references to the Court of Justice that are not currently included on our website, you are also welcome to send us your views. If you choose to do this, please include clear information about the case to help us to identify it.
Further information on intellectual property CJ cases can be found on our website https://www.gov.uk/government/publications/references-to-the-european-court-of-justice.
Wednesday, 19 November 2014
According to the abstract
Patent term extensions are the most important instrument for securing rights to innovative medicines after expiry of the regular patent term. The new manual comments on all relevant provisions including the relevant case law in the U.S., Japan and Europe. In addition, it presents corresponding extension opportunities in Australia, Israel, Korea, Russia, Switzerland, Singapore, Taiwan and in the free trade agreement between the U.S. and the Central American countries. It also comments on the current state of negotiations on the Free Trade Agreement between the European Union and Canada. So the manual covers all important markets, which offer the possibility of a patent term extension. It is aimed at lawyers from pharmaceutical companies and international law firms.Many of the contributors of chapters will be known to readers of this blog. Apart from the editor himself you will encounter the efforts of
Its bilingual German/English synoptic structure is tailored to support the global development of innovative medicines. It facilitates the decision-making in international project teams through a rapid and easy access to all relevant information. It also assists to find uniform argumentation during grant or revocation proceedings across borders.
- Cheol-Gyoon Ahn, Senior Korean Patent Attorney, Seoul, Korea
- Eran Bareket, Attorney at law, Tel-Aviv, Israel
- Chen Ben Dori-Alkan, Attorney at Law, Tel-Aviv, Israel
- Ronnie Benshafrut, Patent Attorney, Tel-Aviv, Israel
- Ruth Fang, Attorney at law, Taipei, Taiwan
- Dr. Nicolai von Füner, Patent Attorney, Munich, Germany
- Dr. Siegfried Grimm, Patent Attorney, Zürich, Switzerland
- Brion P. Heaney, Patent Attorney, Arlington, USA
- In-Hwan Kim, Senior Foreign Legal Counsel, Seoul, Korea
- Peter Maddigan, Barrister, Sydney, Australia
- Dr. Arne Markgraf, Attorney at law, Berlin, Germany
- Dr. Olaf Meiselmann, Munich, Germany
- Kristian Robinson, Patent Attorney, Singapore
- Dr. Regula Rüedi, Patent Attorney, Zürich, Switzerland
- Harry B. Shubin, Patent Attorney, Arlington, USA
- Damian Slizys, Patent Attorney, Melbourne, Australia
- Yoichi Watanabe, Patent Attorney, Tokyo, Japan
- Paul Whenman, Patent Attorney, Sydney, Australia
Monday, 17 November 2014
Review and analysis of pending CJEU referrals and recent CJEU decisions (Dr Robert Stephen, Olswang LLP) here
Amending and attacking SPCs (Dr Dorothea von Renesse, König Szynka Tilmann von Renesse) here
What’s up?” from the perspective of the IPOs
- Patrick Purcell, UK IPO here
- Dr Oliver Werner, German Patent Office here
SPCs involving medical devices (Charlotte Teall, Forresters) here
- Dr Martijn de Lange, Dutch Patent Office here
SPCs for biologics (Mike Snodin, ParkGrove IP) hereThe PowerPoints for the various sessions, together with the speakers' biographical details, have already been uploaded for your delectation and can be accessed here.
The seminar's SPC Law and Practice 2014 - Q&A session can be viewed here
Thursday, 13 November 2014
Michael's post contains all the details.
Friday, 7 November 2014
WARNING! It's a big 2.56 MB file, running to some 143 pages, so think twice before printing it in full -- particularly if your ink cartridge is coming up for replacement.
Thursday, 6 November 2014
|SPCs for fish vaccines? Or is this|
the dawning of the Age of Aquarium ...?
- the speakers' PowerPoints and notes will all be made available on this weblog in the near future;
- the seminar has been recorded on video, which should be processed and published more swiftly than on previous occasions, on the basis that Olswang LLP (the host firm -- thanks!) has had more practice at video-recording seminars than it did when last an SPC seminar was held there.
This year a variety of topics were discussed, with a first-ever mention of the phenomenon of SPC for fish vaccines and the prospects of shoal immunity. But that's another matter and, if you want to know what was said about this and other issues, you shouldn't have long to wait.
Apart from Olswang (whose London office staff also provided the logistics and processed the refreshments), gratitude is also expressed to all of the speakers and participants for giving of their time and effort, and to the Court of Justice of the European Union for their possibly inadvertent contribution by providing so much content for us to analyse and discuss -- a contribution that shows no signs of abating.
Do please be patient: all items will be made available as soon as possible, so there's no need to chase!
Tuesday, 4 November 2014
The defendant (Orifarm) had imported a pharmaceutical product, MSD’s Singulair, from Poland during the term of the paediatric extension of the SPC. The plaintiff brought interlocutory injunction proceedings, claiming that such imports could be prohibited relying upon the "Specific Mechanism".The judgement (in Danish) can be found here.
The Maritime and Commercial Court agreed with the Bailiff's Court, stating that the expression "such protection" under the Specific Mechanism as stated in the Treaty of Accession is to be interpreted as the patent protection being one continuous string of protection. The Maritime and Commercial Court added that the paediatric extension is not dependent on a product being indicated for the treatment of children, but only on whether or not the drug is tested for children.
The protection would not therefore terminate until the paediatric extension had expired.
Thanks, Martin, for this really helpful summary.
Thursday, 30 October 2014
Mike concludes that it is acte clair that the SPC legislation requires the use of the date of validity of a MA to calculate the duration of an SPC. How the date of validity is calculated will depend upon the type of MA involved – but for “centralised” MAs it will involve use of the Notification Date.
In the light of his analysis of the legislation, Mike concludes that it is not necessary for patent offices to refer this matter to the CJEU in order to accept arguments in favour of the use of the Notification Date. Mike’s article was published too late to persuade the Oberlandesgericht Wien not to make a reference on this point. However, Mike hopes that his article will help the CJEU quickly grasp the key points of the matter. He also hopes that they will forgive the title that the publishers chose for his article!
Tuesday, 28 October 2014
On 15 October 2014 the Oberlandesgericht Österreich referred questions to the CJEU on a preliminary ruling regarding the calculation of the SPC term under Article 13 of the SPC regulation. The case has been assigned the reference number C-471/14 (Seattle Genetics). The referral not only asks whether under Community law the authorisation’s notification or the decision date should be used to calculate the SPC term, but crucially first asks whether Community law even applies, or whether instead the relevant date should be determined under national law. The referred questions are (translated from the original German-language decision):
1. Is the date of the first authorisation to place the product on the market in the Community under Article 13(1) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6th May 2009 concerning the supplementary protection certificate for medicinal products determined under Community law, or does the Regulation refer to the date on which the authorisation takes effect according to the law of the respective member state?
2. If the CJEU affirms that the date under question 1 is determined under Community law: which is the relevant date – that of the authorisation or that of the notification?
The need for a referral in this area has been clear, particularly since the UKIPO’s change of practice a year ago to use the date of notification rather than the date of the decision to calculate the SPC term based on centralised authorisations (BL O/418/13 – GENZYME). This approach typically results in a few extra days of term, which can be very valuable. Belgium, Slovenia and most recently Portugal use a similar approach, but other national patent offices have resisted, arguing either that the SPC regulations make it clear that the date of the decision is the relevant date, or that in the absence of a CJEU ruling on the matter there is no need for them to change their practice.
The referral is based on Austrian SPC application no. SZ 39/2012 (“Brentuximab vedotin or pharmaceutically acceptable salts thereof”). The applicant (Seattle Genetics) applied for the SPC based on EP 1 545 613 and Takeda’s authorisation EU/1/12/794/001 for Adcetris (Brentuximab vedotin). The authorisation is dated 25th October 2012, but was notified 5 days later, on 30th October 2012. In calculating the SPC term, the Austrian patent office used the decision date of the authorisation, but Seattle Genetics argued that the notification date should be used, resulting in 5 additional days of SPC term bringing the SPC’s term to 30th October 2027. In its reasoning, Seattle Genetics referred to the practice in the UK, Belgium, Slovenia and Portugal, as well as Art. 13 and Recital 9 of the Regulation, and the authorisation itself which states that the authorisation is valid from the date of notification. The Austrian Oberlandesgericht seems to think that if Community law applies, then the relevant date should be the date of the decision, but if national law applies then in Austria it is likely that the relevant date is the notification date.
It will be interesting to see what the CJEU says. It would be short-sighted if the CJEU only answered these questions with reference to Article 13, though. Whatever the answers, SPC applicants will want to know if the same logic applies to Articles 3(d) and 7 as well ...Thanks so much, Daniel, for taking the trouble to share this with us.
Friday, 24 October 2014
This Special Mechanism allowed the owner of a pharma patent or an SPC to prevent the parallel importation of the patented product from one of the accession states if, at the time of filing, such protection was unavailable in that accession state; anyone who intended to import such a product was required to demonstrate to the relevant national authority that he had given notice of that intention to the holder or beneficiary of the protection.
The questions read as follows:
1 May the holder, or his beneficiary, of a patent or supplementary protection certificate rely upon his rights under the first paragraph of the Specific Mechanism only if he has first demonstrated his intention to do so?
2 If the answer to Question 1 is yes:
(a) How must that intention be demonstrated?(b) Is the holder, or his beneficiary, precluded from relying upon his rights with respect to any import or marketing of the pharmaceutical product in a Member State that occurred prior to the demonstration of his intention to rely upon those rights?
3 Who must give the prior notification to the holder or beneficiary of a patent or supplementary protection certificate under the second paragraph of the Specific Mechanism? In particular:
(a) Must the prior notification be given by the person intending to import or market the pharmaceutical product?or
(b) Where. as permitted by the national regulatory system, an application for regulatory approval is made by someone other than the intended importer, can prior notification given by the applicant for regulatory approval be effective if that person does not itself intend to import or market the pharmaceutical product but where the intended importation and marketing will be carried out under the applicant's regulatory approval?; and
(i) Does it make any difference if the prior notification identifies the person that will import or market the pharmaceutical product?(ii) Does it make any difference if the prior notification is given and the application for regulatory approval is made by one legal person within a group of companies which form a single economic unit, and the acts of importation and marketing are to be carried out by another legal person within that group under licence from the first legal person, but where the prior notification does not identify the legal person that will import or market the pharmaceutical product?
4 To whom must prior notification be given under the second paragraph of the Specific Mechanism? In particular:
(a) Is the beneficiary of a patent or supplementary protection certificate limited to persons who have a legal right under national law to bring proceedings to enforce that patent or supplementary protection certification?or
(b) In a case where a group of companies forms a single economic unit comprising a number of legal entities, is it sufficient if the notification is addressed to a legal entity which is the operating subsidiary and marketing authorisation holder in the Member State of importation rather than the entity within the group that has a legal right under national law to bring proceedings to enforce that patent or supplementary protection certificate, on the basis either that such legal entity may be characterised as a beneficiary of the patent or SPC, or that it is to be expected that such notification in the ordinary course of events will to come to the attention of the persons who make decisions on behalf of the patent or SPC holder?If the answer to Question 4(b) is yes,
(c) is a notification which is otherwise compliant rendered non-compliant if it is addressed to the "the Manager, Regulatory Affairs" of a company when that company is not the entity within the group that has a legal right under national law to bring proceedings to enforce that patent or supplementary protection certificate but is the operating subsidiary or marketing authorisation holder in the Member State of importation and when that Regulatory Affairs department in practice regularly receives notifications from parallel importers regarding the Specific Mechanism and other matters?
Sunday, 19 October 2014
Monday, 6 October 2014
A decision of the Intellectual Property Court (IP Court) granting a Supplementary Protection Certificate (SPC) on a second medical use, despite the existence of a previous SPC for the same product and the same basic patent, contradicting the practice of the Portuguese Patent Office (PTO), was published in the IP Bulletin.
The PTO refused SPC 511 by sustaining that it does not comply with the requirements of Article 3(d) of Regulation 469/2009 (SPC Regulation), alleging that this SPC is not associated with the first marketing authorization (MA) for the same product, since a SPC based on the same patent and on the same active ingredient had already been applied for (SPC 490).
Boehringer filed a judicial appeal against the decision of refusal of the PTO claiming that SPC 490 was applied for the use of the active ingredient dabigatran etexilate (as mesylate) for primary prevention of venous thromboembolic events in adults who have undergone an operation to replace the hip or knee, while SPC 511 is intended to protect the use of the same active ingredient for the prevention of cerebrovascular accident (CVA) and systemic embolism in adult patients with non-valvular atrial fibrillation. Consequently, Boehringer concluded that since the therapeutic use is different, it cannot be said that there is more than one SPC for the same basic patent.
The IP Court allowed Boehringer’s appeal and revoked the decision of refusal of the PTO.
In the aforementioned decision, the IP Court quoted the jurisprudence of CJEU, namely Case 130/2011 Neurim [on which see earlier SPC Blog posts here]), according to which "like a patent protecting a ‘product’ or a patent protecting a process by which a ‘product’ is obtained, a patent protecting a new application of a new or known product, such as that at issue in the main proceedings, may, in accordance with Article 2 of the SPC Regulation, enable an SPC to be granted and, in that case, in accordance with Article 5 of the regulation, the SPC confers the same rights as conferred by the basic patent as regards the new use of that product".
Considering the teachings of the CJEU, the IP Court held that since the new therapeutic use of the drug Pradaxa -- prevention of cerebrovascular accident (CVA) and systemic embolism in adult patients with non-valvular atrial fibrillation -- comprises the active ingredient protected by the basic patent of the SPC 511, it should be understood that this therapeutic use is not covered by any previous MA and therefore SPC 511 must be granted.
This decision shows the harmonization of Portuguese jurisprudence with the jurisprudence of the CJEU regarding SPC and shall serve as an important precedent for the PTO to change its practice relating to SPC on second medical uses".
Thursday, 2 October 2014
Valsartan HCT France: the end of ex parte preliminary injunctions in France?
The Supreme Court confirms the Paris Court of Appeal, rescinding the ex parte Order of the First Instance Court
previous post of January 11, 2013) reversing the Ruling of the judges in Chamber of the First Instance Court maintaining the ex parte interim measures against the companies SANOFI-FRANCE AVENTIS, SANOFI WINTHROP INDUSTRIE and ZENTIVA KS ("SANOFI") (post of November 4, 2011)
NOVARTIS filed an appeal before the French Supreme Court against this judgment, raising three grounds. In its decision issued on September 16, 2014, the French Supreme Court dismissed NOVARTIS's appeal in whole.
NOVARTIS's first ground of appeal
NOVARTIS argued that judges must apply the principle that both sides must be heard. Therefore, according to NOVARTIS, the Court of appeal couldn’t raise ex officio the question of whether the circumstances justified ex parte interim measures without inviting the opposing parties to submit their comments.
NOVARTIS's second ground of appeal
To question the decision issued by the Court of Appeal, NOVARTIS argued that:
* The mere fact that the delay to take interim measures could cause an irremediable harm justified the granting of ex parte interim measures,
* The Court of appeal, to say that the prejudice was not irreparable, ignored the ratio legis of the SPC by ruling that investments to discover the originator product had been compensated by both the patent and the SPC,
* The loss of French market share, an accelerated decrease of the price of the products incorporating Valsartan in France and subsequently in Europe, the launch of other generic medicinal products, the development of parallel imports and the disturbance of the treatments for patients, constitute a very hardly quantifiable prejudice and therefore an irreparable prejudice,
* The loss of market share, a price war, parallel imports and the disincentive to innovation simply cannot be reparable by the payment of damages.
However the French Supreme Court considered that since the Court of Appeal found that:
* The SPC of Novartis expired 17 days after the submission of the application, it was still time to obtain a decision from the judge by complying with the principle of contradiction, by ordering through inter parte proceedings, since there are urgent short-notice summary proceedings;
* There was an uncertainty regarding the imminent marketing of the products on the day of the submission of the application, the prejudice resulting from the marketing of the products 17 days before the supplementary protection certificate expiration was likely to be compensated by the payment of damages it could have obtained inter partes interim measures through urgent short-notice summary proceedings,
the Court could rightly, and in the exercise of its sole discretion, determine that the conditions to order ex parte interim measures were not met.
“But whereas after having acknowledged that the CCP expired 17 days after the presentation of the petition, the judgment noted that it was still possible on October 27, 2011 to obtain, before Nov. 13, 2011, a decision from the judge respecting the principle of contradiction, through urgent short notice summary proceedings or at a very early date by invoking the emergency; after having also noted that there was a doubt about the imminent commercialization of the products concerned on the date of presentation of the petition, it holds that the harm that would result from the marketing of generic 17 days before the expiration of the CCP was capable of being remedied by the award of damages; that these sovereign findings and assessments, apart from the superfluous reasoning criticized by the first part, the Court of Appeal, which was not bound to follow the parties in the details of their argument, could conclude that the circumstances requiring urgent measures under Article L 615-3 of the Code of intellectual property are taken ex parte were not met; that the plea is unfounded”
NOVARTIS's third ground of appeal
NOVARTIS argued that since SANOFI detained the generic medicinal products and that it has declared that the product was already marketed, the proof of imminent harm was sufficiently established to order interim measures.
However, the French Supreme Court ruled that this ground was irrelevant since the Court of appeal had ruled that conditions to grant ex parte interim measures weren’t met.This decision (in the original French) can be downloaded here or accessed online here.
“But whereas the Court of Appeal had held that the requirements to proceed ex parte were not met, the appeal is irrelevant”
Wednesday, 24 September 2014
“The purpose of the present Official Communication is to inform that after analyzing the arguments filed on 06/06/2012 related to Supplementary Protection Certificate (SPC) 474, the date of the Marketing Authorization (MA) that is used to calculate the expiry date is, according to Article 13(1) of Regulation 469/2009 of the European Parliament and of the Council of 6 May 2009, the date written in the MA, in this particular case 07/12/2011.”With this, the expected validity end was 07/12/2026 instead of 09/12/2026.
After publication of the Decision from the PTMO, Takeda appealed from said Decision to the Portuguese Intellectual Property Court requiring that the date to be used in the calculation should be the date of the Notification.
The Court decision was based on the following most relevant reasons:
“…the relevant date to determine the validity period of the certificate consists of the starting date of the marketing authorisation associated therewith. It is from that date that the medicament can start to be commercialized. This does not occur with the pronunciation of the marketing authorisation decision but with the effective validity of that authorisation”.It further clarifies:
“It is provided in Article 297 of the Treaty on the Functioning of the European Union, which replaces the Treaty Establishing the European Community, that decisions that are not a legislative act and mentioning a addressee are notified to him/her and producing effects upon that notification.Thus, this decision confirmed that the date to be considered in the calculation of the duration of a SPC is the date of notification of the decision. Briefly, the Court decided that:
From this it results that the decision to grant a marketing authorisation only has effect from the notification date, for which reason the common practice is to make reference to it by publication in the Official Journal of the mention of the date of the decision and of the date of notification to its addressee.
It would not be understandable how an administrative act granting the authorisation for the practice of a fact could produce effects before its notification to the addressee and how the addressee could know that he/she may legitimately practise that fact without being aware of that decision”
* the decision of grant of a Marketing Authorisation has effect as from its date of Notification, not from the Decision date;
Earlier news from was posted by João on The SPC Blog here this April.* the administrative act which grants an authorisation could not have effect before its applicant had been notified.This decision is in agreement with the previous decision BL O/418/13 of the UKIPO [on which see Mike Snodin's earlier contribution on this blog here].
It is still to be seen what will be the understanding of the PTMO of this decision and if it will apply it (to future cases or, even, to previous cases) or if the PTMO will maintain its practice waiting for a referral to the CJEU on this matter.
Friday, 19 September 2014
Paul incidentally furnished a note for this blog on the Advocate General's Opinion in this case which was not initially published in English. The SPC Blog's note on the ruling can be found here.
Wednesday, 10 September 2014
The seminar, held on Thursday 6 November 2014, runs from 1.30 pm until 6 pm. It will address the following topics:
• Review and analysis of pending CJEU referrals and recent CJEU decisions - Robert Stephen, Olswang LLPThere will be plenty of time for questions and a drink afterwards.
• “What’s up?” from the perspective of the IPOs - Various international IPO representatives
• SPCs involving medical devices - Charlotte Teale, Forresters
• SPCs for biologics - Mike Snodin, ParkGrove IP
• Amending and attacking SPCs – Dorothea von Renesse, König Szynka Tilmann von Renesse
• ‘Quick updates’ - notification dates and more…
Do join us once again! You are very welcome.
Tuesday, 9 September 2014
Alice adds that it also notes discrepancies in SPC protection in European countries which are due to differences in interpretation of the EC Regulation and/or in policy as between national patent offices.
Thanks, Alice! Your efforts are much appreciated.
Monday, 8 September 2014
In this article, Mike discusses the decision of the CJEU in Case C-555/13 Merck Canada. While acknowledging the effect that the ruling has in curtailing the term of Portuguese SPCs based upon certain "old law" patents, he argues that the ruling ought to also provide some beneficial side-effects, in the form of:
(a) increased harmonisation of SPC expiry dates across the EU andThe SPCs that may be affected are those for which less than 10 years have elapsed between the filing date of patent upon which the SPC is based and the date of the first authorisation in the European Economic Area for the “product” defined in respect of the SPC.
(b) an additional day's term for some SPCs in certain countries (such as the UK).
In the Genzyme case that Mike argued before the UK IPO in 2013 (BL O/418/13), the Hearing Officer declined a request (based upon the provisions of the Euratom treaty) to award an additional day’s term to just such an SPC. However, Mike is of the view that the ruling in C-555/13 would appear to undermine the Hearing Officer’s reasons for refusing that request. Therefore, Mike’s Euratom argument may yet rise again!
Wednesday, 20 August 2014
EFTA COURTThis request was received from the Oslo District Court on 23 July. The deadline for written observations from Governments and relevant institutions is Monday, 13 October 2014.
Request for an Advisory Opinion from the EFTA Court by Oslo tingrett dated 16 June 2014 in the case of Pharmaq AS v Intervet International BV (Case E-16/14)
1. Concerning Article 2 of the SPC Regulation, has a product been placed on the market as a medicinal product in the EEA before it has been granted marketing authorisation in accordance with the procedure for administrative authorisation laid down in Directive 81/851/EEC (or Directive 2001/82 EEC) when delivery of the product has taken place in accordance with
(i) “special approval exemptions” granted by the State Medicines Agency to veterinarians and fish health biologists pursuant to Section 3-6 or 3-7 of the Norwegian Regulation of 22 December 1999, alternatively Sections 2-6 or 2-7 of the Norwegian Regulation of 18 December 2009, or2. If question 1 is answered in the affirmative, is such a product outside the scope of the SPC Regulation and is an SPC granted on the basis of such a product therefore invalid?
(ii) what are known as “AR 16 licences” granted by the Irish Department of Agriculture, Food and the Marine pursuant to the Irish Statutory Instrument No 144/2007 European Communities (Animal Remedies) Regulations 2007 part III “Exceptional authorisation”, point 16?
3. Concerning the interpretation of Article 2 of the SPC Regulation, should a marketing authorisation granted for a veterinary medicinal product pursuant to Article 26(3) of Directive 2001/82 be deemed to constitute an administrative authorisation pursuant to Directive 81/851 (or Directive 2001/82) within the meaning of Article 2?
4. (a) Do special approval exemptions pursuant to Section 3-6 or 3-7 of the Norwegian Medicines Regulations of 1999 (FOR-199-12-22-1559) or Section 2-6 or 2-7 of the Norwegian Medicines Regulations of 2009 (FOR-2009-12-18-1839) constitute valid authorisation to place the product on the market as a medicinal product within the meaning of Article 3(b)?
5. When the medicinal product is a virus vaccine, can the scope of protection under the SPC cover not only the specific strain of the virus that is included in the medicinal product and covered by the basic patent, but also other strains of the virus that are covered by the basic patent?
In answering this question, is it of significance whether
a) such other strains have an equivalent therapeutic effect to the virus strain included in the medicinal product or whether the therapeutic effect is not immediately equivalent?6. If an SPC has been granted with a product definition that is not strictly limited to the specific strain of the virus authorised to be placed on the market as a medicinal product,
b) a medicinal product based on such other strain will have to be the subject of a separate marketing authorisation with requirements for documentation of safety and effect?
a) will such an SPC be valid, or
b) will the SPC be valid; such, however, that the scope of protection pursuant to Article 4 does not extend beyond the specific virus strain authorised to be placed on the market as a medicinal product?
Directive 2001/82 [on the Community Code Relating to Veterinary Medicinal Products] or Directive 2001/83 [on the Community Code Relating to Medicinal Products for Human Use], granted for many consecutive years, constitute a de facto marketing authorisation, thereby disqualifying the product in question from applying for a SPC?
If you happen to have information on this topic, I would greatly appreciate it if you could share it with me".Well, readers -- this is your chance! Do please post any useful reading suggestions below and let's see what we can come up with.
Monday, 18 August 2014
The post is quite long and a bit complex, so we thank Michael for getting this case online while packing for his holiday. That's enthusiasm for you!
Friday, 8 August 2014
The 45 page ruling can be read in its entirety here.
Thursday, 7 August 2014
"I would like to report a recent case before the Supreme Administrative Court of Bulgaria regarding an SPC application for Atripla, a drug for treatment of HIV infection.
“a combination of a compound of Formula I or Formula II according to claim 2 with a nucleoside analog having biological activity against HIV reverse transcriptase”.
Although efavirenz was found to be a compound of Formula I and emtizitabine -- a nucleoside analogue -- the court held that the claim envisaged only combinations of two active ingredients, while the applied product consisted of three. Further, the court confirmed that the third ingredient, tenofovir disoproxil fumarate, was also outside the scope of the claim as it was a nucleotide rather than a nucleoside analogue. Although after its intake it was transformed in the human body into a nucleoside, at the time of composing the claimed product it lacked such characteristics. As a result the Supreme Court reversed the decision of the court of first instance and instead upheld the decision of the Patent Office to reject the application of Merck Sharp & Dohme Inc.If you can cope with the original Bulgarian text of the judgment, Dimitar has kindly provided a link to it here.
In its detailed analysis the Supreme Court touched on a number of important topics of the SPC domain. It provided guidance on the methods of interpretation of patent claims, on the applicability of the infringement test and the significance of the Medeva and Eli Lilly decisions. It also commented on decisions of other jurisdictions which had been put forward by the parties in support of their arguments. Therefore, in my opinion the Atripla case resulted in a milestone decision of the Bulgarian case law with respect to the application of the SPC Regulation.
Monday, 4 August 2014
"the term for patent protection of medicinal and plant products (which are subjects of marketing authorizations), can be prolonged up to 5 years depending on the time spent on completing the marketing authorization process (equivalent to SPC)".This is unlikely to be done before all current EU Member States have approved the Association Agreements, but it's at least a step in the right direction.
Wednesday, 30 July 2014
More details, and registration instructions, will be posted as soon as possible.
Monday, 21 July 2014
Lilly v HGS – Article 3(a) SPC Regulation – Guidance on obtaining SPCs based on functional claims
Article 3(a) of Regulation 469/2009 requires that a product which is the subject of an application for an SPC must be “protected by a basic patent in force”. This was held by the Court of Justice of the European Union (the “CJEU”) in Medeva (Case C-322/10 [noted on this weblog here]) to mean that the active ingredient must be “specified” in the wording of the claims.
In October 2012 the Patents Court for England and Wales (Warren J) in Eli Lilly and Company Ltd v Human Genome Sciences, Inc. referred further questions to the CJEU regarding the interpretation of Article 3(a). In December 2013 the CJEU handed down its judgment in the Lilly case (C-493/12), holding that it is not necessary for the active ingredient to be identified in the claims of the patent by a structural formula. Article 3(a) does not, in principle, preclude the grant of an SPC where the active ingredient is covered by a functional claim provided that “the claims relate, implicitly but necessarily and specifically” to the active ingredient in question.
The case returned to the Patents Court (Warren J) in May and June 2014. The judgment provides important guidance as to the interpretation of the CJEU’s decision and the circumstances in which SPCs may be obtained for products based on claims defined in functional terms.
Human Genome Sciences, Inc. (“HGS” – now owned by GlaxoSmithKline) is the proprietor of European Patent (UK) No 0 939 804 which relates to and claims a novel protein called Neutrokine-α and antibodies which bind specifically to it. The patent has been held to be valid by the UK Courts (including the Court of Appeal and Supreme Court) and the Technical Board of Appeal of the European Patent Office. Of particular importance is the wording of claim 13 which claims:
“An isolated antibody or portion thereof that binds specifically to (a) the full length Neutrokine-α polypeptide … or (b) the extracellular domain of the Neutrokine-α polypeptide …”.Eli Lilly and Company Ltd (“Lilly”) wishes to market, in due course, a product containing an antibody (known as tabalumab) that binds specifically to Neutrokine-α. Lilly has not yet received a marketing authorisation (“MA”) for tabalumab.
Lilly issued a claim against HGS seeking a declaration from the Patents Court that any SPC granted to HGS in respect of the patent and based upon any MA for tabalumab would be invalid.
Lilly’s case was that tabalumab is not “protected by” the patent for the purposes of Article 3(a) as tabalumab is not specified in the wording of the claims. That, Lilly submitted, would require a structural definition of the active ingredient in the claims of the patent.
Lilly had originally sought to argue a further ground on which any SPC would be invalid, namely that HGS would not be able to obtain an SPC based on the HGS Patent and an MA held by a third party (Lilly) – the “Third Party Issue”. Lilly discontinued this aspect of the claim before the CJEU hearing in September 2013.
HGS’s case was that tabalumab fell within the scope of protection of claim 13 (as interpreted by section 125 of the UK Patents Act, Article 69 of the European Patent Convention (“EPC”) and the Protocol on the Interpretation of Article 69) and that that claim related “implicitly but necessarily and specifically” to tabalumab, as required by the CJEU.
The judgment of Warren J
As with other decisions of the CJEU in relation to the SPC Regulation, regrettably the guidance given is not clear. This is reflected by the fact that both Lilly and HGS had applied to the Patents Court for judgment in their favour on the basis of the CJEU’s decision. The Court also observed that “one thing the [CJEU decision] does not give is the clear guidance which the reference was designed to obtain” (paragraph 4).
In dismissing Lilly’s claim for declaratory relief, the Court explains (paragraph 67) that the CJEU has clearly held that functional definitions can, in principle, be sufficient to bring an active ingredient within the protection of a basic patent. This is on the condition that the “claims relate implicitly but necessarily and specifically” to the active ingredient.
The Court held at paragraph 70 that the correct reading of the CJEU’s judgment required an application of the relevant rules (i.e. Article 69 EPC or Section 125 Patents Act 1977) to ascertain the extent of the invention and what the claims relate to. If the active ingredient in question is covered by the claims, it is protected for the purposes of Article 3(a) – subject to a proviso.
This proviso is explained at paragraph 66 of the Judgment and is necessary to reflect the approach of the CJEU in Medeva in relation to products containing combinations of active ingredients. A product is not protected within the meaning of Article 3(a) solely by virtue of a claim containing general wording that extends the claim beyond its principle scope (such as “comprises”). However, in the absence of such extending words, the Court held that “the claims have a focused scope and the question is simply whether the product falls within the scope of the claims” (paragraph 66). Lilly had conceded during the course of these proceedings that tabalumab falls within the scope of claim 13 of the patent, and the proviso did not apply since there were no extending words. Tabalumab was therefore “protected by” the patent within the meaning of Article 3(a).
Finally, the Court considered (at paragraphs 44-54 of the judgment) that paragraph 43 of the CJEU’s decision, which relates to whether a patent owner has made any investment in the research leading to the MA, is more relevant to the discontinued Third Party Issue than to the test under Article 3(a). However, the Court made clear that SPCs are intended to be available without discrimination for the type, or stage, of research leading to the grant of the basic patent.
The judgment provides welcome guidance on the interpretation of Article 3(a) and confirms the availability of SPCs for products based on functional claim language (such as for antibodies defined by their binding target). On Friday Lilly was been granted leave to appeal, so the issues will be reviewed further in due course.
Sunday, 20 July 2014
"The purpose of this paper is to set out and discuss the recent jurisdictional developments in the European Court of Justice (ECJ) with respect to supplementary protection certificates (SPCs) including paediatric extensions. During the past five years the ECJ has been particularly active and has clarified a number of highly controversial legal ambiguities, such as the availability of negative term SPCs".You can check out the contents of the issue in which this article appears here, where you will spot the names and contributions of quite a few of our friends and blog-readers.
Monday, 14 July 2014
Meanwhile, blog team member Robert Stephen is amenable to suggestions for topics and speakers. If you have suggestions for either, can you please email Rob at Robert.Stephen@olswang.com and let him know.
Monday, 30 June 2014
- "The Highest Italian Administrative Court has the Final Word on the Xalatan Case and Reinstates the Original Infringement Decision of the Italian Competition Authority", by Michele Giannino (Desogus Law Office) appears in the current issue of the Bio-Science Law Review (BSLR) which, incidentally, has a 20% reduction offer for new subscribers that finishes today.
- "Pfizer's misuse of patent/SPC rights results in an abuse of dominant position", by Gian Paolo Di Santo (Studio Legale Pavia e Ansaldo) appears in the July 2014 issue of the Journal of Intellectual Property Law & Practice (JIPLP), Gian Paolo having acted in this case for Assogenerici and some of the original plaintiffs against Pfizer.
This decision, invalidating the SPC, has now been upheld on appeal: see "Navarra Court of Appeal confirms invalidity of Spanish SPC for telmisartan + hctz", written for today's International Law Office release by Sara Pelaz (Grau & Angulo), here. This helpful note adds that Boehringer still has the option of lodging an appeal with the Spanish Supreme Court.