The SPC blog

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

Monday, 9 October 2017

Swedish Appeal Court opens towards re-examination of Swedish SPC terms

Many thanks to Louise Jonshammar (Awapatent) for providing the following summary of recent decisions of the Swedish Patent and Market Appeal Court on SPC terms following the CJEU's Seattle Genetics case:
"On 4 October, 2017, the Swedish Patent and Market Appeal Court handed down eight decisions in appeal cases regarding re-examination of SPC term decisions. 
The background relates to the famous Seattle Genetics case (C-471/14) in which the CJEU gave a preliminary ruling on the interpretation of Article 13(1) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products. In the judgement, the CJEU held that the ‘date of the first authorisation to place the product on the market in the [European Union]’ within the meaning of Article 13(1) is the date on which notification of the decision granting marketing authorisation was given to the addressee of the decision. As many patent offices around the EU, if not most, calculated the SPC term on the date of grant of the marketing authorisation, the judgement started an avalanche of requests for changes to the already issued SPCs. The different EU countries have handled these requests differently, as re-examination is not provided for in the regulation. 
The Swedish Patent and Registration Office refused to change the term of already issued SPCs unless there was still time within the two months’ appeal limit to appeal the grant decisions – in which case the patentee was urged to file such appeal. The reason for refusal was mainly that new practice is not a basis for re-examination under the Swedish Administrative Law. 
The Patent and Market Court agreed with the patent office and did not change the decisions. Further, the court said that decisions to grant SPC effect not only the applicant but also an unknown number of other actors on the market, having contradictory interests. Therefore, decisions on grant of SPCs shall be considered similar to civil actions, despite the fact that third parties are not parties to these decisions. 
The Patent and Market Appeal Court decisions are long and include a lot of very useful reasoning for understanding the decision. The grand finale of the decisions is a reasoning on the balance of interest between the patentee and third parties. The Patent and Market Appeal Court finds that where the patent protection has ceased and the SPC has come into effect, companies marketing generic drugs may have customised their efforts on the market to fit the decision and prepared according to the final date of the SPC in the decision. If the SPC term has begun, the interest of foreseeability speaks against a change of the SPC term in such cases. Before the beginning of the SPC term, however, the patentees’ interest in a longer term shall prevail. Therefore, as a general rule, decisions on SPC term shall be changed in accordance with the principles set out in the Seattle Genetics judgement, provided that a request for changes has been filed before the beginning of the SPC term. 
The decisions then differ depending on when the patentee filed its request - in some cases the term is extended and the patent office is asked to put that decision into practice, in other cases the request for change of the term is denied because the SPC term has already begun. 
Also, as a point of interest, one may note that the Patent and Market Appeal Court disagrees with the Patent and Market Court with respect to SPC applications being considered similar to civil actions. The fact that a re-examination may have economic consequences for third parties is not a special circumstance which motivates a deviation from the general rule of administrative law. The third party interest shall therefore be considered within the re-examination, which is then what the Patent and Market Appeal Court does in its balancing of interests, as described above. 
Another interesting note is that the Patent and Market Appeal Court has allowed for the decisions to be appealed to the Supreme Court."

Tuesday, 3 October 2017

Switzerland and paediatric extensions - an update

Switzerland is slowly moving towards amending its patent legislation to allow for paediatric extensions in the context of a revision of the Swiss law on pharmaceutical and medicinal products.

The changes in the Swiss Patent Act to allow for pediatric extensions have already been approved by the Swiss parliament in 2016.  The changes allow for:
Pediatric extensions to SPCs under conditions like in the EU; and
Independent paediatric SPCs linked directly to the term of the patent, in cases where there is no regular SPC. 
According to the Swiss Federal Institute for Intellectual Property website (here), amendments proposed to the implementing regulations of the Swiss Patent Act are currently under a general consultation which will end on 20 October 2017. 

The aspired date for the entry into force of the amended Patent Act and the implementing regulations is January 1, 2019.  However, a more likely date is looking like mid-2019.

Many thanks to Claudia Bibus and Siegfried Grimm at E. Blum and Co. as well as Nick Bassil at Kilburn & Strode for providing this information!

Thursday, 14 September 2017

Tenofovir - High Court Decision in France

Those following the tenofovir SPC litigation in Europe will be pleased to hear that the High Court of Paris has recently handed down a decision in relation to Gilead's SPC based on EP0915894.  Denis Schertenleib, who acted for Mylan in these proceedings, has kindly provided a short summary of the case, along with a copy of the decision and an English translation.

"Recently, the High Court of Paris had to opine on the validity of the Gilead SPC on Truvada covering tenofovir and emtricitabine. The SPC was based on the basic patent for tenofovir.  One of its claims covered a combination of tenofovir with another optional therapeutic ingredient.  
In the context of preliminary injunction proceedings, the Presiding judge of the Paris High Court had to decide whether this SPC was likely to be held invalid on the merits. The Court held in a ruling dated 5 September 2017, that the SPC was likely to be invalid.
The reasoning of the Court was based on the finding that the reference to another “therapeutic ingredient” could not be deemed to constitute a functional definition of any compound under the Eli Lilly v HGS doctrine of CJEU case C-493/12. In addition, the Court held that nothing in the description or the prior art could be held to point to Emtricitabine as being this optional therapeutic ingredient. Finally, the Court noted that the combination of tenofovir and emtricitabine could not constitute the core invention of the basic patent under the Actavis v Sanofi doctrine of CJEU case C-443/12. The Court thus held that the SPC was likely to be invalid and that no preliminary injunction could be granted.

The Judgment in French and translated in English can be downloaded here.

The ruling can be appealed and a case on the merits is ongoing.”
Many thanks to Denis for this!

Thursday, 31 August 2017

Call for comments for C-443/17 (Abraxis Bioscience)

The UK IPO is seeking comments on CJEU case C-443/17 (Abraxis Bioscience) with a view to advising the UK government as to whether it wishes to make representations in this reference.  Comments should be sent by email to policy@ipo.gov.uk by 6 September 2017.

As a refresher, the question referred to the CJEU in this case is as follows:
Is Article 3(d) of the SPC Regulation to be interpreted as permitting the grant of an SPC where the marketing authorisation referred to in Article 3(b) is the first authorisation within the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?

Wednesday, 26 July 2017

Canadian Government proposes Certificate of Supplementary Protection Regulation


Canada appears to be moving closer towards having system for patent term extension. On 15 July 2017, the Government of Canada published a proposed Certificate of Supplementary Protection Regulations in the Canada Gazette (here).  In addition, the Government is seeking comments on the proposed Regulation by 30 July 2017.

The background section of the Regulatory Impact Analysis Statement is reproduced here:

"In order to meet Canada’s CETA obligations, the Patent Act (the Act) was amended to create a framework for the issuance and administration of certificates of supplementary protection (CSP), for which patentees with patents relating to human and veterinary drugs may apply. As set out in the Act, the new CSP regime, which will be administered by the Minister of Health (Minister), will provide additional protection from the date of the expiry of the eligible pharmaceutical patent based on the first authorization for sale of a drug containing a new medicinal ingredient or combination of medicinal ingredients in Canada. This new protection, which is intended to partly compensate for time spent in research and obtaining marketing authorization, provides patent-like rights in respect of drugs containing the same medicinal ingredient or combination. The scope of protection can be no broader than the scope of protection afforded by the patent set out in the CSP, and is subject to the same limitations and exceptions as the patent.

The term of a CSP is the difference between the date of the filing of the application for the patent and the date of issuance of the authorization for sale, reduced by five years, and capped at two years [i.e. CSP term = (Notice of Compliance date – Patent filing date) – five years, with a cap of two years].

The Act allows CSP applications to be submitted within a prescribed timeframe from (i) the authorization for sale of a drug, or (ii) the subsequent grant of an eligible patent that occurs after the authorization for sale of the drug. To be eligible, the application for authorization to sell a drug containing a medicinal ingredient or combination must be filed with the Minister before, or within a reasonable amount of time from, when the approval of a drug containing the same medicinal ingredient or combination was first sought in any comparable jurisdictions (the timely submission requirement). For a medicinal ingredient or combination to be eligible for a CSP, a drug containing it must not have been previously authorized for sale (as that phrase is defined) in Canada.

This regime is substantially defined in the amendments to the Act. The proposed Regulations specify the various timelines and requirements necessary for the purpose of the regime."

Friday, 23 June 2017

Paediatric Extensions in Norway

The SPC Blog is grateful to Arne Lund Kverneheim at Bryn Aaflot for the following news on paediatric extensions in Norway:
"Paediatric extensions in Norway will be implemented and available from 1 September 2017. This means that SPCs with expiry dates later than 1 March 2017 will be entitled to extensions provided that the application for the extension is submitted according to the requirement in the regulation or in the transitional regulations. 
The background for the amendments in the Norwegian Medicines Act and the Patent Law is in the EEA committee decision of 5 May 2017 (92/2017) adapting the SPC regulation 1768/92 - 469/2009 to include the EEA states. 
The implication is that any SPC in Norway with expiry date later than 1 March 2017 is entitled to paediatric extensions. The maximum duration of the protection will however be no longer than 6 months after the expiry of the SPC. 
RequirementsThe requirement in Norway will be the same as in EU member states.  Application forms in Norwegian and English will be provided by NIPO. 
NIPO will allow receipt of applications for paediatric extensions from 1 August 2017. The extension will be in force when the application is made public and after implementation of the regulation. 
DeadlinesThe normal deadline to apply for a paediatric extension is 2 years prior to expiry of the SPC. However, in a transition period of 5 years after implementation, which is until 1 September 2022, the deadline is 6 months prior to expiry of the SPC. 
Please note that an application for an extension will not prevent any third party who, between the expiry of the certificate and the publication of the application for an extension, in good faith has commercially used the invention or made serious preparation for such use, to continue such use. 
ExamplesThe transition regulations for SPC with an expiry close to the implementation can be interpreted with the following examples and timeline:
  • SPC expiry 1 April 2017
entitled to a 1 month extension from 1 September 2017 (until 1 October 2017)
applicable from 1 August 2017
  • SPC expiry 1 June 2017
entitled to a 3 months extension from 1 September 2017 (until 1 December 2017)
applicable from 1 August 2017
  • SPC expiry 1 November 2017
entitled to a 6 months extension (until 1 May 2018)
apply by 1 October 2017
  • SPC expiry 1 June 2018
entitled to a 6 months extension (until 1 December 2018)
apply by 1 December 2017"

Many thanks to Arne again!

Monday, 19 June 2017

Max Planck Institute SPC Survey - deadline for participating - 23 June 2017

As many readers of this Blog will be aware, the Max Planck Institute for Innovation and Competition is currently conducting a study on supplementary protection certificates in the European Union on behalf of the European Commission.  The study aims to include the views and opinions of a wide range of stakeholders including pharmaceutical companies, professional and industry associations as well lawyers, patent attorneys and other interest groups.

As part of the study, a survey is being conducted which includes questions on the past experience with the system, general policy considerations, assessment of the present legal rules, as well as some proposals on the potential amendment of the current SPC Regulations. The answers will be collected on an anonymous basis.  The deadline for participating in the survey is this Friday, 23 June 2017

If you are interested in participating in the survey, please contact Victoria Rivas at the Max Planck Institute at victoria.rivas@ip.mpg.de

Friday, 5 May 2017

Darunavir and the interpretation of Article 3(a) by Mr Justice Arnold

darunavir
Earlier this week, Mr Justice Arnold handed down a decision (here, [2017] EWHC 987 (Pat)) relating to the validity of Searle’s SPC to darunavir  in view of Article 3(a) of the SPC Regulation.

The facts of the case are as follows: G.D. Searle LLC hold SPC/GB07/038 (“the SPC”) to darunavir.  Janssen Sciences Ireland UC is the exclusive licensee. The SPC is based on EP 0 810 209, to which claim 1 is directed to a compound presented by Formula I


wherein the substituents P1, P2, R2, R3, and R4 are listed.

Sandoz and Hexal challenged the validity of the SPC on the basis that it does not comply with Article 3(a) of the SPC Regulation because darunavir is not specified or identified in any of the claims of the patent.  In particular, they argued that although darunavir falls within the scope of the claims, it is not specifically identified by name or structure in the claims or in the specification, nor is there any teaching in the patent which points to darunavir.

After briefly reviewing the CJEU’s  “guidance” in the Medeva and Lilly cases in relation to whether a product satisfies the requirement of Article 3(a) of the SPC regulation, Mr Justice Arnold came to the conclusion that it is sufficient for the claim to specify the product by means of a Markush formula which covers it.  Not entirely happy with the CJEU’s unclear tests, he also referred to what he considered as a better test, and as he advanced in Teva v Gilead, which would require that the product falls within the claim and that it embodies the inventive advance (or technical contribution) of the claim.

Kristina Cornish and Dayle Callaghan of Kilburn & Strode LLP were part of the team acting for the defendant in this successful matter.

Thursday, 23 March 2017

Atripla - a combination of issues

Mr Justice Arnold gave his ruling earlier this week in Teva UK Limited & Ors v Merck Sharp & Dohme Corporation [2017] EWHC 539 (Pat).

In brief, Merck Sharp & Dohme (MSD) was granted an SPC for a combination product of  efavirenz, emtricitabine and tenofovir disoproxil fumarate based on EP (UK) 0 582 455 (the product is marketed as Atripla by Bristol-Myers Squibb Co. and Gilead Sciences Inc).  At trial, MSD relied on claim 16 as protecting the product.  Claim 16 reads:
“A combination of the compound of claim 12 or a pharmaceutically acceptable salt thereof with a nucleoside analog having biological activity against HIV reverse transcriptase.”
MSD also previously obtained an SPC for efavirenz based on the same patent.  Teva, Accord and Mylan challenged the validity of the SPC.

Mr Justice Arnold found that the SPC was invalid because it did not comply with either Article 3(a) or Article 3(c) of the SPC Regulation.  More specifically, he found that the scope of protection of claim 16 extended to a combination of efavirenz and tenofovir or a combination of efavirenz and emtricitabine, but not to a combination of all three actives.  He also found that the SPC does not comply with Article 3(c) because claim 16 does not represent a distinct invention from the invention protected by the claims for efavirenz.

Friday, 3 March 2017

Forum Institut SPC Seminar

From Rechtassessor Jean-Claude Alexandre Ho (IP conference manager at FORUM Institut für Management GmbH) comes news of an SPC-related seminar which he is organising:

'Quo vadis, SPC?', the update seminar in which Dr Christopher Brückner, the author of the SPC commentary noted here (participants will receive the second edition on top of course documentation), will speak on the CJEU's referrals from 2011 to 2017 and on how to understand the decisions and which practical consequences we may expect for the future.  

Date: 31 May 2016; venue: Amsterdam.

More information is available here.  

To register, just forward this blogpost to Jean-Claude himself at jc.alexandreho@forum-institut.de or click here.