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News Articles

2017

The latest case on SPCs: the CJEU rules in favour of chaos

02 March 2017

Author: Mike Snodin
Bio-science Law Review (January 2017)

This article was first published in Volume 15, Issue 6 of Bio-science Law Review. It discusses the CJEU's judgement in C-572/15 (F. Hoffman-La Roche).

Whilst focussed upon a seemingly “niche” issue (a transitional provision in the SPC legislation), the judgement in C-572/15 has potentially very broad implications. This is because the CJEU’s ruling leads to an outcome that appears to contravene principles of EU law that are aimed at upholding legal certainty. In this respect, the article starts by highlighting some troubling omissions and (apparent) oversights in the CJEU’s reasoning. It also discusses alternative approaches that could have served to (better) preserve legal certainty and notes the absence of any clear reasons why the CJEU did not adopt such approaches. Finally, the article concludes by noting that SPC proprietors adversely affected by the CJEU’s decision may have the option of seeking recompense via legal actions alleging contravention of the right to (the protection of) property that is enshrined in Article 1 of Protocol 1 to the European Convention on Human Rights.

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2016

Enforcement Of Second Medical Use Patents: Landmark Case Sets The Scene For Future Battles

08 December 2016

Author: Mike Snodin
Pink Sheet (17 November 2016)

This article was first published in the Pink Sheet (https://pink.pharmamedtechbi.com/). It discusses the October 2016 decision of the UK Court of Appeal in Warner-Lambert v Actavis, which relates to the alleged infringement of a second medical use patent by a "skinny label" generic product.

As well as highlighting aspects of the decision that will be welcomed by innovators, the article points to areas where important questions still remain unanswered. These include the following.

(1) Which specific actions must (not) be done by the manufacturer of a "skinny label" generic product in order to avoid infringing a claim directed to an indication that has been carved out of the label of that product?

(2) Could the tests proposed by the Court of Appeal for direct and indirect infringement lead to contradictory results (and/or to liability for infringement arising due to off-label use)?

(3) Which remedies are appropriate in cases where sale of a "skinny label" product is found to infringe a valid patent to a second medical use?

Finally, the article suggests some proactive, practical steps that innovators could take, with a view to minimising the chances of "skinny label" generic products being used in the treatment of patented indications.

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What is the term of a European patent?

22 July 2016

Authors: Mike Snodin and Jim Boff
CIPA Journal (July 2016)

This article, which was first published in the July 2016 edition of the CIPA Journal, explains the numerous reasons why the term afforded to patents in the UK is a day too short. It also explains why this fact leads to a conclusion that the UK is, and always has been, in breach of its obligations under both the European Patent Convention and TRIPS. The article therefore urges an amendment of UK patent law, such that a patent that reaches its maximum term has a last day in force that is the 20th anniversary of the effective filing date of the patent.

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Difficult Questions, Important Answers: The Latest Case on SPCs

05 February 2016

Author: Mike Snodin
SCRIP Regulatory Affairs (1 February 2016)

This article, first published in SCRIP Regulatory Affairs on 1 February 2016, discusses the latest case on SPCs (C-572/15, F. Hoffman-La Roche). In that case, the Supreme Court (Riigikohus) in Estonia has sought clarification from the CJEU on the interpretation of a transitional provision in the SPC legislation that derives from the 2003 Treaty of Accession to the EU. As well as explaining how general principles of EU law could be contravened if the transitional provision is taken at face value, the article outlines two alternative approaches that the CJEU could take to avoid that undesirable outcome. Finally, the article points out that the ruling in C-572/15 could not only issue at a very opportune time (in the light of a possible review of the SPC legislation) but could also attract a significant amount of interest from outside of the world of SPCs.

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2015

The CJEU Calls Extra Time For SPCs - But There May Be Further Battles Ahead For Companies

05 November 2015

Author: Mike Snodin
SCRIP Regulatory Affairs (23 October 2015)

This article, which was first published in SCRIP Regulatory Affairs on 23 October 2015, discusses the CJEU's judgement in Seattle Genetics (C-471/14, which was decided on 6 October 2015). That judgement validates an argument first proposed by Mike Snodin in October 2011, namely that the duration of SPC protection should (where relevant) be calculated upon the basis of the notification date of a "centralised" Marketing Authorisation - and not the (earlier) date of the European Commission's decision to issue the MA. Whilst noting obvious consequences of the judgement (additional duration that should be awarded to certain SPCs), the article also discusses some potentially broader implications with respect to the deadline for filing some SPCs, determining the date of certain national MAs and determining the MA date for the purposes of Articles 3(b) and 3(d). Finally, the article mentions the battles that companies may face when trying to persuade national patent offices and courts to fully implement the decision in respect of SPCs already granted - and points to a recent decision that may help to win those battles.

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Europe is now poised to award longer terms to some SPCs

14 September 2015

News & Views
Author: Mike Snodin

On 10 September 2015, Advocate-General (A-G) Jääskinen of The Court of Justice of the European Union (CJEU) issued his opinion in a case (C-471/14, Seattle Genetics) concerning the calculation of the term of certain Supplementary Protection Certificates (SPCs).

Although not binding upon the CJEU, A-G Jääskinen’s opinion represents good news for those in the innovative pharmaceutical industry. This is because the opinion essentially concludes that:
• the SPC legislation must be interpreted in a manner that allows for longer SPC term to be awarded to certain “centrally” authorised medicinal products; and
• any different interpretation would be contrary to the fundamental objectives of the SPC legislation.

The latter point is particularly important, as it could make it difficult for the CJEU to reach a contrary conclusion in its final judgement - which is likely to issue any time within the next 1 to 10 months. Thus, it appears more likely than not that the CJEU is now poised to confirm the A-G’s opinion (which Park Grove IP is pleased to note is in full agreement with arguments originating in various articles authored by Mike Snodin, and published as long ago as October 2011).

If confirmed by the CJEU, A-G Jääskinen’s opinion may have broader implications, such as providing arguments in favour of:
- setting a later application deadline for SPCs based upon a “centralised” MA; and/or
- providing longer terms (and/or later application deadlines) for SPCs based upon national MAs that are the 1st in the Community and that take effect upon the date on which they are notified to the MA applicant.

However, it remains to be seen whether such arguments will be equally as persuasive as those that have been accepted by the Advocate-General.

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A landmark case for second medical use patents in the UK

29 June 2015

News & Views
Author: Mike Snodin

On 28 May 2015, the UK Court of Appeal issued its judgement in an appeal by Warner-Lambert against a decision of the UK High Court that refused to grant a preliminary injunction aimed at preventing sales of a “skinny label” pregabalin product for which Actavis had sought a Marketing Authorisation.

Although largely positive, the decision of the UK Court of Appeal represents mixed news for innovators.

The good news relates to the standard for proving infringement that was adopted by the Court of Appeal, which now compares very favourably to the much stricter standard for proving anticipation of second medical use claims (which has since been confirmed by a decision of the UK High Court in a different case).

On the other hand, the less positive news relates to:
- the difficulties that are likely to be encountered in seeking preliminary injunctions against “skinny label” generic products; and
- the possibility that, even for innovative medicinal products that are marketed in the UK, freedom-to-operate issues may arise in respect of patents to indications that are not on the product label.

This article discusses these issues and more, including crucial questions that have not yet been answered.

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When public policies collide: the battle to enforce second medical use patents for drugs in Europe

26 March 2015

Author: Mike Snodin
SCRIP Regulatory Affairs (24 March 2015)

This article discusses very important judgements from courts in the UK and the Netherlands that are the first to address the issue of whether a second medical use patent can be infringed by a “skinny label” generic product. The various different conclusions reached by the courts are currently the subject of a great deal of debate. Whilst the article discusses key aspects of those conclusions, its main focus is upon what the author believes are practical lessons that can be learned from the decisions – which lessons can be used by innovators to help improve the chances of their second medical use patents being enforced against skinny label generic products.

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The Court of Justice clarifies certain provisions governing parallel importation

20 February 2015

News & Views
Author: Mike Snodin

On 12 February 2015, the Court of Justice (CJEU) handed down its judgement in Merck Canada, Merck Sharp & Dohme v Sigma Pharmaceuticals (C-539/13). The judgement effectively confirms the earlier opinion of Advocate-General Jääskinen and provides guidance on the interpretation of the provisions of the so-called Specific Mechanism, which governs parallel importation of certain medicinal products from the “newer” Member States of the EU (i.e. states acceding to the EU since 2003).

For a case having a connection with SPCs, the judgement in C-539/13 is fairly unusual in that the responses provided by the CJEU answer more questions than they pose.

Indeed, it is even possible for parallel importers to glean some practical tips from the CJEU’s answers – the most important of which being the necessity to conduct careful due diligence on the status and ownership of the patent and SPC protection in force for the medicinal product(s) to be imported.

Moreover, rights owners who may have inadvertently failed to invoke the Specific Mechanism within 1 month of receiving notification of proposed parallel importation can now be confident of their right to prevent future importation and sales. It may even be possible to recover losses due to past importation and sales, but only if there are convincing grounds to assert that the notification provided by the parallel importer was inadequate (i.e. if it did not meet the standards set out by the CJEU).

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The European Commission submits its views in an important case for SPCs to biologics

06 February 2015

News & Views
Author: Mike Snodin

Pharmaq v Intervet (E-16/14) is a case being heard by the EFTA Court that is potentially of huge importance to those seeking (or holding) supplementary protection for biological active ingredients in European Union (EU) or EFTA Member States. This is because it raises fundamental questions relating to the breadth of protection provided by an SPC to a biological product, and may well lead to an opinion from the court that could influence the extent to which such SPCs can be enforced against the producers of “copycat” (i.e. biosimilar or “me too”) biological products.

Whilst the opinion of the EFTA Court will be important (and potentially persuasive for future cases in the EU), the most interesting aspect of the case is the fact that observations have been submitted to the Court by parties that include the European Commission (EC) and the Government of the United Kingdom.

Significantly, the EC has proposed answers that may have profound (and, in part, undesirable) implications. For example, those proposed answers could lead to both harsh results for innovators and/or prolonged uncertainty for producers of “copycat” biological products. Parties having a stake in either innovative or “copycat” biological products may therefore wish to develop, and advocate to national governments and the European Commission, alternative solutions to the problem of SPC scope for biological products that lead to:

- a fairer result for innovators; and
- more (and earlier) certainty on freedom to operate.

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2014

Supplementary Protection Certificates: the Court of Justice of the EU will have its day after all

24 December 2014

Author: Mike Snodin
SCRIP Regulatory Affairs (22 December 2014)

This article, which was first published by SCRIP Regulatory Affairs on 22 December 2014, reports that the Court of Justice of the EU has now been asked (in case C-471/14, Seattle Genetics) to answer questions on the issue of whether longer SPC term should be awarded 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. The article also analyses the questions referred to the CJEU and highlights potential problems with regard to how they have been framed. In the light of those problems, the article presents an alternative question that is more precisely adapted to the facts underlying the Seattle Genetics case, and expresses the hope that the CJEU decides to answer such an alternative question.

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Supplementary Protection Certificates: the never-ending saga of Article 3(a)

03 December 2014

Author: Mike Snodin
SCRIP Regulatory Affairs (1 December 2014)

This article, which was first published by SCRIP Regulatory Affairs on 1 December 2014, explains why the ruling of the UK High Court from July 2014 in the Eli Lilly v HGS case may well provide what the SPC community has sought for years, namely a test for compliance with Article 3(a) that is not only simple and robust but that is also relatively straightforward to apply in a wide variety of cases. However, the article also explains why this is unlikely to be the end of the saga relating to Article 3(a) and, in this respect, discusses two alternative interpretations of Article 3(a) that have been proposed by some commentators and that could muddy the waters for a number of years to come. Whilst one of those alternative interpretations is perhaps not fundamentally inconsistent with the extent of protection test used by the UK High Court, the same cannot be said for the other - which is based upon an unusual reading of the CJEU’s ruling in Queensland and which appears to be impossible to reconcile with the conclusions reached by the UK High Court. In this respect, the article outlines reasons why that more challenging interpretation must be wrong and why the UK High Court’s extent of protection test must prevail – at least for now.

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The CJEU – for supplementary protection certificates, who needs it?

24 October 2014

Author: Mike Snodin
SCRIP Regulatory Affairs (24 October 2014)

This article, which was first published by SCRIP Regulatory Affairs on 24 October 2014, explains why patent offices in Europe do not need to seek guidance from the Court of Justice of the EU in order to decide to award longer terms to some pharmaceutical supplementary protection certificates (SPCs). In this regard, the article sets out the compelling arguments in favour of the use of the Notification Date for setting the term of SPCs based upon centralised Marketing Authorisations, and explains why contrary arguments put forward by certain patent offices do not stand up to serious scrutiny.

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Every cloud has a silver lining: Portugal's loss may be the UK's gain

09 August 2014

Author: Mike Snodin
SCRIP Regulatory Affairs (June 2014)

This article appeared in the June 2014 edition of SCRIP Regulatory Affairs. It discusses the CJEU's ruling in case C-555/13 (Merck Canada), which ruling provides guidance on how the duration of SPCs should be calculated. That ruling has resulted in the curtailing in Portugal of term for those SPCs based upon certain "old law" patents (those having a term exceeding 20 years from filing). However, Mike argues that a flip side of the ruling ought to be not only increased harmonisation of SPC expiry dates across the EU, but also an additional day's SPC term for some SPCs in certain countries (such as the UK).

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Three CJEU decisions that answer some questions but pose many more

09 July 2014

Journal of Intellectual Property Law & Practice (2014) 9 (7): 599-604
Author: Mike Snodin

This article first appeared online on 22 April 2014 in the Journal of Intellectual Property Law and Practice. It reviews, analyses and comments upon the decisions in cases C-443/12 (Actavis v Sanofi), C-484/12 (Georgetown University) and C-493/12 (Eli Lilly v HGS). Whilst noting areas that have been clarified and speculating upon strategies that may now represent "best practice" in the light of the decisions, the article also points out the many areas of uncertainty that still remain - or that have been generated by the decisions.

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2013

You can count on us: UK IPO agrees to award longer term to some SPCs

15 December 2013

SCRIP Regulatory Affairs December 2013, 15
Author: Mike Snodin

This article appeared in the December 2013 edition of SCRIP Regulatory Affairs. It reports the outcome of a case that Mike argued at the UK IPO, where he persuaded the Hearing Officer to accept a premise that he first outlined in his SCRIP Regulatory Affairs article from October 2011. As a result, SPCs in the UK whose term is set by reference to a "centralised" Marketing Authorisation should now expire a few days later, as the UK IPO has agreed to rely upon the date of notification of the MA (instead of the earlier date of the European Commission's decision to issue the MA).

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2012

Neurim wins the battle but not (yet) the war for innovators

14 September 2012

SCRIP Regulatory Affairs September 2012, 14-15
Authors: Mike Snodin and Michael Pears

This article appeared in the September 2012 edition of SCRIP Regulatory Affairs. It explains the positive aspects that the innovative pharmaceutical industry will find in the Neurim decision. However, it also highlights the difficulties in understanding how broadly (and to whom) the decision can be applied, as well as the challenges to be faced by national patent offices and courts in squaring the Neurim decision with the prior case law of the Court of Justice.

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A brave new world for supplementary protection certificates?

01 August 2012

Life Sciences Intellectual Property Review 2012
Authors: Mike Snodin and Michael Pears

This article appeared in the 2012 edition of Life Sciences Intellectual Property Review. It discusses the opinion of Advocate-General Verica Trstenjak in the case of Neurim Pharmaceuticals (C-130/11). Whilst agreeing that it would be very harsh upon Neurim if they were not awarded and SPC, Mike and Michael highlight possible undesired side-effects in implementing the particular "fix" proposed by the Advocate-General that would award an SPC to Neurim.

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Novartis decision completes a new model for SPCs in EU

17 April 2012

SCRIP Regulatory Affairs April 2012, 5
Authors: Mike Snodin and Michael Pears

This article appeared in the April 2012 edition of SCRIP Regulatory Affairs. It reports the decision in the Novartis v Actavis case at the CJEU (case C-442/11) and explains its significance and practical consequences.

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Master the detail to get the most from SPCs

17 April 2012

Business Development & Licensing Journal (2012) 17 (April): 10-13
Author: Mike Snodin

This article appeared in the April 2012 edition of Business Development & Licensing Journal. It discusses a flurry of decisions on SPCs that issued in 2011 and that profoundly altered the understanding of how the law relating to SPCs is to be interpreted. It also summarises the impact of the decisions from 2011 and outlines some of the opportunities and challenges that have been created.

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Supplementary protection certificates: The CJEU issues its decision in two seminal cases

14 February 2012

Bio-Science Law Review (2012) 12 (2): 58-62
Authors: Mike Snodin, John Miles and Michael Pears

This article appeared in the January 2012 edition of Bio-Science Law Review. It discusses the decisions of the Court of Justice of the EU in the Medeva (C-322/10) and Georgetown et al. (C-422/10) cases, and considers the likely impact of the decisions in the short and medium term. It also discusses possible implications in the long term, and the need for further judicial clarification on certain points.

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European court ruling on SPCs brings relief to industry

08 January 2012

SCRIP Regulatory Affairs January 2012, 7-8
Author: Mike Snodin

This article appeared in the January 2012 edition of SCRIP Regulatory Affairs. It discusses the decision of the Court of Justice of the EU (in case C-125/10) to effectively implement Model A of the 2007 RAJ Pharma article that Mike co-authored. It also discusses the possibility of (negative term) SPCs expiring before the patent upon which they are based, but concludes that there are reasons why any concerns on this point are likely to be short-lived.

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2011

Every day counts: why pharmaceutical companies in the EU need to make sure they get the right SPC term

06 October 2011

SCRIP Regulatory Affairs October 2011, 6-7
Author: Mike Snodin

This article appeared in the October 2011 edition of SCRIP Regulatory Affairs. It argues that the standard practice of many national patent offices is incorrect, and that human medicinal products that are first authorised by the “centralised” (European Commission / European Medicines Agency) procedure should instead have SPC term calculated using the date of notification to the applicant of the European Commission's decision to issue a marketing authorisation. For some medicinal products this could lead to slightly longer (typically 2 to 4 days longer) SPC term.

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Supplementary protection certificates: is a new era beckoning for combination drugs in the EU?

09 August 2011

SCRIP Regulatory Affairs August 2011, 8-9
Authors: Michael Pears and Mike Snodin

This article appeared in the August 2011 edition of SCRIP Regulatory Affairs. It discusses Advocate-General Verica Trstenjak's opinion in joined cases C-322/10 (Medeva) and C-422/10 (Georgetown et al.). In particular, Michael and Mike point to aspects of the opinion that could provide a workable approach for dealing with supplementary protection for combination products. If adopted by the court, that approach could lead to substantial changes in practice in some territories, with resulting benefits for some SPC applicants / holders (increased availability of SPC protection and broader SPCs) and disadvantages for other SPC applicants / holders (possible invalidity of granted SPCs, or refusal of pending applications).

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Hopes rise for a bright future for paediatric SPC extensions in the EU

07 August 2011

SCRIP Regulatory Affairs August 2011, 7-8
Author: Mike Snodin

This article appeared in the August 2011 edition of SCRIP Regulatory Affairs. It reports that Advocate-General Yves Bot of the Court of Justice of the European Union essentially agrees with "Model A" of the 2007 RAJ Pharma article that Mike co-authored (which article was cited by the Bundesgerichtshof in their decision to refer questions to the Court of Justice in case C-125/10).

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2008

Making the Most of Paediatric SPC Extensions

10 June 2008

Regulatory Affairs Journal, Pharma, June 2008, 387-388
Authors: Mike Snodin and John Miles

This article appeared in the June 2008 edition of Regulatory Affairs Journal, Pharma. Following on from Mike and John’s ground-breaking 2007 RAJ Pharma article, the article reports the grant of the first ever negative term SPC by the UK Intellectual Property Office.

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2007

Making the Most of Paediatric SPC Extensions

11 July 2007

Regulatory Affairs Journal, Pharma, July 2007, 459-463
Authors: Mike Snodin and John Miles

This article appeared in the July 2007 edition of Regulatory Affairs Journal, Pharma. It is the first article to ever propose the revolutionary concept of zero or negative term SPCs. Mike and John argue that the acceptance of such SPCs is necessary in order to enable those conducting clinical trials in the paediatric population to benefit from a reward (a six-month extension of SPC term) provided by Regulation (EC) no. 1901/2006.

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