Is there a future for medical devices? - an article

Many thanks to Nicholas Fischer and Andrew Hutchinson (Simmons & Simmons) for sharing their article (here) on SPCs for medical devices which was recently published in Bio-Science Law Review.  A summary of the article is set out below:

Supplementary Protection Certificates (SPCs) have on occasion been sought for medical devices, forcing granting authorities and courts across Europe to consider the question: are medical devices included within the scope of the SPC system? These cases have produced inconsistent outcomes. The European Commission's study into the SPC system and the new EU medical device regulations bring into the spotlight the scope of the SPC system and the regulatory regime relating to medical devices.  

This article reviews UK and European cases on the ability of the SPC system to be applied to medical devices and considers the main issues faced by such applications. It also considers whether now might be the time to introduce a new system for 'medical device SPCs'.

Compliance with Article 3(a): will Eli Lilly help? Here's a new article

News has reached us that a regular contributor to this blog -- and one of the speakers at the recent SPC Blog seminar (Mike Snodin, Park Grove IP) -- has published a new article in Scrip Regulatory Affairs. A copy of the article, entitled “Supplementary Protection Certificates: the never-ending saga of Article 3(a)”, which was first published online by Scrip Regulatory Affairs on 1 December 2014, can be viewed via this link.

Mike’s article explains why the ruling of the High Court, England and Wales, of July 2014 in Eli Lilly v HGS may well provide what the SPC community has sought for years, namely a test for compliance with Article 3(a) of Regulation 469/2009 that is not only simple and robust but which is also relatively straightforward to apply in a wide variety of cases.  However he also explains why, in his view, this is unlikely to be the end of the saga relating to Article 3(a). In this respect, Mike’s article 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.  While one of those alternative interpretations is perhaps not fundamentally inconsistent with the extent of protection test used by the High Court, Mike’s view is that 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 High Court.  Fortunately, however, Mike also outlines in his article the reasons why he believes that more challenging interpretation must be wrong and why the High Court’s extent of protection test must prevail –- at least for now.

The Court of Justice: who needs it? A new article

New has reached The SPC Blog of the latest publication by Mike Snodin of Park Grove IP (a copy of which can be viewed here). On this occasion, Mike’s article (“The CJEU – for supplementary protection certificates, who needs it?”) discusses the arguments for and against the use of Notification Date for “centralised” marketing authorisations (MAs) and explains why the arguments against, as typified by a decision of the Danish Patent Office, are fatally flawed.

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!

More references, more gaps?

... unless it has been
caused by the CJEU

"Two gaps instead of one: the CJEU's effect on Supplementary Protection Certificate jurisprudence" is the title of the June 2014 Guest Editorial in the Journal of Intellectual Property Law & Practice (JIPLP), written by editorial board member and patent attorney Darren Smyth (EIP, London). In keeping with normal JIPLP practice, the full text of this editorial is posted on the journal's informal jiplp weblog, here.

Darren concludes:

"You have all the guidance from the CJEU you are going to get. Every referral you make will result in more “gaps”, not fewer, in the legislative framework. Decide some cases; aim for consistency; but if there happen to be some anomalies, well, it is better than spending the time, effort, and money on a referral that will simply make the issues more complex than they were to begin with".

The trio of Article 3 CJEU decisions from December 2013: a new article

News comes from our good friend and occasional contributor Mike Snodin (Avidity IP) that an article of his has recently been published in the Journal of Intellectual Property Law & Practice (JIPLP).  The article 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). While 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.

This useful six-pager can be accessed by clicking this link.

JIPLP has proved to be a rich source of articles and current intelligence notes on SPCs since it was launched at the end of 2005. Could it be anything to do with the fact that this blogger is its editor?  At any rate, you can get an idea of the range items addressing SPCs by clicking here.  Mike has previously published in JIPLP, as have many other readers of or contributors to this weblog.

Vaccines and SPCs: a fork in the road - now you can read it

Yesterday The SPC Blog mentioned the recent publication of a piece by Simon Cohen and Paul England and expressed the hope that we would be able to host it for the edification of our readers. Well, not only have Lawtext Publishing kindly sent us a pdf, which you can read here, but we received a comment from Anonymous Steve, who wrote:

"I believe that the full text of this article is available from Taylor Wessing using the following link: https://www.taylorwessing.com/fileadmin/files/docs/Vaccines_and_spcs_law_review.pdf".

He's quite right, it is! Thanks, Steve.

Vaccines and SPCs: a fork in the road

The latest issue of the Bio-Science Law Review, published every so often by Lawtext Publishing Ltd, "Vaccines and SPCs: The CJEU Reaches a fork in the Road". The authors are Simon Cohen and Paul England, from the London office of international law and IP practice Taylor Wessing LLP, London. According to the abstract:

"The use of vaccines in the prevention of disease is nothing new and they are often protected by patents and supplementary protection certificates ("SPCs"). However, in more recent times, two developments have taken place: 

(i) guidance has come from regulators that treatment of populations with vaccine combinations is preferred to single vaccines, and  

(ii) there has been an increased need to use adjuvants with vaccines to improve their efficacy. 

Both of these developments have placed strain on the legislative regime governing SPC protection (the "SPC Regulation"), which whilst intended to supplement patents for the protection of investment in medicinal products, was not drafted with such combinations in mind. 

Deciding whether certain classes of medicinal products should be protected by SPCs and, at the same time, maintaining a clear and consistent application of the SPC Regulation has been difficult for the courts. One UK Court of Appeal judge was forced to state that the SPC regime risks failing large areas of pharmaceutical research, making it 'not fit for purpose'. In addition, a UK High Court judge has said that it is "dysfunctonal'. However, until very recently, the interpretation of the SPC Regulation on the subject of SPC protection for combination, including vaccines, had achieved a measure of clarity for makers of combination products. However, an apprent attempt by the Court of Justice of the European Union in Nurim to respond to the commercial argument for wider protection by SPCs expressed by the Court of Appeal judge, has now caused disarray. In that case the court used a so-called teleological approach to theinterpretation of the SPC Regulation that appears to contradict earlier case that were thought to have settled on a strict approach. It is this disarray that caused the frustration expressed by the latter High Court judge and a further reference the the CJEU. 

The case referred, GlaxoSmithKline Biologicals v Comptroller-General of Patents, is where these issues have now come to a head. It concerns vaccines again - adjuvant and vaccine combinations - and takes the SPC regime to a fork in the road: the CJEU can choose to go the new teleological route, or stick to the strict approach. Whichever way the CJEU chooses to go it is likely to have far-reaching commercial consequences for certain medicinal products, such as vaccines, and the pharmaceutical industry in general".

This blog will use its good services to see if it can persuade the publisher -- who has been kind to us in the past -- to let us host the entire text of this piece.

Recent developments: a new article

Published later this week in volume 12, issue 4, of the Bio-science Law Review is this 12-page article by Gertjan Kuipers, Tjibbe Douma and Margot Kokke (De Brauw Blackstone Westbroek, Amsterdam). In addition to the text, this general survey, entitled "Recent European Developments Regarding Patent Extensions (SPCs and Paediatric Extensions)", has some useful tabular representations.

The SPC Blog wishes to thank the BSLR's publisher, Lawtext, for agreeing to let our readers see this ahead of its publication date.

Case comment now available online

Last Thursday The SPC Blog posted a notice concerning a case comment by Mike Snodin, John Miles and Michael Pears (all of Potter Clarkson’s SPC & Regulatory Group), published in Lawtext's Bio-Science Law Review (BSLR).  This case comment discusses the Medeva (C-322/10) and Georgetown et al. (C-422/10) decisions of the Court of Justice of the European Union, as well as three further cases which were decided by reasoned order (Yeda, Daiichi and Queensland).

This blogger has since contacted the proprietor of Lawtext Publishing, who has kindly agreed to make the case comment freely available to readers of this weblog, even if they are not subscribers to the BSLR. You can now read it in full here.

Thanks, BSLR, for this very kind gesture.

Court of Justice rulings and combination products: an article

Volume 12, Issue 2 of Lawtext Publishing's Bio-Science Law Review contains an article from Mike Snodin, John Miles and Michael Pears (all of Potter Clarkson’s SPC & Regulatory Group) entitled “Supplementary protection certificates: The CJEU issues its decision in two seminal cases”. This article discusses the Medeva (C-322/10) and Georgetown et al. (C-422/10) decisions, as well as the three further cases decided by reasoned order (Yeda, Daiichi and Queensland). In the article, Mike, John and Michael conclude that likely consequences of the Medeva and Georgetown et al. decisions in the short to medium term will include:

“• National courts will invalidate SPCs to combination products that have been granted on the basis of the ‘infringement test’ but where the active ingredient(s) are not specified in the wording of the claims of the basic patent. 

• More SPC applications will be filed in which the product is defined as one or more (but not all) of the active ingredients present in the authorised medicinal product. 

• Subject to confirmation in Case C-442/11 of the Court of Justice’s comments on point (C) above, national courts will enforce SPCs to single active ingredients against the manufacturers of generic versions of combination products containing a protected active. 

• Generic manufacturers will delay launch of combination products until SPCs to the individual actives have expired (or have been invalidated). 

Further, although it is a point of view that may not be shared by all practitioners, the authors believe that the decisions may not lead to any changes in established practices with regard to the numbers of SPCs granted for basic patents that protect more than one product.”

In relation to the latter issue, the article points to the similarity in wording between the Biogen decision and the Medeva and Georgetown et al. decisions in respect of comments on the number of SPCs that may be granted for each basic patent, and questions whether any change to the status quo was really intended by the Court of Justice on this issue.

The article also discusses possible longer term implications of the decisions, and suggests that further judicial interpretation will be required in order to clarify what is meant by “specified (or identified) in the wording of the claims” - particularly in connection with patent applications that can be argued to “specify” both a novel active ingredient (A) and the combination of that active with another, specific active ingredient (i.e. A+B).

Mike, John and Michael conclude the article by saying:

“Putting aside the issues where there is a need for further clarification, the Medeva and Georgetown et al. decisions should be welcomed by the pharmaceutical and agrochemical industries as representing a carefully balanced approach that rewards genuine innovation with an appropriate degree of protection.”

The points mentioned above are all explained in more detail in the article.

Dawn of a new era? The AG's Opinion in Georgetown and Medeva

"Supplementary Protection Certificates: is a new era beckoning for combination drugs in the EU?" is the title of an article by Michael Pears and Mike Snodin (both of Potter Clarkson) which has recently been published in Scrip Regulatory Affairs. This article, which considers the effects of Advocate General Trstenjak's Opinion in Joined Cases C-422/10 Georgetown University and C-322/10 Medeva,  concludes with the following observations.

"Although the Advocate General seems to be ruling out an infringement test to establish whether a product is protected by a basic patent under Article 3(a), the precise test to be used remains unclear. At least some form of disclosure of each active ingredient of a product appears to be necessary, but how specific this must be is not known.

What is clear from the opinion, however, is the proposal for SPCs to be obtained for a patented part of authorised products containing a combination of active ingredients. In reaching this conclusion, the advocate general has obviously recognised the importance of providing SPC protection for active ingredients which are first authorised in combination with other active ingredients.

If the CJEU follows the opinion, the narrow interpretation of what is “protected” by a basic patent may mean that some granted SPCs are invalid. On the other hand, the more permissive interpretation of what represents a valid authorisation could provide new opportunities for obtaining useful (and very broad) SPC protection.

Overall, the above-mentioned aspects of the A-G’s opinion provide what seems to be a workable approach for obtaining SPC protection for combination products.

While the facts of the Medeva and Georgetown et al cases relate to combination vaccines, the issues apply equally to other areas of human and veterinary medicine and also in agriculture. Indeed, an increasing trend to authorise medicines and plant protection products in combination suggests that the Court’s decision may have far-reaching consequences. The final judgement will therefore be eagerly anticipated".

You can read this article in full here.

Uncertainty and disharmony: an overview

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

Those four ECJ references: a short article

Via Neil J. Wilkof (Herzog Fox Neeman) comes news of "A Combination Problem - Scope of Protection of Supplementary Protection Certificates (SPC)". This article, penned by David Rose (partner and Head of Life Sciences at SJ Berwin LLP) is an earlier version of a piece which appeared in Scrip Pharma Law.

This three-page article, which you can access here, summarises the focal points of the four England and Wales SPC cases which have been referred for preliminary rulings by the Court of Justice of the European Union, emphasises their importance in defining the balance between the two sides of the pharma industry and doubts that the outstanding questions will be resolved in the course of this calendar year.

Medeva note in latest BioSLR

The Bio-Science Law Review, published six times a year by Lawtext Publishing Ltd, often carries features relating to SPCs. The current issue -- volume 11, issue 1 -- is no exception. It carries a case comment by Sangeeta Puran (Mayer Brown International LLP) entitled "Reference to ECJ in Medeva BV v The Controller General of Patents concerning the conditions to be satisfied for the extension of patent term of patents for medicinal products in the EU". The abstract of this case comment reads as follows:

"In the EU, the term of a national patent or a European patent for drug products is extended through the grant of a supplementary protection certificate. This is governed by Council Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products.

The system recognises that significant periods of the 20 year patent term are lost due to the time it takes to obtain marketing authorisation for a new drug. The Court of Appeal has recently referred to the ECJ questions concerning the conditions that must be satisfied for the grant of a supplementary protection certificate, including whether it can be granted in relation to a patent which does not disclose all the active substances or components in the marketed drug. The current UK approach precludes an extension in such a case because the patent cannot be construed to "protect" the product as required by the regulation, even where the product and patent pass the "infringement test", that is the manufacture or supply of the product would infringe the patent. Other Member States, however, have adopted the infringement test, resulting in an important divergence in the approaches within the EU in respect of the same application for supplementary protection and resulting in dicta repeatedly calling for clarification by the higher court. This case note considers the issues that have led to the current reference to the ECJ and the diverging constructions that will be considered by it when determining the correct approach for patent term extension in the EU".

This piece features two useful figures, one being an example of a project lifecycle curve viewed from a cash flow perspective, the other being a graphic representation of the active ingredients/substances in the Medeva proceedings as they relate to the basic patent. marketing authorisations and SPC products.

Patent extensions: some academic perspectives?

The John Marshall Review of Intellectual Property Law (RIPL) has now published issue one, volume 10 (you can view it here). In the first of its four lead articles, Verne Luckow and Steven Balsarotti write about their empirical study on patent applicants seeking longer patent term adjustments (PTAs).  This study concludes that an understanding calculations behind patent term extensions is the key to the development of licensing and ownership strategies for patented technologies. While this article deals with US extensions relating to delays in grant caused by USPTO bureaucracy, not to European-style SPC extensions, one of the authors' findings will interest readers of this weblog because it indicates judicial attitudes towards the pharma sector as well as signalling originating pharma's intentions with regard to its proprietary technology:

"... Despite the intent of Congress to compensate applicants for delays in prosecution in an industry-independent manner, applicants seeking reconsideration of a patent term adjustment in Federal District Court are highly-biased toward institutions seeking patents on pharmaceutical and related biotechnology inventions. Unlike patent term extensions, which are sought in a six-month period prior to regulatory approval and sale of a pharmaceutical product, and often long after a patent has issued claiming the product, court cases identifying patents needing longer PTAs provide early notice to the public, including investors and competitors, of technologies considered to have particular value to the applicant. ...".

Professor Reichman

The SPC Blog has learned that, this Monday, the distingushed US academic Professor Jerome H. Reichman (Duke University School of Law, Durham, North Carolina), gave a lecture at CEIPI in Strasbourg on "Patents and Public Health: Legal, Economic and Public Policy Aspects of Access to Medicines". If any reader of this was present, can he or she let us know whether this lecture covered the public health and policy aspects of patent term extension, so that we can contact Professor Reichman if necessary and ask for a copy of what he said?

Paediatric extensions: another article

The April 2010 issue of Sweet & Maxwell's monthly European Intellectual Property Review (EIPR) contains an article by Dr Ulrich Reese, Dr Claudia Milbradt and Dr Christian Stallberg (Clifford Chance, Dusseldorf) entitled "The Legal Scope and Content of the Right to SPC Extension under the Paediatric Regulation 1901/2006".

This piece is based on a position paper prepared on behalf of the German Association of Research-Based Pharmaceutical Companies (vfa). The authors explain the objectives of the Regulation and seek to clarify the conditions under which such an extension must be granted.

SPCs and RDP compared

The SPC Blog has just spotted a recent general interest article, "The Supplementary Protection Certificate for Medicinal Products: An Update", written by Carla Schoonderbeek (NautaDutilh) for Who's Who Legal. The article contrasts SPC protection and paediatric extensions with Regulatory Data Protection (RDP) and concludes:

"The SPC has proven an effective instrument in protecting innovation for medicinal products. The most important difference with the instrument of RDP is the duration of the protection. Both RDP and SPC use the first marketing authorisation date as the starting point for the protection period, but RDP is limited to 10 or 11 years, and an SPC can stay valid until 15 years have elapsed.

A disadvantage of both SPC and RDP is that both use the first original marketing authorisation for a specific medicinal product as the basis for protection. The major importance of incremental development of medicinal products after their first marketing is not recognised by either protection mechanism. This may lead to ‘orphaning’ of medicinal products, which could have been extremely useful for different applications other than the one they were originally authorised for, because it is difficult for industry to invest in know-how that will not lead to additional returns".

New note on DuPont application for losartan

A Current Intelligence note on EI Du Pont Nemours & Co. v United Kingdom Intellectual Property Office [2009] EWCA Civ 966, 17 September 2009, by Sebastian Moore and Jonathan Turnbull (Herbert Smith) and entitled "Paediatric extension applications: substance and timing" appears in the current issue of the Journal of Intellectual Property Law and Practice (JIPLP). You can read this note in full on JIPLP's weblog here.

Paediatric exclusivities: a new article

Pediatric Exclusivities in Europe -- a Quest for the Grail?' is the title of an article by Geneviève Michaux (of Counsel. Covington & Burling LLC, Brussels, Belgium), which has recently been published in 64 Food and Drug Law Journal, 631-662 (2009). According to the abstract,

"This article examines the rules applicable to pediatric rewards and their interpretation by the competent European authorities, i.e. the European Commission and the EMEA, and national authorities, i.e. the national Medicines Agencies and patent offices, in particular in relation to medicinal products that are approved at the national level. Depending on the patent protection of the active substance or status of the medicinal product, the reward for pediatric development is an extension of the term of the supplementary protection certificate (“SPC,” the EU equivalent of the patent term extension) or, where the medicinal product has been designated as an orphan, an extension of the term of the market exclusivity (the EU equivalent of the orphan exclusivity). Where the active substance is not or no longer protected by a patent or an SPC, the pediatric obligation is optional and the pediatric research is rewarded by data exclusivity (the EU equivalent of market exclusivity) for the new pediatric data through the grant of a pediatric use marketing authorization (PUMA). Except for the PUMA, the pediatric rewards are subject to stringent substantive requirements, in particular the approval of the medicinal product in all the EU Member States and the so-called “PIP compliance,” i.e., the implementation of the agreed PIP".

To obtain a full text version of the article, or a copy of an entire issue, you must contact FDLI’s Customer Service Department by email at CSDept@fdli.org which says: "Your purchase will be processed quickly, and at reasonable rates".

Paediatric extensions: a major article

"Fostering paediatric research and the right to extend supplementary protection certificates" is the title of a ten-age article in the Journal of Intellectual Property Law & Practice (JIPLP). The authors are Montserrat López-Bellosta and Ana Benetó Santa Cruz (both of Clifford Chance). The online version of this article has been available to JIPLP subscribers since 10 December and the paper version will soon be available too.

According to the article's abstract,

"Legal context: This article analyses Article 36 of EC Regulation 1901/2006 on medicinal products for paediatric use. Among the incentives for promoting paediatric research set out by this Regulation is the possibility of obtaining a 6-month extension to the Supplementary Protection Certificates, given that the conditions set out in Article 36 are met. Granting SPC extensions is reserved to the competent authorities of the EC Member States, this has led to various interpretations of Article 36.

Key points: The article discusses the interpretations of the requirements established by Article 36 for obtaining an SPC extension, concluding that the means of proving compliance with an agreed paediatric investigation plan are not limited to the statement set forth in Article 28.3 of Regulation 1901/2006, and that the required authorizations in all Member States must not necessarily have been granted on the basis of studies carried out according to an agreed paediatric investigation plan. Finally, the article analyses the moment at which an applicant should meet the requirements of Article 36.

Practical significance: The authors argue in favour of an interpretation of Article 36 that avoids introducing factors beyond applicants' control when considering whether the requirements for an SPC extension are met, and which is in line with the underlying objectives of the incentives established by Regulation 1901/2006. The compensation (obtaining an SPC extension) is for performing studies carried out according to an agreed paediatric investigation plan, not for obtaining marketing authorizations".