The Neurim CJEU decision of July 2012 has arguably caused an equal amount of excitement and controversy.  On the one hand, it seemed to open the door to supplementary protection certificates (SPCs) for second or further medical uses.  On the other, it seemed to go against a number of previous decisions.  On a strict literal interpretation of Article 3(d)[1] of the SPC Regulation[2], it should not be possible to obtain an SPC for new applications of old active ingredients that had already been the subject of a marketing authorisation.  In Neurim, based on a teleological interpretation to the SPC Regulation, the CJEU held that such an SPC could be validly granted.

A recent Opinion from Advocate General M. Giovanni Pitruzzella in the Santen SPC preliminary reference[3] urges the CJEU to expressly reject the Neurim decision, considering that the mere limitation of its application or marginalisation would not be a satisfactory option.

The facts in Santen

On 3 June 2015, Santen filed an SPC application relying on European Patent No. 057959306 as the basic patent in force (the “basic patent”) and on an EMA marketing authorisation granted on 19 March 2015 for the drug Ikervis (an eye drop emulsion containing the active ingredient ciclosporin used to treat severe keratisis).  The French National Institute of Industrial Property (“INPI”) rejected the application on the ground that a marketing authorisation had been previously issued for the same active ingredient for a medication called Sandimmun (an oral solution with several therapeutic indications including the eye disease uveitis, an inflammation of some or all of the uvea (the middle part of the eye)).

INPI held that the conditions in Neurim had not been satisfied for two reasons:

  • the basic patent was not limited to the severe keratisis indication – the claims included product only claims and claims to numerous other eye diseases; and
  • Santen had not demonstrated that the marketing authorisation constituted a ‘new therapeutic indication’ within the meaning of Neurim (for example, where the mode of action of the active ingredient differs or where the medical field differs).

Santen appealed the decision to the Paris Court of Appeal and it, in turn, decided to stay proceedings referring two preliminary questions to the CJEU.  The first question has asked the CJEU to consider how the concept of “different application” of an old active substance as understood in Neurim should be interpreted and the question provides a range of possible options from strict to broad interpretations.  The second question asks whether, in the context of determining whether the “[SPC application is] within the limits of the protection conferred by the basic patent” as understood in Neurim, the scope of the basic patent should be the same as the marking authorisation relied upon (i.e. it should be limited to the new medical use corresponding to the therapeutic indication of that marketing authorisation).

Less than six months after the preliminary reference was made by the Paris Court of Appeal, the CJEU had the opportunity to consider the scope and relevance of the Neurim decision in the Abraxis SPC case[4].  In that case the CJEU did not openly criticise the Neurim decision and, instead, limited its ramifications by referring to it as an “exception to the narrow interpretation of Article 3(d)” which “does not, in any event, refer to cases of new formulations of the product at issue”.

Continue Reading Santen SPC case: Advocate General Pitruzzella urges CJEU to reject Neurim

Opinion of the CJEU Advocate-General in Case C-581/18 RB v TÜV Rheinland LGA Products GmbH, Allianz IAED SA: application of the principle of non-discrimination on grounds of nationality in a medical device case.

Background

The effects of the Poly Implant Prothèse SA (PIP) defective breast implant scandal continue to be felt almost ten years since it first came to light that PIP had fraudulently used cheaper, industrial grade silicone in the implants that it manufactured. Due to PIP’s insolvency, those affected have attempted to obtain compensation from other sources, including the relevant notified body, TÜV Rheinland,[1] on the basis that this body had negligently certified PIP’s products and the French regulatory authorities.

Case against PIP’s insurer

The Opinion of Advocate-General Bobek in Case C-581/18 RB v TÜV Rheinland LGA Products GmbH, Allianz IARD SA concerns a German claimant (RB) who pursued a case for compensation in respect of defective breast implants in Germany against Allianz,[2] the insurers of the now-defunct PIP in France. Medical device manufacturers were required under French law to have insurance cover for harm suffered by third parties arising from their activities. PIP had a policy of cover with Allianz, but the cover was limited to damage caused in France. Allianz relied on that territorial limitation. RB maintained that the territorial limitation of insurance cover to French territory was not lawful and constituted an infringement of free movement of goods.

The German court referred the case to the Court of Justice of the European Union (CJEU), asking whether the territorial limitation in the Allianz insurance policy constituted a violation of Article 18 TFEU, which prohibits discrimination on the grounds of nationality.

Within the scope of EU law

Allianz and the French government argued that the case fell outside the scope of EU law on the basis that the issues involved a German patient who underwent surgery in Germany and were therefore purely internal to Germany. The Commission seemingly adopted a similar view.

Advocate-General Bobek disagrees, concluding that it is not possible to say that the situation in the present case falls outside the scope of EU law as it involved the cross-border movement of goods (PIP implants) and provision of services (insurance) in the context of the partial harmonisation of medical devices and liability for defective products under EU law.

Continue Reading Medical Devices and Compulsory Insurance in the EU

The UK government published its Medicines and Medical Devices Bill (the Bill) on 13 February 2020. The Bill seeks to introduce delegated powers which will allow the Secretary of State to amend or supplement the existing UK regulatory framework for medicines, medical devices, clinical trials and veterinary medicines at the end of the transition period for the UK’s departure from the EU (the Transition Period), which is currently scheduled for 31 December 2020. The Bill also consolidates and expands on the existing UK medical devices enforcement powers and provides for an information gateway to permit sharing of information held by the Secretary of State in relation to medical devices.

Continue Reading UK government publishes new draft legislation on medicines and medical devices

Yesterday, the Food Standards Agency (FSA), which regulates foods and food businesses in England, Wales and Northern Ireland, issued its long-awaited statement on CBD in foods.

In January 2019, the European Commission updated the Novel Food Catalogue to state that extracts of Cannabis sativa L. and derived products containing cannabinoids are considered as novel foods, as a history of consumption has not been demonstrated. As a result, all extracts of hemp and derived products containing cannabinoids (including CBD) are now regarded by the European Commission as novel. The FSA responded by stating that it accepted the conclusion of the Commission and was “committed to finding a proportionate way forward…to clarify how to achieve compliance in the marketplace in a proportionate manner”.

Following the UK’s departure from the European Union, the current rules on novel foods will continue to apply until 1 January 2021, when the transition period under the UK’s withdrawal agreement from the EU comes to an end. However, the FSA has now confirmed its position on enforcement and prescribed actions which it considers “are a pragmatic and proportionate step in balancing the protection of public health with consumer choice“.

Continue Reading Food Standards Agency announcement on CBD

Advocate General Kokott issued her opinion last week in the preliminary ruling referral from the UK Competition Appeal Tribunal (CAT). The CAT proceeding is itself an appeal against an infringement finding against a number of companies (except one, IVAX, which is now part of TEVA, which received a ‘No Grounds for Action’ letter).

AG Kokott finds that an agreement to settle a patent dispute may constitute a restriction of competition by object or by effect and that entering into such an agreement may be an abuse of a dominant position. This is in line with the General Court’s recent judgments in Perindopril and Lundbeck, but her views diverge on market definition where she seems to side with the CAT on a narrow, molecule-level definition.

Continue Reading Paroxetine: AG Rules on Reverse Payment Settlement Referral

On 13 December 2019, the European Medicines Agency (“EMA”) published a Questions and Answers document (“Q&A”) providing guidance on the conduct of comparability exercise for advanced therapy medicinal products (“ATMPs”). The Q&A addresses various regulatory questions that arise in situations in which companies developing or marketing ATMPs introduce changes to the manufacturing process and need to generate related comparability data.

Background

EMA’s experience suggests that changes to the manufacturing of ATMPs are “frequent” and even more so in the development of the medicinal product. These changes need, however, to be introduced in accordance with the Good Manufacturing Practices (“GMP”). Moreover, the changes may require a variation of the marketing authorisation for authorised ATMPs or substantial amendments to the clinical trial protocol for ATMPs used in clinical trials.

In addition, the changes to the manufacturing of the ATMP must be supported by the data generated in a comparability exercise. This exercise should focus on the characteristics of the ATMP prior and after the introduction of the manufacturing change. This is valid for both investigational ATMPs and authorised ATMPs.

The position of the EMA is that changes to the manufacturing of the ATMP should not undermine or impact adversely the quality, efficacy or safety of the medicinal product or the related risk-benefit balance. The objective of the comparability exercise is to facilitate the assessment and demonstration of this.

Continue Reading EMA Guidance on Comparability Exercise for ATMPs

You will be aware from previous posts that industry has been concerned for some time about the amount of work to be done to ensure compliance with the Medical Devices Regulation (MDR), and whether this can be completed by May 2020, the date of application of the Regulation. However, so far, the Commission’s response has been that the current deadline is “realistic and achievable” and that there were no plans to delay implementation.

This week, as an early Christmas present to industry, while there is no delay to the data of application of the MDR, there is some good news: a “corrigendum”, or correction, to the MDR, has been approved by the Parliament that adds certain Class I devices to those devices that benefit from the transitional period under the MDR. This will give manufacturers of certain Class I devices additional time to comply with the Regulations.

Continue Reading Delays to the EU Medical Devices Regulations

This is a follow up to our previous posts relating to the European Medicines Agency’s (EMA) various policies on access to documents. This continues to be an area of activity for the EMA and there have been a number of developments that have impacted the EMA’s position. Firstly, Brexit has directly affected one of the main pillars of the transparency activities of the EMA, namely the proactive publication of clinical trial data submitted by pharmaceutical companies in support of certain types of regulatory submissions to the Agency (the EMA’s Policy 0070).

Secondly, while the reactive transparency activities of the EMA relating to access to documents in accordance with Regulation (EC) No 1049/2001 (the EMA’s Policy 0043) have been less affected by Brexit, there may be other challenges for the EMA ahead.

Continue Reading Latest Developments in the Transparency Activities of the European Medicines Agency

EU law places strict controls on the use of nutrition and health claims on food labelling and in advertising. Under Regulation (EC) No 1924/2006 (the Regulation):

  • a nutrition claim is any claim which states, suggests or implies that a food has particular beneficial nutritional properties due to the energy and/or nutrients or other substances it provides or contains (e.g., “low fat” or “source of fibre”); and
  • a health claim is one which states, suggests or implies that a relationship exists between a food category, a food or one of its constituents and health (e.g., “Calcium is needed for the maintenance of normal teeth”).

Under the Regulation, it is only possible to use nutrition claims that are listed in the Annex to the Regulation, and/or health claims that have been authorised by the European Commission following a European Food Safety Authority scientific review. The only exception to these requirements is in relation to claims that are trade marks (or brand or “fancy” names) and general, non-specific health claims (e.g., “Good for you” or “Healthy”). These claims may be used without prior approval, provided they are accompanied by an approved claim (which, in the case of a general health claim, must be an authorised specific health claim, such as the calcium example given above).

Continue Reading Latest View on Health Claims on Foods in the EU

Earlier this month, the European Commission and representatives of the EU Member States discussed potential revisions to the European Commission’s Note on handling of duplicate marketing authorisation applications (the 2011 Note). According to the information published by the Commission, the discussion took place on 7 November 2019 during the latest Pharmaceutical Committee meeting. The discussion was intended to be focussed on duplicate marketing authorisations for biological medicinal products and the outcome of the related public consultation that took place in 2018.

Background

As we set out in our previous blog, the 2011 Note provides guidance on how the European Commission handles requests for duplicate marketing authorisations submitted through the centralised marketing authorisation procedure in accordance with Article 82.1 of Regulation (EC) No 726/2004 which was motivated by concerns that several MA’s granted for the same product could lead to partitioning of the market. As a general principle, the Regulation contemplates the existence of duplicate marketing authorisations only in two situations; first, where co-marketing with an independent company is envisaged and secondly “where there are objective verifiable reasons relating to public health regarding the availability of medicinal products to health-care professionals and/or patients”. In this latter case the Commission has required the applicant to demonstrate that the grant of a duplicate marketing authorisation will result in improved availability of the medicinal product in the EU. The 2011 Note states that, in principle, the grant on “public health” grounds of a duplicate marketing authorisation for a “first generic” granted to an originator (known as an “authorised generic” in the USA) is possible because of its potentially positive impact on the availability of the medicinal product.

Continue Reading Update on EU Duplicate Marketing Authorisations