Patent and Pharma Update, February 2020

Key recent developments in the United Kingdom and Europe relating to patents and the pharmaceutical sector

In this issue we report on the Supreme Court decision of Shanks v Unilever on employee inventor compensation. We update on two CJEU decisions relation to public access to documents submitted to the EMA and a key competition decision on “pay-for-delay” agreements. We cover a string of patent-related UK Court of Appeal cases, including Ablynx v VHSquared on jurisdiction, Anan Kasei v Neo on insufficiency and joint tortfeasorship and L’Oreal v Liqwd on claim amendments and admission of late evidence. We provide brief updates from the EPO on the recent CRISPR priority decision, as well as its AI inventorship decision. We have bumper SPC and FRAND updates covering key Court of Appeal and CJEU decisions in respect of SPCs and a string of interesting interim decisions in the UK in the case of FRAND. We round off the issue with a link to our new IP podcast series and updates on Brexit and the UPC. Continue reading

CJEU AG’s Opinion in Santen referral proposes to abandon Neurim

CJEU’s AG in Santen referral (C-673/18) invites the Court to make a clear choice between reversing Neurim (main proposal) or extending the interpretation of the concept of ‘product’ in order to achieve the result sought in Neurim (alternative proposal)

On 23 January 2020, AG Giovanni Pitruzzella provided his Opinion on the interpretation of Article 3(d) 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 (“SPC Regulation“).

In doing so, AG Pitruzzella makes two proposals to the CJEU.

His favoured proposal would significantly curtail the availability of SPCs for second medical uses of known and previously authorised compounds, as it strictly interprets the meaning of ‘product’ under Article 1(b) and precludes an interpretation of Neurim according to which a marketing authorisation (“MA”) for a “different and new application of an old active ingredient” could be considered as the first MA of a previously authorised active ingredient.

His alternative proposal permit SPCs in a wider set of circumstances by interpreting Neurim as allowing an SPC to be granted if the new MA “covers a new therapeutic indication of said active ingredient or relates to a use of it in which this active ingredient exerts a new pharmacological, immunological or metabolic action of its own”.

Business impact

Article 3(d) of the SPC Regulation provides that an SPC cannot be granted if there has been an earlier MA for the same ‘product’ (ie, the active ingredient or active ingredients of the medicinal product under Article 1(b) of the SPC Regulation). However, the CJEU in Neurim (Case C-130/11) held that Article 3(d) did not preclude an SPC from being granted for a different application for human use of a product that had been previously authorised for a veterinary use, provided that the SPC application is based on a patent for which that second medical use falls within the limits of its protection.

The CJEU’s decision in Neurim was seen as a departure from its earlier case law (Yissum (Case C-202/05) and Pharmacia Italia (Case C-31/03)), as it did not strictly interpret Article 3(d) and indicated that SPCs were available for second medical uses of known active ingredients. This interpretation in Neurim was subsequently resumed notably in paragraph 27 of the CJEU’s decision in Actavis v. Sanofi (C-443/12). This was an encouraging development for the pharmaceutical industry and was an incentive to invest significantly in researching and developing new indications for known products that improve the treatment of patients and save lives.

However, in March of last year, the CJEU held in Abraxis (Case C-443/17) that an SPC could not be obtained for new formulations of previously approved active ingredients, with this following the Opinion of AG Saugmandsgaard Øe that suggested that the “Neurim exception” was limited to the “particular, and probably exceptional, kind of situations at issue in Neurim“ (see our update here). As a consequence, there is uncertainty as to the circumstances in which an SPC can be obtained for a second medical use of a known active ingredient and guidance is needed from the CJEU.

If the Grand Chamber of the CJEU follows the AG Giovanni Pitruzzella preferred proposal then this will severely limit the application of the “Neurim exception” and the availability of SPCs for second medical uses of known and previously authorised products and be a disappointing result for R&D based pharmaceutical companies.

Background

A reference was made to the CJEU by the Paris Court of Appeal following its decision of 9 October 2018. That case related to Santen’s French SPC application (No. 15C0040), which is based on the European Patent, EP 1 809 237 (entitled ‘Ophthalmic oil-in-water type emulsion with stable positive zeta potential’) and a centralised MA for the medicinal product, IKERVIS®. IKERVIS® contains as its active ingredient 1 mg/ml cyclosporine in the form of an emulsion, which is administered as an eye drop for the treatment of severe keratitis in adult patients. Originally the SPC application was for ‘cyclosporine eye drops, emulsion’, but following observations from the French Patent Office this was amended to ‘cyclosporine for use in the treatment of keratitis’.

Prior to the grant of the centralised MA for IKERVIS®, an MA had been granted for the medicinal product SANDIMMUN®, which contained as its active ingredient 100 mg/ml of cyclosporine in the form of an oral solution for the prevention of rejection of solid organ and bone marrow grafts, and for the treatment of endogenous uveitis (an inflammation of some or all of the uvea, which is the middle layer of the eye).

In light of the earlier authorisation for SANDIMMUN®, the French Patent Office rejected Santen’s SPC Application in its decision of 6 October 2017 and held that the requirements in Neurim were not satisfied as: (i) EP 1 809 237 protected not only a new use of cyclosporine (claims 23 to 24) but also types of ophthalmic emulsions of cyclosporine (claims 1 to 21 and 25 to 26); and (ii) the medical use of IKERVIS® was not a new therapeutic use of cyclosporine within the meaning of Neurim, as the therapeutic use of SANDIMMUM® was also for the treatment of ophthalmic inflammations.

The French Patent Office argued that the grant of an SPC is designed to be an exceptional reward for innovative medicinal products, such that several conditions must be satisfied and that Neurim must be narrowly applied. Despite arguing for a narrow application of Neurim, the French Patent Office did not want to limit its application to its specific facts (ie, where a human use follows a veterinary use). The French Patent Office therefore held that an SPC can be obtained if it relates to medicinal product that has a new therapeutic scope. The new therapeutic scope arising from either a medicinal product containing a new active ingredient, or from a medicinal product containing a known active ingredient utilising a different mode of therapeutic action when compared to the earlier authorisation.

On appeal, the Paris Court of Appeal noted the disagreement between Santen and the French Patent Office on the correct interpretation of the CJEU’s decision in Neurim. It also noted that “both medicinal products [in suit] relate to the treatment of inflammation of parts of the eye in humans, using the same anti-inflammatory mechanism of cyclosporine” and that both IKERVIS® and SANDIMMUM® “differ in their therapeutic indications and in their formulation, dosage and posology“, and that “it is not disputed that the [indications of both medicinal products relate to] different diseases, affecting different parts of the eye“. Given the uncertainty over the application of Neurim and when an SPC is available for a different application of a known active ingredient, the Paris Court of Appeal referred the following questions to the CJEU:

Must the concept of a ‘different application’ within the meaning of the judgment of 19 July 2012, Neurim (C-130/11, EU:C:2012:489), be interpreted strictly, that is to say:

–    as limited only to the situation where an application for human use follows a veterinary application;

–    or as relating to an indication within a new therapeutic scope, in the sense of a new proprietary medical product, compared with the earlier marketing authorisation, or a medicinal product in which the active ingredient acts differently from how it acts in the medicinal product to which the first marketing authorisation related;

–    or more generally, in the light of the objectives of Regulation (EC) No 469/2009 of establishing a balanced system taking into account all the interests at stake, including those of public health, must the concept of a “new therapeutic use” be assessed according to stricter criteria than those for assessing the patentability of the invention;

–    or must it on the other hand be interpreted broadly, that is to say, as including not only different therapeutic indications and diseases, but also different formulations, posologies and/or means of administration?

Does the expression “[application] within the limits of the protection conferred by the basic patent” within the meaning of the judgment [of the Court of Justice] of 19 July 2012, Neurim (C-130/11, [EU:C:2012:489]), mean that the scope of the basic patent must be the same as that of the marketing authorisation relied upon and, therefore, be limited to the new medical use corresponding to the therapeutic indication of that marketing authorisation?” 

Analysis

In his Opinion for the Grand Chamber of the CJEU, AG Giovanni Pitruzzella highlights that the CJEU’s decision in Neurim was out of line with its earlier case-law on the meaning of ‘product’ in Article 1(b) of the SPC Regulation. He emphasises that the use in Neurim of the undefined expressions “new therapeutic application”, “new use”, “different application” or “other therapeutic indication” rises several possible interpretations of this decision.

In light of this, AG Giovanni Pitruzzella considers the implications of the conclusions of Neurim, its departure from the CJEU’s earlier case-law and the subsequent case-law of the CJEU.

Considering the earlier case law, AG Giovanni Pitruzzella highlights the CJEU’s decision in Yissum where the CJEU held that “the concept of ‘product’ cannot include the therapeutic use of an active ingredient protected by a basic patent”. In his view, the CJEU’s decision in Neurim “dissociated” the concept of a ‘first MA’ from the concept of a ‘product’ under Article 1(b) of the SPC Regulation in order for it to be linked to the concept of ‘basic patent’ under Article 1(c) of the SPC Regulation. The cases following Neurim, then reaffirmed a strict definition of ‘product’, whilst at the same time acknowledging that Neurim permitted SPCs for new therapeutic indications of an old active ingredient (see GSK (Case C-210/13) and Georgetown (Case C-484/12)). This was the position until the recent decision of the CJEU in Abraxis, which in AG Giovanni Pitruzzella’s view, upheld a “different and inconstant interpretation of Article 3(d)” compared to Neurim, whilst not reversing that earlier decision. To resolve this position, AG Giovanni Pitruzzella’s recommendation to the CJEU is that it should not limit Neurim to a narrow exception on its facts, but that it should make a clear and definitive choice between either reversing Neurim or departing from a strict definition of the meaning of ‘product’ under Article1(b) of the SPC Regulation.

AG Giovanni Pitruzzella’s preference is for the CJEU to maintain a strict definition of ‘product’ and for the CJEU to reverse its decision in Neurim, as electing any criterion other than a chronological one for determining the first MA would be contrary to the clear drafting of Article 3(d). In the alternative, to permit SPCs for second medical uses of previously authorised products under Article 3(d) would require that the CJEU adopt a broader, less strict interpretation of ’product’ under Article 1(b).

Over several pages of his Opinion, AG Giovanni Pitruzzella considers the need for the CJEU to define “which type of research is encouraged” by the SPC Regulation and the current ambiguity that exists on this topic. In his Opinion, the reward of an SPC was not created for any kind of research, but he recognises the inconsistencies of the CJEU’s statements in Neurim and Abraxis. In doing so, he quotes and appears to endorse the CJEU’s statement in Abraxis that “the legislature intended, in establishing the SPC regime, to protect not all pharmaceutical research giving rise to the grant of a patent and the marketing of a new medicinal product, but to protect research leading to the first placing on the market of an active ingredient or a combination of active ingredients as a medicinal product”. AG Giovanni Pitruzzella therefore concludes that the SPC system should be consistent, easy and transparent, such that it achieves the correct balance of interests between the various stakeholders, and that this was not achieved in Neurim which “altered this balance in favour of pharmaceutical companies”. This, in his view, supports his preferred recommendation to the CJEU to reverse the decision in Neurim and maintain a strict definition of ‘product’.

Should the CJEU not agree with this conclusion, in the alternative, AG Giovanni Pitruzzella proposes that the correct balance needs to be found between strictly limiting the availability of SPCs to situations where a human use would follow a veterinary use and permitting SPCs for any subsequently authorised products that included the same active ingredient, such as new formulations, posologies or modes of administration. In his view, the correct balance is found if the MA on which the SPC is based “covers a new therapeutic indication of said active ingredient or relates to a use of it in which this active ingredient exerts a new pharmacological, immunological or metabolic action of its own.

A translation of the conclusion of AG Giovanni Pitruzzella’s Opinion, which is not currently available in English, is:

In light of all of the foregoing considerations, I suggest that the Court, mainly, respond to the Paris Court of Appeal (France) as follows:

Article 3(d) […] read in conjunction with Article 1(b) […] must be interpreted as meaning that the marketing authorization referred to in Article 3(b) of that regulation, relied upon in a supplementary protection certificate application relating to a different and new application of an old active ingredient, cannot be considered to be the first marketing authorization for the product in suit as a medicinal product when this active ingredient has already been the subject of such an authorization per se.

In the alternative, in the event that the Court decides to proceed to the interpretation of the Neurim decision, I propose that the Court answer the questions referred by the Paris Court of Appeal as follows:

1) Article 3 […] must be interpreted as meaning that the grant of a supplementary protection certificate for a different application of an active ingredient for which a previous marketing authorization has been granted in the Member State concerned, within the meaning of the decision of 19 July 2012, Neurim Pharmaceuticals (1991), (C-130/11, EU: C2012: 489), requires that the marketing authorization relied upon to apply for a supplementary protection certificate covers a new therapeutic indication of said active ingredient or relates to a use of it in which this active ingredient exerts a new pharmacological, immunological or metabolic action of its own.

2) Article 4 […] must be interpreted as meaning that, in the case where the supplementary protection certificate relates to a different application of an old active ingredient, the concept of ‘product’, in the meaning of this provision, designates only said application and does not extend to the active ingredient as such or to other applications thereof.

Frederic Chevallier
Frederic Chevallier
Partner, Paris
+33 1 53 57 13 60

CJEU refuses UK High Court’s request for preliminary ruling on SPC applications based on third-party MAs, on account of referred question being “hypothetical” (C-239/19 Eli Lilly v Genentech)

On 5 September 2019, the Ninth Chamber of the CJEU refused a request for referral in relation to the interpretation of Article 3(b) 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 (‘SPC Regulation‘).

Business impact

In its order, the CJEU held that this request for a preliminary ruling was manifestly inadmissible a under Article 52(3) of the Rules of Procedure of the Court of Justice, as the question referred was hypothetical for the purposes of the dispute in the main proceedings.

The referral request was made by High Court of Justice (England and Wales) in proceedings [2019] EWHC 388 (Pat) between Eli Lilly and Genentech. The referral was concerned with whether the SPC regulation should preclude SPC applications based on third-party marketing authorisations (‘MAs‘), which is where a patent holder seeks to obtain an SPC for a product without the consent of the unrelated third party that has developed that product and obtained the necessary a MA for it.

This issue is not a new one, and was previously referred to in Eli Lilly v HGS (C-493/12). Although it was not being pursued as a standalone ground, the CJEU decision observed in this case that if an SPC were granted to the patent holder, even though he was not the holder of the MA granted for the medicinal product developed from the specifications of the patent, and had therefore not made any investment in research relating to that aspect of his original invention, that would undermine the objective of the SPC Regulation. In a similar vein, in Gilead v Teva (C-121/17; a case that did not concern grant of SPCs based on third-party MAs) the CJEU held in paragraph 50 of its decision that when applying Article 3(a) of the SPC Regulation no account should be taken of research which took place after the filing date or priority date of the basic patent, as this would enable the SPC holder to unduly to enjoy protection for those unknown results.

The refusal of the reference means that disappointingly, the rather important question of SPC applications based on third-party MAs remains unanswered. Nevertheless, it is likely that there will be a further reference on this issue in the future, perhaps from one of the other national courts where the dispute between Eli Lilly and Genentech remains live, or from the Court of Appeal in the UK (should this happen before Brexit).

Background

The referral request was made by the UK High Court in proceedings which related to Genentech’s patent EP (UK) 1 641 822, entitled ‘IL 17A/F heterologous peptides and therapeutic uses thereof’ (the ‘Basic Patent’) and Eli Lilly’s MA for their product ‘ixekizumab’ marketed under the brand name ‘Taltz’.

Genentech contended that the formulation for ixekizumab fell within the scope of the Basic Patent, and applied for an SPC on the basis of the Basic Patent and Eli Lilly’s MA for ixekizumab.

Eli Lilly in turn contended that two grounds precluded the grant of the SPC: 1) the SPC application at issue did not comply with Article 3(a) of the SPC regulation, since the formulation for ixekizumab was not protected by the Basic Patent; and 2) the application did not comply with either Article 2 or Article 3(b) and (d) of the SPC Regulation, because the MA for ixekizumab is not a relevant MA, since it is owned by a third party and was relied upon without that party’s consent.

By the time the referring decision as handed down, the Basic Patent had already been held to be invalid in parallel proceedings. Nevertheless, Mr Justice Arnold considered it necessary to make a referral to the CJEU on whether the SPC Regulation should preclude SPC applications based on third-party MAs. Various factors played a role in making the referral:

  1. Even though the Basic Patent had been held to be invalid in parallel proceedings, it may be maintained on appeal;
  2. Because of Brexit, it is highly probable that the Court of Appeal will cease to have jurisdiction to refer a question for a preliminary ruling to the Court of Justice, so it was considered necessary that the High Court refer such a question now;
  3. As of the date of the reference decision, Eli Lilly and Genentech were in dispute on this issue not only in the United Kingdom but also in other Member States;
  4. This issue had arisen in other previous cases.

Keeping the above in mind, Mr Justice Arnold referred the following question to the CJEU:

Does [the SPC Regulation] preclude the grant of an SPC to the proprietor of a basic patent in respect of a product which is the subject of a marketing authorisation held by a third party without that party’s consent? 

Analysis

The CJEU’s order clarifies that the role of the CJEU is to aid with interpretation of such EU law as is necessary for national courts to give judgment in cases upon which they are called to adjudicate. A reference for a preliminary ruling made by a national court is to be rejected where it is obvious that the interpretation of EU law that is sought is unrelated to the actual facts of the main action or its object, or where the problem is hypothetical.

In considering whether the clarification or interpretation of EU law sought in the referral is necessary, the CJEU held that it is not sufficient to say that there may be an appeal down the line which may render the hypothetical scenario true. Neither is it of relevance that the same issue exists in proceedings in other jurisdictions, or may have been raised in previous proceedings – the existence of disputes in other Member States of the European Union or of previous disputes does not support the conclusion that the interpretation of EU law that is sought is necessary for the resolution of the dispute which the referring court is called upon to resolve.

The CJEU also clarified that the referring court could not pre-emptively request a reference pending Brexit, on the basis that the appeal court might subsequently lose its jurisdiction to refer the same question because of withdrawal from the European Union pursuant to Article 50 of the TFEU, and while EU law continues in full force in the UK.

Conclusion

Although the refusal of the CJEU to decide on the referral is disappointing, it is hoped that the question of SPC applications based on third-party MAs will not remained unanswered much longer, and that there will be a decision that clarifies this issue in the foreseeable future. Meanwhile, the CJEU’s order sheds light on some important issues like the CJEU’s approach to references in light of Brexit, which will no doubt inform litigation strategy in the coming months.

Sebastian Moore
Sebastian Moore
Partner
+44 20 7466 2801
Martina Maffei
Martina Maffei
Associate
+39 02 0068 1353
Priyanka Madan
Priyanka Madan
Associate
+44 20 7466 2986

 

Preparations for the UPC continue despite an “unpredictable environment”

The UPC Preparatory Committee has issued a “Status of the Unified Patent Court Project” statement and review of 2018, confirming that there are now 16 states which have ratified the UPC, and that German ratification is still awaited (dependent on the outcome of the complaint pending before the Constitutional Court in Germany) before the project can move into provisional application phase. This latter phase is allows the courts to be prepared and judges to be appointed.

 

Despite the current, somewhat unpredictable environment, the technical and operational preparations are continuing allowing for the project to move at pace in the event of a positive outcome from the German Constitutional Court“.

The press release says nothing more than was already known, but it does confirm that the status of the project is constantly being reviewed, stating that the Chairman of the UPC Preparatory Committee “continues to meet with the Executive Group and the operational team on a monthly basis” and noting that those that have applied for judicial positions in the Unified Patent Court are being contacted separately.

Author

Rachel Montagnon
Rachel Montagnon
Professional Support Consultant, London
+44 20 7466 2217

Advocate General proposes literal interpretation of Article 3(d) SPC Regulation in Abraxis (C-443/17)

The Advocate General of the CJEU proposed a narrow interpretation of Article    3(d) in the Opinion given yesterday in Abraxis Bioscience LLC v Comptroller General of Patents 13 December 2018, one that would marginalise the effect of the CJEU’s decision in Neurim (C-130/11). If followed by the CJEU, this position would be met with disappointment by the pharmaceutical industry, which continues to make significant investments in researching and developing formulations that improve efficacy and new uses of known products.

Continue reading

Patent and Pharma Update – December 2018

Key recent developments in the United Kingdom and Europe relating to patents and the pharmaceutical sector

This issue reports on several ground-breaking decisions from the UK courts on second medical use patents and skinny labels, infringement by equivalents and the possibility of global FRAND licences for standard essential patents (SEPs).  We also look at some significant decisions from the CJEU on SPCs and reimbursements in relation to medicinal products and a few developments at the European Patent Office. Finally, we provide our usual round-up of the latest UPC developments (this time from Italy) and Brexit-related developments relevant to the pharma sector. Continue reading

French court upholds validity of MSD’s SPC protecting ezetimibe and simvastatin in combination

A French Court has upheld the validity of a Supplementary Protection Certificate (“SPC“) protecting the ezetimibe+simvastatin combination under Article 3(a) of the SPC Regulation.

Merck Sharp & Dohme (“MSD“) is the owner of a basic patent covering the compound ezetimibe. The basic patent also covers ezetimibe’s combinations with statin compounds, such as simvastatin, in its dependent claim, and simvastatin was already known as at the priority date. On the basis of this basic patent, MSD was granted an SPC for ezetimibe that expired on 17 April 2018, and an SPC for the combination ezetimibe+simvastatin expiring on 2 April 2019. Facing generic entry for the combination product when the ezetimibe SPC expired, MSD initiated preliminary injunction proceedings against a generic company, and a main revocation action was initiated by another generic company against the combination SPC.

In the PI case, the President of the Paris First Instance Court and the Paris Court of Appeal refused to grant the injunction on 5 April 2018 and 26 June 2018 respectively, relying primarily on the CJEU referrals in Georgetown and Sanofi to rule that since ezetimibe is the only “core of the invention” in the basic patent, the combination SPC could not be granted for ezetimibe+simvastatin.

Nevertheless, on the merits, the Paris First Instance Court upheld the validity of the combination SPC in a decision issued on 25 October 2018. The Court ruled on the basis of Georgetown and Sanofi as well as the decision in Gilead on 25 July 2018, that for the purposes of Article 3(a) of the SPC Regulation, “if the product, which is a combination of active ingredients according to Article 1 of EC Regulation No. 469/2009, necessarily belongs to the invention covered by the patent and if each active ingredient is specially identifiable, the grant of an SPC for the combination of active ingredients is possible“, as in the present case. Although the SmPC of the ezetimibe product mentioned the possibility of combining ezetimibe with statin compounds even before the combination was authorised as a medicinal product, the Court disagreed with the generic and also ruled that the marketing authorisation for the ezetimibe product could not be considered the first marketing authorisation in respect of the combination product for the purposes of Article 3(d) of the SPC Regulation.

In addition to the SPC argument, the decision rules on other issues, such as the statute of limitation of a revocation action (not time barred in the present case), and the sufficiency of disclosure of the combination ezetimibe+simvastatin in the basic patent (upheld on the basis of the test set in the finasteride decision of the French Supreme Court).

Please see here for the court’s decision in French.

Contacts

Frederic Chevallier
Frederic Chevallier
Partner
+33 15 357 1360
Krishna Kakkaiyadi
Krishna Kakkaiyadi
Associate
+44 20 7466 2979

 

Draft Withdrawal Agreement Approved by UK Cabinet – IP and Marketing Authorisation Provisions Summarised

As was widely reported yesterday evening, the Draft Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union and the European Atomic Energy Community (the Draft Withdrawal Agreement (14 November 2018)), detailing the arrangements for the UK to leave the EU has now been agreed by the UK Cabinet. The draft is as agreed between the UK and the EU’s negotiators. As stated in HSF’s Brexit Withdrawal Agreement webinar invitation here, a special European Council, anticipated to be held on 25 November 2018, will be asked to approve the Draft Withdrawal Agreement and the full text of the political declaration. The deal will also have to pass through the European Parliament. However, the main challenge to a deal being ratified is the requirement for approval by the UK Parliament. The first vote by the UK Parliament is expected within two weeks of the European Council.

We set out below a summary of the Draft Withdrawal Agreement’s provisions on intellectual property. The situation is not much changed from the previous draft issued in March 2018 although the provision for geographical indications has now been agreed: EU-wide rights will be replaced or recognised in the UK and provision has been made for pending applications, including for supplementary protection certificates (SPCs). The sharing of information for assessment of marketing authorisations between the MHRA and the EMA and vice versa is also provided for.

The Draft Withdrawal Agreement provides for an implementation/transition period from the date the UK leaves the EU (29 March 2019) to end of 31 December 2020. If the Draft Withdrawal Agreement is agreed, this transition period will mean that effectively the UK will continue to be treated as part of the EU from a legislative point of view. As the Commission’s press release puts it,”During this period, the entire Union acquis will continue to apply to and in the UK as if it were a Member State”. IP registrations and enforcement will carry on as normal during this period. Until the end of the transition period you will still be able to acquire/register and maintain EU-wide IP rights that will have effect in the UK. See the detail in our summary section below.  However, “as of the withdrawal date (i.e. including during the transition period), the UK, having left the EU, will no longer be part of EU decision-making. It will no longer be represented in the EU institutions, agencies and bodies, and persons appointed, nominated, or representing the UK, and persons elected in the UK, will no longer take part in the EU institutions, agencies, and bodies“.

The accompanying political agreement document “Outline of the political declaration setting out the framework for the future relationship between the European Union and the United Kingdom” (currently a summary version, with a fuller version to follow) looks to the future relationship between the UK and the EU post-transition. There is mention of IP in the section on Economic Partnership, but all that is said is: “Protection and enforcement of intellectual property rights beyond multilateral treaties to stimulate innovation, creativity and economic activity”.  Under ‘Basis for cooperation’, the political agreement states that “Terms for the United Kingdom’s participation in Union programmes, subject to the conditions set out in the corresponding Union instruments, such as in science and innovation, culture and education, development, defence capabilities, civil protection and space”. There is also mention of “Cooperation in matters of health security”.  For more on the impact of no deal on the pharma industry see our post on the UK Government’s “no deal technical notices” published on 23 August 2018.

Summary of the Draft Withdrawal Agreement’s provision for IP and marketing authorisations:

Continue reading

Brexit “no deal” technical notices published on Patents, Trade marks, Designs, Copyright, GIs, and Exhaustion of rights

The latest tranche of “no deal” technical notices was released yesterday afternoon by the UK Government. Amongst them are several notices that highlight the Brexit issues faced by intellectual property right owners and, in some cases, confirm the Government’s approach to resolving them. The Government also released this news story today which comments on the guidance given in the technical notices and comments on the Government’s longer term aims for IP protection.

Key announcements, in the context of no deal, are:

  • Provision of a new right to replace unregistered Community design rights, to be known as “the supplementary unregistered design right“.
  • Existing EUTMs and Community registered designs will be replaced with new, equivalent rights in the UK at the end of the implementation/transition period, “with minimal administrative burden“.
  • The SPC, compulsory licensing, pharmaceutical product testing exception and patenting of biotechnological inventions regimes will remain unchanged at least initially.
  • If the UPC comes into force the UK will replace unitary patent rights with equivalent rights if the UK needs to withdraw from the new system, although the UK “will explore whether it is possible to remain within it“. The Government’s news story states that “The UK intends to stay in the Unified Patent Court and unitary patent system after we leave the EU.”
  • UK originating sui generis database rights will no longer be enforceable in the EEA; “UK owners may want to consider relying on other forms of protection (e.g. restrictive licensing agreements or copyright where applicable) for their databases
  • The UK will set up its own GI schemewhich will be WTO TRIPS compliant“. The new rights “will broadly mirror the EU regime and be no more burdensome to producers“.  Since the UK would no longer be required to recognise EU GI status, EU producers would be able to apply for UK GI status. Those wishing to protect UK GIs in the EU will need to submit applications on a third country basis.
  • The UK will continue to accept the exhaustion of IP rights in products put on the market in the EEA by, or with the consent of, the rights holder. However, the EU will likely not consider that goods placed on the UK market are exhausted in the EEA, and thus permission may need to be sought from the rights holder to transfer goods to the EEA that have legitimately been put on the market in the UK. The Government news story says that “The UK looks forward to exploring arrangements on IP cooperation that will provide mutual benefits to UK and EU rights holders and we are ready to discuss issues the EU wishes to raise in the negotiations on our future relationship, including exhaustion of IP rights”.

Links to the notices:

  1. Patents
  2. Trade marks and designs
  3. Copyright
  4. Geographical Indications
  5. Exhaustion of IP rights

More detail on each of these is provided below. For those with an interest in Life Sciences please also see our blog post on the notices related to that sector that were released last month.

Continue reading

CJEU SETS OUT TEST ON THE INTERPRETATION OF ARTICLE 3(a) SPC REGULATION

The Court of Justice of the European Union (CJEU) has today delivered its decision on the interpretation of Article 3(a) SPC Regulation in Case C-121/17 Teva v Gilead.

The CJEU has said that in the case of an SPC for a combination product, Article 3(a) will be satisfied if, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:

  • the combination of active ingredients necessarily, in the light of the description and drawings of that patent, falls under the invention covered by that patent, and
  • each of those active ingredients is specifically identifiable, in the light of all the information disclosed by that patent.

The CJEU has made it clear that these are matters for national courts to decide.

Business Impact

This is a very important decision for all stakeholders in the pharmaceutical industry. It relates to the ability of patentees to obtain SPCs, a sui generis right, which effectively extends the duration of patent protection for products (i.e. active ingredients or combinations of active ingredients) of medicinal products covered by marketing authorisations (MAs).

It is the first time that the Grand Chamber of the CJEU (sitting as 15 judges) has provided guidance for national courts to interpret Article 3(a) of the SPC Regulation, although other Chambers of the CJEU have also tackled this issue in the past. Continue reading