EU Commission consultation on SPCs and pharmaceutical research exemptions

The EU commission has announced a consultation (available here) on improvements to the SPC system.  Possible improvements could include the creation of a European SPC title, the introduction of an SPC manufacturing waiver and an update on the scope of EU patent research exemptions.

Responses to the consultation must be submitted via an online questionnaire (available here).  The deadline for filing submissions is 4 January 2018.

Swedish Patent and Registration Office appeals to the Swedish Supreme Court on the correction of SPC terms

As previously reported on this blog (here), the Swedish Patent and Market Court of Appeal (PMCA) found that SPCs granted pre-Seattle could be corrected to have the duration calculated based on the notification date rather than the decision date, if applicable. The PMCA found that the Regulation 469/2009 itself did not provide for any legal remedies to correct the term (i.e. Article 17.2 of 1610/96 is not applicable), but that correction could be made under general principles of Swedish national administrative law.

This decision has now been appealed to the Supreme Court by the Swedish Patent and Registration Office. The questions discussed in the appeal relate only to Swedish administrative law and not to the Regulation or other EU law.

The Supreme Court must grant leave to appeal in order to hear the case on the merits. If they do, it will be most interesting to see how they deal with the pending referral in C-492/16 (Incyte).

Many thanks to Hampus Rystedt at Zacco for providing these new developments.

Tenofovir in Denmark - Accord Healthcare fends off Gilead's motion for a preliminary injunction

Nicolaj Lindgreen and Nicolaj Bording at Kromann Reumert report the following news on Gilead's SPC for the combination of tenofovir and emtricitabine in Denmark:

On 26 October 2017, the Danish Maritime and Commercial High Court issued a ground-breaking decision rejecting Gilead's motion for preliminary injunction against Accord Healthcare Limited based on Gilead's Danish SPC for the combination of tenofovir disoproxil (as fumarate) and emtricitabine. 

Accord had defended the motion for preliminary injunction by arguing non-infringement and invalidity of the asserted SPC.  

The Court supported Accord's argument that the SPC's combination of tenofovir disoproxil (as fumarate) and emtricitabine was not protected by the basic patent, and, accordingly, the SPC had been granted in contrary to Article 3(a) of the SPC Regulation.
The only claim in the basic patent that concerns the potential combination of tenofovir with another compound is claim 27, which claims an optional combination of tenofovir with "other therapeutic ingredients".  

Gilead had argued that the skilled person would understand the words "other therapeutic ingredients" in claim 27 as referring to emtricitabine. Hence, according to Gilead, the combination of tenofovir disoproxil (as fumarate) and emtricitabine was covered by the basic patent.  

Accord had argued, in particular, that case law from the CJEU dating from after the grant of the SPC makes it clear that a "product" according to the SPC Regulation has to be specified in the claims, either by reference to the compound's name, its chemical structure or by a functional definition, provided that the functional definition necessarily and specifically relates to the compound in question. Clearly, Accord argued, the words "other therapeutic ingredients" in claim 27 did not specify emtricitabine, neither by name/chemical structure nor by a functional definition, as the words "other therapeutic ingredients" say nothing about the specific function or nature of such "other therapeutic ingredients".  

As indicated, the Court agreed with Accord's invalidity arguments stating that Accord, on this basis, had "proved that the certificate-in-suit is invalid". Hence, the motion was rejected. 

The decision is ground-breaking as this is only the second time in 40 years that a motion for preliminary injunction in the patent area is rejected with reference to invalidity of the asserted right. Normally, it is considered close to impossible to fend off a motion for a preliminary injunction in a patent-related case, if invalidity arguments are the only defence. 

In terms of infringement, the Court found that, had the SPC been valid, Accord's combination product was covered by the SPC. Accord had argued non-infringement referring to the fact that the SPC was granted for tenofovir disoproxil in its fumarate salt form in combination with emtricitabine, whereas Accord's product contained tenofovir disoproxil in its free base form. The Court concluded that Gilead's marketing authorisation on which the SPC had been granted, which did not specify the fumarate salt form of tenofovir, covered tenofovir in all its forms, and, accordingly, so did the SPC. 

Nicolaj Lindgreen and Nicolaj Bording acted for Accord Healthcare Limited.

Tenofovir - the Swiss Bundespatentgericht goes for the infringement test

The SPC Blog is grateful to Siegfried Grimm at E. Blum & Co. for providing the following summary of a recent Tenofovir case in Switzerland:

The year is 2017 B.C. Europe is entirely governed by European Legislation. Well, not entirely... One small country of indomitable Swiss still holds out against the invaders. And life is not easy for the European judges who reside the fortified camps of Luxembourg ... 

In its decision of October 3, 2017 (here in German), the Swiss Federal Patent Court clarified what the criteria are for deciding “whether the product is protected by a basic patent in force”.  The Swiss court clearly refused to adopt the CJEU's “Medeva” line of decisions. As a consequence, Swiss SPCs will be assessed based on the infringement test.  No additional criteria, such as “specified in the wording of the claims” (Medeva), “the claims relate, implicitly but necessarily …” (Eli Lilly), “core inventive advance …” (Actavis) or the like are to be applied.  Accordingly, the Swiss court applied a more liberal approach compared to the CJEU, leaving room for Swiss SPCs where European SPCs are likely not available.  

The SPC in question relates to tenovofir disoproxil fumarate + emtricitabine.  Claim 1 of the basic patent covers tenovofir disoproxil fumarate and claim 27 mentions “optionally other active ingredients”, without mentioning of emtricitabine.  The Swiss court came to the conclusion that this SPC is protected by a basic patent in force and thus perfectly complies with Swiss practice.  The court also came to the conclusion, that the above CJEU decisions will not help deciding the case, as Eli Lilly might be in favor of such decision while Actavis would rule against it.  

The decision is open to appeal within 30 days. 

Interestingly, the same case is litigated before the High Court, [2017] EWHC 13 (Pat), now pending before the CJEU.

"SPC Law and Practice 2017: you can’t keep a good blog down": now open for registration

Anyone working with SPCs must have a very special sort of understanding...

This year's seminar run by The SPC Blog, "SPC Law and Practice 2017: you can’t keep a good blog down” is now open for registration. After a year with our SPC feet up, the new referrals have reopened some issues and we’ll be taking the usual punchy look at the evolving case law and practice with speakers from private practice and the IPO.  This year we have a new venue, the CMS office at 78 Cannon Street, and the date of the seminar is the afternoon of Friday 1 December 2017.

The link to the invite is here!

The planned agenda (subject to some evolution..) is:

A review of the recent case law – Catherine Katzka (Kilburn and Strode)
“The IPO examiners” – practice and case law update from around Europe
Inventive advance – [speaker to be confirmed]
The Max Plank review of SPCs – Roberto Romandini (MPI)
Q&A

Further speakers to be confirmed in due course.

We will try to accommodate all comers, but if demand for places outstrips the supply it may be necessary to limit the number of people attending per law firm to give as many firms as possible a chance of attending.  Preference will be given to anyone from industry, since they are kind enough to provide the patents, the SPCs, the litigation and the competitive edge that makes the whole seminar possible.

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

Many thanks to Louise Jonshammar (Awapatent) for providing the following summary of recent decisions of the Swedish Patent and Market Appeal Court on SPC terms following the CJEU's Seattle Genetics case:

"On 4 October, 2017, the Swedish Patent and Market Appeal Court handed down eight decisions in appeal cases regarding re-examination of SPC term decisions. 

The background relates to the famous Seattle Genetics case (C-471/14) in which the CJEU gave a preliminary ruling on the interpretation of Article 13(1) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products. In the judgement, the CJEU held that the ‘date of the first authorisation to place the product on the market in the [European Union]’ within the meaning of Article 13(1) is the date on which notification of the decision granting marketing authorisation was given to the addressee of the decision. As many patent offices around the EU, if not most, calculated the SPC term on the date of grant of the marketing authorisation, the judgement started an avalanche of requests for changes to the already issued SPCs. The different EU countries have handled these requests differently, as re-examination is not provided for in the regulation. 

The Swedish Patent and Registration Office refused to change the term of already issued SPCs unless there was still time within the two months’ appeal limit to appeal the grant decisions – in which case the patentee was urged to file such appeal. The reason for refusal was mainly that new practice is not a basis for re-examination under the Swedish Administrative Law. 

The Patent and Market Court agreed with the patent office and did not change the decisions. Further, the court said that decisions to grant SPC effect not only the applicant but also an unknown number of other actors on the market, having contradictory interests. Therefore, decisions on grant of SPCs shall be considered similar to civil actions, despite the fact that third parties are not parties to these decisions. 

The Patent and Market Appeal Court decisions are long and include a lot of very useful reasoning for understanding the decision. The grand finale of the decisions is a reasoning on the balance of interest between the patentee and third parties. The Patent and Market Appeal Court finds that where the patent protection has ceased and the SPC has come into effect, companies marketing generic drugs may have customised their efforts on the market to fit the decision and prepared according to the final date of the SPC in the decision. If the SPC term has begun, the interest of foreseeability speaks against a change of the SPC term in such cases. Before the beginning of the SPC term, however, the patentees’ interest in a longer term shall prevail. Therefore, as a general rule, decisions on SPC term shall be changed in accordance with the principles set out in the Seattle Genetics judgement, provided that a request for changes has been filed before the beginning of the SPC term. 

The decisions then differ depending on when the patentee filed its request - in some cases the term is extended and the patent office is asked to put that decision into practice, in other cases the request for change of the term is denied because the SPC term has already begun. 

Also, as a point of interest, one may note that the Patent and Market Appeal Court disagrees with the Patent and Market Court with respect to SPC applications being considered similar to civil actions. The fact that a re-examination may have economic consequences for third parties is not a special circumstance which motivates a deviation from the general rule of administrative law. The third party interest shall therefore be considered within the re-examination, which is then what the Patent and Market Appeal Court does in its balancing of interests, as described above. 

Another interesting note is that the Patent and Market Appeal Court has allowed for the decisions to be appealed to the Supreme Court."

Switzerland and paediatric extensions - an update

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

The changes in the Swiss Patent Act to allow for pediatric extensions have already been approved by the Swiss parliament in 2016.  The changes allow for:

• Pediatric extensions to SPCs under conditions like in the EU; and
• Independent paediatric SPCs linked directly to the term of the patent, in cases where there is no regular SPC. 

According to the Swiss Federal Institute for Intellectual Property website (here), amendments proposed to the implementing regulations of the Swiss Patent Act are currently under a general consultation which will end on 20 October 2017. 

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

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