Denmark - Gilead successfully enforces its SPC for Truvada

Last year, the SPC Blog reported (here) the decision of the Danish Maritime and Commercial High Court not to grant a preliminary injunction against Accord Healthcare Limited on the basis of Gilead's SPC for the combination of tenofovir disoproxil (as fumarate) and emtricitabine.

On 7 March 2018, the Eastern High Court in Denmark overturned this decision and granted the preliminary injunction against Accord.

Mikkel Vittrup and Jeppe Brinck-Jensen at Plesner (who assisted Gilead in this case) have kindly provided the summary below of the Eastern High Court's decision.

The Eastern High Court (the court of appeal) in Denmark has granted a preliminary injunction against Accord Healthcare Limited on the basis of Gilead's Danish SPC for TRUVADA®, overturning the first instance decision of the Maritime and Commercial High Court. The Eastern High Court did not accept that Accord had proven that Gilead's SPC was invalid. Furthermore, it found that the SPC was infringed even though the title of the SPC mentioned a specific salt of the active ingredient tenofovir disoproxil, and Accord's product was not sold as such a salt.  

In relation to validity of the SPC, the question was whether the active ingredient emtricitabine was specified in the wording of claim 27 of the basic patent by the wording "other therapeutic ingredients", for the purposes of Article 3(a) of the SPC Regulation. Gilead's SPC is for the combination of active ingredients tenofovir disoproxil and emtricitabine, and it was not in dispute that tenofovir disoproxil is explicitly named in the claims of the basic patent. 

Accord argued that claim 27 did not relate implicitly, but necessarily and specifically, to the combination of tenofovir disoproxil and emtricitabine, and therefore that the SPC did not meet the requirements of Article 3(a) as interpreted by the CJEU in Eli Lilly (Case C-493/12). At first instance, the Maritime and Commercial High Court agreed with Accord.  

The Eastern High Court did not agree.  

It stated, referring to the Protocol on the Interpretation of Article 69 EPC and the Eli Lilly decision, that the claims of the basic patent - including in relation to the question of which active ingredients are covered by the claims - should be interpreted in the light of the common general knowledge of the skilled person. 

The Eastern High Court referred to a declaration and oral testimony of Gilead's expert (a Danish HIV clinician) and found that the skilled person at the priority date of the basic patent (July 1996) would have understood "other therapeutic ingredients" as compounds contributing to antiviral activity, including in particular for the treatment of HIV, and therefore that the skilled person would think of a combination of tenofovir disoproxil with another NRTI, a NNRTI or a protease inhibitor. The Eastern High Court concluded that the term "other therapeutic ingredients" in claim 27 only concerned a limited number of compounds.  

Consequently, the Eastern High Court found that it could not be rejected with the sufficient degree of certainty that claim 27 implicitly, but necessarily and specifically also related to emtricitabine. 

The Eastern High Court also gave weight to the existing doubt as to the interpretation of Article 3(a), in particular in view of the pending referral to the CJEU (Case C-121/17).
The Eastern High Court's decision - overturning the first instance decision from the Maritime and Commercial High Court - also confirms the well-established Danish case law according to which a preliminary injunction will rarely be rejected on the basis of alleged invalidity of the asserted IP rights.  

In relation to infringement, the High Court concluded that Gilead had rendered it probable that the fumaric acid salt and the free base of tenofovir disoproxil should be considered the same active ingredient within the meaning of the SPC Regulation. Consequently, Gilead's SPC was infringed by a combination product containing the free base of tenofovir disoproxil, even though the title of the SPC mentioned tenofovir disoproxil as a fumaric acid salt. 

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.

Specific Mechanism applies to paediatric extensions, says Danish Court

From Martin Dræbye Gantzhorn (Partner, Head of Life Science & Healthcare, Horten Advokatpartnerselskab, Copenhagen) comes this swift, short note to inform readers of The SPC Blog that in October the Danish Maritime and Commercial Court rendered a very rare decision on the scope of the "Specific Mechanism". The proceedings concerned the question whether a paediatric extension to a SPC will also prolong the patentee's protection under the "Specific Mechanism". In short:

The defendant (Orifarm) had imported a pharmaceutical product, MSD’s Singulair, from Poland during the term of the paediatric extension of the SPC. The plaintiff brought interlocutory injunction proceedings, claiming that such imports could be prohibited relying upon the "Specific Mechanism".

As its primary line of defence, the defendant held that the paediatric extension did not prolong the protection conferred by the "Specific Mechanism". As its second line of defence, the defendant held that, even if such protection could be conferred by a paediatric extension, such extension would only be applicable to those of the plaintiff's products which -- by their strength -- were indicated for children.

The Bailiff's Court (the court of first instance) held that the patent, the SPC and the paediatric extension thereof were to be considered as a single coherent right that covers all products and not just the ones authorized for the treatment of children. Accordingly, the Bailiff's Court found for the plaintiff.

The Maritime and Commercial Court agreed with the Bailiff's Court, stating that the expression "such protection" under the Specific Mechanism as stated in the Treaty of Accession is to be interpreted as the patent protection being one continuous string of protection. The Maritime and Commercial Court added that the paediatric extension is not dependent on a product being indicated for the treatment of children, but only on whether or not the drug is tested for children.

The protection would not therefore terminate until the paediatric extension had expired.

The judgement (in Danish) can be found here.

Thanks, Martin, for this really helpful summary.

Denmark's new post-Medeva guidelines on "specified"

From our friend Sidsel Hauge (Partner and European Patent Attorney, Awapatent A/S, Copenhagen) comes news of the Danish Patent Office's new guidelines on the interpretation of "identified/specified" after Medeva.  The following is Sidsel's unofficial translation:

Protection by a basic patent, particularly for combination products (Last update: 17‐12‐2012)

___________________________________________________ 

Before a product which consists of a composition of two or more active ingredients, known as a combination product, can be considered to be protected by a basic patent according to the Regulation, the combination of the active ingredients must be specified by the wording of the claims of the basic patent in accordance with the judgment of 24 November 2011 in Case C‐322/10 (Medeva) of Court of Justice of the European Union. 

For example, a combination product consisting of the two active ingredients A and B is considered to be protected by a basic patent, if the combination A and B appear in the wording of the claims. 

The product is considered to be specified in the wording of the claims when the product is described by a chemical name or a structural formula, i.e. specifically mentioned or being comprised by a Markush formula. 

A product may in some cases be considered to be specified in the wording of the claims of the basic patent, if the product is specified by functional terms. The actual protection will always be decided from case to case on a case by case basis. 

If the basic patent in an administrative re‐examination could be limited so that the combination of the active ingredients remains in wording of the claims of the basic patent, we also consider the combination product to be protected by the basic patent and thus Article 3, point a, to be fulfilled. 

You can read more about the effects of the foregoing for applications for a certificate for combination products under Combination products.

Novartis/Teva settlement in Denmark: the terms

The SPC Blog thanks Mette Clausen Hygum (Plesner, Copenhagen) for letting us have the following note, the contents of which are self-explanatory:

The parties in the Danish case Novartis AG and Novartis Healthcare A/S v Teva Denmark A/S concerning the scope of protection of Novartis's SPC for Valsartan, have agreed to end the case on the terms proposed by the Danish Maritime and Commercial Court.

Following a preliminary injunction case against Teva concerning Novartis's patent covering (amongst others) the active ingredient Valsartan, Novartis filed a declaratory action against Teva claiming that Teva should acknowledge that Novartis' SPC for the active ingredient Valsartan not only protected products containing Valsartan as the only active ingredient but also products containing a combination of Valsartan and one or more other active ingredients.

Teva refused to give such acknowledgement and claimed that Novartis' SPC only protected products containing Valsartan and thus not Valsartan in combination with other ingredients.

Only a few weeks before the oral hearing in September 2010 Teva announced that for commercial reasons Teva would not market any products containing Valsartan before expiry of the SPC. The reason for the decision was, according to Teva, that the Danish Medicines Agency, following a re-evaluation of the reimbursement for the antihypertensive products acting on the renin system [1], had decided to remove the general reimbursement for various products, including products containing Valsartan and Hydrochlorothiazide.

Based hereon Teva claimed that the case should be dismissed as there was no actual commercial dispute between the parties.

The oral hearing was held on the 15 September 2010 and the case was afterwards ended in accordance with the proposal from the court, which reads as follows:

"In continuation of the hearing held on 15 September 2010, the Danish Maritime and Commercial Court held a deliberation on the merits of the case and, on that basis, requested the Parties to enter into the following Agreement, it being understood that the Danish Maritime and Commercial Court will close its file on receiving information that the Agreement be concluded between the Parties:

(1)           Teva Denmark A/S and all companies in the Teva-Group commit themselves to Novartis AG and to all companies in the Novartis-Group, not to produce, import or export, market, bring into circulation or in any way, whatsoever, use medicals containing Valsartan, alone or in combination with one or more other active ingredients, until the time where the Plaintiff’s SPC has expired, and in so far and for such time as this SPC is valid, including any period for which its validity may be extended on the basis of the Plaintiff’s application of 13 September 2010 or any other application  for extension that the Plaintiff might make at any later stage.

(2)           Teva must no later than on 6^th October 2010 pay to Novartis the costs of the case with 450,000 DKK. In the case of delayed payment, interest must be paid in accordance with Article 8 of the Danish Act on interests on delayed payments.

(3)           This Agreement enters into force immediately and is enforceable in accordance with the provisions of Article 478, Section 1, Number 2, of the Danish of Administration of Justice Act, so that it is immediately enforceable.

Done in Copenhagen this 21^st September 2010 as a part of the official records of the Danish Maritime and Commercial Court

For Novartis AG and all Novartis Companies                             

For Teva Denmark A/S and all Teva Companies"

---

[1]       The reason was that losartan was out of patent protection which is why several companies have launched generics at a price compared to that of the generic ACE-inhibitors.

SPC search in Denmark and Switzerland: a reader asks ...

One of our readers, head of IPM in an Indian pharma company, has written to ask for some advice:

"I want to know the I would like to know how to search the SPC details in Denmark and Switzerland. I have been trying for a long time but couldn't reach the right URL. Can you please help me in this regard?"

If anyone has some helpful hints, can he or she please post them as a comment below this blogpost?

Losartan and Caspofungin in Denmark

As you may recall, the Blog reported that an application was made for the paediatric extension of Caspofungin in Denmark in February this year. Andreas Schmitt of A.S. Dataservices writes:

"Denmark has recently granted pediatric extensions for Losartan and Caspofungin (see here for page of Patent Journal).

The expiry date given for Caspofungin doesn't take the extension into account, but after contacting the Danish Patent Office, they informed me that the date will be corrected in one of the next issues of the journal."

Harmonisation in Denmark: Patents covering pharmaceutical compositions may now be designated as basic patents

Casper Struve (Zacco Denmark A/S) has provided information on how the Danish Patent and Trademark Office deals with SPC applications where the basic patent is a pharmaceutical composition patent:

"The current Danish guidelines for SPC examination (as valid from 19 October 2005) explicitly states that patents on pharmaceutical compositions cannot be designated as a basic patent. This has long been the position of the Danish Patent and Trademark Office.

This position of the Danish Patent and Trademark Office have changed as explained in the following.

A hearing at the Danish Board of Appeal was scheduled for 25 March 2009 regarding the above issue of whether or not SPC applicants may validly designate pharmaceutical composition patents as basic patents. The hearing was cancelled, as the Danish Patent and Trademark Office in letters to the appellants dated 20 March 2009 acknowledges that neither the SPC regulation nor the preparatory work speaks against that a patent protecting a pharmaceutical composition containing the product concerned in the SPC application can be used as a basic patent for a supplementary protection certificate.

In letters relating to Case No CA 2007 00042 and Case No CA 2000 00008 dated 20 March 2009 the Danish Patent and Trademark Office states the following:

"In relation to the present case the Danish Patent and Trademark Office have
considered that a patent that solely protects a pharmaceutical composition containing the product cannot be used as a basic patent, cf. the definition of basic patent in Regulation (EEC) No 1768/92, Article 1(c).
[...]
The Danish Patent and Trademark Office acknowledges that neither Regulation EEC No 1768/92 concerning the creation of a supplementary protection certificate for medicinal products, nor the preparatory work (KOM(90) 101 final edition), speaks against that a patent protecting a pharmaceutical composition containing the product concerned in the SPC application, can be used as a basic patent for a supplementary protection certificate."

This new position adopted by the Danish Patent and Trademark Office is welcomed and seen as a positive step in harmonising the SPC regulation on community level. It should be incorporated into the new guidelines for examination of SPC's, which will issue together with the long awaited guidelines on Paediatric SPC extensions. Rumour has it that these guidelines are very close to being finalised."

First paediatric extension application filed in Denmark

In October 2008 the first application for extension of a supplementary protection certificate under Regulation 1901/2006 on Medicinal Products for Paediatric Use was filed in Denmark. The filing took place before the Danish Patent and Trade Mark Office had even issued a request form and formal guidelines regarding supplementary protection for medicinal products for paediatric use, but it was still in accordance with the amended patent regulations that entered into force on 1 May 2008. In addition, the filing took place before the Danish Agency for Governmental Management had approved the official fee for such types of application. 

[Source: note by Casper Struve and Ellen Wetke (Zacco) for Intellectual Asset Management magazine].