The SPC blog

A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Wednesday, 23 May 2018

Germany - Gilead's SPC for Truvada nullified by the Federal Patent Court

Last week, the German Federal Patent Court nullified Gilead's German SPC for the combination of tenofovir disoproxil and emtricitabine.  Eva Geschke (Wildanger) and Derk Vos (Maiwald), who acted for Generics UK, have provided the following summary on the case:
"On May 15 the 4th Nullity Senate of the German Federal Patent Court (FPC) nullified Gilead’s German SPC DE 2005 000 0041.8, which had been granted for tenofovir disoproxil in combination with emtricitabine. 
This combination of active ingredient is present in various anti-HIV drugs marketed by Gilead and other companies such as TRUVADA® and ATRIPLA®. Four claimants (Teva GmbH, Hexal AG, Generics [U.K.] Ltd., and Hormosan Pharma GmbH) had challenged the validity of the SPC arguing that the product in question was not protected by claim 27 of the basic patent.  While tenofovir disoproxil was specified in the claim, the parties were in dispute on the issue whether the active ingredient emticitabine was specified in the wording of claim 27 of the basic patent by the term “other therapeutic ingredients” for the purpose of Art. 3 (a) SPC-Regulation according to the criteria set by the CJEU in Eli Lilly (C-493/12). 
The FPC in its preliminary opinion had outlined its interpretation on the criteria set by the Eli Lilly decision (C-493/12) in that a functional definition – as a broad generic term, under which various actives may fall – only relates implicitly, but necessarily and specifically, to the active in question as defined in the SPC, i.e. emtricitabine in the present case – if said active forms an active ingredient which is comprised by said generic term. The FPC demands at the same time that it is excluded that other active ingredients are representatives of said generic term, which, however, do not share the specific medicinal characteristics of the active ingredient in question. 
In defending their SPC, Gilead took the position that the CJEU’s case law, and in particular the Eli Lilly decision, does not require any further criteria than the assessment of Art. 69 EPC and the protocol of its interpretation for the determination whether a product is protected by the basic patent or not. 
It appears that the FPC did not follow the interpretation advanced by Gilead on the Eli Lilly decision but considered that further criteria are to be met in addition to the coverage of the product by Art. 69 EPC for an active ingredient to be implicitly, but necessarily and specifically referred to in a claim of the basic patent. 
The Claimants argued that the generic term “other therapeutic ingredients” was completely unspecific and covered various compound classes with different medicinal characteristics and thus the wording used in claim 27 was not suitable to specifically identify the active ingredient emtricitabine of the product in question. 
The FPC decided that the wording “other therapeutic ingredients” was insufficient to specify the active ingredient emtricitabine according to the criteria set by the Eli Lilly decision. Consequently, the requirements of Art. 3 (a) SPC-Regulation were not fulfilled for the product in dispute.

The decision taken by the FPC is in line with the decision taken by the Munich District Court in the preliminary injunction proceedings initiated by Gilead in August 2017, where the District Court rejected Gilead’s request on the grounds that Art. 3 (a) of the SPC-Regulation is not met. 
In addition, the position from the FPC is also in agreement with the opinion of the AG Wathelet, issued on April 25, 2018 in the CJEU referral C-121/17, which referral originates from the parallel invalidation proceedings in the UK
The reasons for the decision will be issued by the FPC in due time. "

Many thanks to Eva and Derk!

Thursday, 17 May 2018

China - patent term extensions allowable soon?

There have been reports (here and here) of rumors that China will start allowing patent term extensions for pharmaceutical patents.  Does any SPC Blog reader have more information on this exciting development?  If so, please leave a comment below or email us here

Wednesday, 9 May 2018

Update from Finland - rectifying the term of an SPC

Kirsikka Etuaho, Jukka Taskinen and Janina Hakanpää of Espatent have sent us the following update on the rectification of an SPC term in Finland:
The Finnish Patent Office recently published two announcements, one in January and one in April 2018, regarding the relevant dates for the term of supplementary protection certificates. 
According to a judgement of the Court of Justice of the European Union given on 20 December 2017 in case C-492/16 (Incyte Corporation), the authority that has granted a SPC must rectify the term of valid SPCs at the request of the holder. The Finnish Patent Office has individually contacted by letter all SPC holders in position to make such a request. Since January, many of the requests have already been processed and requestors informed accordingly. 
The rectification possibility applies to SPCs granted on the grounds of both a centralized marketing authorization and a national marketing authorisation. The date of the relevant marketing authorisation is set to be the date on which notification was given of the marketing authorisation decision (case C-471/14 (Seattle Genetics)). 
In their announcements, the Finnish Patent Office further gave some practical advice to the requestors on the information and enclosures needed.

Many thanks!

Wednesday, 2 May 2018

European Commission paper on Brexit and SPCs

The European Commission recently published a short document on the consequences of Brexit on SPCs.

The general message is:
Subject to any transitional arrangement that may be contained in a possible withdrawal agreement, as of the withdrawal date, 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 and Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products will no longer apply to the United Kingdom. 
The document highlights the following consequences:

- on the calculation of the duration of SPCs:
  • An authorisation to place the product on the market granted by a United Kingdom competent authority as of the withdrawal date will not be considered a first authorisation to place the product on the market in the European Union for the purposes of Article 13 of Regulation (EC) No 469/2009 and Regulation (EC) No 1610/96.
  • However, an authorisation to place the product on the market granted by a United Kingdom competent authority before the withdrawal date is to be considered as the first authorisation to place the product on the market in the European Union for the purposes of Article 13 of Regulation (EC) No 469/2009 and Regulation (EC) No 1610/96.
- on applications for SPCs as of the withdrawal date in the United Kingdom
As of the withdrawal date, the Medicinal Products and Plant Products regulation no longer apply to the United Kingdom.  The document footnote does indicate that for applications for an SPC filed before the withdrawal date, the EU is trying to agree solutions with the UK in the withdrawal agreement.
 Watch this space.



Tuesday, 1 May 2018

Update on IL PTE practice on biological drugs and PTE filing deadlines

Liad Whatstein of Liad Whatstein & Co has kindly provided the following updates on patent term extensions on biological drugs and filing deadlines in Israel.
Israeli PTO clarifies rules on Patent Term Extensions for Biological Drugs 
In a recent precedential decision, the IL PTO held for the first time that biological products which contain an earlier approved protein may be eligible for PTE if it can be shown that structural differences between the proteins such as differences in glycosylation have an impact on the activity or pharmacokinetic profile of the protein. If sufficient evidentiary basis is provided with the PTE petition, this important decision will make it possible to obtain PTE orders for biological drugs which contain as the active ingredient proteins that carry the same INN (international nonproprietary name) as in previously approved drugs. 
The decision involved a petition filed by Bayer to extend the term of a patent claiming the production method of the drug KOVALTRY, a recombinant human coagulation Factor VIII. Under Israeli law, patent term extension can only be granted when the regulatory approval “is the first regulatory approval permitting the use of the compound in Israel for pharmaceutical purposes”. The examiner cited against the PTE petition several earlier registrations of Factor VIII products and, in particular, an earlier Bayer Factor VIII product, KOGENATE. The examiner’s position was that earlier registrations of products containing Factor VIII preclude the eligibility for PTE of later products containing Factor VIII, irrespective of differences in the properties or methods of manufacture of the protein. 
On appeal, the Commissioner upheld the rejection of the PTE petition for KOVALTRY but adopted a significantly more flexible approach. The Commissioner recognized that an approach whereby any earlier registration of a protein of the same name precludes eligibility for PTE for later products does not take into account potential differences between biological products. The Commissioner therefore set a two-step test to determine eligibility for PTE for biological products. First, a biological drug that has been approved as a biosimilar will not be eligible to PTE. Second, if the drug was approved as a new drug, it will be necessary to evaluate whether the protein is structurally different from similar proteins which have been previously approved and whether such structural differences have an impact on activity. Structural differences can among others be in the amino acid sequences, the three-dimensional conformation or glycosylation. Functional differences can among others relate to pharmacokinetic parameters of the drug such as bioavailability or half-life or to different immunogenic effects. 
In the present matter, the drug was approved as a new biological drug. The patentee demonstrated that it manufactured the drug using a recombinant process which is different from the recombinant process used to manufacture the earlier Factor VIII drug. The patentee also showed that the later Factor VIII product differs from the previous product in the level of highly branched sialylated glycans and the level of α-gal-linked glycans. The Commissioner recognized that even minor structural differences can result in functional differences which will support a PTE. However, the patentee failed to produce evidence to establish that the structural differences are translated into a different pharmacokinetic profile or to any benefit to patients. Therefore, even under the Commissioner’s flexible approach, the PTE petition was denied but the principles determined in the decision are very significant for future reference by patentees (Decision dated April 16, 2018 in Petition to extend IL 124123 in the name of Bayer Healthcare LLC). 
New rules for determining the 90-day deadline for filing a PTE petition under Israeli law 
Under Israeli law, a petition for Patent Term Extension must be submitted within 90 days from “the date of registration of the pharmaceutical preparation” in the Israeli Drug Register. The deadline is non-extendable. Late filing will result in the loss of eligibility for PTE. 
Under the PTO traditional practice, the PTO has counted the deadline as of the date of registration which appears on the Marketing Approval. In a new decision, the Commissioner of Patents held that the 90-day deadline is to be counted from the date of delivery of the marketing approval by the Ministry of Health to the owner of the registration and not from the date of registration. The date of delivery may be a few days after the date of registration. Furthermore, if the registrant proves that the marketing approval did not reach it on the delivery date, the 90-day deadline will start upon the date of actual notice that a marketing approval was issued (Decision dated April 16, 2018 in Petition to extend IL 124123 in the name of Bayer Healthcare LLC). 
This new decision should also be seen as another favorable development following the 2016 PTO change in practice with regard to the determination of the date of the earliest Marketing Approval in the Recognized Countries for the calculation of the 14 years cap for the PTE duration. The PTO aligned its position with the CJEU ruling in case C 471/14 Seattle Genetics which held that the calculation of the duration of supplementary protection should be based on the EMA MA notification date rather than the EMA MA grant date. In late 2017, after discussions at the Knesset Law Committee in which Liad Whatstein & Co. took part and despite protest by the Israeli generic industry, new Regulation 2(c)(3) of the PTE Regulations endorsed the 2016 PTO change in practice. 
Thanks Liad!

Wednesday, 25 April 2018

C-121/17 - The Advocate General advises the CJEU

The Opinion of Advocate General Wathelet in the UK reference for a preliminary ruling from the Court of Justice of the European Union in Case C-121/17 (Teva UK Ltd and others v Gilead Sciences Inc.) was posted on the Curia website (here) this morning.  At the time of this blogpost, the Opinion was only available in French.

As a recap, the referring court asked the following question:
What are the criteria for deciding whether "the product is protected by a basic patent in force" in Article 3(a) of Regulation No. 469/20091 ?
The Advocate General has advised the Court to rule as follows (thanks to Google translate):
"Article 3 (a) 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, precludes the issue of a certificate supplementary protection relating to active ingredients which do not appear in the wording of the claims of the basic patent. The fact that a substance or composition falls within the scope of the protection of the basic patent is a necessary, but not sufficient, condition for constituting a product protected by a patent within the meaning of Article 3 (a) of Regulation No 469/2009. 
A product is protected by a patent within the meaning of Article 3 (a) of that Regulation if, on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and specifically identifiable in the wording of the claims of the basic patent. In the case of a combination of active ingredients, each active ingredient in that combination must be specifically and precisely as well as individually identifiable in the wording of the claims of the basic patent."

Friday, 6 April 2018

An SPC Hat-trick: a THIRD referral under Article 3(a) heads to the CJEU

Many thanks to Nicholas Fischer and Andrew Hutchinson (Simmons & Simmons) for sharing their article (here) on the latest referral to the CJEU on SPCs from the UK Court, which will be published in Bio-Science Law Review.

In short summary, the UK Court of Appeal referred another question to the CJEU seeking clarity concerning the correct interpretation of Article 3(a) of the SPC Regulation. This makes it a hat-trick of referrals (England 2 – Germany 1) trying to understand what it means for a product to be ‘protected’ by a patent. This referral follows Sandoz’s appeal of Arnold J’s first instance decision, in which the outcome was held to be clear (in favour of SPC grant), even if the legal test was not. The UK Court of Appeal has overturned Arnold J’s decision, stayed the appeal and referred another question to the CJEU.

The question asked by the Court of Appeal is:
“Where the sole active ingredient the subject of a supplementary protection certificate issued under [the SPC Regulation] a member of a class of compounds which fall within a Markush definition in a claim of the patent, all of which class members embody the core inventive technical advance of the patent, is it sufficient for the purposes of Article 3(a) of the SPC Regulation that the compound would, upon examination of its structure, immediately be recognised as one which falls within the class (and therefore would be protected by the patent as a matter of national patent law) or must the specific substituents necessary to form the active ingredient be amongst those which the skilled person could derive, based on their common general knowledge, from a reading of the patent claims?”
Following the CJEU hearing the Teva v Gilead referral on Article 3(a) on 20 February (sitting as a Grand Chamber of 15 Judges) it will be interesting to see whether they deliver an overarching decision on Article 3(a) or approach this step-wise via the subsequent referrals from Germany and now the UK. We have heard that there will be an AG opinion in that case on or around 25 April so watch this space.

Thursday, 29 March 2018

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. 

Friday, 23 March 2018

Forum Institut SPC Seminar 2018

From Rechtassessor Jean-Claude Alexandre Ho (IP conference manager at FORUM Institut für Management GmbH) comes news of an SPC-related seminar which he is organising:
'Quo vadis, SPC?', the update seminar in which Dr Christopher Brückner, the author of the SPC commentary noted here (participants will receive the second edition on top of course documentation), will speak on the CJEU's referrals from 2011 to 2018 and on how to understand the decisions and which practical consequences we may expect for the future. A half-day pre-course will be offered for attendees without prior SPC knowledge/education.

Date: 16 May 2018 (pre-course: 15 May 2018); venue: Amsterdam. 
More information is available here.   
To register, just forward this blogpost to Jean-Claude at jc.alexandreho@forum-institut.de or click here.

Thursday, 22 March 2018

Belgian Office for Intellectual Property issues practice note on the calculation of the duration of SPCs

The Belgian Office for Intellectual Property recently issued a circular letter (here in Dutch and here in French) providing details on the calculation of the duration of SPCs in view of the CJEU Seattle Genetics (C-471/14) and Incyte (C-492/16) decisions.  Stijn Lagaert of Gevers provides below an overview of the practice at the Belgian office.
Background
In 2015, the Court of Justice of the European Union (CJEU) issued a decision in C-471/14 (Seattle Genetics). As discussed in more detail here, it ruled that the date for calculating the SPC duration is the date of notification of the decision granting Marketing Authorization (MA), rather than the decision date itself. While Belgium previously already calculated the duration based on the notification date of EU marketing authorizations, it issued a 2016 circular letter to detail its practice. More recently, the CJEU provided more details about the correction of SPC durations that were granted based on the decision date (C-492/16 – Incyte). 
Circular letter of March 2018
The Belgian Office for Intellectual Property has recently issued a circular letter providing further details about the practice in Belgium in relation to the date of the MA. While the practice remains the same for an MA granted by the European Commission (i.e. the notification date published in the Official Journal), the circular letter is perhaps more interesting in relation to the notification date of a national MA. The Belgian Office states that it will consider the date of the decision to be the date of the MA if there is no official publication of the notification date. The applicant has the option to provide proof that it was only notified at a later date in order to use that notification date as the date of the MA. 
Fellow practitioners will appreciate that the circular letter links its practice for the ‘date of the MA’ to both Art. 7 and Art. 13 of the SPC Regulations. Thus, the Belgian Office will use the notification date both for the calculation of the SPC duration and for calculating the deadline for filing the SPC application.  
After Seattle Genetics, some SPC specialists cautioned that the CJEU decision only ruled in relation to the date used for determining the duration of the SPC (Art. 13), but did not necessarily read on the grant date of the MA for the calculation of the deadline for filing the SPC application (Art. 7). In addition, it did not provide guidelines for determining the notification date of national MAs, beyond referring to national law. These issues were e.g. raised by Mike Snodin and Michael Pears. The circular letter provides some welcome clarifications about both aspects, at least under Belgian practice. 
Advice
As the notification date of a national MA will likely be a few days after its decision date, we suggest saving and filing proof of the date of notification in these instances to enjoy the longer SPC duration in Belgium. The proof can be an official publication of the notification date or any other proof. This is of course only relevant in those cases were the national MA is the first to place the product on the European market.