France - Paris Court of First Instance nullifies Truvada SPC

Moving on to France on the tour of national court rulings on Gilead's SPC on the combination of tenofovir disoproxil and emitricitabine: Gerard Dossmann and Marianne Gabriel, who acted for Biogaran, report below the recent decision of the Paris Court of First Instance to nullify Gilead's SPC FR05C0032.  A copy of the judgement can be found here.

By judgment of May 25th, 2018, the Paris Court of First Instance canceled the SPC on the combination of "tenofovir disoproxil and its salts, hydrates, tautomers and solvates in combination with other therapeutic compounds such as emtricitabine". 

The basic patent mentioned, in its claim 27, a "pharmaceutical composition comprising a compound according to any of claims 1 to 25 [i.e., tenofovir disoproxil], together with a pharmaceutically acceptable carrier, and optionally, other therapeutic ingredients. " 

The Paris Court of First Instance held that "the patent on the basis of which the SPC 0032 was delivered does not mention, in the wording of its claims, emtricitabine, the active ingredient on which the SPC relates in combination with the tenofovir disoproxil, neither makes it necessarily and specifically identifiable, nor does it mention a functional formula implicitly but necessarily and specifically aiming at emtricitabine, so that the product is not protected by the basic patent and that the condition laid down in Article 3 (a) of Regulation (EC) No 469/2009 is not fulfilled ". 

After citing the case-law of the General Court of Justice and the brief of the General Attorney Wathelet, the Court specified the conditions to which a claim must comply in order for a product to be considered protected by the basic patent and therefore meet the requirement of Article 3 (a) of Regulation (EC) No 469/2009. 

Thus, according to the Court, "the requirement for that product to be protected by a basic patent in force "presupposes":

• "that the product is mentioned in the wording of one of the claims or at least, if not mentioned by name, that it is necessarily and specifically identifiable as such by a person skilled in the art"
• “and that where – in the case of a combination of active ingredients – each active ingredient be also mentioned in the claims or, failing that, necessarily and specifically identifiable individually',
• “one must note that if it may considered that - to be considered protected by the basic patent – an  active ingredient is not mentioned in the claims of the basic patent by means of a structural definition but simply by means of a functional definition, it is also important to establish that these claims, interpreted inter alia in light of the invention’s description, as provided by Article 69 of the Convention of 5 October 1973 on the Grant of European Patents (EPC ) and its interpretative protocol, implicitly but necessarily aim in a specific manner at the active principle in question. " 

The Court of First Instance also ruled on the interpretation of Article 69 EPC and held that "the interpretation pursuant to which, for the person skilled in the art, in the context of European Patent No 894, the sentence 'and, where appropriate other therapeutic ingredients' would target an active ingredient with therapeutic properties which may be capable of being combined with tenofovir disoproxil, such as emtricitabine, clearly exceeds what is permitted by Article 69 EPC and its interpretative protocol in this respect, therefore leading to the admission that "the protection also extends to what, in the opinion of a person skilled in the art having examined the description and the drawings, the patent owner intended to protect", and may therefore disregard the reasonable degree of legal certainty that third parties are entitled to expect. " 

The Court noted, for the sake of completeness, that the purpose of Regulation (EC) No 496/2009 had been respected in the present case, since the owner had a 15-year monopoly between February 5th,  2002, date on which the marketing authorization was granted for the drug on the tenofovir disoproxil subject of the patent no. 894 and July 25th, 2017, the patent’s expiry date, so that it did not suffer from any lack of protection within the meaning of recital (9) of the Regulation.

This very recent judgment is not yet final.

Many thanks to Gerard and Marianne!

European Commission proposal for manufacturing waiver

Today, the European Commission published its proposal to amend Regulation (EC) No 469/2009 on SPCs to introduce a manufacturing waiver, i.e. an exception to allow manufacturers of generics and biosimilars to manufacture certain pharmaceuticals for export outside the EU during the SPC term. A copy of the proposal is available here.

The results of the studies on the legal aspect of SPCs by the Max Planck Institute (here) and on the economic impact of SPCs, pharmaceutical incentives and rewards in Europe by Copenhagen Economics (here) were also published on the Commission website today. 

GDPR notification

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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!

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. 

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!

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.

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!