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GR – Novartis AG & Novartis Hellas SA v. WELDING GmbH & Co KG

30 Mar 2016

Novartis AG & Novartis Hellas SA v. WELDING GmbH & Co KG, Greece , First Instance Court of Athens (temporary relief proceedings), Judgment No. 295/2016

The applicants claim that the respondent put in the Greek market generic pharmaceutical products under the mark RIVASTIGMINE/WELDING in the form of transdermal plaster, subject to a dosage scheme falling within the scope of EP No. 2292219 (EP 219), owned by Novartis AG, duly validated in Greece and valid unitl 11.10.2026. The original pharmaceutical product corresponding to EP 219 is marketed in Greece under the trade mark EXELON via Novartis Hellas, a subsidiary of Novartis AG. Accordingly, citing an urgent need to address the infringement, the applicants filed a preliminary injunction action.

The law
The Court reiterated the classic ‘batch’ of patent jurisprudence rules. In particular, it held that:

“As regards the production of goods, novelty exists when the good differs from similar goods on account of new, substantial characteristics, whereas regarding the production of an end result, novelty exists when there is a notable improvement of an already known end result, regardless of whether such improvement concerns only the method of production or only the end result or both, and does not appear as simply an adaptation of elements of already known methods, without a notable result or improvement or as merely a new use in another subject matter of a medium which is already known and in a manner already known (Supreme Court 1654/2013, 545/1996, ΑΠ 1588/1991). An inventive step exists when, according to the skilled person, the “invention” cannot be obviously deduced from the state of the art at the crucial point in time. “… “Under articles 7, 8 of Law no. 1733/1987, the substantive requirements for the grant of a patent (novelty, inventive step and industrial application) are not assessed by the Greek Patent Organization (OBI). Accordingly, a patent may be invalidated, in the context of civil proceedings, either via an action seeking a declaratory judgment or in defense against a main infringement action. Moreover, the invalidity of the patent may be claimed as a defense in the context of preliminary relief proceedings., though no res judicata is produced in this case.  Thus, the practical value of a patent registration lies in the transfer of the onus of proof upon the defendant / alleged infringer”.

Factual background
According to the Court, “Novartis AG was the first company to market rivastigmine drugs n the form of soluble drinks and pills, the protection for which has expired. It was a significant invention in the early 1980s. Rivastigmine was patented for the first time by Sandoz AG, later merging with CiBA-Geigy AG, and evolving to become Novartis AG. The product was approved for the treatment of Alzheimer in May 1998. The drug had significant side effects for patients and a significant portion of the patients were not able to tolerate the maximum approved dose of 12mg daily.  Seeking to solve this problem Novartis AG successfully turned to the administration of rivastigmine via transdermal patches. Accordingly, it is now co-owner with “LTS Lohmanm, Therapie- Systeme AG” of EP No. 2292219/12.6.2013 entitled “Transdermal therapeutic system for administration of rivastigmine”, having 01.12.2005 as a priority date, validated in Greece by virtue of no. 3080936/17.06.2013 European Patent Translation Filing Certificate and is valid until 11.10.2026. The concession of an exclusive license to the second applicant to use the invention in Greece was duly registered before the Greek Industrial Property Office (OBI) on 01.08.2013…”

“…The EP relates to a novel dosage regime on a transdermal patch to treat Alzheimer’s disease, characterized by a larger starting dose than what was known at the time. Only Novartis AG markets original medicinal products covered by EP 219 in Greece, through its subsidiary Novartis Hellas Sa. The product is a transdermal therapeutic system (TTS), under the trade mark EXELON, which releases a particular quantity of rivastigmine in a period of 24 hours. The invention refers to rivastigmine in the form of free base or pharmaceutically acceptable salt, for use in a method of preventing, treating or delaying progression of dementia or Alzheimer’s disease wherein the rivastigmine is administered in a TTS and the starting dose is the one set out in the single claim of the EP….”

“…The patent describes in detail the technical problem which the invention purports to solve and the solution proposed and applied, so the claims to the contrary put forward by the respondent must be rejected. The sole claim of the disputed EP is as follows: ‘1.Rivastigmine for use in a method of preventing, treating or delaying progression of dementia or Alzheimer’s disease, wherein the rivastigmine is administered in a TTS and the starting dose is that of a bilayer TTS of 5 cm with a loaded dose of 9 mg rivastigmine, wherein one layer:

has a weight per unit area of 60 g/m and the following composition:
–  rivastigmine free base 30.0 wt %
– Durotak® 387-2353 (polyacrylate adhesive) 49.9 wt %
– Plastoid® B (acrylate copolymer) 20.0 wt %
– Vitamin E 0.1 wt %

and wherein said layer is provided with a silicone adhesive layer having a weight per unit area of 30 g/m2 according to the following composition:
– Bio-PSA® Q7-4302 (silicone adhesive) 98.9 wt %
– Silicone oil 1.0 wt %
– Vitamin E 0.1 wt %. “‘

That is, the EP under dispute, covers a regimen of 9 mg rivastigmine per transdermal patch of 5 cm2 per 24 hours, as is clear from the abstract of the patent, where it is expressly stated that the starting dose is equivalent to the one provided by a bilayer TTS of 5 cm with a loaded dose of 9 mg rivastigmine. The characteristic which sets the invention apart from the state of the art is the starting dose which is already effective in therapeutic terms in contrast with the orally administered forms of rivastigmine and although it is larger it presents notably milder side effects. ”

“…13 pharmaceutical companies filed with the EPO an opposition against EP 219, which was accepted by the EPO’s Opposition Division, though, on the basis of the documents submitted, the Court cannot safely diagnose the ground of invalidity. In particular, the Court considers, based on an expert opinion, that the Opposition Division did not examine the novelty and inventive step of the EP in dispute, but apparently accepted the opposition on the ground that the subject-matter of the EP as claimed extends further to the patent application as initially filed. The Court comes to the same conclusion based on the preliminary opinion of the Opposition Division dated 19.12.2015 . Novartis AG filed an appeal against the said decision, which has a suspensive effect, and, thus, the EP is valid at the time of the hearing of this action…”

“…The respondents arguments over lack of novelty are rejected. The fact that the starting dose of 4,6 mg/24 hrs is not mentioned in claim 1, does not mean that it is not covered by the EP, since the claim describes specifically the characteristics thereof which “give” this starting dose of 4,6 mg/24 hrs. ” In reaching that conclusion, the Judge relied on the expert opinion of a University professor, furnished by the applicants, who also testified at the hearing as a witness but also mentioned judgment No. 20 197/2013 of Manheim’s District Court, submitted by the applicants, as well as a UK decision furnished by the respondent.

Further, the Judge ruled that all 3 dosage forms of the EXELON patches are covered by EP 219 and that the examples cited in the single patent claim are explanatory of the and are non-limiting. “…Accordingly, the qualitative and quantitative composition elements referred to in the EP under dispute should not be perceived as independent structural characteristics of the claim and are, thus, irrelevant to the subject matter of the invention, i.e. the particular dosing schedule, as provided for by the summary of the invention, but it is the starting dose that is important. Moreover, the description of the EP under dispute discloses, as shown in figures 2 and 3, two different structured TTS with or without the adhesive layer, which, in each case, release the same amount of rivastigmine. The EP cites a number of dosage examples stemming from the particular starting dose and the circumstances off the case suggest that they refer to one dosage regimen. The above are, according to the Judge, verified by a judgment of the Danish courts. The designation of the starting dose was the result of experimental work and not of a simple mathematical computation and adjustment of the ratio of the orally administered drug to the transdermal one, unlike the respondent’s claims.”

The Judge rejected the respondent’s claims that EP 219 is invalid because the initial EP application included only one TTS, characterized by a particular adhesive layer including silicone polymer and an adhesive agent and that these characteristics should be regarded as important elements of the invention, not described in the application. The Judge held that based on the overall description of the TTS it can be concluded that the additional adhesive body does not affect the permeation of the drug through the skin and, accordingly, is not a significant characteristic of the invention demanding specification in the patent application. The key element of the invention is, according to the Jydge, the starting dose of rivastigmine administered by TTs and not the structural elements thereof, which may differ.

Considering that (i) the respondent has been granted marketing authorization and that the competent authorities approved and published the relevant price list for generic pharmaceutical products under the name  RIVASTIGMINE/WELDING 4,6 mg/24h and RIVASTIGMINE/WELDING 9,5 mg/24h and so the respondent can place such goods in the market, (ii) that the active substance of the said products is rivastigmine at a starting does of 4,5 mg/24 hr, (iii) the excipients are “Film Poluester, Silikon -coated polyester, σε ποσότητα 5 cm/patch, fluomo-coated polyester,  of 12 cm2 per patch, and Drug Matrix acrulic adhesive 15 mg, acrulates copolymer 6mg, ethul acetate, adhesive Matrix silicone adhesive 15 mg” for RIVASTIGMINE/WELDING 4,6 mg/24h and “Film Poluester, Silikon -coated polyester, of 10 cm2 per patch, fluomo-coated polyester of 20 cm2 per patch, and Drug Matrix acrulic adhesive 30 mg, acrulates copolymer 12mg, ethul acetate, adhesive Matrix silicone adhesive 30 mg” for  RIVASTIGMINE/WELDING 9,5 mg/24h, the Judge held that these two generic products are identical with those covered by the EP, while the mere fact that they do not include silicon and Vitamin E oils is not enough to differentiate them, since the difference concerns excipients not contributing to therapeutic action or permeation of the active substance of the product. Moreover, the fact that these prodcuts have been characterized as generics suggests that they are substantially similar from a quantitative and qualitative aspect of the composition of their active substance in relation with the applicants’ products. Notwithstanding the above, generic products can be marketed so long as they do not infringe upon the patent rights of the first applicant (Novartis AG).  According to the Judge, the imminent marketing of the above generic pharmaceutical products, which violate the first applicant’s rights calls for temporary relief action, as it would also prejudice the reputation of the applicants and potentially also harm them from a financial aspect.

Accordingly, the Judge accepted the temporary relief action and ordered the respondent to provisionally cease and refrain from producing and marketing medicinal products falling within the scope of EP 219 under any brand name, including RIVASTIGMINE/WELDING 4,6 mg/24h και PJVASTIGMINE/WELDING 9,5 mg/24h, as well as withdraw any such products from the market. A pecuniary penalty of 50 EUR per packaging including a relevant medicinal product was threatened upon the respondent in case of violation of the Court’s orders.

Analysis – Practical significance
This judgment is the second successful attempt of Novartis to stop the marketing of generic rivastigmine TTSs. In 2015, under judgment  4888/2015, it was successful against SANOFI-AVENTS S.A (Greek subsidiary of SANOFI-AVENTIS). In the same case, but in main infringement proceedings, under, the IP Chamber of the Mutli-Member First Instance Court of Athens decided to stay proceedings (judgment No 3955/2015) and appoint two independent experts to provide their opinion on the validity of the patent in dispute. This type of procedural development is very common in patent litigation concerning pharmaceuticals, as Greek IP courts do not include patent experts in their composition and the particular subject-matter is too technical for the IP judges to assess. What is interesting is that, the Court treated an application by SANOFI-AVENTIS SA to lift the preliminary injunction against them, in the same manner; namely it held that its lack of technical expertise required to address the merits of the case meant it should wait for the appointed experts’ opinion. The Court went into the discussion of a specific balance of rights in the matter and also ruled that a potential judgment to lift or maintain the preliminary injunction may affect the experts’ opinion. To rebut  the argument that the urgent nature of the lift application called for a swift judgment, the Court held that the strict time limit given to the experts addresses such need in a satisfactory manner .

The Judge in the case presented here followed the footsteps of the previous preliminary injunction judgment and adopted the basic outline of its reasoning. Her call follows the key mentality of judges in preliminary injunction actions involving EP  infringement and EP invalidity claims: as a rule of thumb, the scales tilt in favour of the patent owner, who, in balance, is considered to stand to lose more than the defendant / counter-claimant.  Of course, in this particular case, the Judge remained unconvinced that the EPO’s Opposition Division had struck down EP 219 for the same reasons invoked by the respondent. This may have facilitated its ruling that the EP owner and its licensee are entitled to a preliminary injunction, even after the the EPO’s Opposition Division decision, based also on the suspensive effect of an appeal before the Board of Appeal, under article 106(1) of the Munich Convention.

Head note and summary: Nikos Prentoulis, Prentoulis Lawyers and Consultants