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GR – Novartis & Novartis Hellas v. GPH

16 Feb 2017

Novartis AG & Novartis Hellas SA v. GPH Ltd, Greece , First Instance Court of Athens (temporary relief proceedings), 21 December 2016, Judgment No. 8512/2016

Novartis AG and its Greek subsidiary, Novartis Hellas,  initiated successful temporary relief proceedings against GPH Ltd in defense of their rights to EP No. 2292219 (EP 219), which covers a transdermal therapeutic system (TTS) for administration of rivastigmine, marketed in Greece under the trade mark EXELON by Novartis Hellas.

GPH had obtained marketing and price authorization to introduce in the Greek market generic pharmaceutical products – TTSs under the mark RIVAMYLAN under a dosage scheme falling within the scope of EP 219.

The law
According to the Court “novelty exists, as far as the production of goods is concerned,  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.

“An inventive step exists when, according to the skilled person, the “invention” cannot be obviously deduced from the state of the art… At any rate, the product itself is protected, regardless of the method of production or use and the protection of product patents is significantly wider than that of a patent for methods of production of products”.

“Moreover, in case of alleged infringement of a patent, the owner is entitled to seek that the defendant ceases and desists the infringement under art. 17 (1) of Law No. 1733/1987. The same protection is afforded to a patent licensee  (art. 17 (3) of Law No. 1733/1987). Such claim also arises from the provision of art. 60 of the Civil Code on the protection of products of the mind, which may apply complementary [to law No. 1733/987].

“Also, when the infringement takes place with competitive intent, namely with the aim of posting clientele, and is an act contrary to established business morals, the aggrieved party may also rely on art 1 of Law No. 146/1914 on Unfair Competition which allows equivalent claims and may apply complementary [to law No. 1733/987]. Additionally, if urgent need is substantiated, temporary relief measures are allowed in case of patent infringement”.

Factual background – Court’s findings
The Court held that Novartis AG “is co-owner of EP No. 2292219/12.6.2013 entitled “Transdermal therapeutic system for administration of rivastigmine”, with priority as from 01.12.2005. The patent was validated in Greece by virtue of no. 3080936/17.06.2013 European Patent Translation Filing Certificate, published on 11.7.2013 and is valid until 11.10.2026.

The concession of an exclusive license to the second applicant [i.e., Novartis Hellas] to use the invention in Greece was duly registered before the Greek Industrial Property Office (OBI) on 01.08.2013, under prot. No. 4842/1.8.2013.

In Greece, only Novartis AG markets original pharmaceutical products covered by the patent; this is done via its Greek subsidiary, Novartis Hellas. The products are marketed under the brand EXELON and are  a transdermal therapeutic system releasing a given quantity of rivastigmine within 24 hours.

As the Court held, 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 transdermal therapeutic system (TTS) and the starting dose is the one set out in the single claim of the EP.

“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 %. ”

Accordingly, the Court continued, the EP “covers a dosage scheme of 9 mg rivastigmine per transdermal patch of 5 cm2 per 24 hours, as deduced from the abstract of the patent, where it is 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 has notably milder side effects”.

The Court also acknowledged that there has been a successful opposition against EP 219 before the EPO. However, it ruled that the EPO’s Opposition Division accepted the opposition only on the ground that that the subject-matter of the EP as claimed extends further to the patent application as initially filed, “without examining the novelty and inventive step of the EP”.

Also, 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 the temporary relief action.

The Court rejected GPH’s claims that the application, as filed, did not refer to a dosage scheme independent of the TTS structure, that the invention is not sufficiently disclosed and that there is no inventive step.

In particular, the Court accepted that the starting does of 4,6 per 24 hours, although not “arithmetically” mentioned in the EP’s single claim is protected considering that the claim describes in particular the characteristics which produce this starting dose, and cited judgment VIACZ4448/14 of the Warsaw Court of Appeal on this matter, as well as judgment 20197/13 of the Manheim District Court.

The Court also held that “the contents of the single claim explain the invention and are not limiting and, accordingly, the qualitative and quantitative composition elements referred to in the EP should not be understood as independent structural characteristics of the claim and, so,  it is the starting dose that is important for the subject-matter of the invention (judgment VIACZ4448/14 of the Warsaw Court of Appeal). The description of the EP presents two TTSs with different structure, with or without 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 relates to one dosage regimen. It is concluded that the EP in question relates to a novel, at the priority date, pharmaceutical use and, in particular, to a method of treatment in which rivastigmine is administered via a TTS with a starting dose that is the initial dose absorbed by the human body in a period of 24 hours. The claim of the EP in question covers all TTSs that release the same quantity of rivastigmine (see also  decision 19 cg 84/13ν of the Commercial Court of Bonn). I also note that the summary of the characteristics of the said pharmaceutical products mentions that each 5cm TTS contains 9mg rivastigmine and that the starting dose is 9mg under which the release rate per 24 hours is 4,6. Moreover, it is concluded that the initial application of the first applicant [Novartis AG] included the term “starting dose” in connection with a TTS with the particular structure and cited examples so that the average skilled person could assess this characteristic without the need for further specification thereof this was unambiguously clear from the application, as filed, (see also judgment 295/2016 of the First Instance Court of Athens and cited judgments therein)”.

According to the Court, “[t]he characteristic protected by the claim is the starting dose of rivastigmine administered via the TTS and not its structural characteristics which may  vary. Accordingly, the contrary arguments of the respondent must be rejected”.

The Court ruled that any TTS with the dosage regiment of EP ‘219 infringes upon the patent and cited the above Greek and foreign judgments to support its finding. It further ruled that GPH obtained marketing authorization by the Greek National Organization for Medicines (Ethnikos Organismos Farmakon – EOF) for generic pharmaceuticals under the marks RIVAMYLAN 4,6 mg/24hr and RIVAMYLAN 9,5 mg/24hr, the starting rivastigmine dose of which is covered by EP 219, as also stated by expert opinion submitted to the Court.

Moreover, following decision No. Γ5 95827/11-12-2015 of the Health Minister the price of such of such generic products was determined and, therefore, the respondent would now be free to market them in Greece.

However, according to the Court, “this would also harm the reputation of the applicants, as it would create the impression that their invention does not merit patent protection. Moreover, the applicants would suffer monetary damage, since consumers would turn to the cheaper, generic products, and the respondent would gain unfair benefit by introducing such products in the market at a time that the EP in question is still valid, considering also that such market launch would be inexpensive and free ride on the reputation of the product of the first applicant [Novartis AG]”.

The Court also rejected GPH’s claim over abusive exercise of the applicant’s rights to the EP. GPH’s argument was that the applicants could not assert their rights to EP 219, because (a) it had been repealed and (b) the marketing of a generic product would lead to a drop in EXELON’s price to the benefit of consumers, health funds and the public interest in general.

The Court ruled that such arguments find no legal ground and do not constitute “abusive exercise of a right” as enshrined in the Greek Civil Code. This, according to the Court, would apply even more so, since the patent is still valid and the marketing of the respondent’s products is a clear violation of the applicants’ rights.

In view of the above, the application was accepted in part and GPH was ordered to provisionally cease and refrain from producing and marketing the RIVAMYLAN 4,6 mg/24h and RIVAMYLAN 9,5 mg/24h products, to withdraw from the market any such products, within 5 days as of service of the judgment, or, in case of non compliance, the Court would allow the seizure of such products. Moreover, the Court threatened GPH with a pecuniary penalty of 100 EUR for each product found on the market after 5 days have lapsed as of service of the judgment.

However, the Court rejected the applicants’ request to publish a summary of the judgment in the press, considering that the preliminary relief granted is already adequate. It also rejected the applicants’ request that GPH is ordered to refrain from producing and marketing [other] pharmaceutical products that infringe upon EP 219 as inadmissible “because the applicants do not claim that the respondent produces or intents to market in Greece or possesses other pharmaceutical products than those described in the temporary relief action, considering also that the existence of urgency, which would justify temporary relief action, is decided on the basis of a particular set of facts.”

The applicants’ request that the respondent furnishes them with copies of the monthly production, sales and stock data, as per the Greek Pharmaceuticals Code,  was also rejected as inadmissible, because the applicants’ legitimate interest to such data was not set out in the action and also because such data were not accurately defined in the action.

The judgment was published on 21 December 2016.

A copy of the judgment (in Greek) can be read here.

Summary: Nikos Prentoulis, PRENTOULIS Lawyers & Consultants