Date of publication: 7 July 2017
Irina Kirichenko, Patent Attorney of Ukraine
If a pharmaceutical drug was to have a motto my defendant would perfectly take the Latin expression “Citius, Altius, Fortius!” — motto of the Olympic Games which means “Faster, Higher, Stronger”.
So-called doping scandal raging in the world of elite sports, related to taking by athletes of Meldonium preparations, made this drug popular not only at the territory of post-Soviet countries, but brought fame to it all over the world. Efforts of the employees of Grindeks, as well as the company’s investments into scientific research, resulted not only in bringing an effective pharmaceutical drug of a perfect quality (cardioprotector of new generation) to the market, but also in winning recognition of the drug by millions of doctors and patients.
The story was as follows. Meldonium molecule was synthesized in the mid-70s by the Institute of organic synthesis of the Academy of Sciences of Latvian Soviet Social Republic. Similar to the medical biography of Nitroglycerin the history of creation of Meldonium started from the explosive ordnance sphere. According to the words of its inventor, Professor Ivars Kalvins, the idea of synthesizing Meldonium originated through the necessity to utilize rocket fuel (heptyl). Later it turned out that the substance acts as a pacemaker and starting from 1980s it was used in clinical practices. Since then the drug was produced by Riga pharmaceutical enterprise (mainly for export).
Ukrainian market saw the drug at the end of 1990s.
The “patent” history of Meldonium is also great. In 1976 the drug received the inventor’s certificate in the USSR and in 1984 a patent was received in the USA. In 1992 due to collapse of the Soviet Union the inventor’s certificate was re-registered in the form of patents in the Baltic countries and countries of CIS and its original trade name received legal protection as of the trade name in 60 countries.
But the price of popularity is high. After expiration of the term of patent protection and loss of the monopoly in this segment of the market the producer of Meldonium lost millions of dollars by the reason that many cheap generic copies entered the market. But this is the fate of all the original drugs. After the moment when the originator (following the costly scientific research) brings its product into the market it instantly becomes the subject matter of marketing research by the generic companies which closely follow its success on the market and prepare themselves to production of the generic.
The generic will only need to prove its equivalence to the reference (original) medicinal product. This is why the copy is always cheaper than the original and the “golden years” of the monopoly of the new drug at the market is, at best, limited by the term of the patent protection and rarely lasts for more than 25 years (20 years – is the standard term of patent protection + 5 years of the “privileged” term provided for the research of the drug).
The more balanced is the correlation between the risk and the benefit of the drug, the earlier the regulatory authorities will launch its generic copies “for the good of people” after waiting a five-year term (at best) of the data exclusivity – the minimum term of protection from copying. It is the effectiveness of the drug which causes the necessity to perform protection of the patent rights duration of validity of which is short-lasting.
Another case is the trade mark to the drug. Suchwise, Mildronate is the proper name given to the products of the company-manufacturer. This name will ever be applied to the original drug – preparation of Meldonium, regardless of the patent protection.
However, there are generic companies which, by copying other companies’ innovations and avoiding investments to the research, try also to save on advertizing. “I am the same as the original drug – signals the new-born Meldonium generic in the price-list, – only much cheaper”.
When it entered the Ukrainian market the company bumped into the consequences of popularity of its pharmaceutical drug and, in addition to making investments into scientific research, had to invest resources into the court disputes related to protection of intellectual property rights to the drug. One of the recent examples – the claim on protection of the company’s rights to its well-known trademark in Ukraine (See. “APTEKA Weekly” No. 6 (1077) as of February 20, 2017).
One may also dwell upon the factors of popularity of the mentioned trade mark supported by kilograms of documentary evidence constituting five volumes of the case materials. After consideration of the mentioned materials the economic courts came to the unconditional conclusion on well-known status of the trademark.
And the conclusions of the court investigation, which were based on the fundamental research carried out by the court expert Petrenko S.A. within this case, were made, among other things, upon application of knowledge from the fields of chemistry, medicine and pharmacology and allowed the court to establish the semantic identity of the names of the original drug and its generic copy, as well as decrease the quantity of semantic and phonetic “variations” sameness of which cannot be disguised by no “identifiers” such as “Extra”, “Super”, “New” etc.
In its turn, having unwound this tangle of conflicts of intellectual rights, medical testimonies and economic interests the economic courts of Ukraine, once again, affirmed the highest level of their competence in settlement of such complicated and multi-faceted disputes as the disputes regarding the intellectual property rights in the pharmaceutical sphere.
LIMITATION PERIOD: when the opponent takes time before the attack
Virtually every court process related to protection of patent rights proves correctness of the proverb: “The best defense is offence!”. The claim for protection of the right to an invention (utility model) from its unauthorized use, as a rule, always “runs against” a counter-claim – on acknowledgment of invalidity of the patent. Why?
Firstly, it looks nice. The position of the respondent from guilty and apologetic (“invented the drugs ourselves, but were not aware that it is protected by the patent”) immediately turns into righteous and accusatory (“This is a surefire decision – not subject to patent protection!”).
Secondly, and that is the main thing, – the initial claim will be considered by the court only after consideration of the counter-claim and this is right. What kind of protection will it be if the patent is recognized to be invalid, i.e. the one which did not come into force?
Even if the plaintiff, who lodges the counter-claim and provides the proof of the obviousness of the invention and having smeared its originality, fails to challenge your patent, it always wins in the tactical sense. In the course of consideration of his claim (and performance of the court examination – or many of them) many things may happen, in particular, the term of validity of the patent may expire and it will be impossible to impose prohibition on its use in hindsight (the consignments of the premature generic will be produced, sold and taken according to their intended purpose).
But there is one additional procedural bonus for the manufacturer of the generic. Lodging the claim on cancellation of the patent the mentioned manufacturer does not have to burden himself with stating reason for going to the court (explain why this patent is hindrance for him), as well as to worry about any limitation period. The limitation period is not applied to counter-claims because there is logic to it: “I was manufacturing the products relying upon this evident decision and found out about your patent rights only after studying your claim against me”.
If the manufacturer, which has devised and tested its new drug (for example, use of the well-known pharmaceutical drug called Sildenafil under its side effect), not wishing to violate anybody’s rights, carries out the patent search and finds out with regret that another company was several years ahead, and the patent stays valid, the manufacturer will have to postpone production of its “Viagra” as soon as I have the limitation period (three years from the moment of publication of information about the patent) and will not likely find valid explanation for missing it (unless, of course, I will be helped by the patients who used the drug according to its initial purpose which inspired me to create this innovation).
It means that there is an exception to every rule – one must only find such exception.
Earlier “APTEKA Weekly” highlighted the end of the process of cancellation of registration of the drug entitled “Oftamirin” (See “APTEKA Weekly” No. 16 (978) as of April 27, 2015) as violating the patent rights of “Eye antiseptic” under the patent No. 64800 as of March 15, 2004 (the object of protection was represented by a pharmaceutical composition on the basis of miramistin – “Oftamirin”) owned by Megainpharm GmbH (Austria). And now, as far as one year after, based on the Judgment of Kyiv Economic Court of Appeal as of July 12, 2016 in the case No. 910/21617/15 the patent of Ukraine No. 64800 was recognized to be invalid, i.e. the one which did not exist.
At first, by issuing a decision in the case 910/21617/15 as of March 24, 2016 the Economic Court of Kyiv dismissed the stated claims of the PrJSC “Pharmaceutical Firm “Darnitsa”. The decision was motivated by the fact that the plaintiff missed the limitation period. The latest document confirming the fact of awareness about the patent No. 64800 was dated back to 2009 and by the moment when the claim was lodged (in 2015) the limitation period, some way or another, had expired.
Pursuant to the Article 256 of the Civil Code of Ukraine (the “CCU”) the limitation period is the term within which a person may file a suit to the court with a claim of protection of one’s own right and interest. Pursuant to the Article 257 of the CCU duration of the general limitation period constitutes three years. The Article 261 of the CCU stipulates that the limitation period commences from the day when the person found out (in this case the limitation period for the plaintiff starts from the date of lodging by him to the Ministry of Health of the application on registration of the medical product – February 07, 2008) or could find out about the violation of his own right (publication of information on registration of the patent No. 64800 in the bulletin “Industrial property” – March 15, 2004) or about the person who violated it.
However, Kyiv Economic Court of Appeal cancelled the mentioned decision counting the limitation period from the moment of commencement by the Economic Court of Kyiv of the proceedings under the claim filed by the patent owner to the court on protection of the rights to invention “Eye antiseptic” (which could be possible only in case of lodging a counter-claim under this case) under such way of thinking – each person who committed a violation, in case of the negative decision which came into legal force, may file a claim against the opponent providing substantiation that the latter had very good protection by which violated his right to continue violation further.
It is worthwhile drawing attention to the following. By choosing the most efficient, to our mind, option of defense – missing by the plaintiff of the limitation period, we were forced to turn down the struggle in this process essentially – i.e. not use our procedural rights in the sense of proving the patentability of the invention called “Eye antiseptic” (here is either/or situation – either we agree that the plaintiff, which used to produce the drug from 2004 till 2009, has not missed the limitation period lunging into endless whirl of legal expert examinations, or supply irrefutable (in our opinion) reasons that the limitation period expired, at least, six years ago relieving our client of extra expenses for legal representatives and settlement of invoices drawn by the expert institutions).
We chose the latter and lost.
For me – the representative of the patent owner who “lost” the patent of the company – of importance was new experience which I gained in this case. By choosing the most rational way of defense of the company’s rights I violated the unwritten rule of my profession: taking part is most important, not winning.
Following the path of appointment of the repeated examination and search for the specialists scientifically competent to carry out the search of the matters of patentability of a pharmaceutical drug we would not, possibly, have arrived to the first decision and the patent No. 64800 would continue to be in effect ensuring Okomistin’s monopoly at the market of eye drops, as well as giving work on its protection to many of our colleagues.
Here comes the conclusion: do not violate the foundations of the profession – do not be an egoist looking for shortcuts to winning: work yourself, but let other people work as well too!
“AND HEAVILY SWALLOWED ASPIRIN …”
On May 25 there will have been 13 years since the moment when the Supreme Economic Court of Ukraine upheld the judgement on dismissal of the claim lodged by “Bayer Aktiengesellschaft” which demanded removal of two medical terms from the orders of the Ministry of health protection of Ukraine: i.e. “Aspirin-sensitive asthma” and “Aspirin ulcer”. These terms were used to warn patients about side effects of acetylsalicylic acid and of another nonsteroidal anti-inflammatory drug (NSAID), other contraindication to use by the patients with hypersensitivity to acetylsalicylic acid (allergy). The stated claims were motivated by the fact that “reference to allergy may harm reputation of the plaintiff’s drug and the trade marks attaching to it” and, consequently, harms the image of the trade mark and of its manufacturer.
I believe that even from the standpoint of pure logic such requirements seem to be exaggerated. The medicinal drugs are intended for the people and their health. From the earliest times their producers follow the fundamental rule “Primum non nocere” (first do no harm). And many serious diseases (for example, Alzheimer’s disease) were named after the doctors who devoted their lives to their study, methods of diagnostics and treatment, those who tested new drugs and vaccines on themselves.
The priority of the safety of use of medicinal drugs is formalized legislatively – by the law of Ukraine “On medicinal products”. Pursuant to the Article 3 of the Constitution of Ukraine – “An individual, his life and health, honour and dignity, inviolability and security shall be recognised in Ukraine as the highest social value”.
In the course of drafting the statement of defence we studied thousands of pages of scientific and reference materials and provided the proof that “aspirin” is a part of medical terminology functional purpose of which is to assist the specialists (medical and pharmaceutical professionals) and consumers to be familiar with the ingredients of the medicinal drugs, their action, side effects and counterindications.
In particular, the reference guide put together by Mashovskiy M.D. called “Medicinal preparations”, which is considered to be a so-called “Bible” for doctors and pharmacologists states that the term “aspirin” is much wider than the reference to NSAID. It also includes specific names of illnesses developed as a result of long-term administration of this type of drugs, for example, “Aspirin-sensitive asthma” and “Aspirin ulcer”.
According to the terminology of Martindale pharmacopoeia and the titles of the scientific papers referred to by the authors the word “aspirin” (“aspirin” (noun), “aspirin“(adjective) etc.) represents the specific notion which is generally accepted as a name of a number of pharmaceutical compositions of NSAID group active ingredient of which is represented by acetylsalicylic acid, as well as the illnesses arising on the basis of their administration.
The text of the contested Order of the Ministry (the same as of any regulatory act) was based on the notions and terminology accepted in this sphere, medical and pharmaceutical. The terms used in the Order must be strictly regulated and be understandable both to medical personnel, as well as to the patients. Otherwise, various readings and uncertainty may arise and, correspondingly, harm inflicted to the health of consumers of certain medicinal drugs.
On May 25, 2004 in the process of sustaining the cassation appeal lodged by the State pharmacological center of the Ministry of Health Protection of Ukraine against the Judgment upheld by Kyiv Economic Court of Appeal on February 03, 2004 in the case No. 39/311 under the claim (on acknowledgment of the Order No. 8 to be invalid) lodged by “Bayer Aktiengesellschaft” against the mentioned Ministry the panel of judges of the Supreme Economic Court of Ukraine, in particular, established the following:
“All aspirin agents in the whole world have the same properties and side effects which are confirmed by sufficient factual data and described in the professional literature of many countries. It means that the plaintiff did not provide proof to the court why the name “ASPIRIN”, used in negative sense, may lead to inflicting harm to the plaintiff’s business reputation and, thus, there is no doubt that the medicinal drugs under the trademarks “АСПІРИН” and “ASPIRINUM” (owned by the plaintiff) have the same counterindications.
The name “aspirin” («аспірин», «аспирин» – in Cyrillic characters) represent the generally accepted name of acetylsalicylic acid and preparations on its basis, as well as of the illnesses developed as a result of long-term administration. In its turn “acetylsalicylic acid” is a chemical and pharmacological name not known by a wide circle of consumers as a synonym to “aspirin”.
Suchwise, the courts of the first and appellate instances violated the terms of the Article 3 (6) of the Law of Ukraine “On protection of consumers’ rights” which stipulates that the consumers have the right to receive necessary, accessible, authentic and timely information about the goods (works, services), their quantity, quality, assortment, as well as about their manufacturer (performer, seller).
Summing up the above we may come to conclusion that replacement in the text of the Order No.8 of the Ministry of health protection of Ukraine as of January 15, 2003 of the generally-used term “aspirin” by the term acetylsalicylic acid (which is known only to a narrow circle of specialists) may lead to harm suffered by the patients with hypersensitivity to aspirin who will not timely receive indispensable information, i.e. upholding of the stated claims of the plaintiff will lead to inflicting harm to the population of Ukraine which constitutes violation of the Article 3 of the Constitution of Ukraine.
Based on this the Supreme Economic Court of Ukraine dismissed the plaintiff’s claims on acknowledgment of the Order of the Ministry to be invalid in the part of use of the trade mark for goods and services “ASPIRIN”.
And for the author of this publication the poem of Bella Akhmadulina “Entrance to the cold” has become fateful:
And heavily swallowed aspirin
makes your spirit easy,
and gives the virtuous vantages of illness
and bravery which chills your heart.