Market “Pharmacing”

Irina Kirichenko, Patent Attorney of Ukraine
Source: Yurydychna Praktyka

After expensive research and launching of a new medicinal product on the pharmaceutical market, it immediately becomes the subject of marketing research by generic companies

When we say “Mildronat” – we understand “unlimited opportunities”: the so-called doping scandal in high-performance sport related to the use of medicines based on meldonium by the outstanding athletes brought the world popularity to this product being famous all over the post-Soviet space.

Experiment Consequences

It was like this: the molecule of meldonium (the international non-proprietary name of a chemical substance – trimethylhydrazinium propionate) was synthesized in mid-1970s at the Institute of Organic Synthesis of the Academy of Sciences of the Latvian SSR. Like the medical biography of nitroglycerin, the history of the creation of meldonium began with a request from the explosion engineering field: according to its creator, Professor Ivars Kalvins, the idea to synthesize meldonium appeared due to the necessity to utilize rocket fuel (heptyl). Later, it was found out that the substance proves itself as a cardioprotector, since the 1980s it was used in clinical medicine (approved for use in 1984), and since then it has been produced by “Grindeks” – a pharmaceutical company headquartered in Riga (mainly for export).

In our country medicinal product “Mildronate” was registered in 2000.

The patent history of meldonium is also quite rich: in 1976 the product received the author’s certificate of the USSR, and in 1984 was patented in the US.

In 1992 due to the collapse of the USSR, the USSR’s author’s certificate was transformed into the patents of the Baltic and CIS countries, and its original trade name – Mildronate – received a legal protection as a trademark in 55 world countries.

The Price of Popularity

If the sports fans just a year ago began enthusiastically counting how many millions of dollars shall the famous tennis player Maria Sharapova lose (who was caught using the “Mildronate” worth only fifty cents after WADA banned it), its manufacturer – the company producing the original meldonium “Grindeks” (Latvia) after the expiry of meldonium patent protection and thus losing its monopoly on the market of products based on trimethylhydrasine propionate, has already lost tens of millions of profits due to the launch of market generic copies of “Mildronate” onto the market.

This, unfortunately, is the fate of all original products: after the “parent” company brings its creation to the market, having conducted multimillion-dollar researches regarding the quality, effectiveness and safety of the new medicine, it immediately becomes the subject of marketing research of generic companies that keep a wary eye on the product’s success in the market and prepare for the release of its generic – a pharmaceutical copy of the medicinal product’s brand.

Generic should prove only its equivalence with the reference (original) product – there is no need to re-conduct the expensive trials of the reproduced drug, therefore the copy is always cheaper than the original.

Thus, the golden years of the monopoly of new medicine in the market can last maximum the term of patent protection and rarely reaches 25 years (20 years – is a standard term of patent protection, plus 5 preferential years for the research of the medicine).

The more significant the pharmacotherapeutic effect of the product, the earlier the country’s health authorities “produce for the benefit of the people” its generic copies, at best withstanding a five-year period of data exclusivity – a minimum of copyright protection.

Another matter is the trade mark of the medicinal product: for example, Mildronate is its own name for the creation of “Grindeks”, which will forever remain with the original product of meldonium manufactured by this company.

However, there are generic companies that, while reproducing someone else’s work and not investing in its research, want to save money on advertising: “I’m the same as Mildronate – the newborn generic of meldonium signals with its name in the price list – only much cheaper”.

Side Effects

From the very beginning of its entry into the Ukrainian market, “Grindeks” faced the costs of Mildronate’s popularity and, in addition to investing in scientific developments, had to invest in litigation to protect its intellectual property rights to this medicinal product.

One of the most recent examples is a claim on the protection of the company’s rights to the famous mark “MILDRONATE”/“МИЛДРОНАТ”/“МІЛДРОНАТ”, on the recognition of this mark as well-known and the cancellation of protection documents relating to the labeling and packaging of “Mildrokard”, which has been considered by commercial courts of Ukraine during two years and ended with the abolition of the legal protection of “MILDROKARD” and patents for industrial designs associated with the name of the medicinal product Mildrokard. The court obliged “Niko” Company – the manufacturer of Mildrokard – to stop using the disputed trade name “MILDROKARD”, which upon the complex expert studies was recognized as similar to the confusion with marks “MILDRONATE”, “МИЛДРОНАТ” and “МІЛДРОНАТ” produced by Grindeks.

It is worth to mention that Grindeks won the dispute in all proceedings: the judgment of the Commercial Court of Kyiv City of October 26, 2015, (in case No. 910/16297/14)53564855, was retained without any changes by the Judgment of Kyiv Commercial Court of Appeal of November 8, 2016. On November 21, 2016, in pursuance of the abovementioned judgments of the Commercial Court of Kyiv City issued the court orders, which voluntarily were executed by the State Intellectual Property Service of Ukraine, in particular: the amendments were introduced into the State Patent Register of Ukraine for industrial designs regarding the revocation of Patents of Ukraine No. 22173 and No. 22174 for industrial designs, the State Register of the Certificates for Trade Marks regarding the declaring the Certificate of Ukraine No. 129623 for “MILDROKARD” void. The respective publications were made in the official bulleting “Industrial Property”; register “Information of well known trade marks in Ukraine” concerning the «MILDRONATE»/ «МИЛДРОНАТ»/ «МІЛДРОНАТ» becoming well-known in our country since June 11, 2009, with regard to AKCIJU SABIEDRIBA “GRINDEKS” for products of the fifth class of International Classification of Goods and Services for the purposes of the registration of marks, in particular: “medicines, immunostimulants for healthcare purposes”.

Separately, it will be useful to focus on a fundamental study conducted by forensic expert S.A. Petrenko within the framework of this case: expert conclusions, including those made with the use of knowledge in the field of chemistry, medicine and pharmacology, have made it possible to establish the fact of the semantic similarity of the names “Mildronate” and “Mildrokard”, and to reduce the number of semantic and phonetic variations of “Mildronate”.

In their turn, the commercial courts of Ukraine, having brilliantly undone the knot of collisions concerning intellectual property rights, medical indications and economic interests, have once again confirmed their highest level of proficiency in the resolution of such complex disputes as the intellectual property disputes in pharmaceutical field.