Megainpharm GmbH had a patent for the invention, protecting a pharmaceutical composition, which is used to treat local infections of the mucous membrane of the eyeball. Using the formula described in this patent, the Ukrainian pharmaceutical company Farmak produced the Okomistin medicine.
The Kyiv company Darnitsa, one of the largest pharmaceutical companies in Ukraine, is a manufacturer of the Oftamirin medicine, the sale of which Megainpharm GmbH tried to stop.
In July 2013, the Austrian pharmaceutical company Megainpharm GmbH filed a lawsuit against the pharmaceutical company Darnitsa, demanding the cancelation of the Oftamirin medicine registration, to oblige the pharmaceutical company Darnitsa to stop using the Eye Antiseptic invention and stop selling Oftamirin and other medicines made on the basis of miramistin.
Megainpharm GmbH substantiated its claims by the fact that the registration made by Ministry of Health of Ukraine in the name of Darnitsa the Oftamirin medicine (eye/ear/nasal drops, fluid 0.1 mg/ml, 5 ml in bottles No. 1 – registration certificate No. UA/12521/01/01), the active substance of which is miramistin, violates the intellectual property rights of Megainpharm GmbH, as the owner of the Ukrainian patent for invention No. 64800, based on which the original Okomistin medicine is produced.
Forensic examination indicated that in the Oftamirin medicine all the features included in the independent claims of the Eye Antiseptic invention were used. This became the basis for satisfying the claims of the Austrian pharmaceutical company by the Kyiv Economic Court. The court canceled the registration of Oftamirin, ordered Darnitsa to stop using the Eye Antiseptic invention and stop selling Oftamirin and other medicines made on the basis of miramistin.
The decision of the Economic court was upheld by the Courts of Appeal and Cassation in 2016.
However, at the same time with the first lawsuit, Darnitsa had begun another one.
In August 2015, the Kyiv Commercial Court started proceedings under the lawsuit of the pharmaceutical company Darnitsa against Megainpharm GmbH. Ukrainian company demanded to cancel the patent for the Eye Antiseptic invention on the grounds that it does not satisfy the criteria of patentability as ‘novelty’ and ‘inventive step’.
The trial lasted more than a year.
The court ruled in favor of the Austrians, but the Kyiv Economic Court of Appeal overturned this decision and ruled in favor of Darnitsa, which invalidated the patent for the Eye Antiseptic invention.
In its decision, the judges noted that “… the Eye Antiseptic invention does not satisfy such patentability criteria as ‘novelty’ and ‘inventive step’, since on the date of April 24, 2000, which claimed priority when filing patent application No. 64800, ше was already known the use of miramistine as an antibacterial drug with a wide spectrum of action for the treatment of infectious diseases, regardless of the localization organ and caused by pathogens sensitive to miramistin…”.
It means, that Eye Antiseptic invention turned out to be not new in comparison with another invention, the Drug product, the application for which was filed earlier only for 37 days.
Supreme Economic Court of Ukraine upheld it in 2016.
Invalidation of the Eye Antiseptic invention patent had given Darnitsa the right to review the court decision in the first case.
The Ukrainian company appealed to the court to review the decision due to newly discovered circumstances, in which it asked the court to cancel the decision to stop the sale of Oftamirin.
The Economic Court of Kyiv satisfied the statement of Darnitsa and review its ban on the sale of Oftamirin.
Megainpharm GmbH lawyers tried to impeach a judgment, but in 2016 the appeal and cassation instances upheld the decision of the court of first instance, and in 2017 the Supreme Court of Ukraine refused to allow the case to be heard.
Despite the advantage of the first move and the rapid attack, which seemed to have already brought victory to Megainpharm GmbH, the weak dispositions on the eve of the battle determined the outcome of the battle.
At the same time as repelling the attack on the main front, Darnitsa conducted reconnaissance and launched a strike from the flank.
In the third move, the side that started the battle in defense completed the rout of the enemy.
The pharmaceutical company Darnitsa retained its position in the Ukrainian market and continues to sell the Oftamirin medicine, while Megainpharm GmbH lost the patent for the invention and lost the right to produce drugs on its basis, and, accordingly, lost a part of the profit.
Obviously, before going to court, Megainpharm GmbH hadn’t taken into account the vulnerability of its own patent and as a result, paid for it. Therefore, the ancient truth that wars are won at the preparation stage also applies to military operations on the legal front – declaring war on a competitor and opposing him with his patent, first check that it satisfies the criteria of patentability.
Bogdan Lesyk, attorney at law, lawyer at Crane IP Law Firm