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What do the Penicillin Vials, Medical Gloves and Morphine Molecule have in Common?

Date of publication: 28 September 2018

Irina Kirichenko, Patent Attorney of Ukraine

Source: ZN.ua

These are all objects of patent protection — our intellectual property. If I were asked to name its main feature at the end of the second decade of the XXI century, I would definitely name the absence of innovation.

In fact, the patent today has become a weapon of competition, allowing privatizing the well-forgotten old without making any investments in the ‘candle factory’ inherited from the Soviet Union times.

Developing national legislation in the field of intellectual property, we have simplified the patent protection of any household object by so much that it is even strange, why anybody hasn’t yet patented the wheel or air composition, gaining a monopoly on life and movement in the country for the next 20 years.

And it finally happened: on February 1 the draft Law No. 7538 On Amendments to Certain Legislative Acts of Ukraine for Improving the Legal Protection of Inventions and Utility Models was registered in the Parliament. The draft document is aimed to harmonize the Ukrainian legislation in the field of intellectual property with the EU directives and regulations, as well as to implement the relevant provisions of the EU-Ukraine Association Agreement pertaining to legal protection of inventions and utility models.

In particular, the draft law proposes to provide that the object of useful model shall only be a device in any field of technology. As of today, any product (device, substance etc.) or process can be considered to be such an object.

In my professional work I have often dealt with well-known drugs from the State Pharmacopoeia of the USSR – both their composition (diclofenac plus talc) and chemical formulas of medicines (promedol, morphine etc.) – patented as useful models.

Paradoxically, when imported to Ukraine, a long time registered in Ukraine medicine falling within the category of generics (medicines having long lost their patent protection) appears in the list of counterfeit goods, and the only way out of this situation is to get rid off such a ‘cracker-barrel’ patent in court.

Against the background of such examples as a patent for morphine formula, the problem of ‘evergreen’ patents (methods of treatment, diagnosis etc.) does not seem to be so serious.

Pursuant to the draft Law No. 7538, the legal protection of utility models will not extend to the following objects:
– new forms of the medicinal product, well-known by its technology level, including salts, esters, ethers, compositions, combinations and other derivatives, polymorphs, metabolites, pure forms, particle sizes, isomers, new dosages or any new property, or a new use of a well-known medicinal product;
– surgical or therapeutic methods for treating a person or an animal;
– methods of diagnosing the human or animal body;
– people cloning processes;
– processes for change of the people’s genetic identity through the germline;
– use of human embryos for industrial or commercial purposes;
– human body at various stages of its formation and development, as well as the simple detection of one of its elements, in particular, the gene sequence or parts of the gene sequence.

This draft law also proposes to exclude the provisions pertaining to declarative patent (on utility models), which is now issued based on the results of a formal examination of the application.

The novations will not affect real innovations: the draft law envisages the provision of additional protection for those inventions, the object of which is the active substance of the medicinal product, as well as for the process of medicinal product production or its use, the animal protection products and the plant protection products, allowed for market in Ukraine. Thus, the owner of such a patent has the right to extend the term of validity of intellectual property rights to such an invention (additional protection), which will be certified by the certificate of additional protection issued upon filing of application. Such application is filed on a fee-paid basis. In addition, for maintaining the additional protection certificate its owner will pay a fee on full or partial-year basis.

The application for additional protection will be considered by the examination institution under procedure determined by the Ministry of Economic Development and Trade of Ukraine. The term of additional protection will not exceed five years.

Consequently, the patent for a new medicinal product will be valid for a maximum of 25 years, just as it is now.

The essential provisions of the draft law pertain to the following:
– the use of invention (utility model) in studies conducted with a view to prepare and submit information for registration of a medicinal product or animal protection product will not be recognized as a violation of patent rights to inventions (utility models);
– any person may file a substantiated application to the Appeals Chamber for recognizing the rights to invention (utility model) as invalid in whole or in part on grounds of the non-conformity of the invention (utility model) with the patentability requirements. The application for recognizing the right to an invention as invalid can be submitted to the Appeals Chamber within nine months from the date of publication of information on the state registration of the invention, and the application for recognizing the rights to utility model as invalid can be filed throughout the whole term of validity of property rights to the utility model.

This provision will significantly reduce the share of unfair registrations and will reduce the cost of application to the court: an application for recognition of an invention (utility model) as invalid shall be considered within four months from the date of receipt by the Appeals Chamber of an application, provided that the fee for its filing is paid in full. However, the period may be extended for two months upon the application of a party to such application and upon payment of the relevant fee.

Based on the results of consideration of the application, the Appeals Chamber will take a reasonable decision, which can be appealed against by both interested parties to the court within two months from the date of its receipt.

As it is mentioned in the accompanying materials to the draft document, the process of appeal through the Appeals Chamber will help to reduce the activity of dishonest owners of the so-called trolling patents, when the intellectual property rights to the utility model are acquired under a simplified procedure, which allows the unfair owners to prohibit third parties from using obvious technical solutions; in other words it is actually a way to monopolize the public domain in various fields of technologies, thereby obtaining a competitive advantage.

“I can not but praise those who were first to extract morphine from the poppy heads”, — wrote Mikhail Bulgakov in 1927 (“Morphine”). In 90 years’ time (at the end of 2017) its chemical formula was patented in Ukraine.