Evergreen patents (Evergreen Patents)

"Existence of such patents also allows the companies to patent holders  not to develop new technologies and   not to produce new medicines on  the markets before  the expiration of life of old patents,  thereby artificially holding development of new medicines and  collecting the maximum profit from  patients in    this or that country"  — the representative of the Russian pharmaceutical company told in 2017.

By  some estimates, in  pharmacology such secondary patents make more than 70%,  the managing partner of the Center of intellectual property Skolkovo Anton Pushkov estimated for Forbes.

"  The point is that  when the patent comes to an end, the price promptly falls and  the value of medicine for  the company very quickly directs to  zero. Therefore they  naturally go for  all tricks as much as possible to extend the validity of patents  — in addition to actually formula of substance aim to patent a production method, a method of application, application on  new therapeutic groups, application in  a combination with  other medicines   and so on  indefinitely"  — Roman Kutuzov, the deputy chief editor in  Vademecum says Forbes.

Alexander Gorkov,  the development director and  medicine of the company  in the field of the digital onkodiagnostiki UNIM, notes that  especially often such method is applied in  the "developing" markets where  the patent law " has no strong tradition and  the "cancelling' solutions can be lobbied   including with  the argumentation of benefit to the state interests".

"The problem  is that  the global player patents the medicine and  then sets high price, developing the market through advertizing (education of doctors, routing of patients , etc.). Then there is a local producer with  technical capability to copy a product (to create "generic') and  to transfer a cash flow from  import to  the intra trade sphere"  — Gorkov explains.

The complexity,   according to him, is  that  investments of the global player "are lost" product quality of the local player "often kompromissno, proceeding from  the state interests". Besides, centralization of purchases of medicine often  does not lead to  falling of the price, and  only to  redistribution of cash flows and  massive public relations  in the spirit of "revived the industry",  the development director and  medicine of UNIM concludes.

 Specify in the Center of intellectual property Skolkovo that   in most cases, obtaining such patents saves balance between developers and  producers of analogs and   does not pose threat for development of the pharmaceutical market.

"However long patent protection of medicines contradicts the interests of manufacturing companies of analogs of these medicines. Therefore the legal procedures directed to  protest of the patents protecting the most demanded and  expensive medicines also is widespread practice, especially in  those  countries where  the market of pharmaceutical medicines most"  — the interlocutor of Forbes says.

The representative Skolkovo specifies that  practice of patents for  improvement of old,  already known product, is widespread  not only in  pharmaceutics,  but also  in  other areas.

"It  reflects a way of development of any technology when  the disruptive idea is followed by gradual improvement and  completion"  — he explains.

 Patents for  different polymorphic (crystal) forms of the known active agent forming a medicine basis, pharmaceutical compositions  on the basis of active agent belong to such patents, for example, (for  stability augmentation, solubility, bioavailability , etc.), new dosage forms  on the basis of active agent, the most effective dosages and  the modes of introduction of pharmaceutical compositions, use of the known connections or  pharmaceutical compositions on  new appointment, are specified by the interlocutor of Forbes.   According to him, in  many cases obtaining such patents is connected with  carrying out long and  expensive researches, and  the patent protection provided with such patents covers rather narrow area of the equipment (has the small volume of claims),  without interfering directly with use of the known active agent in a different way or  on  other appointment.

Juridical party

Legally such concepts as  "secondary" or  "evergreen" patents, no, but  they  are widely used by politicians and  in  media as  Andrey Moskvich explained. Such patents are aimed at  prolonging patent protection, i.e. to receive temporary monopoly for  the known medicines which are used or in  new dosages or are applied to  new groups of patients, he added. It  is connected with  specifics pharm the industry which spends a lot of time and  funds for  scientific research and  obtaining permissions for  entry of new medicines into  the market from  the Ministry of Health, FDA  or  the equivalent organizations in  Europe ( in particular, performing clinical trials, analyses of results and  creation of evidential base).   In this connection  the pharmaceutical companies try to receive long patent monopolies in    this or that country for  the medicines to pay back the investments.

" The cunning schemes of receiving a set of patents in  each country protecting the different nuances connected with  one medicine are for this purpose applied. In  these nuances  there are also opportunities for   big pharma to receive unreasonably long patent protection of medicines, and  for  bioanalogues (generics) to dispute these  patents"  — he says.

   At the same time, as the concept  has no legal force, the states  cannot legislatively cancel "secondary patents".  At the same time  to control an opportunity to issue unreasonably long monopolies separate pharm to the companies on  the vital drugs, the different countries resort to  different methods. So, in  Europe, Canada, China and  India,   according to him, there are restrictions for  patenting of methods of treatment. In  the USA  the majority of states created the laws aimed at  prevention of aggressive judicial activity of "patent trolls" who can be also applied to  unfair pharm to the companies.

In  Russia of still similar restrictions and  laws is not present, he recognizes.

"But  in  Russia there is a developed patent legislation which, from  my point of view, already  more than  is enough to solve a problem of unreasonable monopolies (in  any industries), if  to treat it and  to apply correctly and  consciously,  as  the Chamber by  patents to disputes in  this solution made"  — the interlocutor of Forbes is sure.

Examples of disputes in Russia

Biocad wins against subsidiary of Roche a patent dispute

In 2017 Russian Biocad carried the case from child structure of Roche in the dispute concerning the "evergreen" patent connected with rituximab. Read more here.