IPRs and implications in SSI pharma units

Dr Parikshit Bansal, in this article, discusses the myths and misconceptions regarding IPRs, especially amongst pharma SSIs and brings out the practical utility of IPRs for even small pharma units.

Intellectual Property Rights (IPRs) are legal rights associated with the creations of the mind or ‘intellect.’ Depending upon the nature of ‘creations’ there are eight different mechanisms to protect intellectual property namely patents, copyright, trademarks, industrial designs, layout designs of integrated circuits, geographical indicators, Plant Varieties Act and trade secrets.

The legal rights conferred on a person(s) under any of these eight mechanisms are called “Intellectual Property Rights”. Of these, patents are the most important IPRs for pharma units. When we speak of IPRs and patents, there is an immediate feeling amongst personnel of pharma SSI units that IPRs have no meaning for them — they are neither conducting any research nor are they filing any patents. So what use are IPRs for them? However, this is a wrong attitude.

Myths and misconceptions

Since we are not doing any research, IPRs are not important for us.

Wrong. IPRs are not only for research, but for innovation and a better way of doing anything. In fact, patents are granted for novelty, non-obviousness and industrial application — all of which SSIs can easily do. Improvements in machinery, processes or even in products, are all significant and patentable provided they meet criteria of the ‘trishul’ i.e. novelty, non-obviousness (inventive step) and industrial application.

The cost depends upon whether you are filing the application as an individual or as an organisation. To encourage individual inventors, the fee for individuals is much lower

IPRs cost a lot of money

The cost depends upon whether you are filing the application as an individual or as an organisation. To encourage individual inventors, the fee for individuals is much lower. As on today, the official fee for filing a patent application is Rs 1,000 (for individuals) and Rs 5,000 (for corporates/organisations). Attorney fee for handling patent application ranges from 15,000-20,000. Even after patent is granted, ome fee is payable every year to keep it ‘alive’ or patent dies. Fee is lower in initial years and increases in later years.

We are just following a well-defined production process, which is routine and being done for so many years. IPRs have no meaning for us.

Wrong and dangerous. A new improved process developed by some other industry within the country or abroad can result in much cheaper and better products. This can literally wipe out the existing domestic industry, if it is not alert. Agreed that an industry does not have resources to conduct research and generate new technologies. However, it can source new and improved technologies.

We were manufacturing a product. Recently under modified Patent Act, product patents have come into force. Can we be forced to stop making these products?

No. Remember that patents are never granted retrospectively. They are granted for new innovations and inventions. In fact, leave alone stopping production, nobody can even patent what you are producing since it was already in public domain i.e. public knowledge.

On a visit overseas, we came across a very good technology. However, we cannot use it since it is already patented.

Wrong. Patents are valid only in the country in which they are filed. If you came across a good technology patented in Malaysia, check whether patent is filed in India also. If not, you can copy the same without any fear. However, if patent is also filed in India, then also all is not lost. Try to get a license and go ahead. A person who has filed patent also wants to make money and it is good to have a buyer for one’s patent.

We were developing a very good herbal product. Recently somebody told us that a firm in USA has already obtained ‘world patent’. What shall we do?

Firstly, world patent does not exist. There is no such thing as world patent. Patents are granted individually, country by country. The costs involved are so high that generally patents are filed only in few countries. In remaining countries, where patents are not filed, the technology can be copied freely.

Secondly, most likely the firm has filed for international patents. Check out from patent office or from Official Journal of Patent Office (formerly Official Gazette of India) whether patent has been filed in India or not. If not, nothing to worry. If yes, check out the details — whether your process is really same? If not, nothing to worry. If yes, check out date when filed. If you can prove that the knowledge disclosed in the patent was already in public knowledge, you can get the patent revoked or cancelled. If none applies in your case, you may try to get license from original inventor who filed the patent.

We are just an SSI. We do not conduct any research nor follow any policy for new products. Can IPRs help us in increasing our business profits?

Yes. IPRs are powerful tools, which can greatly benefit business/SSIs provided you understand and exploit their potential. There are many ways in which IPRs can enhance business profits.

• By giving access to latest improvements/technologies not only for new but existing processes, through patent databases.
• By helping industry quickly identify relevant national or global partners whether in industry or academic institutes. IPRs thus act as a bridge between knowledge creators (scientists/researchers) and knowledge users (SSIs/industry/manufacturers).
• By generating revenue through licensing out of SSIs own patents, if any
• By saving money on R&D and giving direct access to the latest technologies
• By helping industry to know the ’global movement’ of technology in an accurate and precise manner

We do not have money to create R&D infrastructure. Can we still innovate?

Yes, by going in for partnerships whether it is with established industries or academic institutes. Everybody has strengths and weaknesses — sometimes partnerships can lead to elimination of weaknesses and emergence of strong business units. IPRs act as a bridge between “Knowledge Creators” (academic institutes, universities, research institutes) and “ Knowledge Seekers” (industry, SSIs), enabling them to have 100 per cent benefits of R&D at zero cost! IPRs enable easy access of the technologies vide the patent databases. Academia-industry partnerships thus hold the key to innovation and technology development, especially in pharma industry.

Conclusion

Remember, patents are meant for the benefit of inventors, innovators and ultimately society. While rewarding inventors by granting them exclusive rights, they also lead to progress and innovation since latest technology and advancements get disseminated and are used freely by others, wherever patents do not exist and also by licensing where patents do exist.

The writer is with IPR Cell, Dept. of Pharmaceutical Technology, National Institute of Pharmaceutical Education and Research (NIPER), Phase X, Mohali-160062 Punjab. Email-pbansal@niper.ac.in