Herbal products like all other products can also be protected from copying and get various forms of rights from the government. Since the rights are granted by the state for a property that has emanated from the use of mind or intellect these are called as intellectual property rights. Four different types of intellectual property rights (IPRs) are possible namely patents, trademarks, designs and copy rights.
Patents are exclusive protection granted by the state to inventors who disclose the invention to the state. The Indian Patent Act as undergone major changes and now offers provisions for protection of processes, products and a combination of process cum product. Patents are granted for inventions and not for discoveries. Patents are not granted if the invention is not obvious.
Patents are granted for - Inventions and not for discoveries, Rights given to inventor by the State on disclosure of invention, Rights are for specified territory and for specified period.
Criteria for granting patents are: Prior art [documented, published, in public domain]; Inventive step; Useful to Society (animals and man); Obviousness.
Patents can be for - Process; Product/composition; Process cum product.
When it comes to prior art, anything in public domain in published form becomes public domain proof of the same, prior art (means what is known) can be even form ordinary publications like news papers, magazines, books, and not necessarily in scientific journals/publications. Public domain also would include “presentations or talks given in public meetings, conferences, seminars, colloquiums etc”. Hence, scientists should avoid making presentations of any ideas, data, theories, findings that can be patented in any seminars.
Presentations within your own group in the lab does not become putting it in public domain. It is advisable that if you have any doubt about patentability of your materials/data it is better to check with an IPR attorneys, file a provisional application before going public. Provisional application for patent can be filed as soon as you have some idea, partial data and one gets twelve months to file the full patent application.
Inventive step is important especially in case of herbals as a large pool of data is in public domain through traditional knowledge and documented books. In fact the traditional knowledge digital library (TKDL) created by the Government has actually reduced the possibility of obtaining patents for herbals known in traditional knowledge (Ayurveda).
Hence, there are some challenges in overcoming absolute non-patentability in herbal drugs. These are due to the following clauses in the Indian Patent Act.
Section 2 (1) (j): “Invention” means a new product or process involving and inventive step and capable of industrial application.
Section 2 (1) (ja): "Inventive step" means a feature of invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention not obvious to a person skilled in the art.
Section 3 (c): The mere discovery of a scientific principle or the formulation of 20 [or discovery of any living thing or non-living substance occurring in nature].
However, this does not mean that it is impossible to get patents for herbals.
It is important to know the basics of what can be and what cannot be patented when it falls in herbals area, which are highlighted in brief below:
- Patents are not granted for - Non-obvious inventions; Those known already – documented, traditional knowledge; Those occurring in nature e.g. piperine, taxol, baccosides, cultivars, etc; New use of a known substance; and Frivolous inventions.
- Patents are grantable for - Processes that show improvements than known already e.g. better extraction processes, better dosage forms, stable formulations, better tastes/aroma; Processes that can give plants that give higher yields [not just hybrids]; Processes that involve biotechnological interventions; Processes that improve bioavailability; Processes that provide synergy/antagonistic activity; and Processes for standardization, fractionation, isolation, etc.
Further – Patents are grantable for – [products] Formulations that are novel; Novel combinations involving selection of – specific items/ingredients; specific proportions; specifically processed mats; Novel combinations that show synergy/antagonisms - resulting in better activity or lesser AEs; better stability, better absorption/bioavailability; Novel combinations with formulation aids that show inventive steps - can be even addition of - perfume/flavour or stabilizers or penetration enhancers or change formats that provide benefit to users etc; Uniquely standardized to provide specific quality those are responsible for activity e.g. ratios of components etc; Uniquely delivered for e.g. Taxol injections - 3 hr/12 hr/8 hr through special tubing's; and Patents are grantable for combination of processes and compositions.
Hence, it is recommended that for herbals patents - Take the route of provisional application filing – to get the protection date; Complete disclosure to be filed within 12 months; Involves careful drafting – citing of prior art/earlier patents citing/references; Involves providing detailed disclosures; Involves providing examples of the inventive steps claimed fully [not necessarily like a clinical trial results]; Can include drawings, figures, tables, etc; Involves making specific claims that will need to be protected - can be one or two main claims and several subsidiary claims; Naming inventors carefully - all sign certain documents; and Naming the owner of the patent.
Some words of advice are:- Drafting a patent application is as much of an art as that of science. It is better to take help from experts for doing this. One can of course learn by getting trained.
- Deciding the claims to be made is also very important and expert help is of great use. Please go for it even if it costs a bit.
- Be very careful in naming “inventors”. The standard rules that apply to deciding “authors for a scientific paper” should be the norm. Only those who have contributed significantly to the idea, generation of data need to be named. The general practice of naming lab technicians, heads of department, co-workers who helped in some data generation, need not be named as “inventors”. Inventors can be different from the owner of the patent.
- Also MSMEs and SSI industries may find out that there are provisions in patent act for small entities to file patents, where the cost of filing and annual fees are lower than for a large firm or organisations.
- It is important to recognize that while it may be easy to get a patent for a composition of selected herbs, it may not be a strong protection as if one of the herbs is removed or added to the same composition, it will not infringe the patent and protection is weak. It is best to combine many aspects given above to apply and get protection.
Trade marking for herbal products
Trade marking is a protection for a name upon registration for a word or term that is created normally not given to already known words.
- Unless the same has been in use for long/gained goodwill-popularity/can be traced to the first user
- Given for use with specific class of services or products e.g. foods/medicines/pharmaceuticals/engineering goods, retail trade
- Publishing in the trade mark journal-transparent system, objections can be made, and the trade mark is granted with a certificate.
- Is perpetual unlike patents which has a life specified.
- Helps in branding the product or services
- A mark that has got registration under Trademarks Act is denoted by R in a circle. Many applications for trademark keep hanging in the trademark office and take many years before the same is granted. In such cases it is common to name the marks or the trade names with the terms “Trade Marking” along with such word. This does not give any protection but acts as a warning if someone wants to use the same.
- While many years ago to search for trade names that have been applied for and are pending for registration, now a days it is easy and can be done over the net.
- It is best to check before adopting any trade names, as if it belongs to anyone else the litigations on trade names are long, time consuming and costly.
- Trade marking leads to differentiation and branding. Branding promotes investments in – product/technology/marketing leading to business building. Only permitted for P&P ASU medicines, and not for classical ASU products. An office order issued by the Department of Ayush has prevented from using brand names for classical products and also use of parts of classical Grantha names with the name of herbal products. Some of us and some members of Ayurvedic Drug Manufacturers Association (ADMA) have given a structured presentation to the Department of Ayush officials and the matter has also been discussed in some of the ASU, DTAB meetings but the official position for allowing branding of classical ayurvedic herbal products have not been still taken and notified. Instead the Dept of Ayush seems to have gone against this and notified that names of ayurvedic products, cannot have “prefix and suffixes” from the Grantha names. This is not a step in the right direction, and needs to be reviewed.
Design registrations
Designs of any products or packages can be registered. And the same applies to even herbal products.
Before adopting any bottles, packs, dispensers, it is best to check if the design has been registered. Alternatively if an herbal product is made in a new design for say tablets, or candies, chewing gums or such other devices etc it may be good to consider making it with registerable designs and such protection can sometimes be of great value.
Copyrights for herbals related matter- Copy rights are also registerable.
- Includes specific text matter, advertisement materials, jingles, music elements, documentaries, product promotion literatures, clinical trial reports, books, PIL’s, Training Manuals, etc.
- State that the material is Copyrighted, and who owns the same
- Provisions for reproductions to be cited.
- Photocopying for personal use is okay.
- Is a matter of severe discussion and legal battles in pharmaceuticals area for new drugs where the published data of the new drug belongs to the innovators and cannot be cited by the generic applicant
- Large firms have policy of the same under data management
- Exact copying to be avoided, and if needed and done provide correct and full references to the original copyrighted material.
- It is important to know that most of us make photocopies of published papers in Journals. This is strictly not good as long as the photocopying is for personal use. Sending such copies or using it for other purposes may put one into trouble if one complains. If you need to do this do so, but attach a slip or a note to the copy made so “that it is for personal use “
- Many of us also quote from published material many of which are copyrighted. Doing so without giving reference and also doing so where “exact parts /paras/sentences” are copied may turn out as infringement of copy rights. Copying may also turn out to become cases of “plagiarisms”. One needs to be careful in this area an area where many of us do not have good awareness let alone competency.
- Till a few years ago, to check if any copyrighted material is being used, it was very difficult and time consuming as it had to be done manually searching “potential areas”, with the advent of IT tools it is much easier now, and can be done as easily as “at the click of the mouse”. Examples of Sites called “Turn it in” and similar cites are available to trace if any Copyrighted material is used in any submission. Most such sites may need to be subscribed and accessed with log in Id’s and passwords. In one paper that I was reviewing, I was given access to this site and it was wonderful to get so much information, which almost lists which sentences have been lifted from which publication.
Just because many of the audience come from MSME/SSI herbal industry or may be researchers/academicians, it is not necessary that they cannot protect their herbal products/findings. One needs to be finding the right combination of IPRs and the IPR tools and use them.
(Author is chief scientific officer, Ayurvidye Trust, Bangalore)