“Intellectual property Rights” is the broad term for the area of law that involves the protection of proprietary rights in the creations of human mind and intellect. Broadly this can be categorised as creations and innovations like : inventions which are subject matter of Patents; device, brand, heading, label, ticket, name, signature, word, letter, numeral, shape of goods, packaging or combination of colours or any combination thereof, which are subject matter of Trademarks; works of literature, art, music, films, dramatic works, sound recordings, broadcasts, software, which are subject matter of Copyrights; novel and aesthetic features or appearance of a product or part thereof, which are subject matter of Designs; and also other creations of mind that are subject matter of trade secrets, and other forms of exclusive rights in intangible property.
Intellectual Property protection is a crucial aspect in the field of healthcare. Most important IP forms of health care are:
· Patents on chemical compounds /Pharmaceutical composition/medical and diagnostic products
· Copyright which protects the expressions of ideas which includes databases and informatics, software related to collection, organisation and dissemination of patient / medical information, journals, medical publications
· Trademarks on brand names for products such as drugs and medical devices, and services related to healthcare
· Design protection for various articles and products used in the healthcare industry
· Trade secret and privacy rights in patient lists and patient information
Healthcare is intrinsically related to the fields of bioinformatics, biotechnology, pharmaceuticals, drugs and drug discovery, medical and clinical research, diagnostic devices, medical devices, pharmacological products, etc.
Innovation has a dramatic impact on the healthcare and related sectors. Patents and various others forms of IP form a crucial factor in innovation, ensuring that companies have the possibility of being rewarded for the enormous investments needed to research and develop new medicines and medical devices which are vitally important in healthcare.
Patents , trademarks, copyrights, designs, confidential trade secrets, confidential or non-confidential know-how form the most important forms of IP assets of a healthcare organization having equal importance as other strategic complementary assets of the business.
Patent system encourages innovation by providing statutory right and monopoly for the inventors over their innovation for a limited period of time in exchange for full disclosure of such inventions.
A product or process that is new, involving inventive step and capable of industrial application, and is not falling in any of the non-patentable categories, can be the subject matter of Patents. Patents are territorial in nature and is effective within the jurisdiction in which the same is filed. Novelty being a crucial aspect of patent filing, it is necessary that inventors take timely steps to file patents applications by way of provisional applications or complete specifications before the invention is used commercially or divulged to the public.
Patent protection is preferred by right holders for several reasons other than the promised monopoly for a duration of 20 years in respect of the invention. Patents places the right holder in a position to prevent copying, take infringement actions, defend against infringement claims, earn revenue from licenses, establish better bargaining position, enhance value of business assets, to name a few. Conversely, the disclosure requirements of sensitive and confidential data and information, difficulty in establishing and satisfying the requirements of novelty and efficacy criteria, cost and expenses if filing and prosecuting applications etc. are deterrent factors that influence the decisions of inventors to obtain patent protection.
The Patents Act with reference to patentability in the field of healthcare and allied field of pharmaceuticals and drug discovery lays down some guidelines as to what shall be considered as Non-Patentable:
· Section 3(d) of the Patents Act which deals with efficacy criteria provides that mere discovery of a new form of known substance which does not result in the enhancement of the known efficacy is not patentable. As per the explanation of this provision, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy. Therefore a new drug which is a bio equivalent of a known drug will not satisfy the efficacy criteria. The new form of a known substance should provide significant therapeutic advantages as compared to the existing form. Even though in majority of cases, applications for patent of new forms of known drugs have been rejected by the Patent Office invoking Section 3(d) of the Act, in rare cases, such as in the case of Cadila’s application for patent in Crystalline form Clopidogrel Besylate, used to prevent clotting of blood and in treatment of cardiac ailments, patent has been granted on the finding that the new form exhibited enhanced efficacy.
· Section 3(e) states that substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance is not an invention.
· And section 3(i) states that any process for the medicinal, surgical, curative, prophylactic diagnostic therapeutic or other treatment of human being or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products is not patentable
Thus according to the Act, the following are not inventions and hence not patentable:
· mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance;
· the mere discovery of any new property of a known substance;
· the mere discovery of new use for a known substance;
· the mere use of a known process unless such known process results in a new product or employs at least one new reactant;
· the mere use of a known machine or apparatus
The Indian law also provides for the procedure of compulsory licencing under Section 84 of the Act, wherein any person may request a compulsory license if, after three years from the date of the grant of a patent, the needs of the public to be covered by the invention have not been satisfied; the invention is not available to the public at an affordable price; or the patented invention is not “worked in,” or manufactured in the country, to the fullest extent possible. In the landmark case of Natco vs. Bayer, India’s first compulsory license was granted for Bayer Corporation’s anti-cancer drug – Sorafenib Tosylate named NEXAVAR in favour of Hyderabad based generic drug manufacturing Company – Natco Pharma Limited. The order for Compulsory Licensing was granted on the challenge that Bayer’s patent did not satisfy the criteria of meeting the reasonable requirements of the public with respect to patented inventions and that the patented drug is not made available to the public at a reasonably affordable price.
In addition to the aforementioned grounds, according to Section 92 of the Act, compulsory licenses can also be issued suo motu by the Controller of Patents pursuant to a notification issued by the Central Government if there is either a “national emergency” or “extreme urgency” or in cases of “public non-commercial use”. The said section enables the Government of India to notify to the public of such extreme circumstances, whereupon, any person interested can apply for a compulsory license and the Controller in such case may grant to the applicant a license over the patent on such terms and conditions as he thinks fit.
The patentee, however, has the right to be heard in the compulsory licensing application process.
Copyrights form another crucial and very important form of IP especially in the healthcare business, where the informatics plays a major role, particularly in this era of fast growing intelligent networks, connectivity, and internet of things.
Copyright law does not protect ideas; it only protects expressions of ideas. If you create a database, or write software source code, the underlying ideas and functionality are not protected. Copyright law will help you protect the expression of the same and enable prevention of substantial copying of the same.
In the field of healthcare, there is a growing need and awareness for copyright protection, particularly in relation to Databases and Informatics.
Databases: Databases are becoming increasingly important to the health care industry. There is an “informatics” wave taking over the industry with business adopting technology for data sharing for improved quality measures. Huge amounts of capital is spent annually for the use of commercial electronic databases, creating such databases, segmenting the information and dissemination of the same. These include databases of chemical structures and gene sequencing information for scientific research and development purposes, collections of medical treatment outcomes and efficacy studies, and patient data. Generally, databases are subject to copyright protection as collections or compilations under copyright laws, thereby conferring at least some degree of originality in the selection, arrangement or coordination of the contents.
As technology advances, software plays an increasingly important role in medical innovation. Software now commands everything from surgical instruments that combine cutting edge hardware with next generation analytics and controls to complex analytical and diagnostic platforms. Therefore, importance of copyright protection for software applied in the field of healthcare and related fields cannot be overlooked.
Electronic Medical Records which is a computer-based, interactive tool for pertinent patient data with general database information, and having unique data storage, configuration, reconfiguration and presentation possibilities can also be protected as a software.
The acquisition, use, manipulation, protection and distribution of health care information will continue to be big business and present great opportunities for growth of both the Health Law and Intellectual Property practice areas.
Another major area where copyright protection finds relevance is in the field s of Telemedicine — this is a new area of health care that is entirely technology-based and technology-dependent. It allows use of telecommunication and information technology to provide healthcare from one geographic location to patients in another geographic location. Telematics improves access to medical services and reduce therapy costs where possible. Digital platforms and software that allows access, storage and sharing of patient and medical data could be protected under copyright law.
Other areas which may be protected under copyright in the field of health care and medicine are cover journals, medical literatures, educational brochures for patients, websites and online sources, operational guidelines etc.
As with any product, trademarks play an important role in a healthcare organisation’s IP portfolio. The Healthcare sector may enjoy proprietary rights in a number of trademarks such as the name and mark used for providing healthcare services, names of pharmaceutical drugs or medical devices, distinctive logos, names or marks used in respect of various healthcare initiatives of healthcare institutions, distinctive marks or slogans used as part of healthcare provider’s branding campaigns, to name a few. Confusion over the source of goods and services, particularly provided in the field of healthcare and allied fields, often results in highly undesirable consequences. Therefore, it is pertinent to dedicate time and effort to create distinctive brands that will be capable of identifying the services of the proprietors from those of others. Trademark searching is an important measure to assess infringement risk and availability for use and registration, when launching a new healthcare related product or services. Trademark searching is helpful when establishing a product or brand name to ensure it is distinct and not confusingly similar to other names in the space so it may be registered as a trademark itself.
Trademark law protects distinctive and non-functional terms, designs and other ways of distinguishing the goods or services of one proprietor from those of others. It does not protect the underlying goods or ideas themselves. The “strength” of a trademark is connected to its distinctiveness. The more distinctive a mark, the greater the protection it receives compared to other marks for similar goods or services.
The standard test for trademark infringement is whether there is a reasonable likelihood of confusion as to the source of the goods or services in question.
A design encompasses any features applied to a product such as the aesthetic aspects of shape, configuration, pattern, ornament or composition of lines or colours applied to any article in two or three-dimensional form which are judged solely by the eye. The article should be novel and capable of being made and sold separately.
In the field of health care, protection under Designs is applicable to articles such as syringes, containers, tablets/capsules, blister packs and other such products that enjoy novelty in its configuration.
The registered owner of a Design may, in the case of an infringement file a suit against the infringing party to prevent the infringement from taking place and also recover an adequate sum as damages from the infringer. The Court or any adjudicatory body, in case of an infringement suit would look at the articles from the point of view of the average customer and analyse whether the two are likely to cause obvious confusion in the minds of the consumer.
Undisclosed information, generally known as trade secret or confidential information, provides protection for any formula, pattern, compilation, program, device, method, technique, or process that is secret. Trade Secrets is an alternative way of protection as opposed to Patents. Trade secrets play a significant role in medical data and information protection. Any confidential aspects of your innovation that can be reverse engineered by competition can be protected as trade secrets.
As opposed to Patents which provide for monopoly and proprietary rights for a limited period of time and thereafter enters the public domain, Trade Secrets essentially enjoy a longer lifespan. The advantages of keeping proprietary information and data as Trade Secret are that there is no expense incurred for application and maintenance of patents and there is no undesirable disclosure of information. The trade secret of the Coca Cola recipe is a widely referred example for well-maintained trade secrets. On the other hand, the necessity to keep trade secrets confidential may involve considerable effort and is at perpetual risk of losing protection if there is an inadvertent leak of such information. Trade Secret would be a preferred alternative only in cases where the underlying technology or formulation can be kept a secret even after divulging the product to the public.
Patient lists can also be protected as trade secrets as they consist of patient data that are not readily ascertainable to the outside world. This was affirmed in the decision In re Phoenix Dental Systems, Inc. v. Phoenix Dental Systems.
The key is to simply keep your confidential data as a secret with only limited access to the same. Non-disclosure agreements and confidentiality provisions are important tactics in establishing trade secrets. There is no separate and exclusive law for protecting undisclosed information/trade secret or confidential information.
The following aspects are to be considered while protecting important IP in the field of Health Care;
· As the biggest improvements in healthcare now rely on treatments such as combination therapies, and with the increasing use of data and software to improve existing technology, health care sector needs to take appropriate steps by way of patent, copyright, designs or trademark protection or by way of maintaining trade secrets, to safeguard its intellectual property from misuse, authorised use, illegal copying and infringement.
· Make sure that all externally sourced research or software is commissioned properly, and that the ownership and direction of all IP is clearly laid out from the start.
· Clarity with reference to the ownership of copyright material, such as test results, and the creation of data; test results can have significant value in the commercial life of products needs to be attained. The protection of confidential information needs to be given utmost importance
· The healthcare industry is forced to share information in their everyday routines and hence the platforms for data and information sharing may be adequately protected to prevent loss of rights.
· If associated with educational institutions, healthcare needs to ensure agreements with them academicians, who often wish to publish the results of experimental works
· The patents of the health care need to be maintained even after the grant of the patent with annual renewals and filing of working of statements.
Ms Elizabeth Puthran
Patent and Trademark Attorney Founder, Puthran Associates