Intellectual property rights are awarded to individuals over creative works: inventions, literature, writings, designs etc. These rights give the owner the right to protect the work from unauthorised use by others for a limited time until the owner has rights over the intellectual property. Intellectual property has played an important role in the promotion of inventions in different fields. Evidence suggests that pharmaceutical and chemical industries have predominantly pushed the need for a patent system in order to boost innovations in the field of technology and science.
Indian laws recognise many forms of intellectual property and patent is one of such form of intellectual property which is devised to give protection to inventions. It gives the owner an exclusive right to prevent others from selling, distributing, using the patented invention without authorisation or licence to use such invention for the till the time the patent is in force. The purpose behind giving such protection to individuals is to incentivise for more inventions necessary for the development of mankind. Such developments in research increase the knowledge base and such knowledge is further made available to the public thereby increasing access to knowledge. Patenting system helps in setting the direction of innovation for health and has significant implications on access to medicines and medical technology.
Every day, the patenting regime sees new inventions and the two dimensional world has now experienced a modern technological advancement in the form of 3D printing. 3D printing first came into light when engineer Chuck Hall invented a 3D printer in 1986. The 3D printer turns a blueprint of the object into a tangible object. The blueprint is known as a Computer Aided Design or a CAD file which transforms the blueprint image into a series of two dimensional cross sectional slices using a software. The printer then prints layered products and this process of printing 3D products by forming layers is called additive manufacturing or commonly known as 3D printing. Similar to the technique of printing tangible objects using CAD files, CAD files can also be created by scanning a 3D product and this technique is called 3D scanning using a 3D scanner.
3D printing has already started making waves in various industries and the industry which could or has gained the most from the advent of 3D printing is the medical industry.
With the help of 3D printing, it has been easy to produce cost effective and customisable products in less time and because of this the medical industry has seen a significant boost. Specialists at National University of Singapore developed have new ways to print tablets and other drugs by combining various other drugs customised to meet the needs of individual patients. Given the various uses of 3D printing in almost all sectors and areas, it is also important to understand the legal implications and the nature of IP protection required. A robust mechanism has to be developed to provide protection for all the aspects of 3D printing.
3D Printing and its Impact on Medical Industry
3D printing technology is proving to be a real table turner in the medical field with the development of new drugs crafted to fit the requirements of each individual patient, development of new machines, prosthetic limbs, printing of tissues to repair the damaged tissue to printing whole new skin from the scratch.
It is out in the open that nearly thousands of people die and suffer due to unavailability of organ donors or delay in such donations. The problem of non- availability or delay in procuring organs for transplant could be attributed to various factors, one of which is the difficult and time taking process of finding the right match for the receiver. There are different processes of organ transplantation in a human body and often in a traditional organ regenerative system, the host rejects the tissue which is planted in his system for implantation. The issue of rejection of tissue from the donor by the host system could simply be avoided by taking cells/tissue from the patient’s body itself. That is when the concept of 3D printing of organs comes into the picture. The process of bioprinting of organs involves first preparing a blueprint of the cell structure of the organ and then segregating the isolated stem cells based on the particular organ specifics. These isolated cells form bio-ink which ultimately print the organ. Using the bioprinter gives us the freedom to customise based on our needs and requirements and we can also control the cellular pattern in this process. Thus 3D printing of organs has the potential to be more efficient than traditional organ regeneration by allowing precise cell placement and the customised printing by controlled speed and resolution.
3D Printing and Patent Regime in India
3D printing of organs has not only revolutionised the science of organ transplantation but if made patentable it would bring great changes to the patenting regime as well.
3D printing of objects opens new doors of legal issues for the law enforcement agencies to cope with. There are two aspects which we need to analyse firstly with respect to patentability of such inventions and secondly if a patent for such invention is granted, then plethora of issues relating to enforcing such patents and liability to deter infringement by users.
- Patentability of Subject Matter:
Patents Act governs the patent laws in India, 1970 (the Act) under this law patent is granted upon fulfillment of three conditions namely:
2. non- obviousness; and
3. industrial application.
All the three conditions listed above are to be fulfilled for an invention to be patentable. Bioprinting of organs using 3D printers while fulfilling all three above listed conditions, makes the same eligible for a patent. However, the patentability of medical innovations in certain cases opens up the dialogue where technology and morality are seen as two conflicting issues and morality is upheld in most of these cases. Section 3 of the Act is one such provision which has restricted the scope of protection given to creative inventions. India is a signatory to Trade Related Intellectual Property Rights (TRIPS) Agreement and the interplay between international policies and domestic laws has had a significant bearing on how the laws are shaped. Section 2 (1) (j) introduced by Patent Act (Amendments), 2000 read with Section 3 (j) carves out the exceptions to patentability of innovations relating to plants and animals however, this somehow left some room for hearing aids prosthetics, pace makers and they are eligible for patents. Biotechnology advancing at such a fast pace, especially the boom in the field of medical innovations has led to a heated debate about what should be considered as patentable subject matter and what could not be patented due to the ethical dilemmas surrounding the particular arena.
The issue of patentability in case of innovations such as bio printing becomes prominent given that they involve naturally occurring organs and this is where the Indian Patent Office has its hands entrapped in ethical dilemmas and moral rules of society. Section 3 (b) reads as-
“an invention the primary or intended use or commercial exploitation of which could be contrary to public order or morality or which causes serious prejudice to human, animal or plant life or health or to the environment;”
The provisions in the Act clearly prohibit granting of patents for 3D printing of organs based on the process where a three dimensional object is printed which is primarily meant to substitute a damaged or non –functional part of the organ. With a plain reading of Section 3 (j) it is clear that 3D printing of animal organs would strictly fall under the exception hence 3D printing of organs for animals is not patentable because in the process the naturally occurring organ or bio material has to be used. However the phrase “leaving part thereof” is slightly confusing and its interpretation leads to a conclusion that the recent amendment to patent law in India is leaning towards the patentability of 3D printed or bio printed organs and tissues.
Apart from the conflicting results from interpretation of the provisions, in the case of Association for Molecular Pathology v. Myriad Genetics The United States Supreme Court held the opinion that bio printed organs can be granted the protection of patent. The court suggested a separation of the naturally occurring organ or bio- material from the actual product. However if this decision applies to Indian situation is another question and to answer this we have to look at the process of bioprinting more closely and our focus should be on the man -made characteristics and qualities. Here the organ is printed using the bio- material, which is distinct from the naturally occurring organs, which are developed in the body biologically and without any interference from humans. The bio printed organ is developed in controlled conditions significantly different from the naturally occurring organs. The bioprinting process of generating organs/tissues merely replicates the process of natural organ generation but it is in no manner the same naturally occurring organ/tissue.
It is clear to us that the stand of indian patent laws when it comes to patentability of bio printed organs is completely confusing. However if the patents were to be granted for such processes, there is another issue of liability in cases of infringement which we have to figure out.
- Infringement of Patents and Liability:
The enforcement of protection is particularly problematic due to the ability of allowing consumers to take power of manufacturing from manufacturing companies. This could lead to some serious implications ranging from replication of products at home making it difficult to pin liability on one person, to huge losses caused to the patent owners. Big pharmaceutical corporate houses could lose billions due to the unauthorised use of bio printers.
According to Section 48 of the Act, the patent owner gets exclusive right to use, sell, etc. with the patented product. The owner also has the right to prevent others from using, selling, or making the patented products without a licence or permission to do the same. Hence as much as using the patented product could lead to infringement and each unauthorised use of such product is a lost potential sale amounting to great deal of loss to the owner.
With the growing technology and new inventions, there are also new ideas, which could be threatening to the patenting regime. New coming websites, which allow people to create things by allowing designs for free or a meagre amount have played a significant role in facilitating patent violations by the users. The Do-It-Yourself (DIY) websites share the CAD files for free and with an easy download facility in a cost effective way to print the products, these websites have enabled the users to replicate the products which could have cost thousands of rupees in a normal course. The nature of CAD files is also significant while we consider the factors which are prominent in such patent violations, the CAD files can easily be shared online and once the user has gained access to the CAD file, the user gets full liberty to use, sell, and distribute the patented product without any consent and knowledge of the owner. The cost of medical technology being extremely high has made access to healthcare and such technology very limited and this problem has led to individuals producing counterfeit goods to sell at cheaper costs in the market. The rate of infringement of patented goods in this scenario is very high.
Additionally with the websites being the facilitators or intermediaries in such situations, the liability of the website for infringement is also crucial. The concept of contributory infringement is fully developed in copyright infringement cases but in the field of patent law, the jurisprudence is still evolving. For the time being, Intermediary Guidelines, 2011 could prove useful to some extent.
The manner in which these websites operate is also important here because the user data is protected by rules of privacy followed by the websites and it keeps the infringers in these cases anonymous, hence the liability cannot be pinned on one person directly, resulting in piles of litigation. The rights granted with patents include the right to prevent others from producing the product and in the case when the identity of users is left anonymous by the websites, it is very difficult to trace the infringers and otherwise effective mechanisms of injunction cannot work. It is also imperative to decide whether the mere download of the CAD file would result in infringement or when the actual printed product only amounts to infringement.’
The concept of bioprinting is absolutely set to bring landmark changes to the patenting regime in India, however, we need to focus on the process of bioprinting distinct from biomaterial or naturally occurring organ/tissue facets of the process. With 3D printing comes solutions to many problems ranging from making easily available prosthetic limbs for amputees to providing cost-effective space technology. Much like the internet, it is heavily criticised because of legal problems brought forth by this movement. However, with the help of some solutions, 3D printing could be the solution to many problems in the world. As technology is growing with the changing dynamics and needs of society, it is up to us to rise to the level of 3D printing to deal with the legal challenges that it poses before us.
Sakshi hails from Rajiv Gandhi National University of Law, Punjab and spends most of her time reading books and exploring new music. Her interest area lies in corporate, securities, financing and banking laws. For any clarifications, feedback, and advice, you can reach her at firstname.lastname@example.org