3D Printing In Pharmaceutical Industry

3D Printing In Pharmaceutical Industry: The technology and formulation developed to efficiently transport a pharmacologically active molecule in the body in order to achieve therapeutic efficacy in a safe manner is referred to as drug delivery. Controlling the release profile, which changes the pharmacokinetics of a medicine, can increase the efficiency and safety of a pharmaceutical product. In the clinical setting, inter-species heterogeneity is a common stumbling block. Because of the significant risk of unfavorable side effects, personalized therapy and dosing is gaining popularity. When the bulk manufacture of medications focuses on the average population, the risk of adverse responses is higher in the pediatric and geriatric groups. Multiple active component dosage forms, where the formulation can be as a single mix or multi-layer printed tablets with sustained release qualities, can benefit from 3D printing. This reduces the frequency and number of dosage form units eaten on a daily basis by the patient. The polypill concept, which uses 3D Printing In Pharmaceutical Industry to create personalized dose forms, has a lot of potential. This allows all of the medications needed for the therapy to be combined into a single dose form unit. Three-dimensional printing is a new rapid prototyping approach that involves depositing numerous layers in a certain order to create solid items. Rapid prototyping entails the creation of physical models in three dimensions using computer-aided design software. It’s also known as solid free form fabrication and additive manufacturing. 3D printing technology has given designers and manufacturers new flexibility when creating complicated items, which can be used in personalized and programmed medicine. It’s a good way to get around some of the problems with traditional pharmaceutical unit operations.

Types of 3D Printing In Pharmaceutical Industry

Pharmaceutical businesses are always on the lookout for novel medication design ideas, focusing on material qualities, procedures, and technologies. In order to obtain tailored drug dosing and develop a patient-centric product, 3D printed pharmaceuticals have created breakthroughs in all three areas. They’re simple to build and personalize, and their inexpensive cost allows them to be mass-produced on a modest scale. Unused resources and manufacturing expenses are avoided, and droplet sizes can be precisely regulated to develop multi-dosing goods. Inkjet printing allows for precise control of viscosity, allowing for the creation of microcapsules. Fused Deposition Modelling (FDM), Thermal Inkjet Printing (TIJ), Inkjet Printing, Direct-Wise, Zip Dose, and Vat Photo polymerization are all examples of pharmaceutical 3D technology.

3D Printing and Intellectual Property Rights

The intellectual property rights regimes of various jurisdictions have been shaken by 3D printing, particularly in light of patent law. Indeed, it is anticipated that by the end of 2018, 3D printing would have cost the world at least USD 100 billion every year. There is also the intangible cost of inventors’ subsequent scepticism in the patent regime, in addition to this measurable loss. Because of its potential to manufacture in the microcosm, 3D printers are a big source of concern. Patent enforcement becomes practically difficult when patented objects are produced at home. In this section of the report, we look at 3D printing and the challenges it brings to India’s patent system.

The allure of 3D printing is that it allows customers to ‘manufacture’ at home, taking control away from traditional businesses and supply networks.  However, this seizure of power has negative effects for patent holders in terms of pinning liability and creating losses. Patent law issues relating to 3D printers can be divided into two categories: first, reproduction of patented products, and second, obtaining patents for 3D printed products/processes.

Simply put, every printed copy of an innovation represents a possible sale that the patent holder has missed out on.   A patent holder has the right to prevent third parties from creating, using, or selling a patented product without their approval under Section 48 of The Patents Act, 1970 (Hereinafter referred to as ‘1970 Act’). As can be seen, unlike copyright, patent goes a step farther and bars not just sale but also mere utilization. As a result, utilizing a 3D printer to create patented objects and then using those products would unavoidably be considered infringement under the 1970 Act. The main issue with additive manufacturing stems from the existence of websites like Thingiverse and Shapeways, which allow members of the ‘Do-It-Yourself community’ (‘DIYers’) to create and share designs for free. Patent breaches, both intentional and unintentional, are made easier when ideas are in the form of CAD files since they may be quickly transferred. This accessibility, along with the low cost of 3D printers, encourages DIYers to create patented items in the form of practical ideas. As a result, patented goods’ CAD file versions become readily available, increasing infringement. Apart from the fact that they are freely available, such an internet sharing model also provides anonymity to infringers. Rather than financial exploitation, the motivation for developing and releasing CAD files appears to be a desire to cultivate interest among amateurs and enthusiasts. As a result, websites enable anonymous downloads and appear unconcerned about the absence of earnings. Apart from not requiring identity credentials for downloading CAD files, it’s also unclear how many individuals who download the CAD file really make the patented goods. The answer to this question is significant because, under the 1970 Act, a patent holder’s rights include the ability to prevent others from making the goods. However, determining how many users make the patented product after downloading the CAD file is impossible. It is currently debatable whether simply downloading the CAD file of a copyrighted product constitutes an infringement, making it difficult to assign liability only on the basis of downloads.

Obtaining Patents with 3D Printed Products/Processes Apart from these concerns, it’s also crucial to know whether all 3D printed products can be patented. It is unrealistic to believe that all goods can be. An invention must meet the standards specified in 2(j) as well as pass the filters listed in sec 3 to be patented under the 1970 Act. As a result, it must be new, contain an imaginative step, and be industrially applicable. It also can’t be one of the exceptions listed in Section 3 of the 1970 Act. This might cause a lot of confusion in the world of 3D printing. Bioprinted organs, for example, may not be able to be copyrighted because they are considered “naturally occurring.” However, following the United States Supreme Court’s decision in Association for Molecular Pathology v. Myriad Genetics, it seems likely that 3D printed organs will be able to be patented, although naturally existing materials will not. However, in the context of India, the decision can be different. Patents on “plants and animals in whole or in part” are prohibited under Section 3(j) of the 1970 Act. 144 Biomaterial from that/an animal would be required to make a 3D printed organ of that/an animal, and would fall neatly under the phrase ‘any component thereof’ as defined under Section 3 (j).Even if it is not naturally occurring and includes a significant amount of human intervention, a 3D printed organ of an animal may be unable to be copyrighted. As a result, with the introduction of 3D printing, India’s patent regime will need to reshape itself in order to avoid becoming obsolete. The method of pinning liability will be discussed in the next section.

Assessing when there is an infringement

Direct, indirect, and contributory infringements are the three categories of infringement. The most prevalent type of infringement is direct infringement, which occurs when a product that is substantially similar to a patented product or innovation is promoted, sold, or used commercially without the owner of the patent’s consent. Indirect infringement is defined as deceptive or unintentional infringement. A person may be held accountable for indirect infringement if he intentionally assists in the violation of a patent. Furthermore, if such material is sold or supplied unintentionally, the person may be held accountable for contributory infringement. The small number of case laws on contributory and indirect infringement theories in India is a key challenge when it comes to pinning culpability on an infringer. Contributory infringement can be proven using the ‘active inducement’ test or the ‘substantial non-infringing purpose’ test, both of which are based on US legal decisions. The substantial non-infringing use test may not be very helpful in the case of 3D printing in India, as there may be a wide range of potential non-infringing uses. It may be necessary to define what constitutes contributory infringement in order to determine the applicable infringement theory. For the time being, Intermediary Guidelines, 2011 may be useful in some ways.

The way these websites function is also crucial since the user data is protected by the websites’ privacy policies, and it keeps the infringers nameless in these circumstances, thus liability cannot be easily put on one person, resulting in a slew of lawsuits. Patents grant the right to prevent others from producing the product, and when users’ identities are anonymized by websites, it is extremely difficult to track down infringers, and effective injunctive methods are rendered ineffective. It’s also critical to determine if infringement occurs simply by downloading the CAD file or only when the printed product is infringing.’

Conclusion

The notion of bioprinting is certain to bring significant changes to India’s patenting regime; however, we must distinguish between the bioprinting technique and the biomaterial or naturally occurring organ/tissue aspects of the process. Many problems can be solved with 3D printing, from making amputee prosthetic limbs more accessible to offering cost-effective space technologies. It, like the internet, has been heavily criticized as a result of the legal issues that have arisen as a result of this movement.3D printing, with the help of some solutions, could, however, be the answer to many global challenges. As technology advances to meet society’s changing dynamics and requirements, we must climb to the level of 3D printing to meet the legal problems that it presents.

Author: Anuja Saraswat – a student of  B.A.LL.B (Hons.) from NMIMS Kirit P. Mehta School of Law (Mumbai), in case of any queries please contact/write back to us via email [email protected] or contact us at IIPRD.