Patent and other IPR in drug delivery
IP refers to “thought creations” that span from technical and literary inventions to creative endeavors. The creator of an IP is entitled to exclusive rights over its inventions known as IP rights (IPR). For a set period during which the creator profits from his work these IPRs are assigned to him for a given innovation. The various IP types, all protected by law, are patents, copyrights, trademarks, business secrets and designs. In the pharmaceutical sector, these patents are by far the most important IP.
Ethical issues in Patent Law
Research universities and other academies participate in rigorous research efforts that produce scientific evidence in many areas. However, all these efforts could be in nothing unless scientific evidence is transposed in due course into clinical testing and therapy for patients. However, the academic structure continually failed to provide researchers with assistance for their valuable products to be marketed. Academic institutions have therefore had to work with pharmaceutical corporations to transform their scientific findings into a commercial product that can be delivered to the public. In this approach, although with a licensing charge, the institution shall forward a patented invention to a private enterprise. However, it can lead to many questions of ethics and policy.
Another harsh state is to arrange a transfer agreement with later researcher in the same subject with a “through” provision for a university having a patent about the new inventory. The term “attain” is an explicit declaration in the context of patent rights since it is a conditional licencing procedure where successive investigators must share the IPR with the other researchers by employing the initial patented innovation (research tool). It can therefore constitute a major obstacle to further study.
Multiple patents on a single invention, especially in pharmaceutical research, may diminish prospective research on the same discovery as all patentees with proper royalties have to be appealed. The “tragedy of anticommons” is noted for this negative influence in further study and involves various stakeholders for the same commodity.
One of the “knowledge-driven” industries is the pharmaceutical industry. The costly and unpredictable nature of pharmaceutical research is very high. A innovative, inventive and beneficial product or procedure may be the results of the study. In this highly competitive industry, pharmaceutical businesses are obliged to protect their ideas by gaining patent rights over the invented product or procedure from any unlawful commercial usage. The following categories may cover pharmaceutical patents in India. This classification is based on the Indian Patent Office’s list of pharmaceutical patents:
- Drug Compound Patent: By their chemical structure itself, these patents claim a pharmacological molecule. These claims are generally referred to as claims of the Markush type. A Markush claim is a claim in one or more portions of the therapeutic molecule that contains numerous ‘functionally identical’ chemical entities.
Drug compound patents provide the company’s product as far as feasible, since other firms are not permitted to prepare or to produce/sell any formulation containing that drug prior to the end of the above patent on any way of synthesis.
- Composition/Formulation Patent: These patents call for a certain technique to prepare a formula and/or quantity of their essential constituents. For instance, the Indian Patent No. 203986 claimed the following ayurvedicAntiRetroviral Syndrome for the treatment of AIDS.
- Synergist Combination Patent: The synergy of drugs happens when two or more medications interact so that one or more effects of those medicines are amplified or increased. New synergistic medicine combinations can be achieved with patents.
The following was, for exemple, claimed in Indian Patent No. 206328 for a synergistic combination of roflumilast with salmeterol:
“Salmeterol or the pharmacologically tolerable salt is a drug consisting of a PDE-inhibitor administered oralally, of the PDE4 inhibitor group and/or a G2 adrenactor-agonist in combination, in which the PDE-inhibitor is roflumilast, pharmacological tolerable roflumilast salt, and/or roflumilast N-oxide and the G2 adrenoceptor-agonist.”
- Technology Patent: These patents are based on the methods used to solve various challenges relating to technology such as stabilisation, taste masking, solubility increase etc.
For instance, the Indian patent no. 227933 claimed following taste disguised formulation.
“A pharmaceutical formulation of a disguised flavour which, while administering the formulation, remains, in particular in the form of suspension, characterised by at least the following ingredients in an aqueous vehicle:a) a cells of cellulosic polymer soluble in organic solvents but virtually insoluble in the water regardless of pH; an acid-soluble methacrylic polymer, virtually insoluble, at neutral or alkaline pH and an active ingredient distributed homogenously in a molecular state and in the mix, as an atomised matrix; b) an alkaline agent or a mixture;”
- Polymorph: Polymorphs are diverse physical shapes of a well-known chemical or crystal structure. Polymorphs tend to eliminate contaminants or improve compound stability.
The Crystalline Form B4 of atorvastatin magnesium, as described by X-ray powder diffraction pattern, is claimed by the Indian patent No. 237261, for example. The crystalline form demonstrates pureness above 98%.
- Biotechnological Patenting: In the creation of pharmaceutical products, biotechnology includes the utilisation of live organisms or biological components. Patents in biotechnology encompass a broad spectrum of diagnostic, therapeutic and immunological goods.
Indian patent No. 234072, for example, claims the interferon-alpha aqueous, human serum albumin-free interferon solution, non-ionic detergent, pH-adjustment buffer 4.5-5.5, benzyl alcohol and optionally an isotoning agent.
Moreover, the first product patent given by the Indigenous Patent Office after the introduction of the product patent regime in 2005 was above Indian patent No. 234072. F. Hoffmann-La Roche, Switzerland is the proprietor of the patent.
- Process Patent: A process patent does not claim the product itself, but simply includes a new and creative procedure for the production of a specific product.
The Indian patent no. 206678, for example, claimed a synthesis procedure in respect of L-lactone from formula 3, 6-dialkyl-5,6-dihydro-4-hydroxy-2h-pyrene-2-one.
In the pharmaceutical industry, patents are a significant element of protection for inventions. There can be no overemphasis on the crucial need of patent protection. Indeed, a company’s monetary profits through patent rights can be utilised to engage in other research and development operations and patents are therefore properly viewed as “research currency.” While the securement of drug patents appears to be a “game stunt,” it is very important for further research and development on new drugs.
The patent rights are quid pro quo, since by patenting their invention, the proprietors have the exclusive period in exchange for the complete disclosure of sufficient information about the patented product (where no competitor may market the same product). Other scientists can use this new knowledge base to “invent” the patent and find new ways to achieve the same outcome.
Contributed by:– Nidhi Jha, Legal intern at LLL