Context: Bedaquiline has now become the cornerstone to cure drug-resistant tuberculosis (DR-TB). Last week, a major barrier for drug-resistant TB care ended, when Johnson & Johnson’s patent on bedaquiline expired in July.
Bedaquiline is an antibiotic drug used in the treatment of tuberculosis (TB), particularly in cases of multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB).
About Patent
- It is an exclusive right granted by the Government to the inventor to exclude others to use, make and selling an invention for 20 years.
- It is granted for:
- new invention
- involves an inventive step that did not exist before
- such a thing has not existed before and has industrial applications.
- When a patent is granted on a particular invention, it means that no other person can either produce or sell those inventions in the market for commercial purposes without the approval of the creator of such invention.
- India grants legal protection to various inventions through the Patents Act, 1970.
- The main aim to enact patent law is to encourage inventors to contribute more in their field by awarding them exclusive rights for their inventions.
- An invention is considered new if, on the date of filing the application, any such invention is not known to the public in any form, i.e. oral, writing, or any other form.
- It is a territorial right, so it can only be applied in the country where it has been granted.
- Any legal action against infringement or infringement of patent rights can only be taken in that country. To obtain patent protection in different countries, each country must apply for a patent.
- The Patent Cooperation Treaty (PCT) provides a way to file an international patent application in which a patent can be filed through a single patent application in a large number of countries.
- A patent owner has the right to grant a license for use or even sell the ownership of a patent.
- The Patents Act, 1970 was amended by the Patents (Amendment) Act, 2005 regarding extending product patents in all areas of technology including food, medicine, chemicals and microorganisms.
Working of Pharmaceutical Patent System
- The drug patent system was created to reward pharma companies for innovation, ensure returns on investment, and ultimately promote innovations that make human life better and easier. This monopoly right was given only for a certain number of years to the inventor of the patent, which, after the expiration of this duration, is taken away from them and the technology or the product becomes easily accessible to any other person and he may not earn any more profit from his own creation.
Ever-green patenting
- Ever-greening of patents is a process whereby the time of the rights in the patent is extended without any enhancement in the therapeutic efficacy of the Drug.
- This is done by making minor changes to the original drug, such as a new formulation or a slight modification in dosage, and then filing for a new patent.
- This allows the company to maintain its exclusive right to manufacture and sell the drug, even if it is essentially the same as the original.
- This can limit competition from generic manufacturers and keep drug prices high, making access to essential medicines difficult for those who cannot afford them.
Indian law about the evergreening of patents in India
- Section 3(d) of the Indian Patents Act states that the mere discovery of a new form of a known substance that does not result in the enhancement of the efficacy of that substance, or the mere discovery of any new property or new use for a known substance, or the mere use of a known process, the machine, or apparatus unless such known process results in a new product or employs at least one new reactant, is not considered to be an invention.
- Section 3(e) of the Indian Patents Act states that a 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 patentable.