When the world is thriving technology and innovation as success, patent provides exclusive rights to the owner to treat his intellectual property well by protecting it from others. But, what if such rights are violated or what we can consider as a violation is a critical story. The Indian Patent Act (IPA) provides enforcement of patent by way of suits for infringement. However, IPA doesn’t provides specific definition about what is an infringement but yes it does describes the rights conferred to the owner which include making, distributing, mortgaging, or selling the invention in India so that it is to be understood that patent infringement is the unauthorized making, using, offering for sale, selling any patented invention, or importing into India of patented invention during the live term of a patent. Indian patent law provides protection over product as well as process patent where the burden of proof in case of infringement lies with respect to the nature of the patent in dispute. When we specifically talk in case of process patent the burden of proof lies on the defendant and in reverse to which in case of product patent the burden lies on the patentee to prove his case.
However, the acts are exempted to be an infringement if the patent has been used for the research purpose or supply of the patented drug to the health institutions or to the needed country or use of the invention on the foreign vessels and also in case of parallel import or the authorized use of the invention.
A strong IP regime attracts new investments and extends new technologies to grow. The Indian courts follow the tradition of civil suits in case of patent infringements where suits are instituted in district or the high courts and civil remedies are awarded. Day to day India has ushered improvements in IP enforcement, where eminent rate of success to the patent holder is centered. In light of the above discussed climate of infringement, there is lot more layers are to be created and that will bring the clear sky for patent holders.
Pharmaceutical industries always demand the protection of their constant research and product of that research which serves the public at large to cure various diseases. Laws are to help right ones and to avoid wrong ones; the provision provided under the Indian patent law leave the primary threat to others which helps the industry and pay off the struggle and efforts of the patent holder.
Natco and Bristol Meyers Squibb Settlement
A settlement has been made by the two Pharma giants NATCO and BMS in the matter of drug named “Entecavir”. The drug is used in the treatment of hepatitis B infections and considered to be the one of the important drug for the country. The dispute of the patent concerned the use of “Entecavir” oral composition prescribed for once a day having 1% drug concentration. It was well known that before 1995, Indian Patent Act was not granting product patents and hence the drug did not process an Indian patent. The claim of the drug in India for the administration for once a day was having very narrow scope and hence many pharmaceutical companies could work around the claim and launch their own generic product. In the same matter injunction was granted against Ranbaxy when they had launched the generic version of the same drug.
Similarly the issue was raised against NATCO when they had launched their independent drug, X-Vir and challenged BMS in IPAB and settlement was entered with BMS. The issue was well known and curious for the Pharma industry however the settlement terms were kept confidential.
Patent Revoked-“ Valganciclovir-Roche”
The Controller General of Patents revoked a patent granted to Roche for Valganciclovir. Valganciclovir is an anti-retroviral drug which is used for the treatment of active cytomegalovirus retinitis (CMV) infection. The infection if not treated, can cause blindness in persons living with HIV. It is also used for post operative treatment for persons who have received an organ transplant. Roche was granted a patent for Valganciclovir in 2007 in India. The grant of the patent in India also looked as restrictions or a threat to cheaper generic versions of the drug that can not enter the market. The principle ground for revocation of the patent was that the drug formulation was known and similar prior art has been existed which then added with the non patentability under section 3 (d) of the Indian Patent Act, 1970 showing “efficacy”. The Oxford English Dictionary broadly defines 'efficacy' as 'power or capacity to produce effects’. The arguments were made stating that the drug was having improved bioavailability where whether the improvement of oral bioavailability constitutes enhancement of the known efficacy of that substance was discussed. By considering the thorough arguments The Controller ruled that the present patent was a ‘mere use of a known process’ which was not patentable under Section 3(d), Patents Act as well as known by the prior arts. And by considering all such arguments and evidences the patent granted to Valganciclovir was revoked.
Source: Controller’s decisions. Indian Patent office