Beijing Xinbo Technology Trading Co., Ltd.

Song Dynasty) The World Trade Organization (D) Agreement on Trade-Related Aspects of Intellectual Property Rights (DingR) sets minimum levels of protection for many forms of intellectual property rights, including pharmaceuticals. The Indian government signed the Agreement on Trade-Related Aspects of Intellectual Property Rights in 2006. After India promulgated a new patent law in 2016, many patent holders sought to enter India's increasingly important health care market.
Song Dynasty) However, even the current patent law promulgated in 2006 includes some special provisions.
Song Dynasty) One of these clauses is Section 1. Section 1 creates an additional hurdle for pharmaceutical companies to patent their own products. It states that derivatives of a known drug cannot be patented unless they can show different effects. In other words, if a After a drug is developed and patented, but then a new (arguably better) version is created, the original patent does not apply to the new version. Unless clinical improvement is demonstrated to the satisfaction of the Indian government, none of these new versions was granted a new patent. Therefore, to obtain a patent, it is not just as simple as proving consistent "novelty, commercial applicability and non-obviousness" according to the standards listed in the R agreement.
Song Dynasty) Novartis's Gleevec faces a similar problem. This anti-cancer drug has been developed since 2001. The newly developed version is considered by India to lack innovation and is not suitable for granting a new patent.
Song Dynasty) & Any authorized patent with such a high monopoly price is against public order. &rThe Intellectual Property Appellate Board of India said so in its ruling.
Novartis is not convinced by this ruling. "The improvement of Gleevec has been carried out for several years, and the changes are not just a little bit, but the progress is breakthrough." &rNovartis wrote on its group's international website.
Song Dynasty) Looking at generic drugs from another angle
Song Dynasty) If Novartis wins the lawsuit, all of India will be forced to grant more patents, thus limiting the production of generic drugs. This will be a huge problem for patients in poor countries. A fatal blow.
Song Dynasty) This is not a good thing for many international humanitarian organizations, because organizations such as Doctors Without Borders, the Global Fund, the US President’s Emergency Plan for AIDS Relief, UNITAID and UNICEF are not allowed to Don’t rely on cheap Indian generic drugs to run your program. Doctors Without Borders, a medical humanitarian relief organization, pointed out that the organization purchases % of its anti-HIV drugs from India.
Song Dynasty)
Song Dynasty) Médecins Sans Frontières' "Medical for the Sick" project manager in India, Meng Gani, told reporters in an interview that India's patent system prevents the "old wine in new bottles" model, and encourage drug innovation. This patent system will protect new pharmaceutical ingredients, that is, effective chemical ingredients that can make new contributions to existing medical products. For example, the new AIDS drugs that have been patented in India: getravir and etravirine.
Song Dynasty) According to Meng Gani, anti-HIV drugs are a good example of the possible consequences of this verdict. Due to competition from generic drugs, first-line drugs for the treatment of AIDS have become affordable, but patients are gradually becoming resistant to current drug ingredients and urgently need to switch to second-line drug treatment. Therefore, the application of second-line drugs and improved formulations is urgent. Some key drugs are currently being produced as generic drugs in India, but if Novartis wins the lawsuit, it will jeopardize the production of such generic drugs because many pharmaceutical companies will apply for patents for their drugs in India.
Song Dynasty) & But not all patent applications are for new drugs, most of them are new uses, new forms and new formulations of existing drugs. These applications should be rejected because these innovations are common practices in the pharmaceutical industry. This (rejection) approach will also help generic drugs enter the market earlier, making it easier for more patients to obtain affordable drugs. &rMeng Gani said.
Song Dynasty) A member of the Indian Pharmaceutical Enterprises Alliance explained: &We realize that the industry will be hit. &rThe alliance represents the interests of large generic pharmaceutical companies. "We are seeking a solution to address government concerns about patient availability and affordability of medicines without threatening the long-term growth of the pharmaceutical industry." &r
宋体) As these lawsuits drag on, the Indian government is considering other ways to obtain cheaper drugs. The country's government plans to provide free generic drugs to public hospitals, which will significantly increase sales of cheap generic drugs. The government may also develop a price control mechanism for patented medicines. However, generic drug companies are not without regulatory pressure. Ministers plan to expand price controls to include a wide range of generic medicines.