Lalit Mahajan<\/strong> patent application\ndealt with whether a method for detecting the presence of antibodies in human\nplasma is covered under Section 3 of the Patent Act. The Patent Examiner\ndetermined that the invention was a device rather than a procedure or method,\nmaking the opposition’s contention unsustainable.<\/p>\n\n\n\nThe\nNovartis case in India brought the pharmaceutical industry under the purview of\npatent law and set a significant precedent for accessibility to medications.\nThe decision prioritized social justice over commercial interests and\nbenefitted India’s local industries while still upholding global intellectual\nproperty commitments. It was the first time that India had enacted a drug\npatent ban with minimal modifications to an existing one.<\/p>\n\n\n\n
India\nviews the procedure of medical treatment exclusion broadly, leading to a higher\npercentage of medical innovations being excluded from patentability. Overall,\nIndia’s approach to patent policy in the medical field prioritizes\naccessibility to healthcare and local industry development over commercial\ninterests.<\/p>\n\n\n\n
UK: <\/h3>\n\n\n\n
The UK also had a similar ban on patenting medical procedures until 1997. After that, the UK allowed for patenting specific medical procedures, but only if they met novelty, inventive steps, and industrial applicability criteria.<\/p>\n\n\n\n
Since\nthe inception of patent law in the UK, it has been necessary for an invention,\nidea or method to have “industrial applicability” in order to be\neligible for patenting. Medical procedure patents were excluded from this\nrequirement as they were deemed to lack industrial applicability and were also\nconsidered to be a violation of ethical principles. The Parliament later\namended the Patents Act of 1977 to align with the European Patent Convention,\nbut it still prohibits medical procedure patents for diagnostic, therapeutic,\nand surgical processes.<\/p>\n\n\n\n
USA: <\/h3>\n\n\n\n
In\nthe USA, any innovative and\neconomically beneficial technique, equipment, or manufacturing is patentable\nunder the law. While medical procedure patents are granted, there is no\nspecific legal action provision in case of a violation. This means enforcing it\nis impossible while the inventor may have a monopoly. The Court established\nthis rule after the Ex parte Brinkerhoff, Ex parte Scherer, and Pallin cases.\nIn the Pallin case<\/strong>, the Court\noverturned the first two cases, recognizing a greater responsibility to balance\npublic health with social benefit and imposing limitations on the patentability\nof medical, surgical, and therapeutic processes.<\/p>\n\n\n\nAustralia: <\/h3>\n\n\n\n
The\npatentability of medical procedures has been controversial in Australia.\nMedical procedures involving medical devices or pharmaceuticals are patentable,\nbut surgical and therapeutic methods are generally not.<\/p>\n\n\n\n
Before\nthe 1977 Patents Act, Australian patent law did not explicitly prohibit the\npatenting of medical treatment procedures, but it was left to the courts to\ndecide. However, both Australia and the UK have since changed their laws to\nexclude medical procedures from patent protection. In Australia, courts have\nthe power to determine whether an invention is “particularly\nundesirable,” and critics argue that patenting medical procedures is\nusually inconvenient. In the case of Anaesthetic Supplies Pty Ltd v Rescare\nLtd, the Federal Court held that patenting medical procedures were not usually\nproblematic. The issue was again raised in Bristol Myers Squibb Co v F H\nFaulding & Co Ltd, in which the judges disagreed on whether medical\nprocedures could be patented.<\/p>\n\n\n\n
<\/span>Criticism and Issues Associated with Patent Protection of\nMedical Procedures <\/span><\/h2>\n\n\n\nMedical\nprocedure patents have been controversial for many years, with critics raising\nconcerns about the ethical, societal, and human rights implications of granting\nsuch patents. One of the main concerns is the potential conflict between\nmedical practitioners’ ethical responsibilities and the patenting of medical\nprocedures. Governments often refuse medical procedure patents based on moral\nand rational considerations rather than scientific or technological ones\nbecause they may not be affordable to some patients and may limit the spread of\nknowledge and information.<\/p>\n\n\n\n
Critics\nalso argue that medical procedure patents could harm the relationship between\ndoctors and patients. If a medical procedure is patented, a doctor’s judgment\nin treating patients could be influenced by the nature of the patented\nprocedure, which could be harmful to the patient. Furthermore, applying\nlicensing fees or royalties to exclusive monopolies can increase the financial\nburden, especially for those who require modified therapy.<\/p>\n\n\n\n
Another\nconcern is that granting medical procedure patents may result in unjustified\nmonetary benefits for inventors and private firms. Critics argue that doctors\nshould undoubtedly be rewarded for their innovations, but not just financially.\nMedical procedure patents may lead to situations where inventors and private\nfirms invest in procedures where patents are almost expected to be awarded. It\ncould lead to a need for more incentives for doctors to innovate.<\/p>\n\n\n\n
The\nfear of violation or infringement is also among the most serious concerns\nraised by critics of medical procedure patents. In emergency situations,\ndoctors who perform a patented medical treatment will be protected under the\ncurrent equitable principle of necessity. However, critics argue that it is\ndifficult to envision a doctor refusing to perform an emergency procedure out\nof fear of patent infringement. The issue is that when it comes to the\npatentability of non-emergency operations, the “fear of infringement”\nargument holds little significance on its own.<\/p>\n\n\n\n