Rice Pharmaceutical is a renowned MNC, holding many patents worldwide. One of the famous drug of this company is its anticancer drug which is marketed in the name of Glivec. The company holds patent on alpha crystalline

Rice Pharmaceutical is a renowned MNC, holding many patents worldwide. One of the famous drug of this company is its anticancer drug which is marketed in the name of Glivec. The company holds patent on alpha crystalline form of this drug in 35 country around the world which was about to expire. The company came up with the new form of this drug as beta crystalline salt form of the free base Imatinib. This drug is administered to cancer patients who are suffering from chronic myeloid leukemia. Though the said drug does not cure the disease but still it controls cellular action. As such the cancer becomes manageable to some extent for many patients. It filed a patent application in India claiming that Beta form has many advantages over the Alpha form including more beneficial flow properties, improved thermodynamic stability (better storage of drug) lower hygroscopicity (longer shelf life) and notably a 30% increase in bioavailability (absorption into blood stream). It further claimed that the aforesaid properties make the invented product 'new' (and superior) as it stores better and is easier to process. At the time of filing of patent application by Rice Pharmaceuticals Alpha crystalline was manufactured by six pharma company in India as generic version as affordable prices. The Assistant Controller of Patents rejected the application for the grant of patent to Rice pharmaceuticals on the grounds that the said drug is pre existing version of Alpha form with no superior efficacy therefore it is not novel. As per Sec. 3(d) of the Patent's Act 2005 no significant improvement has been made. Against this order Rice pharma filed Writ Petitions before Madras High Court contesting that sec.3(d) of the Indian Patents Act is not in accordance with TRIPS agreement, is vague, arbitrary and against the Article 14 of the Constitution. The Court held that sec.3(d) is not unconstitutional as its goals is to give residents convenient access to life saving drug. As such it cannot be regarded as ambiguous and arbitrary. There are certain issues which arise here. They are whether the Appellant's product satisfies the tests and thus qualifies as 'invention' within the meaning of Clauses (j) and (ja) of section 2(1) can its patentability still be questioned and denied on the ground that sec 3(d) puts it out of the category of 'Invention'. Rice Pharmaceutical filed appeal in Supreme Court of India against this order. The court came up with the concept of superior efficacy in the case of pharma patent. The court held that in case of chemicals and especially pharmaceuticals, if the product for which patent protection is claimed is a new form of a known substance with known efficacy, then the subject product must pass. In Bishwanath Prasad Radhey Shyam v. Hindustan Metal Industries (PTC (suppl) (1) 731 (SC)), Supreme Court held that the object of patent law is to encourage scientific research, new technology and industrial progress. The price of the grant of monopoly is the disclosure of the invention at the Patent Office, which after the expiry of the fixed period of monopoly, passes into the public domain. The fundamental principle of patent law is that a patent is granted only for an invention which must have novelty and utility. Section 3(d) was amended to make it even more constructive than before. The test of enhanced efficacy in case of chemical substances, especially medicine, should receive a narrow and strict interpretation. A subject matter in order to get a patent under the Patents Act, 1970 has to pass the test of invention and patentability, both being distinct concepts. Section 3(d) provides a bar that incremental inventions of chemical and pharmaceutical substances need to pass extra threshold of enhanced efficacy in order to be patentable. Normally, the patent-eligibility examination should precede and the patentability examination should follow. But in the case of Section 3(d), the patentability examination is conducted right at the beginning and under the garb of a patent-eligibility examination. Section 3(d) of the Patents Act, 1970 is construed as a refinement of patentability criteria to cater for 'evergreening' – a specific problem inherent in pharmaceutical innovations. More specifically, the 'enhanced efficacy' criterion can be seen as refinement of 'non-obviousness' principles, i.e. most forms of existing pharmaceutical substances are deemed obvious, unless they demonstrate increased 'efficacy.' At some level, section 3(d) could also be said to embody a utility test, i.e. unless the new form has significantly enhanced utility over and above what existed before in the art, it is not patentable. Efficacy need not be quantified in terms of numerical value to determine whether the product is efficacious because it is not possible to have a standard numerical value for efficacy for all products including pharmaceutical products. Questions: (a) A new test of enhanced efficacy for claims that covers incremental changes to existing is a threshold to get patent. Explain.