Glivec is the beta-crystalline form of imatinib mesylate manufactured by a Swiss drug company XXX. The drug is administered to cancer patients suffering from chronic myeloid leukemia. It does not cure the disease but con

Glivec is the beta-crystalline form of imatinib mesylate manufactured by a Swiss drug company XXX. The drug is administered to cancer patients suffering from chronic myeloid leukemia. It does not cure the disease but controls cellular action, thereby making cancer manageable to some extent for many patients. While this drug is a great advance in the treatment of cancer, patients are obliged to take it for the rest of their lives. XXX developed Glivec in the 1990s and received Food and Drug Administration (US) approval for marketing in the United States in May 2001. The drug is produced by XXX in Beta form, while it is generically produced in Alpha form in India. XXX filed a mailbox application for a patent in India in July 1998, and was granted "Exclusive Marketing Rights" (EMR) in 2003. EMR meant that XXX could prevent Indian pharmaceutical companies from producing and selling generic versions of the drug for 5 years or until the decision on the application for a patent. The Beta form has, according to XXX, many advantages over the Alpha form, including more beneficial flow properties, improved thermodynamic stability (better storage of drug), lower hygroscopicity (longer shelf life) and, most 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". Reckoning and availing of its rights under EMR dispensation, XXX filed an infringement suit against six generic competitors who were producing Glivec in the Indian market: A, B, C, D, E and F. The said producers, along with cancer patient advocacy groups and legal rights organizations, filed pre-grant opposition to the patent for Glivec. XXX, holding EMR rights priced Glivec at about 10 times the price that generic producers were selling at. Consumers suffered the high price at which XXX was selling and in many cases had to forego the drug on the account of affordability. XXX's application for patent was taken out of the mailbox for consideration after amendments were made to the Patents Act. But before it was taken up for consideration, the patent application had attracted the said pre-grant oppositions in terms of section 25(1) of the Act. The Assistant Controller of Patents and Designs at the Chennai patent office heard all the parties and rejected the application for grant of patent to the subject product by separate, though similar, orders passed on the opposition petitions. The Assistant Controller held that the invention claimed by XXX was anticipated by prior publication, the invention claimed was obvious to a person skilled in the art and further that the patentability of the alleged invention was disallowed by Section 3(d) of the Act. In particular, he was not convinced that the patent application presented a new substance because Glivec was simply the salt of a known substance. He observed that although the new Beta drug could be more effectively absorbed into the bloodstream, this bioavailability was not an improvement in efficacy as required by Section 3(d). At that time, the Appellate authority under the Act had yet to become functional. The applicant XXX therefore, challenged the orders passed by the Assistant Controller in Writ petitions filed directly before the Madras High Court. After the formation of the Intellectual Property Appellate Board (IPAB), the writ petitions challenging the orders of the Assistant Controller were transferred from the High Court to IPAB. The applicant's appeals against the orders passed by the Assistant Controller were finally heard and dismissed by the IPAB by a long and detailed judgment. The IPAB reversed the findings of the Assistant Controller on the issues of anticipation and obviousness. It held that the applicant's invention satisfied the tests of novelty and non-obviousness. The IPAB, however, held that the patentability of the subject product was hit by section 3(d) of the Act. Referring to section 3(d) the IPAB observed : "Since India is having a requirement of higher standard of inventive step by introducing the amended section 3(d) of the Act, what is patentable in other countries will not be patentable in India. As we see, the object of amended section 3(d) of the Act is nothing but a requirement of higher standard of inventive step in the law particularly for the drug/pharmaceutical substances." The IPAB also noted the following observations of the Madras High Court : "We have borne in mind the object which the amending Act wanted to achieve namely, to prevent ever-greening; to provide easy access to the citizens of the country to life saving drugs and to discharge their constitutional obligation of providing good health care to its citizens." In the light of the High Court's observation, the IPAB also referred to the pricing of the drug Glivec by the applicant, while it enjoyed EMR over it, and held that the patentability of the subject product would also be barred by section 3(b) of the Act. In this regard, the IPAB observed that when the applicant was holding the right as EMR, it used to charge ₹1,20,000/- per month for a required dose of the drug from a cancer patient, which was too unaffordable to the poor cancer patients in India. Furthermore, the grant of product patent on the application may create a havoc on the lives of poor people and their families affected with cancer for which this drug is effective. This will have disastrous effect on the society as well. Considering all the circumstances placed before the IPAB, it observed that the applicant's alleged invention was not worthy of a reward of any product patent on the basis of its impugned application for not only for not satisfying the requirement of section 3(d) of the Act, but also for its possible disastrous consequences on such grant as stated above, and also for attracting the provisions of section 3(b) of the Act which prohibits grant of patent on inventions, exploitation of which could create public disorder among other things. IPAB upheld the decision of the Assistant Controller on section 3(d) of the Act to the extent that product patent cannot be made available to the Applicant. Against the order of the IPAB, XXX directly moved the Supreme Court through a petition under Article 136 of the Constitution. XXX engaged senior counsels to argue their case in the Supreme Court. Counsels appearing for XXX strenuously argued that section 3(d) was not meant to be an exception to Clauses (j) and (ja) of section 2(1) of the Act. They insisted that section 3(d) had no application to the case of the subject product. The subject product, having satisfied the tests of invention as provided in Clauses (j) and (ja) of section 2(1), could not be denied patent for allegedly failing to satisfy the tests under section 3(d). XXX's counsels submitted that section 3(d) was a provision put in ex abundanti cautela non nocer (abundant caution does no harm) to remove all doubts and also that it was a provision ex majore cautela (out of abundant caution). The counsels submitted that the primary purpose of section 3(d), as was evidenced from the legislative history, was to prevent "evergreening" and yet to encourage incremental inventions. "Evergreening" is a term used to label practices that have developed in certain jurisdictions wherein a trifling change is made to an existing product, and claimed as a new invention. The coverage/protection afforded by the alleged new invention is then used to extend the patentee's exclusive rights over the product, preventing competition. It was further argued that, by definition, a trifling change, or in the words of the section "a mere discovery of a new form of a known substance", could never ordinarily meet the threshold of novelty and inventive step under clauses (j) and (ja) of section 2(1). An invention cannot be characterized by the word "mere". The word "invention" is distinct from the word "discovery". The counsels therefore, submitted that section 3(d) operated only as ex majore cautela, ensuring that mere discoveries could never, by an effort at interpretation of clauses (j) and (ja) of section 2(1), be considered inventions. What is 'enhanced efficacy'?