Glivec is one of the most celebrated cancer medicines of the modern era. Novartis sought an Indian patent not on the underlying molecule, imatinib, but on a specific crystalline form of imatinib mesylate. The Indian Patent Office refused it. The appellate board refused it. In April 2013, so did the Supreme Court of India.
What makes the case a landscaping lesson rather than a pharmaceutical one is the reason for refusal. Nobody held that the claimed form was already known in exactly that shape. The application ran into a provision that exists in Indian law and in very few others, and that had never before been tested at this level.
The IP move
India rewrote its patent law in 2005 to begin granting product patents on pharmaceuticals, as its international obligations required. Parliament paired that opening with a filter. Section 3(d) provides that a new form of a known substance is not an invention unless it demonstrates enhanced efficacy over the known substance.
The whole case turned on the meaning of one word. The Supreme Court held that in the case of a medicine, efficacy means therapeutic efficacy: whether the drug works better on the patient. Novartis had evidence of improved physical properties, including better bioavailability and better handling characteristics, and argued that these were exactly the kind of improvements the pharmaceutical industry values and invests in. The Court accepted that they were real advantages and held that they were still not the advantage the statute asked for.
Novartis also argued that the provision was being read so strictly that it would deter research investment in India altogether. The Court's answer was that the strictness was the point. Section 3(d) was a deliberate legislative choice, drafted to stop incremental reformulation from extending exclusivity on a molecule indefinitely. The application failed on a standard the statute had set out in advance, not on the quality of the science it described.
The takeaways
Patentability is territorial. The same application can succeed in one country and fail in another for reasons that have nothing to do with the quality of the work behind it.
A refusal at the end of a long prosecution is the most expensive possible way to learn a rule that was published before you filed.
Knowing what a jurisdiction excludes from patentability is as valuable as knowing what has already been granted there.
The evidence you will need is decided by the statute, so the time to design your experiments is before filing, not during examination.
Where the law blocks a patent, the value usually has to be protected another way: trade secrets, regulatory exclusivity, brand, distribution or simple speed to market.
The lesson for your business
Before you commit a budget to a filing programme, map the terrain. What is excluded from patentability in the countries that matter to you, what has already been granted in your space, and what standard will your particular claim actually be judged against once an examiner picks it up? A landscaping exercise answers those questions in weeks and for a known fee. Prosecution answers them in years, charges considerably more, and delivers the answer at the point where you can no longer act on it.
