A product patent offers broader IP protection when compared to a process patent, which offers a limited protection to a specific process by which a product can be manufactured/synthesized provided the product was not patented. A classic example of a product patent is shown below, which usually covers any New Molecular Entities (NME)/ New Chemical Entities (NCE) or their combinations while the process patent covers the methodology or a synthetic route to prepare a product. This is a unique case wherein the product and process are filed in the same application, do you reckon this as a case for divisional application?2.
In an ideal scenario, the process and product applications are filed by different applicants (shown below). The applicant, Bristol Myers, covered the product including Markush elements while the other applicant, Hetero Research foundation, entered the market 20 years later for a process to manufacture the same product claimed by Bristol Myers. Even though Hetero Research Foundation claimed for an improved and effective process for synthesizing the product, it might have been an infringement if they had entered the market during the term of the product patent.
Other important pharmaceutical patents include new form of known substances. According to the Patents Act 1970, a new form of known substances are not patentable under section 3(d) unless they show improved efficacy3. An application filed by Italfarmaco Spa, the applicant, for a novel derivative of Somatostatin analogue is a testament to section 3d (shown below). This application was eventually granted after objections were raised under section 2(1)(j) and section 3(d). The applicant overcome the objections by proving that the new form of known substance showed enhanced efficacy over the parent compound. And interestingly the applicant excluded “indole” in the main claim which was the important component of the prior art (shown below).
Yet another important pharmaceutical patent application include combinations. In an interesting example, filed by Dow Global Technologies, an application for combination of drugs was granted. Initially, the IPO had raised objections citing prior arts for other combinations of the same active ingredient used by the applicant. However, the applicant secured grant for this patent, by successfully overcoming the objections raised by the IPO while suggesting they are different combinations and proving synergistic effect of the combination of drugs. A combination of active ingredients are patentable if they show synergism and not mere admixture of combined properties.4
In essence, some of the important types of pharmaceutical patents are covered here and the subsequent blogs will cover insights into reply to FERs and the arguments raised by the applicants to overcome the objections etc.