The primary motivation behind choosing the topic is to analyze the novelty criteria for Active Pharmaceutical Ingredients (API) products and process patents. As a pharma chemist specializing in organic chemistry, the genuine concern is whether a general Markush structure could destroy the novelty of a drug molecule. It was argued in Dr. Reddy (UK) Limited vs. Eli Lilly case that a general formula can cover the patented compound olanzapine (Fig. 1a). However, to interpret each compound from a general formula, it needs length and breadth of knowledge of organic/medicinal chemistry. One general formula can produce trillions of drug molecules, which indicates that unless a single compound has not been synthesized, it might not be possible to prepare in the laboratory. For instance, if only R1 (Fig. 1b) is substituted and other variables are kept constant, it may give thousands of compounds. Another aspect is the biological activity of chemical compounds, which shows that one molecule might have one or more activities against many diseases. Therefore, based only on the theoretical aspect of the general formula, it is improbable that a person skilled in art can guess the actual pharmacological activity of a predicted compound.
Audience Take Away:
- Explain how the audience will be able to use what they learn?
- Audiences in medicinal chemistry will learn to establish novelty to discover patented inventions.
- How will this help the audience in their job?
- This presentation will help the researcher to open their capacity to work towards patents rather than just journal publications.
- Is this research that other faculty could use to expand their research or teaching?
- A presentation about the novelty of drug molecules will be helpful for academic and industry research.
- Does this provide a practical solution to a problem that could simplify or make a designer's job more efficient?
- Will it improve the accuracy of a design, or provide new information to assist in a design problem?