29 October, 2019
Recent trends in cancer chemotherapy treatments indicates that employing effective drug combinations in optimal doses are more effect. Same is true for variety of medical conditions where it is found that single-agent therapies are not very effective. In fact, the difficult to cure disease conditions such as AIDS, tuberculosis, leprosy, cancer, malaria, diabetes do respond well to the combination therapies. Basic trend in such combination normally point towards pushing the dose content of each combination to get best results. These combinations at times results into falling short of providing optimal efficacy due to the manner in which the drugs components interact. However, encouraging results are forthcoming particularly in cancer therapy where cytotoxic drugs are found to be most effective when given in combination to achieve additive or synergistic effects.
Combination therapy and patent eligibility
These possibilities in combination therapies opened a new area of drug development for targeted therapy and looking for possible patent grants for such combination drugs. Combination drugs for examples gefitinib and Erlotinib (useful for non-small-cell lung cancer patients with EGFR mutations), panitumumab and cetuximab (useful for metastatic colon cancer, vemurafenib for patients with melanomas harboring BRAF mutations), and crizotinib (useful for lung cancer patients with EML4-ALK translocations) are found to have effective response in reducing tumour size with reduced toxic effects. Other examples include combination therapy using metformin and repaglinide for treatment of noninsulin-dependent diabetes mellitus. Innovative drug developers see the possibility in obtaining patents in this niche space. But they may have to cross certain hurdles in obtaining drug combination patents. One effective patent strategy is to demonstrate synergistic effect of such combination with supportive studies disclosed in the specification and another approach could be to establish novelty /non obviousness in the combination. In the combination drug area, patent examiners invariably seek evidence of additive effect /synergistic effect before he ventures into other patentability issues.
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For further information, please contact:
DPS Parmar, Head of the IPAB practice group LexOrbis
mail@lexorbis.com
