IP Challenges with Combination Drug Patents in Pharmaceuticals: A Critical Analysis
DOI:
https://doi.org/10.56042/jipr.v31i4.15977Keywords:
Combination Drug Therapy, Intellectual Property (IP), Pharmaceutical Patents, Non-Obviousness, Incremental Innovation, Patentability Criteria, Market Exclusivity, Generic Drug Access, Compulsory Licensing, Regulatory Framework, Access to Medicines, Patent Law Reform, Healthcare CostsAbstract
The article critically examines the intellectual property (IP) challenges of combination drug patents in the pharmaceutical industry. Although combination therapies are critical in treating complex diseases, patenting them involves significant hurdles due to stringent requirements for novelty and non-obviousness. The discussion raises ethical concerns regarding incremental innovation, where patents may protect combinations that offer limited clinical advancements, thereby restricting competition and delaying generic drug entry. The example of pembrolizumab (Keytruda) underscores the complexities involved in patenting combination therapies and suggests the need for reform in patent law such as revising non-obviousness criteria and strengthening compulsory licensing to align innovation with public health goals.
