Why cannot a drug developer patent a natural drug?
Answer by Dr. Daniel Sparks, PhD
Natural substances and unmodified natural drugs are generally not patentable under patent law (such as U.S. 35 U.S.C. § 101) because laws of nature, natural phenomena, and products that already exist in nature are considered judicial exceptions to patent eligibility. Patent protection is critical to drug development because it grants companies a temporary monopoly. This exclusivity allows developers to recoup the billions spent on research and clinical trials by protecting them from cheap, immediate copying. Developing a new pharmaceutical is a long and expensive process where ~90% of drug candidates fail during clinical trials. A strong patent portfolio gives investors the guarantee of future returns, which is essential for funding early-stage biotech research.
To get a patent, a company must publicly disclose the drug's exact chemical makeup and how to manufacture it. This public disclosure prevents researchers from duplicating efforts and accelerates follow-on scientific discoveries. The premium revenues gained during the period of patent protection are claimed to be important to be reinvested into discovering the next generation of life-saving medications. Patents serve as tangible assets that allow smaller research labs to license their discoveries to larger pharmaceutical corporations with the resources to run large-scale global clinical trials.