What is Patentable in Pharma?
In the pharmaceutical industry, a patent grants the patent holder exclusive rights to prevent others from making, using, or selling an invention for a specified period, typically 20 years. To be
patentable, an invention must be novel, non-obvious, and useful. In pharma, this generally includes new drugs, methods of manufacturing, formulations, and new uses for existing drugs.
What Constitutes a Novel Drug?
A
novel drug is one that has not been previously disclosed or used publicly. It should not only be unique in its chemical structure but also represent a
significant advancement over existing therapies. Novelty is judged against prior art, which includes any publicly available information before the date of the patent application.
How is Non-Obviousness Determined?
Non-obviousness is a critical criterion for patentability in pharma. An invention is considered non-obvious if someone with ordinary skill in the field would not find it an apparent extension of existing knowledge. For instance, altering the
formulation of a known compound to improve its stability or reduce side effects could be seen as non-obvious if it requires inventive ingenuity.
Can Methods of Manufacturing Be Patented?
Yes, methods of manufacturing are often patentable. This can include innovative processes that make production more efficient, environmentally friendly, or cost-effective. For example, a unique
synthesis method for an active pharmaceutical ingredient (API) that improves yield or purity could be patented. These patents can be as valuable as patents on the drugs themselves.
Are New Uses for Existing Drugs Patentable?
New uses for existing drugs, sometimes referred to as
drug repurposing, can be patentable. This involves discovering a previously unrecognized therapeutic benefit of a known compound. For instance, if a drug initially approved for hypertension is found to be effective in treating a different condition like migraines, the new use can be patented, provided it meets the criteria of novelty, non-obviousness, and utility.
What are Formulation Patents?
Formulation patents protect the specific combination and
composition of ingredients in a pharmaceutical product. This can include the ratio of active to inactive ingredients, the method of delivery, or the stabilization of the active ingredient. These patents are crucial as they can extend the market exclusivity of a drug beyond the original compound patent.
What Challenges Exist in Patentability?
One of the significant challenges in patentability in pharma is the increasingly stringent examination of what constitutes non-obviousness. Additionally, the rise of
generic competition and the scrutiny over
evergreening practices—where companies make minor changes to extend patent life—pose challenges. Regulatory hurdles and the need for substantial evidence to support claims of novelty and utility also add layers of complexity.
How Do Patents Impact the Pharmaceutical Industry?
Patents play a crucial role in the pharmaceutical industry by encouraging
innovation and investment in R&D. They provide a financial incentive for companies to invest in the costly and time-consuming process of drug development by offering a period of market exclusivity. However, they can also lead to high drug prices and limited access, prompting debates over the balance between rewarding innovation and ensuring public health.
Conclusion
Understanding what is patentable in pharma is essential for navigating the complex landscape of drug development and commercialization. Patents protect various aspects of pharmaceutical inventions, from novel drugs to manufacturing methods and new uses for existing drugs. Despite the challenges in obtaining and defending patents, they remain a cornerstone of the industry's innovation-driven model.
