What Are Composition of Matter Patents in Drug Development?

In the competitive world of pharmaceuticals, protecting innovative drug discoveries is not just a priority—it’s a necessity.This article explores composition of matter patents, a cornerstone of intellectual property protection in drug development, and their role in safeguarding pharmaceutical innovations.

Composition of matter patents, also known as primary patents, are a key form of intellectual property (IP) protection in the pharmaceutical industry, and they provide the strongest patent protection for new drugs. These patents specifically cover the chemical composition of a drug that contains a pharmaceutically active ingredient that has not been previously disclosed or patented. These are important because they stop their competition from developing the same compound during the period of this patent. This is similar to innovation in any other industry where the idea needs to be patented to avoid competition from copying it.

In essence, it’s a type of patent that protects new chemical compounds, mixtures, or compositions for things like medicines and more. When considering applying for the Composition of Matter patents, it’s important to answer a few questions. Is the invention new and does it have an exclusive active ingredient? Have you done the market research to know if there is a medical need for this invention? Are you able to fully lay out the composition of the medicine/innovation for the patent? Is there a market potential for this? Do you have all the necessary resources (cash, scientific experts, lawyers, investors, etc.) for this project?

Here’s a deeper look at what these patents are and why they are so crucial in protecting drug innovations:

Important Features of Composition of Matter Patents:

A composition of matter patent protect new, pharmaceutically active chemical compounds that have not been patented or described in scientific literature before. These patents are also called “primary” patents because they cover the fundamental chemical composition of the drug.

This type of patent offers the best protection for a drug because it covers the chemical structure of the active compound. Regardless of how the compound is made, formulated, or used (whether in different dosages, forms, or methods), the composition of matter patent ensures the drug’s exclusivity in the market. As long as the chemical composition remains unchanged, the patent holder is protected from competitors. These patents typically last for 20 years, and they can be extended using secondary patents.

Composition of matter patents typically includes broad structural claims that protect the overall chemical family or structure of the compound. They may also contain narrower claims for specific compounds within the broader chemical structure. These claims are designed to cover variations of the drug while preventing others from developing similar compounds or drugs with similar effects. It’s extremely important to be detailed and fully cover every aspect of the compounds for best protection from competition.

Examples of Composition of Matter Patents:

Astrazeneca’s composition of matter patent BR-9814118-A: The present invention relates to a process for sterilizing a powder form of a glucocorticosteroid, sterile glucocorticosteroids, sterile formulations containing the glucocorticosteroids and their use in the treatment of an allergic and/or inflammatory condition of the nose or lungs.
You can also check out this link for other Aztrazenca’s patent family.

In addition to the primary claims on the chemical composition itself, composition of matter patents often include secondary claims that cover other aspects of the drug. These might include:
- Formulation: How the drug is prepared or formulated (e.g., tablet, liquid, injectable).
- Method of Use: The specific way the drug is intended to be used, such as for treating a particular condition or disease.
These secondary claims provide additional layers of protection, ensuring that competitors cannot replicate the drug’s formulation or its specific application without infringing on the patent. When considering primary and secondary claims, it’s important to be as narrow or specific as possible to protect every aspect of the product as possible.

Importance in Drug Development:

What happens when a company invests billions in a breakthrough drug, only to see competitors replicate it? This is where composition of matter patents come into play. The composition of matter patents are critical in the early stages of drug development, as they offer a legal barrier against competitors who might try to create a similar drug or compound. They help pharmaceutical companies secure their position in the market, maximize return on investment, and fund future research and development.

To Conclude:

The composition of matter patents represents a powerful and comprehensive form of protection for new drugs with new active ingredients. By securing exclusive rights to the chemical composition of a drug, these patents prevent others from manufacturing or selling similar drugs without permission. As a result, they are essential for protecting a company’s investment in drug development and maintaining market exclusivity.