Patenting a New Formulation
Claim a New Formulation as a Composition of Matter
A new formulation of an existing drug can be patented as a composition of matter. The new formulation must somehow differ from all existing formulations. Often, the new formulation will combine a known molecule with a combination of other ingredients to achieve more desirable properties. For example, a variety of drugs have been reformulated to provide “extra strength” and “extended release” versions.
One specific example of a reformulated drug is Adderall, which provides mixtures of different amphetamine salts. The new formulation provides amphetamine to the body at a more desirable rate. Although amphetamine is well over 100 years old, chemists continue to develop new ideas for providing this old drug in a new way. Making a new formulation is a cost-effective way to create a new drug product. Many pharmaceutical companies share the opinion that the best way to make a new drug is to start with an old drug.
Distinguish New Formulation Chemically
An inventor should claim a new formulation as a composition of matter any time the invention differs from the prior art based on chemical composition. If the new formulation can be distinguished based on using new ingredients or different combinations of known ingredients, then it is likely that the invention could be defined as a composition of matter. Here, it is essential to understand the underlying chemical features of the invention. Making chemical distinctions requires developing a comprehensive understanding of the invention at the molecular level.