Formulation Patents—New Formulation of Known Compound
New Formulation of Existing Compound Patentable
Often, new chemical compositions are made from known chemical compounds. For example, a known compound may be reformulated with other substances to create a new composition of matter. Provided that the resulting composition is both new and not obvious, it can be patented.
Making a new formulation by reformulating a old drug product occurs frequently in the pharmaceutical industry. For example, the drug amphetamine has been known since 1887. However, since that time, that single compound has been marketed and sold as part of many different drug formations, including the following: Benzedrine; Psychedrine; Adderall; Dexedrine; Dextroamphet; Dextrostat; and ProCentra. Many of these products received patent protection. In each case, amphetamine (a known drug) was mixed with other substances to create a new amphetamine formulation.
A New Formulation is a New Composition of Matter
Reformulating an old drug into a new formulation creates a new composition of matter, provided that the new formulation is different from any previously disclosed mixture of substances. A new composition of matter can be patented. That patent would cover the new formulation but neither (a) previously existing formulations nor (b) the original drug.
The idea of patenting a new formulation of an existing compound can be illustrated through the evolution of amphetamine formulations.
- In 1887 the Romanian chemist Lazăr Edeleanu first synthesized the molecule amphetamine. At that time this molecule was new. Mr. Edeleanu could have patented the compound amphetamine. He would have been entitled to exclude others from making, using, or selling any formulations of amphetamine. This should make sense because he was the first to create the molecule.
- After Mr. Edeleanu first made amphetamine, subsequent inventors made amphetamine pills. Those pills included amphetamine, mixed with other substances. The compound (amphetamine) was the same; but the formulation (the mixture) was different. From the standpoint of patent law, each different mixture would be considered a new composition.
- Nearly 100 years later, amphetamine became extremely popular as a treatment for Attention Deficit Hyperactivity Disorder. Drug companies rushed to mix amphetamine into new formulations having new properties. For example, the drug Adderall provides a mixture of different amphetamine salts, which give the formulation different properties.
- Several new formulations (same compound, amphetamine) have since been patented.
Mixing the same old active ingredient into a new mixture creates a patentable new formulation.