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One type of patent is the patent on the composition of matter. A patent on the composition of matter lists the types of molecules under investigation and expected to have promising biological activity. The number of molecules can be enormous, even in the millions. The named molecules constitute the 'claims' of the patent, and the text of the patent should provide an indication of which molecules are likely to be better than others. This is an important part of patent disclosure. Composition patents are typically filed around the time animal efficacy studies are conducted in preclinical research. At this stage, researchers are likely to understand the value of the project, which will justify securing patent application protection.
Why do patents on the composition of matter include so many potential molecules? The breadth of patent claims gives a discovery team more freedom to operate or FTO. Why do you need freedom to operate? Remember that patent claims are written during preclinical research. Follow-up research may reveal previously unknown safety issues or other problems. These problems may require changes in the planned medication. Well-written, broader claims can enable changes that may be necessary. Broader claims also help keep competitors at bay by forcing them to be more creative if they want to use your patent disclosure to jump-start their own research program. Note that as more and more patents for small molecule drugs are filed, the intellectual property space around some types of molecules is becoming very crowded. Gaining the freedom to operate in a drug project is sometimes a challenge.
Formulation patents protect innovations in drug formulation – perhaps an essential pill coating or ratios of ingredients in the formulation. Dosage patents exist for cases where a very specific dosage regimen is required to ensure the safety and efficacy of the drug. You can even patent the synthetic method used to prepare the final drug or an important intermediate. The design or invention of a new formulation or dosing protocol will not be discovered until a compound enters clinical trials, so these types of patents are generally filed long after a composition of matter patent has been filed.
All patents for a drug program form something called a "patent wall," which protects the invention from competitors. Although the patent wall includes patents, it can also include other intellectual property rights, such as trade secrets. Of all these protections, the composition patent is generally the strongest protection, although its protection is often the first to expire as the composition patent is often filed first.

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