common types of pharmaceutical patents

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One patent type is the composition of matter patent. A composition of matter patent lists the types of molecules that are being researched and expected to have promising biological activity. The number of molecules can be huge – even in the millions. The listed molecules form the “claims” of the patent, and the text of the patent must provide some indication of which molecules are likely better than others. This is a key part of the disclosure of the patent. Composition of matter patents are typically filed around the time of animal efficacy studies in preclinical research. At this stage, researchers will likely understand the value of the project, which will justify securing the protection of patent filing.
Why do composition of matter patents include so many potential molecules? The breadth of the patent claims gives a discovery team more freedom to operate or FTO. Why do you need freedom to operate? Recall that patent claims are written during preclinical research. Subsequent research may reveal previously unknown safety issues or other problems. These problems might require changes to the planned drug. Well written, broader claims can accommodate changes that might be necessary. Broader claims also help keep competitors at arms length by forcing them to be more creative if they want to use your patent disclosure to jumpstart their own research program. Note that, as more and more patents for small molecule drugs are filed, intellectual property space around some types of molecules is becoming very crowded. Obtaining freedom to operate in a drug project is sometimes a challenge.
Formulation patents protect innovations of drug formulation – perhaps a vital pill coating or ratios of ingredients within the formulation. There are dosing patents in cases that require a very particular dosing regimen to ensure safety and efficacy of the drug. You can even patent the synthetic method used to prepare the final drug or a key intermediate. The design or invention of a new formulation or dosing protocol will not be discovered until a compound advances into clinical trials, so these types of patents are generally filed well after a composition of matter patent.
All the patents for a drug program form something called a “patent wall”, which protects the invention from competitors. The patent wall does include patents but can also include other IP like trade secrets. Of all these protections, the composition of matter patent is typically the strongest protection though its protection often expires first as the composition of matter patent is often the first to be filed.