Medical Procedures & Pharma Patents In The US

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An invention that is novel, useful, and non-obvious is eligible for a patent in the United States. The United States Patent & Trademark Office (USPTO) categorizes patents into utility, plant, and design patents based on their subject matter. But can you patent a medical procedure? Yes. Pharma or medical patents fall under the category of utility patents. Considering their health impact on the public, pharma patents receive two protections- one from the Food & Drug Administration and another from the USPTO. Here we explore the pharma patents in correlation with the USPTO patent grant. 

Table of Contents

Types of Medical Patents  

The USPTO lists the following categories as eligible for patents in the medical domain:  

  1. Medical Devices: Physical devices and diagnostic tools are patentable in the US. Examples are surgical tools, stents, pacemakers, etc.  
  2. Pharmaceutical Drugs & Chemical Products: Chemical compounds and substances that will help in the formulation of medicines to treat medical conditions fall under this category.  
  3. Health Care IT: Methods and systems that streamline storage and access to the medical histories of patients can be patented.  
  4. Surgical Methods: Novel techniques in performing surgeries are eligible for patenting. The US is among the few countries that allow medical procedures and treatments to be patented.  
  5. Regenerative Medicines: Stem cell and tissue transplant technologies fall in this category.  

USPTO Requirements For Method Of Treatment Claims 

Besides the basic criteria of novelty and non-obviousness, the method of treatment claims should have subject matter eligibility and a written description and enablement. The written description refers to the precise physical steps that must be mentioned. Listing only diagnostic methods of observation will make your application invalid.  
Alongside the steps, the document must also explain the effectiveness of the treatment. In order to do so, sufficient testing needs to be conducted to support the invention so you can patent a medical procedure. 

Patenting New Use of Known Drugs 

If you have discovered a new and non-obvious way of using an existing drug, aside from its intended usage, it qualifies for a patent under the USPTO guidelines. You are required to attach method and not composition claims with such patents.  
Drug repurposing, as it is called has immense potential but the difficulty in patenting, as well as subsequent hardships of challenging infringement, have made them less viable for investment.  

Patenting New Use Of Known Devices

If the criteria of non-obviousness is proven and fulfilled, then a patent may be granted for the new use of a known device. But such cases are rare as proving that the new use of the device would not be obvious to someone in the field is cumbersome.  

Conclusion

The colossal amount of time and investments spent on medical inventions requires putting a sound patent strategy in place right from inception. The patent process is mostly similar to other patents barring a few additional requirements listed by the USPTO. An experienced firm will help you navigate the legal and administrative waters when it comes to medical and pharma patents.  

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