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Protecting New Drug Inventions

Jul 16 2020

Posted In:

20/20 Blog

Palo Alto, CA —“We are passionate about creating new molecular therapies and identifying existing drugs to repurpose for eye disease,” said Vinit Mahajan M.D., Ph.D. associate professor of ophthalmology at Stanford University and vice chair for research in the ophthalmology department. “We have a unique platform to identify important disease molecules and a pipeline to successfully execute challenging drug design projects.”

During a recent lab meeting, postdoctoral fellow Dylan Parsons Ph.D. answered common questions around drug patents.

What are patents? 

Patents are a form of intellectual property that grant inventors the rights to exclude others from making, using, or selling their invention for a set number of years in exchange for public disclosure of the invention. Academic researchers file patents with their university. Here at Stanford University, the first step is disclosing the invention to the office of technology licensing. Next a provisional patent application is typically filed. This establishes the date of the invention and provides a measure of protection for one year until the actual patent is filed. Provisional applications are much cheaper than the patent. In academia, we file provisional applications just before publicly disclosing the invention at a conference poster, lecture outside the university, or publishing a manuscript.

What is a license and what is an option?

A patent holder may license her product to another party, like a pharmaceutical company. In exchange for compensating the patent holder, a license holder may use, modify, and/or sell the patented product. Option agreements allow prospective license holders to briefly “hold” a product and assess its viability without committing to a licensing agreement.

How long do patents last? 

An approved patent lasts for 20 years, though patents can be extended. The Hatch-Waxman act allows for patent extension for up to five years to compensate the time a drug takes to gain FDA approval. A “new use” claim can add an initial three years to the patent of an already patented drug. This can be invoked when a company discovers a new use for a drug already developed for an alternate purpose. 

Why do we have patents and why do they expire?

Pharmaceutical companies invest large amounts of time and resources into developing drugs, most of which never make it to market. Pharmaceutical companies expect to capitalize on the few drugs they successfully develop. This is where patents come in. A patent allows a pharmaceutical company to be the sole profiter of their invention for a certain number of years, which allows them to recuperate the expenses they incur during research and development. On the other hand, drugs are not a commodity - they are often a necessity. Patient populations deserve the right to access a drug regardless of their economic status. To balance the interests of companies and patients, patents allow pharmaceutical companies to make money from their drugs for a certain number of years before they are no longer protected and become generic. Generic drugs are produced at a much lower cost and are usually more affordable. 

What are the most common types of patents? 

There are four main types of patents in the pharmaceutical industry: product patents which claims a new chemical entity by chemical name and structure, process patents which claim the chemical or other processes used to manufacture the drug, formulation patents which claim the dosage form for the pharmaceutical, and method of use patents which claim the use of a drug to treat a particular disease.

What is the difference between a new use claim and a method of use claim?

While both types of claim focus on a drug that is to be used for a new indication different than its original target there are key differences. A new use claim is simply an extension of a current patent and only grants three additional years while a method of use claim is an entirely new patent.

What is the most powerful type of patent?

Product patents give inventors the most control over a drug. They give sole rights to the manufacturing use and importation of the drug covered by the patent as well as any other compounds covered. 

What are the pros and cons of a product patent claim? 

Pros

·       Inventor has exclusive rights to the chemical structure of a drug

Cons

·       Have to be first to discover a drug, which typically requires large amounts of time and money

·       Inventing a new drug is risky because it is very difficult to get FDA approval

What are the pros and cons of a process patent claim? 

Pros

·       Inventor has rights to the way a drug is synthesized

·       Burden of proof falls on the potential infringer

·       No new FDA approval is required

Cons

·       A competing company only needs to develop a novel route to the active pharmaceutical ingredient to be able to synthesize and manufacture their own version of the drug

What are the pros and cons of a formulation patent claim?

Pros

·       One of the easiest ways to extend the overall patent lifetime of a drug 

·       Can cover a class of drugs/compounds, which is easier to develop than novel drugs for a target indication

·       Often used for developments of new methods of administration or novel dosage formulations

Cons

·       May require new FDA approval

·       Easiest type of patent for competitors to work around

What are the pros and cons of method of use patent claims? 

Pros

·       Gives sole right to use a drug in a way other than intended by its original patent

·       Synthesis and human testing have already been done

·       Most common patent for repurposed drugs

Cons

·       No rights to the compound chemical structure or way it's manufactured

·       Need to obtain FDA approval by showing efficacy against patented indication

For more information on Stanford University’s patent process, visit the Office of Technology Licensing.