Regulatory Open Forum

What happens if a drug's patent expires before it can hit the market?

In general the patent is valid for 20 years. For whatever reason the drug (assuming it's effective) was not brought to the market, do other companies get to develop it? How does it work?

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Lisa Chang
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Lisa,

"What happens if a drug's patent expires before it can hit the market?"

It should be analyzed in detail based on actual circumstances in real world (e.g., including, but not limited to, patent term extension during FDA review, if applicable)

To respond to your hypothetical questions, basically once the patent expired, you lose the rights to enforce your patent claims. Thus, it is free for others to use!

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Dr. David Lim, Ph.D., RAC, ASQ-CQA
President and Principal | REGULATORY DOCTOR
http://www.RegulatoryDoctor.US
http://www.GlobalComplianceSeminar.com
Phone (Toll-Free): 1-(800) 321-8567
E-mail: David@RegulatoryDoctor.US

Original Message:
Sent: 03-03-2016 21:12
From: Yuchun Chang
Subject: Patent Expiration

What happens if a drug's patent expires before it can hit the market?

In general the patent is valid for 20 years. For whatever reason the drug (assuming it's effective) was not brought to the market, do other companies get to develop it? How does it work?

------------------------------
Lisa Chang
------------------------------

Assuming you are interested in the US market and you move forward with approval, you would be able to garner 5 years of Waxman-Hatch marketing/data exclusivity, provided your application were based primarily on data you owned or produced.  That would block others from generic entry for 5 years and in 4 of those FDA could not accept an generic 505(j) application.  However, someone else could get to market by also producing a full 505(b)(1) application since there would be no patent barrier.

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Robert Meyer
Director, Virginia Center for Translational and Regulatory Sciences
University of Virginia, School of Medicine
Charlottesville VA
United States

Original Message:
Sent: 03-03-2016 21:12
From: Yuchun Chang
Subject: Patent Expiration

What happens if a drug's patent expires before it can hit the market?

In general the patent is valid for 20 years. For whatever reason the drug (assuming it's effective) was not brought to the market, do other companies get to develop it? How does it work?

------------------------------
Lisa Chang
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Thank you David and Robert!

It was just sort of an "oh what if?" question. I guess even if a separate company starts to develop it, they would need to do a lot of work in order to catch up.

Best,

Lisa

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Lisa Chang

Original Message:
Sent: 03-04-2016 09:10
From: Robert Meyer
Subject: Patent Expiration

Assuming you are interested in the US market and you move forward with approval, you would be able to garner 5 years of Waxman-Hatch marketing/data exclusivity, provided your application were based primarily on data you owned or produced.  That would block others from generic entry for 5 years and in 4 of those FDA could not accept an generic 505(j) application.  However, someone else could get to market by also producing a full 505(b)(1) application since there would be no patent barrier.

------------------------------
Robert Meyer
Director, Virginia Center for Translational and Regulatory Sciences
University of Virginia, School of Medicine
Charlottesville VA
United States

Original Message------

Thank you David and Robert!

It was just sort of an "oh what if?" question. I guess even if a separate company starts to develop it, they would need to do a lot of work in order to catch up.

Best,

Lisa

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Lisa Chang
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Hi David,

Thank you for providing the example. I had read more about the case and realized that one of the assumptions that I had was each drug (or biologic) would have a single patent for its structure/function that could bar others from manufacturing the same product. But as seen in the example you provided, that is not the case. Manufacturer A has a rather "generalized" patent and won the case. That's why even though the two drugs are not identical, A was successful in the patent court. Do manufacture B&C not have patent on the drug themselves to prove that the two drugs are different?

David, I hope my understanding of the case is correct and please correct me if I am wrong.

Thank you,

Lisa

Original Message:
Sent: 03-17-2016 12:26
From: David Lim
Subject: Patent Expiration

Lisa,

Your assumption is reasonable sometimes.  But some other times, one's assumption can be really challenging depending upon the type of drugs.

A manufacturer (called "A") received an FDA approval for an antibody under BLA on August 27, 2015. They brought a patent infringement suit in 2014 against two other manufacturers (called "B and C"), who market a rival drug. Both drugs have been approved by the FDA last summer. 

From a recent trial, A won over the patent infringement suit. The B and C now state they will appeal to the FCC of Appeals. 

Your assumption needs to be under check.  

Thank you.  

s/ David

______________________________________________
Dr. David Lim, Ph.D., RAC, ASQ-CQA 

REGULATORY DOCTOR and Compliance Seminars 

http://www.regulatorydoctor.US

Phone (Toll-Free): 1-(800) 321-8567

E-mail:  David@RegulatoryDoctor.US

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Original Message------

Hi David,

Thank you for providing the example. I had read more about the case and realized that one of the assumptions that I had was each drug (or biologic) would have a single patent for its structure/function that could bar others from manufacturing the same product. But as seen in the example you provided, that is not the case. Manufacturer A has a rather "generalized" patent and won the case. That's why even though the two drugs are not identical, A was successful in the patent court. Do manufacture B&C not have patent on the drug themselves to prove that the two drugs are different?

David, I hope my understanding of the case is correct and please correct me if I am wrong.

Thank you,

Lisa

Thank you, David. I appreciate the time you took to answer my questions, provide additional resources, and mostly importantly give me a different perspective on things that may seem easy/straightforward.

Original Message:
Sent: 03-21-2016 11:30
From: David Lim
Subject: Patent Expiration

Lisa,

"Do manufacture B&C not have patent on the drug themselves to prove that the two drugs are different?"

They (B/C) didn't have patents to cover an antibody for the same target but had agreements to co-develop the antibody.  The B/C then purchased a special FDA voucher (priority review) from another pharma firm, obtaining an FDA approval before the A.  

Your question was rather intriguing. In some circumstances, an unusual step can be taken as in this case.  You may read further here.  

Thank you.  

s/ David

______________________________________________
Dr. David Lim, Ph.D., RAC, ASQ-CQA 

REGULATORY DOCTOR and Compliance Seminars 

http://www.regulatorydoctor.US