How to extend drug patent [You Asked]



Last updated : Aug 27, 2022
Written by : Sage Crankshaw
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How to extend drug patent

Can a patent term be extended?

What is the maximum amount of time that the patent can be extended? A maximum of 5 years can be restored to the patent. In all cases, the total patent life for the product with the patent extension cannot exceed 14 years from the product's approval date, or in other words, 14 years of potential marketing time.

How long do drug patents last?

Patent terms are set by statute. Currently, the term of a new patent is 20 years from the date on which the application for the patent was filed in the United States.

What happens when drug patent expires?

When a drug's U.S. patent expires, manufacturers other than the initial developer may take advantage of an abbreviated approval process to introduce lower-priced generic versions. In most uses, generics are clinically equivalent to the original branded drug.

Why do drug patents expire?

Generic Drugs and Patent Expiration Because the drug patent lasts only 20 years, brand-name drug producers move quickly to profit on their product. After approval from the FDA, this time frame is typically between 7 and 12 years. Once the patent expires, the generic companies come into the picture.

Who can apply for patent term extension?

To apply for PTE, the owner of the patent or its agent (“the applicant”), has to submit an application under 35 U.S.C. § 156 to the United States Patent and Trademark Office (“USPTO”) within the sixty-day period beginning on the same date the product received permission for commercial marketing or use from the FDA.

What happens after 20 years of a patent?

Why can't patents be renewed once they've lived out their 20 years? A patent becomes public domain (free for use by the public) upon its expiration, which is defined as 20 years from the patent's earliest non-provisional filing date. MPEP §201.04. The 20-year patent term applies to utility and plant patents.

Can you renew a patent?

Can patents be renewed? U.S. patents issue for fixed terms and generally cannot be renewed. A U.S. utility patent has a term of 20 years from its earliest effective, non-provisional U.S. filing date.

Can you patent a new use for an existing drug?

But while a new use for an old invention does not make the old invention patentable, the new use itself might be patentable. In fact, new-use patents comprise a significant part of the patent landscape—particularly in pharmaceuticals, when drug companies obtain new-use patents to repurpose old drugs.

How long until a drug becomes generic?

Generic drugs do not need to contain the same inactive ingredients as the brand name product. However, a generic drug can only be marketed after the brand name drug's patent has expired, which may take up to 20 years after the patent holder's drug is first filed with the U.S. Food and Drug Administration (FDA).

What is the difference between patent and exclusivity?

Patents are granted by the patent and trademark office anywhere along the development lifeline of a drug and can encompass a wide range of claims. Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not.

What is the best pharmaceutical patent you can get?

An active ingredient patent, or active pharmaceutical ingredient patent (API), is probably the strongest means of protecting a newly invented drug, as active ingredient patents cover the structural formula of the drug.

Are all new patented drugs profitable?

Drugs are granted 20 years of patent protection, although companies often do not get a product to market before as much as half of that period has already elapsed. Once a drug enters the market, however, patent protection can result in high profits, with gross profit margins exceeding 90%.

What is a patent term extension application?

The application is submitted by the owner of record or its agent. The product has been subject to a regulatory review period before its commercial marketing or use. No other patent has been extended for the same regulatory review period (i.e., only one patent can be extended per approved product)

What is Pte Pharma?

Patent term extension (PTE) is a statutorily-based mechanism to compensate inventors for patent term loss due to regulatory delay during the drug approval process at the United States Food and Drug Administration (FDA).

Why are some drugs patents extended past the original 17 year period?

They have potential for abuse. Why are some drug patents extended past the original 17 year period? According to the Hatch-Waxman Act of 1984, up to five years extension can be added to a patent to make up for time lost while products went through the FDA approval process.

Whats the longest a patent can last?

A U.S. utility patent, explained above, is generally granted for 20 years from the date the patent application is filed; however, periodic fees are required to maintain the enforceability of the patent.

Can I buy an expired patent?

You can buy an expired patent by performing a patent search through the USPTO website (more on this later) and checking to see if the patent has expired. Once you find a patent that has expired and you want to buy, you can go ahead and contact the patent owner to negotiate purchasing the patent.

Is there a lifetime patent?

Patents do not last forever. They protect certain claims contained within the patent for a limited period of time.

Can a patent be renewed after 20 years expire?

No, you cannot renew a patent for an additional 20-year term. Utility patents have a 20-year term and design patents have a 15-year term. Patents rights are discharged discharged into the public domain when they expire. Under some circumstances, the patent term may be extended.

Can I extend my provisional patent?

A provisional application for patent has a pendency lasting 12 months from the date the provisional application is filed. The 12-month pendency period cannot be extended.


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How to extend drug patent


Comment by Hong Midden

well drugs are supposed to make patients feel better but a new scandal is living a rather bitter taste drug manufacturers are allegedly using loopholes to extend their patents that could mean high costs for patients and taxpayers we're now joined by mcdonald niketan the chief director at the Department of Trade industry we understand that the djia one that issues patents in South Africa good morning and thank you very much MacDonald for joining us now these companies are allegedly changing drugs slightly so that they can renew their patents and this helps them to keep their high prices is this problem widespread we are morning to the US and it to yourself thanks but generally you'll find that this will be a system called substantive examination which means that the scientists in the area of pharmaceutical should be vigilant to see to it that the system is very straight and then in a country like South Africa you find that we use what we call depository system in other words these are the so-called week patents inverted commas and therefore we do not have a rigorous system that the scientists subject them to and therefore a pharmaceutical company may be justified to take some chances oh now you seein it is who's responsible we're changing the system it is the DTI on behalf of the government and then as for now we have a draft policy that is before cabinet and then in the cabinet cycle and all those issues are subject of discussion and then the cabinet will release the draft for public consultation public comment and then pharmaceutical comp Chinese and those who are very serious about access to medicines all of them would have to debate and that finally cabinet will have to take a decision for or against now now McDonald shouldn't the DTI try to fast-track this draft policy process so that the law can change to enable the DTI to implement a more rigorous system because until then we as patients yourself and everybody else might be paying much more than we should be for our medication instead for instance of benefiting from generic ones yes you are right this government is very serious on that note it is the first one who have released a to targeted a targeted stakeholders this draft policy may be for a period of three years a consulting now we have sort of a well formatted a draft policy and then as I told you it is before cabinet and it will I try to release it to the public so we are fast-tracking it but mind you we are not only dealing with patrons we are also dealing with other domains of intellectual property like copyright we also have to talk about access to nailing materia for their people who have a difficulties in laning and trademarks and the desire but but let's focus just focusing on the patients around the suit achill products for the moment are you talking to the health department about the drugs that need to be focused on in the interim to ensure that these loopholes that currently exist in the system are not abused by the pharmaceutical industry yes correct we are talking to the Department of Health and then as an example in two thousand and six seven we we were engaging with each other to an extent that we even pass the patents act a cappella mph as the Pitons act of 2006 to see to it that we should allow a patron inventas or pharmaceutical companies generic companies to do what we call studies or boiler provisions to such an extent that they shall be allowed to make a research on a alive patent or a patent that has not yet expired and then in so much that when it expires already they should have a product that was trying to speedy the issue of access to a generics and access to drugs okay thank you very much we're going to have to leave you there that's the Department of Trade and Industry chief director make Donald Nash's tender on the line to us from our studios in Pretoria yes that moves anca calm


Thanks for your comment Hong Midden, have a nice day.
- Sage Crankshaw, Staff Member


Comment by geitaR

Thanks for this interesting article


Thanks geitaR your participation is very much appreciated
- Sage Crankshaw


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