At the time of fling an ANDA application (Generic drug application), an applicant must provide, information related to any patents listed for the reference listed drug (RLD) in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations which is commonly called as the Orange Book.
In its ANDA application, a generic applicant must submit to FDA one out of four certifications specified in Act regarding the patents for the RLD.
These certifications are:
A Paragraph 1 certification states that there are no patents listed.
In this case FDA may approve the ANDA application immediately. One or more applicant may enter.
In the ANDA application for Paragraph-I certification applicant must certify that such patent information has not been submitted by the new drug application (NDA) holder (Innovator) for listing in the Orange Book.
Paragraph 2 certification states that the listed patents have expired.
In this case also, FDA may approve the ANDA application immediately. One or more applicant may enter in the market.
In the ANDA application for Paragraph-II certification, applicant’s patent certification must state that such patent has expired.
In Paragraph III certification the listed patents is not expired and will be expired on a specific date.
In this case, FDA may approve the ANDA application which is effective on the date of expiration of the patent. One or more applicant may enter.
In the ANDA application for Paragraph-III certification, applicant’s patent certification must state the date on which such patent will expire.
In paragraph IV certification generic product applicant does not infringe on the listed patents or that those patents are not enforceable.
In this case, Generic applicant (ANDA) provides notice to innovator/patent holder. Entry of first to file may or may not occur.
From where these Paragraph certifications comes?
In 1984, US Congress passed The Drug Price Competition and Patent Term Restoration Act which is commonly known as the “Hatch-waxman Act.”
As per the rule of this Hatch-waxman Act, Innovator (Branded drug companies) are required to list patents which includes composition (substance), formulation, and method of use in FDA’s Orange Book ( Approved Drug Products with Therapeutic Equivalence Evaluations).
However generic company (ANDA applicant) files an Abbreviated New Drug Application (ANDA) and certifies against any one out of four types of patents certification (discussed above) listed in the Orange Book.
How this Act named as Hatch-waxman Act.?
The official name of this Act is “The Drug Price Competition and Patent Term Restoration”. In 1984 this Act was sponsored by Orrin Grant Hatch an American attorney and politician serving as the senior United States Senator for Utah and represented by Henry Arnold waxman an American politician who served as the U.S. Representative for California’s that time, since then this Act was informally known as Hatch-waxman Act.
Why This Hatch waxman Act was required?
In the early 1980s US congress observed that very few generics were coming to market after expiration of the patent.
After studied the issue, US congress found that generic drug companies were facing difficulties that time for marketing generic versions (ANDA) of innovator products after the expiry of the patent(s) due to irregular and uncertain regulatory pathway for filing the ANDA.
It was also observed that there are some Regulatory delays too in marketing of drug products faced by innovator (branded) drug companies.
The Act provides protection to drug innovators on the other hand this act also encourages generic drug companies by facilitating and providing incentives for companies to file ANDAs.
How this Hatch-waxman Act helps both Innovators as well as generic drug companies?
First start how this Act helps innovators:
Drug innovators were provided protections in following ways:
First, this Act has introduces with a new kind of market exclusivity, under this clause, new five-year period of data exclusivity awarded when the FDA approves marketing of a drug that is a new chemical entity, during that period the FDA cannot approve a generic version of the drug. Second, this act has made provision for the extension of the term of the existing patent for innovator drugs if innovator discovers new indication or new dosage form of the patented drug.
Third, the Act also has the provision to allow the life of patents covering a drug to be extended by duration of the time the drug is under regulatory review by the FDA, ensuring innovator companies that regulatory review will not unduly put away patent life.
Under this Act the drug innovator requires to provide the FDA details about the numbers of patents innovator believes cover its drug. FDA publicly lists those patents in the Orange Book without evaluating whether the patents cover the drug or not and also states that in case of regulatory delay in approval the life these listed patents gets extended.
Now let me explain you that how this Act helps generic drug companies:
First this Act has made provisions for the marketing of generic versions of patented drugs on the day after patent expiry. In this case a generic applicant only requires to scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovators drug) and need not to provide the preclinical (animal) and clinical (human) data to establish safety and effectiveness. This application is called ANDA.
Second, this Act provides opportunities to challenge the validity of patents issued to innovator drug companies by generic companies. This is called ANDA with a Paragraph IV certification and if ANDA gets approved generic applicant gets 180 days Exclusivity.