1. FDA Patent Search
2. Patent and Market Exclusivity
3. International Markets Compulsory Licenses
4. Paragraph IV Patent Certifications
5. Suitability Petitions

One of the main services of the FDA is to provide patents to drug developers. However, recent changes have altered the rules regarding Abbreviated New Drug Applications. This can affect any prospective patents that have yet to be filed, making it easier for generic drug manufacturers to compete with brand name developers. Find out what's necessary for an FDA patent search.

Since Oct. 6, 2016, new regulations have been in place that change the rules about ANDAs and 505(b)(2) new drug applications. Some of these new regulations require some additional filings if you're looking to get a patent. This could potentially change the outcome of applications for generic drug treatments. These applications were created to allow drug manufacturers to enter the market faster with fewer costs. 

New laws make it even easier for companies to get their drugs on the market now. ANDAs no longer need clinical trial data if they can demonstrate that the drug produces the same effect as an already approved drug, and the 505(b)(2) petitioners can use trial data from sources other than themselves. The new regulations also specify the Orange Book as the authoritative source for all FDA patents. With these rules in place, applying for an FDA patent is significantly easier. Defending a patent is easier as well, as ANDA and 505(b)(2) petitioners have greater means to challenge NDA applicants over patent disputes.

Patent and Market Exclusivity

While they sound like they should be the same thing, patent and market exclusivity are distinct concepts as defined by the FDA. A patent can be issued at any time during the development of a drug and includes a variety of different claims regarding effects. Exclusivity, on the other hand, deals with exclusive marketing rights as determined by the FDA, whether a drug is patented or not. Exclusivity was implemented by the FDA as a concept to provide a balance between creating new drugs and creating generics for competition. 

Exclusivity is granted upon approval by the FDA. Patents, in contrast, can be granted at any time during a drug's development cycle. You'll find numerous drugs with various patent and exclusivity statuses; some having both and others having neither. Patents and exclusivity don't even have to have the same claims. However, you can be sure that if a drug appears in the Orange Book and is officially listed, there's a patent for it.

International Markets Compulsory Licenses

Compulsory licenses are used to allow certain drugs to hit the market before normal exclusivity terms would allow them to. This is a great way to keep drug prices down and is a normal practice in places like India and Brazil. The pharmaceutical lobby in the United States disagrees with the use of compulsory licenses except in rare cases of public need. However, organizations like Doctors Without Borders strongly support compulsory licenses because they keep drugs more affordable. 

Paragraph IV Patent Certifications

There are some instances in which production of a generic drug can be introduced before the patent of the brand name drug expires. All one has to do is successfully argue that the brand name drug's patent is invalid or won't be compromised by the generic drug. If a generic drug manufacturer comes forward with a Paragraph IV patent certification, and the brand product filed an infringement suit, the generic drug is always postponed from the market for 30 months or until the patent expires.

The FDA wants FDA patent search to be convenient, so it keeps a list of drugs that have received a paragraph IV patent certification. While this list doesn't publicly display the name of the applicant, it does contain information about the application date, the drug product, the dosage form, and more.

Suitability Petitions

Suitability petitions are a way for generic drugs to reach the market based on certain criteria. They must differ from a registered listed drug in the following ways.

  • Route of administration
  • Dosage
  • Strength
  • Different active ingredient

A suitability petition must first be approved before it can be included in an ANDA. Suitability petitions in progress can be viewed through the FDA's website.

If you need help with your FDA patent search, you can post your legal needs on UpCounsel's marketplace. UpCounsel accepts only the top 5 percent of lawyers to its site. Lawyers on UpCounsel come from law schools such as Harvard Law and Yale Law and average 14 years of legal experience, including work with or on behalf of companies like Google, Menlo Ventures, and Airbnb.