Orange Book listed patents are those patents that the U.S. Food and Drug Administration (FDA) has approved and deemed both safe and effective for the general public's use.

Orange Book Listed Patents

The Orange Book provides information on patents for drugs that the FDA has approved for public use, which makes it much easier for generic drug companies to identify whether or not the drug they wish to manufacture is already patented and FDA-approved. However, not all FDA-approved patented drugs are listed in the Orange Book, and that could be for two reasons:

  • The patent is a process patent and not a patent on the actual medication.
  • The patent holder failed to ask the FDA to include it in the Orange Book.

More specifically, pharmaceutical patents are only permitted if they are ‘"composition" or ‘"method of use" patents. This means that the patent must cover the actual drug compound, formulations of the drug, or the method of treating a certain disease by administering the drug. However, process patents, which identify the method for making the drug compound, are not permitted.

Submission of Patent Information to the Orange Book

As of November 21, 2017, the Orange Book drug listing and search results will provide patent submission dates when available. This is in compliance with the final FDA rule that was part of the 2003 Medicare Modernization Act.

By knowing the date the patent was submitted, you will have clarification on whether or not the patent will trigger a 30-month patent litigation stay. Previously, if you had wanted to know the date of submission, you would have had to contact the Orange Book staff. This often caused problems for generic companies when they tried to determine if a patent was late-listed, relisted, or properly listed.

It is important to note that the new information only goes back to 2013, when the FDA first began the collecting of patent information. If you do not find a listed patent, you may still need to contact the office to locate older ones.

Benefits of the Orange Book

  • The Orange Book makes it easier for drug makers to monitor for new generic drugs that come on the market and infringe on their own patents. Therefore, such businesses holding patents on FDA-approved drugs will very easily know if new generic versions are being manufactured and sold.
  • If a drug maker finds the new generic version in the Orange Book, it can notify the new creator of possible infringement and can subsequently file a patent infringement suit (without having to see the generic drug that was created).
  • Filing a lawsuit will generate an automatic 30-month hold, meaning that the new generic drug maker cannot sell its drug.
  • The Orange Book is available for anyone to view online, for free.
  • Consumers can view the drug's expiration date and any other pertinent details regarding a specific drug.
  • The Orange Book also displays the dates on which drugs were submitted for patent protection and the dates on which patents became effective. Note that this information is only available for those drugs for which patents were obtained on or after 2013. For any drugs patented before 2013, the interested party must reach out to the FDA for exact dates of patent submissions.
  • The patent submission date also helps generic drug makers know whether or not they can, in fact, create and sell their generic version of that drug and whether or not 30 months have passed since the drug patent became effective.

Requirements for Submitting Reissued Patents

When an original patent is relisted, the new drug applicant (i.e., the generic drug maker) must include information on whether or not a patent submitted for relisting is a reissuance of a patent that was previously submitted for listing. The submission would still be subject to the 30-day time period for timely filing of patent information.

The original patent and the reissued patent would then be treated as one for the purpose of certification requirements. Further, the 30-month holding period, as well as the 180-day exclusivity period, would be counted from the latest day of such reissuance.

Certifications to a Reissued Patent

In the case where a 505(b)(2) or ANDA applicant does not provide a patent certification or statement of the original patent due to untimely filing, it could be considered late-listed. If this occurs, the applicant will be required to provide a patent statement or certification for a reissued patent even if it was filed in a timely manner and does not differ from the patent. Instances where this may occur include:

  • If an applicant submits a paragraph IV certification to an original patent and the patent suit came about within about 45 days of the notice of the certification, the 30-month stay would not be affected.
  • If an applicant submits a section viii statement or a paragraph III certification and submitted a paragraph IV certification, a 30-month stay would be allowed.
  • If an applicant submits a paragraph IV certification to an original patent and no patent suit was initiated within the 45 days that the paragraph IV certification was filed, a 30-month stay could occur.

180-Day Exclusivity for Reissued Patents

There are also instances where there may be a 180-day exclusivity period in the case of an amended patent certification to reissuance of an original patent where paragraph IV certification was submitted. Examples include:

  • If there are multiple applicants for eligibility for 180-day exclusivity, the first one who applied will need to submit a paragraph IV certification to the reissued patent within 30 days of its being listed.
  • If no applicant had submitted a paragraph IV certification on the original patent but then filed their paragraph IV certification after the patent was reissued, 180-day exclusivity could result.

When a listed patent is challenged by an applicant in a supplement or amendment to an ANDA or 505(b)(2) application, a paragraph IV certification must be provided regardless of:

  • The applicant already giving notice to another paragraph IV certification
  • A patent infringement case being started in response to a notice

Clarification of 20-Day Period

With the proposed FDA rules, there would be clarification for the time frame in which a notice of a paragraph IV certification to a patent can be provided to an NDA holder as well as each patent owner.

  • The new rules clarify the practice that a notice sent before an FDA acknowledgment letter or paragraph IV acknowledgment letter is invalid.
  • According to the rules, when a patent is issued after the NDA approval is received, any notice that has been sent before the first working day after the patent was published in the Orange Book would be invalid.
  • The new rules provide specifics about the calculation of the 20-day period for delivering notices. The first day of the 20-day period will commence the day after the date of the postmark on the paragraph IV acknowledgment letter. All weekdays are to be included except for federal holidays. If the deadline is not met, the FDA will move the date of submission by the number of days past the time frame the applicant took to submit.

Certification for a Patent That Was Reissued to the Original Drug Maker

In this instance, you are a generic drug maker who received a certification or applied for a new drug after you noticed that the original drug maker was in fact listed in the Orange Book. If you were required to obtain a certification or statement to the original patent of the original drug maker, then you will be required to obtain a new certification or statement for any reissued patents for that particular drug. However, if you weren't required to submit such a certification after you initially applied for the new drug, then you won't need to do so for any reissuances.

Medicare Modernization Act of 2003

In 2015, the FDA issued regulations that had long been awaited to implement the Medicare Modernization Act of 2003. The proposed rules list multiple provisions for:

  • Submitting patent by NDA holders
  • Patent certifications by ANDA and 505(b)(2) applicants
  • Notices for paragraph IV certifications
  • The particulars of 30-month litigation
  • Other supplements to ANDA and 505(b)(2) applications

If you need help with reviewing Orange Book listed patents or you are unsure whether or not you can apply for a new generic drug based on what you find in the Orange Book, you can post your legal need 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, Stripe, and Twilio.