Drug patents and FDA approval are often discussed together, but they serve very different purposes. The distinction between the two is not always well understood, even amongst those in the industry. Understanding the difference is important, because a drug can be patented without being FDA approved, and FDA approval does not grant or protect a patent. Patents and FDA-granted exclusivity can also overlap, but they are distinct forms of protection. Read on to learn more about drug patents and FDA approval and how they differ.

Pharmaceutical Patents

Pharmaceutical patents are intellectual property rights granted by the U.S. Patent and Trademark Office (USPTO) to the inventor of a product or treatment. These are exclusive rights that exist for a specified period (typically 20 years) that allow the inventor to be the sole producer, preventing others from producing and selling the product or service. Patents are essential to protect the investment into the development of a pharmaceutical drug or treatment. Pharmaceutical patents encourage innovation while rewarding companies for their creativity and contributions to medicine.

A drug must meet a set of specific criteria to receive a patent. For instance, the USPTO must deem an invention new, useful, and non-obvious. Based on these requirements, various types of pharmaceutical patents exist.

Product patents are filed for physical products, such as drugs. The USPTO forbids identical copies of patented products, even if different manufacturing steps were used.

Process patents apply specifically to the manufacturing process, but not the final product. Since the product is not patented, two manufacturers could produce the same product using different processes.

Product-by-process patents protect both the product and the manufacturing process behind it. Companies use these when a comparator product distinguishes itself from the product solely by the manufacturing method.

Formulation patents are filed for drugs that are created with differing dosage forms. These patents cover drug additives and delivery methods. These patents often help to protect drugs past their initial patent.

Combination patents protect two or more active ingredients, prohibiting competitors from using the same combination of ingredients in their formulations.

Method-of-use patents focus on specific therapeutic applications of a drug. This patent prohibits other manufacturers from producing the same molecule for the same therapeutic use. These patents allow manufacturers to obtain multiple patents for a single molecule, based on clinically validated uses.

Patents are essential in protecting the investment into a potential novel treatment and encourage innovation by allowing pharmaceutical companies to potentially recover their research and development investments.

FDA Approval

New drugs must be submitted to the FDA for approval through a New Drug Application (NDA), which provides evidence demonstrating the drug’s safety and efficacy. Documentation provided with the NDA submission includes clinical trial data, animal studies, active and inactive ingredients, bioavailability, manufacturing information, and proposed packaging. The FDA’s Center for Drug Evaluation and Research (CDER) evaluates the data submitted by drug manufacturers and determines whether the drug’s benefits outweigh its potential risks. As part of this review, CDER considers clinical and nonclinical testing data, the drug’s intended use, the condition it is designed to treat, and available treatment options. Once CDER has completed its evaluation and determines safety and efficacy, the FDA may approve the drug for marketing in the United States.

Beyond FDA approval, FDA regulatory exclusivity provides a temporary delay to block the approval of competitor pharmaceuticals for a specified period. Exclusivity is a regulatory incentive to encourage and reward drug development. The FDA permits companies with drug exclusivities to market their drug, while denying marketing privileges to competitors. While both patents and exclusivities encourage innovation by allowing manufacturers to recoup costs from their investments, exclusivities are typically much shorter in duration, and are simply marketing rights, not property rights. The FDA-provided temporary protection to brand name products from generic competition allows for other competitors in the future. Generic products approved through an Abbreviated New Drug Application (ANDA) may also qualify for exclusivities, limiting competition to the brand and/or authorized generic.

Much like patents, there are multiple distinct types of exclusivities with different requirements, lengths, and protections. Regulatory exclusivity is based on federal law and FDA determinations. The FDA evaluates whether a product and its approval meet the requirements for a specific type of exclusivity and records the applicable exclusivity in its regulatory databases. To qualify for certain exclusivities, such as Pediatric exclusivity, the applicant must provide specific study data.

• New Chemical Entity (NCE) exclusivity gives five years of protection and applies to any entity that has never been submitted for a previous NDA.
• Orphan Drug exclusivity gives seven years of protection to drugs approved to treat rare diseases. An orphan drug designation must be granted prior to approval.
• New Clinical Investigation exclusivity gives three years of protection for any previously approved active ingredient in a 505(b) NDA with a different use case.
• Generating Antibiotic Incentives Now (GAIN) offers a five-year exclusivity extension to drugs that have been designated as a qualified infectious disease product (QIDP) prior to NDA approval.
• Pediatric Exclusivity gives six months of added protection to drugs that meet pediatric study requirements. Pediatric Exclusivity is the only exclusivity that also attaches to listed patents.
• Patent Challenge Exclusivity gives 180 days of protection upon approval for the first complete ANDA containing a Paragraph IV challenge of an existing brand patent.
• Competitive Generic Therapy (CGT) Exclusivity offers 180-day exclusivity to certain qualifying ANDAs designated as CGTs if the applicant is a “first approved applicant.”

Multiple exclusivities granted to NDA holders may be combined to extend market protection.

Putting It All Together

While the FDA does not grant patents, the FDA’s Orange Book contains both applicable patents and regulatory exclusivity information for each approved drug. However, the Orange Book’s patent listings are not a definitive determination that a patent is valid or enforceable. A generic manufacturer may be unable to enter the market because of patents, exclusivities, or both. FDA approval allows a drug to be marketed in the U.S., while patents and regulatory exclusivity can determine how long competitors must wait before entering the market.  Contact PHSL for more information or for assistance on product launch planning.