The following data is extracted from IQVIA’s Ark Patent Intelligence Data Exclusivity module and is intended to give a brief outline of GAIN exclusivity.

Introduction

One of the major threats worldwide is antibiotic resistance, and as per a report published in 2019 by the Centers for Disease Control and Prevention (CDC), nearly 2.8 million antibiotic-resistant infections occur annually in the US^1,2. Also, scientific research and development on these antibiotics require a lot of time, money, and resources. Therefore, there is a need to strengthen antimicrobial drug research and development to achieve more effective antibiotics for public health treatment. In view of all the above factors, the US Congress passed the Generating Antibiotic Incentives Now (GAIN) Act in June 2012 under section 805 of the Food and Drug Administration Safety and Innovation Act^3,4. The launch of an antibiotic drug in the market requires many resources, and therefore patent protection alone cannot compensate as the required incentives to the sponsors. Non-patent exclusivities, such as GAIN exclusivity, provides 5 years of additional protection to the approved antibacterial and antifungal drugs to prevent generic entry into the market^3,4.

Apart from providing exclusivity extension for 5 years, the GAIN Act also supports the pharmaceutical companies by encouraging research and development of new and more efficient antimicrobial drugs. The US Food and Drug Administration (FDA), with the help of the scientific community, reviews and revises a minimum of three guidance documents in a year to help in the clinical development of antifungal and antibacterial drugs³. The FDA also sponsors workshops, conferences, worldwide advisory meetings, and provides incentives to the regulatory committees to overcome current challenges of multi-drug resistance, and thereby, aims to develop safe antifungal and antibacterial drugs³. Lastly, the CDC helps in promoting education, innovation, and implementation of antibiotics stewardship programs. These collaborated and coordinated stewardship programs target the promotion of the appropriate usage of antibiotics, monitoring the advised prescription, increasing awareness about the spread of infections caused by resistant pathogens and probable drug treatment for its reduction, and thus, improving patient health^3,4,5.

Qualified Infectious Disease Products (QIDPs)

The FDA provides certain antimicrobial drugs, a designation known as QIDP, on which the GAIN is applicable³. Under section 505E(g) of the Food, Drug, and Cosmetic (FD&C) Act, a QIDP is defined as:

1. an antibacterial or antifungal resistant pathogen, including novel or emerging infectious pathogens; or
2. qualifying pathogens listed by the Secretary under subsection (f) of the FD&C Act^3,6.”

A QIDP designation plays an important role in identifying a drug candidate intended to treat a serious or life-threatening infection, which in turn aids in the development of new antibacterial and antifungal drugs. A drug candidate designated as QIDP can result in increased market protection by 5 years through GAIN exclusivity and thus, incentivises the sponsors to invest more in antimicrobial or antibiotic resistance research areas³.

• The drug should be used for the treatment or diagnosis of a severe or life-threatening infection⁴.
• Biologic products and devices are not qualified for a QIDP designation⁴.
• It is granted for a specific drug product for a specific indication for which the applicant has requested. Thus, the same applicant may get QIDP designation for multiple dosage forms or indications of the same active ingredient³.

A QIDP designation may also be eligible for priority review designation by the FDA if it meets the criteria of ‘first application or efficacy supplement submitted for a specific drug for a specific indication’^3,4. If approved, the FDA would review the application within 6 months on a ‘priority basis’, as the drug would improve the treatment of a life-threatening infectious disease^7,8 .

A QIDP designated drug, apart from getting an advantage of a 5-year exclusivity extension under the GAIN Act, is also entitled to Fast Track designation by the FDA, if the sponsor has requested it^4,8. It will enable more frequent communication between the FDA and the sponsor regarding the drug’s research and development, and thus expedite the approval process^7,8,9.

GAIN Exclusivity

The GAIN Act provides 5-year exclusivity extension on applications that have already received other exclusivities, such as new chemical entity (NCE) exclusivity for 5 years, orphan drug exclusivity (ODE) for 7 years, paediatric exclusivity for 6 months, etc^3,4. For instance, if a QIDP was qualified as an NCE, and was also granted a paediatric exclusivity, then the exclusivity along with GAIN would be 10.5 years^3,4. There is detailed coverage and explanation of the drugs that have received GAIN exclusivity in the Data Exclusivity module of Ark Patent Intelligence.

Although the GAIN Act has been designed to target the unmet need of overcoming the drug resistance caused by antimicrobial drugs, the low number of drug approvals under the Act does not reflect that. However, from an alternative perspective, 147 QIDP designations have been granted by the FDA from 2012 to 2017, indicating that the GAIN Act is aiding pharmaceutical companies in the research and development of antimicrobial drugs³. Yet, benefits from the GAIN Act to patients are still far away, and additional ways need to be identified to launch new antimicrobial products for human use^3,10.

Conclusion

Antimicrobial drug resistance has increased in recent years due to consumption of more antibiotics, which poses a serious health hazard. The GAIN Act’s approval has promoted the research and development of antimicrobial drugs to overcome this challenge, and additionally provided 5-year exclusivity extension. However, as of now, the low number of drugs approved for GAIN exclusivity is not very promising. Thus, it shows that further studies need to be done to fulfil the patient’s unmet needs and provide effective antibiotic treatment to cure them of the diseases.

References

1. https://www.who.int/news-room/fact-sheets/detail/antibiotic-resistance
2. https://www.cdc.gov/drugresistance/biggest-threats.html
3. https://www.fda.gov/media/110982/download
4. https://www.fda.gov/media/111091/download
5. https://www.cdc.gov/antibiotic-use/stewardship-report/pdf/stewardship-report.pdf
6. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=317.2
7. https://www.gao.gov/assets/690/682391.pdf
8. https://www.govinfo.gov/content/pkg/BILLS-112s3187enr/pdf/BILLS-112s3187enr.pdf
9. https://www.fda.gov/patients/learn-about-drug-and-device-approvals/fast-track-breakthrough-therapy-accelerated-approval-priority-review
10. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6986775/

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