Patent protection for pharmaceutical products has an impact on the pharmaceutical market and innovation. As pharmaceutical products require regulatory approval before commercial use, and because regulatory approvals commonly issue after a relevant patent’s statutory term has begun, drug products typically have less than the full patent term remaining at the time the drug is launched. In the United States, the “Patent Term Restoration” portion of the Hatch-Waxman Act remedied this situation by affording NDA holders the opportunity to extend the life of one patent for up to five years, depending on the period of exclusivity lost due to the regulatory approval process.
Regulatory exclusivities prevent potential generic competitors from filing an application seeking regulatory approval for a competing generic drug product, or prohibit the FDA (or equivalent regulatory authority outside the United States) from approving the generic drug application. To obtain market approval, pharmaceutical manufacturers submit large amounts of clinical data to the regulatory authority. This data may costs hundreds of millions of dollars to produce. Generic drug manufacturers may later use that data to obtain approval of their generic versions of the drug product. Data exclusivity prevents generic competitors from relying on the clinical data submitted by the original pharmaceutical manufacturer for a certain period of time. The Hatch- Waxman Act awards a five-year data exclusivity period for drug products containing a new chemical entity.
The availability of such patent term extensions and data exclusivity periods varies in other countries. Being up-todate with the current requirements outside the United States is critical for successful drug development and for maximizing the commercial life of a pharmaceutical patent portfolio. Asia and South America present challenges due to frequent changes in the regulations and to the wide variability in approaches among neighboring countries.
This article provides a summary of the data exclusivity and patent term provisions in certain key Asian and South American countries.
Chinese law provides for a data exclusivity period of six years for new chemical entities. Patent term extensions for regulatory delays are not available in China.
Data exclusivity and patent term extension for regulatory delays are not available in Hong Kong.
Under the Pharmaceutical Affairs Law, the Japanese regulatory authority re-examines the safety and efficacy of drugs after drug approval in view of the data collected during the re-examination period. The re-examination period lasts from four to 10 years after drug approval. The data submitted to the regulatory authority is not available to generic drug companies during the re-examination period. Accordingly, the re-examination system effectively works as a data exclusivity system in Japan.
The re-examination system applies to new chemical entities and previously approved drugs that receive approval for new clinical indications. For new chemical entities, the re-examination period used to be six years from the date of drug approval. Since April 1, 2007, the re-examination period for new drugs is eight years. Previously approved drugs that receive approval for new clinical indications are subject to a shorter, fouryear reexamination period.
Patent term extensions for regulatory delays are available in Japan. The patent term can be extended for up to five years. Unlike in the United States, more than one patent can be extended in Japan.
The United States-Korea Free Trade Agreement, which took effect March 15, 2012, amended the Korean Pharmaceutical Affairs Act. The revised Act and its implementing regulations include provisions for patent term restoration and data exclusivity for patented pharmaceuticals. These revisions apply to all members of the WTO pursuant to TRIPS.
Korea’s patent term restoration provisions permit a patent term extension for up to five years to compensate for patent term lost to regulatory delays.
The new provisions provide for a five-year data exclusivity period that is similar to that provided in the United States. Generic companies are prohibited from submitting generic drug applications in Korea for at least five years from the original company’s approval date for a new chemical entity.
Data exclusivity is available in Malaysia. The term is determined by the director of pharmaceutical services and will not exceed five years for a new drug product containing a new chemical entity.
Under current law, patent term extensions based upon regulatory delays are not available in Malaysia. Patents with an effective filing date before August 1, 2001, are entitled to a patent term that is the longer of either 20 years from the filing date or 15 years from the issue date.
Data exclusivity and patent term extensions for regulatory delays are not available in the Philippines.
Thailand provides for a five-year data protection period that guarantees that the confidential data of a new drug applicant will remain confidential.
Patent term extensions for regulatory delays are not available in Thailand.
Vietnam provides for a five-year data exclusivity period, unless the generic applicant has obtained the original manufacturer’s permission to use its data. If the applicant requests that the data be kept secret, the Vietnamese regulatory authority is required to keep the data confidential unless the disclosure is necessary to protect the public.
Patent term extensions for regulatory delays are not available in Vietnam.
Data exclusivity and patent term extensions for regulatory delays are not available in Argentina.
Brazilian law does not currently provide a data exclusivity period for human pharmaceutical products. The Brazilian Pharmaceutical Regulatory Agency can approve a generic drug application at any time after market approval of a new chemical entity.
Brazilian law does provide for market exclusivity rights for veterinary drugs. A veterinary drug receives a 10-year exclusivity period if it is a new chemical entity and a five-year exclusivity period if it is not a new chemical entity.
Brazil does not provide patent term extensions based upon regulatory delays.
Chile provides a five-year data exclusivity period to new chemical entities as long as the drug application includes undisclosed data that is not publicly available and the filing of the drug application in Chile occurs less than a year after the drug has been approved outside of Chile. The nonpublication requirement has traditionally been difficult as Chile’s regulatory authority has found publication of abstracts and partial clinical results to be sufficient to deny data exclusivity. More recently, however, Chile’s regulatory authority has found that publications must contain the clinical data in its entirety in order to deny data exclusivity. The requirement to file in Chile within the oneyear window obligates pharmaceutical companies to prioritize the Chilean market, which may be challenging.
Chile permits patent term extension for regulatory delays. Unlike most countries, Chile does not place a time limit upon the extension.
Data exclusivity and patent term extensions for regulatory delays are not available in Mexico.
Understanding and taking advantage of data exclusivity periods and patent term extensions are important in making global pharmaceutical marketing decisions. The availability and requirements of data exclusivity and patent term extensions outside the United States are in flux, particularly due to the requirements of TRIPS and the negotiation of trade agreements. As the availability of data exclusivity periods and patent term extensions differs for small molecules and biologics in certain jurisdictions, remaining aware of the changing data exclusivity periods and patent term extensions in different countries will continue to be important.