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Cambodian IP News.

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Bolar Provisions Under Cambodian Patent Law

Cambodian Patent Law contains no corallary to the concept of a "Bolar Provision" under US-Law. This is a limitation of patent rights that allows for certain uses of a patented invention, which otherwise would be infringing, for the sole purpose of generating information for seeking regulatory approval in a country.

The most typical case is to allow generic drug manufacturers to engage in certain activities related to the development and preparation of their products before the expiration of the corresponding patents. The provision is named after the U.S. court case Roche Products, Inc. v. Bolar Pharmaceutical Co., which helped establish its legal framework. Given that Cambodian Patent Law currently excludes pharmaceutical products from protection at all, a Bolar Provision would not be necessary.

The Bolar provision recognizes the importance of promoting competition and public health by enabling generic drug manufacturers to conduct research, testing, and experimentation with patented drugs without infringing on the patent holder's rights. It typically allows them to perform activities such as manufacturing, testing, or obtaining regulatory approval for generic versions of patented drugs during the patent's term.

The provision is particularly relevant to the pharmaceutical industry, as it helps facilitate the timely availability of generic drugs once the patent protection for a brand-name drug expires. It allows generic manufacturers to prepare and submit their applications for regulatory approval in advance, shortening the time between patent expiration and the availability of affordable generic alternatives.

Once Cambodia's exception to its TRIPS-obligations expire, and pharmceutical products become protectable, it is conceivable that the Patent Law will be amended to include such a Bolar exception.


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