In general, the granting of patent rights is a very positive act. Patent rights are forms of intellectual property rights that serve to promote innovation, encourage research and development, and deepen knowledge and expertise. However, there are rare instances during which the granting of these intellectual property rights would not be in the public’s best interest. For this reason, just as with other rights related to intellectual property, there must be exceptions and limitations to patent rights.
Exceptions and Limitations to Patent Rights
There are several important reasons why the intellectual property rights applicable to patents must sometimes be limited. Unfettered access to patent rights may sometimes expose some or all members of the public to certain risks; these members of the public can sometimes be protected through the limiting of these intellectual property rights. Exceptions and limitations also help to provide a proper balance between the desires of holders of patent rights, third parties, and the public.
According to the Standing Committee on the Law of Patents (SCP), there are nine areas in which these exceptions and limitations are often invoked. Three of these areas will be discussed in the following paragraphs. These areas are the following: experimental use and scientific research, government use, and extemporaneous preparation of medicines.
Experimental Use and Scientific Research
Exceptions and limitations to patent rights often apply when experimental use or scientific research is involved. These exceptions are intended to support development goals and facilitate the completion of public policy objectives. Such objectives may include the provision of access to medical supplies as well as the protection of the environment. They also ensure that the provision of educational and instructional material remains unhindered by unjustifiable use of intellectual property rights. This fact applies to intellectual property in Malaysia as well as internationally.
It should be noted that these exceptions and limitations only impose slight restrictions on patent holders. They do not restrict the scope and extent of experimentation and research involving the item protected by the patent. Furthermore, the terms “experimental use” and “scientific research” are deliberately worded as broadly as possible. In this way, many different types of experiments and research can be carried out without violating these exceptions and limitations.
If the granting of patent rights would contradict a government’s decision to use a patented item for its own purposes, the government’s ruling takes precedence. “Government” may refer to a national, territorial, provincial, or regional government. Generally, there are no limits regarding the use of a patented item by a government no matter where in the world the government is based. Therefore, trademark agents in Malaysia must adhere to these government decisions before addressing any matter related to intellectual property in Malaysia.
That being said, government use of such items tends to be rare. Governments, especially those below the national level, almost never need to override intellectual property rights for patents. The overriding of patent rights by a government usually takes place during times of national crisis or emergency. In those extreme instances, the government’s need to save lives or preserve the well-being of the country becomes so important that all rights related to intellectual property, whether in Malaysia or elsewhere, become secondary.
Extemporaneous Preparations of Medicines
In many countries, the extemporaneous preparation of a medicine in a pharmacy is beyond the scope of patent protection. This is because such preparations relate to individual cases. This means that the medicines are not general products; therefore, protection via intellectual property rights cannot be applied to them. Any treatments, procedures, or other actions related to such preparations are also barred from receiving intellectual property protection via patent rights.
The specific details related to patent rights and extemporaneous preparation of medicines differ from country to country. In some countries, such preparations can be protected by a patent if they are provided to a patient more than once. In others, medicines which are not mass-produced are beyond the scope of intellectual property protection. Several countries also provide exceptions for intellectual property protection related to the pharmacist’s activities in preparing such medicines. However, in most countries, intellectual property protection is a matter completely separate from that of extemporaneous preparation of medicines because the exact details related to such a patent would often be overly complex.
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