A patent provides a patent proprietor with the right to exclude others from utilizing the invention claimed in the patent. When the subject matter of the invention is a process, the patent will prevent others from using the process.
Under the infringement provisions in the Singapore Patent Act, Section 66 (1)(b) provides that when a process is patented in Singapore, a person who uses the process or offers it for use in Singapore without the consent of the patent proprietor will be liable for infringement. Specifically, if the person uses a process that is the same as the patented process or a process that includes every step of the patented process with additional steps, he will infringe the patent.
However, if a person uses the process in another country, and then imports or sells the product in Singapore, is he liable for infringement? Singapore Patent Act Section 66(1) (c) provides that in such scenario, the person will be liable for infringement only if the product is obtained directly by means of the patented process. A similar provision is also found in the UK Patent Act.
Thus, the critical issue is the definition of “directly”. The Singapore Patent Act does not define ‘directly’. However, a leading UK case, which is an important reference for Singapore Patent Law, may shed light on what a “product obtained directly by means of the patented process” is.
In Pioneer Electronics Capital Inc. v Warner Music Manufacturing Europe GmbH, [1997] RPC 757 (CA), the dispute related to a patent for manufacture of master disks by Pioneer Electronics Capital Inc. (“Pioneer”). The master disks were used for mass production of compact disks (“CD”) and did not have the capability to play music. The patent covered the process of making the master disks but not the process of producing the CDs from the master disks. Pioneer initiated an infringement lawsuit against Warner Music Manufacturing Europe GmbH (“Warner”) who imported the CDs into the UK that were made from the master disks in facilities outside of the UK. Pioneer claimed that the CDs were obtained directly from the patented process. Warner argued that the CDs did not share the “essential characteristics” of the master disks. Therefore, the disks could not be deemed as direct products of the patented process.
The Court of Appeal (“Court”) agreed with Warner and held that the finished CDs were materially different from the master disks. Warner’s CDs were derived from the master disks, but it required using three additional stages of manufacture. Further, the master disks were not able to perform the same function as the resulting CDs. Thus, importing the CDs by Warner was held not to infringe Pioneer’s patent.
In reaching their decisions, the Court identified a consistent theme:
… the product obtained directly by means of a patented process is the product with which the process ends; it does not cease to be the product so obtained if it is subjected to further processing which does not cause it to lose its identity, there being no such loss where it retains its essential characteristics.
Whether a product retains its essential characteristics is a matter of fact and may vary from case to case. According to the above case, the approach of the Court in analyzing infringement suggests that the protection scope of a process patent should be restricted to the immediate products of the patented process and should not be extended to derivatives or follow-up products.
The above discussion is particularly interesting for pharmaceutical patents. In practice, many pharmaceutical patents relate to process of making chemical compounds for pharmaceutical use. Chemical compounds that cannot be directly administered are often, used as active ingredients for selected pharmaceutical compositions. The preparation of pharmaceutical compositions usually requires further processing and addition of excipients so that the compositions become suitable for administration. As evidenced by Pioneer v. Warner, a patent for a process of making the chemical compound may not be able to cover all products of the patented process. As a consequence, importing and selling of the composition in Singapore may not infringe the patented process. Patent proprietors in the pharmaceutical sector should bear this in mind when seeking protections for their products in Singapore, if they only have patent protection for the method of manufacturing the pharmaceutical.