In reference to World Intellectual Property Organization Handbook (WIPO), a patent means a document or tittle granted by government or regional authority which describes an invention that provides solution of which it cannot be exploited without authority of the owner. For a patent to be granted, one must fulfill the tri conditions namely novelty which requires the invention to be new. It must disclose an inventive step which requires non obviousness and lastly the invention has to be applicable to an industry.
It is important to note that in Uganda, Patents have a domestic legislation’s called the Industrial Property Act Cap 244. According to Section 45 of the same Act has the same position of patent protection of 20 years with African intellectual property Organization ARIPO and World Intellectual Property Organization (WIPO). After the 20 years the patent goes to the public domain for Example paracetamol commonly known as Panadol. Any pharmaceutical industry can manufacture Panadol because its patent expired and now in public domain.
Exploring Bolar exemptions, we can trace its origins in the famous U.S case of Roche Products Inc v Bolar pharmaceutical Co. 1984. This case is significant on patent law and the manufacturing of generic pharmaceuticals. Roche products was the holder of the patent of flurazapan hydrocloride issued in the US in the year 1967 and expired in 1984 however two years before it expired, Bolar pharmaceuticals developed a generic version of the drug for bio equivalence testing targeting FDA approval.
Roche argued that Bolar`s use of its patented compound for testing constituted patent infringement reasoning that it had commercial intent. On the other hand, Bolar contended that its action fell under the experimental use and public policy exemption justifying its actions.
On determination, the lower court agreed with Bolar however in the ruling of US court of appeal for federal courts held that Bolar’s use of the patented compound amounted to infringement. Reasoning that it was preparing for commercial purpose post patent expiration. This controversy slowed down advancements in the pharmaceutical industry in the U.S of which the congress responded by passing the drug price competition and patent term restoration Act of 1984 commonly known as Hatch –Waxman Act.
Under Section 271 of the same act created a safe harbor allowing generic drug manufacturers to use patented compounds for testing for FDA approval without infringement. This opened door for experimental research on existing compounds advancing global competition and innovativeness in the pharmaceutical industry hence the adoption of BOLAR EXEMPTION.
In Uganda the Bolar exemption was adopted under Section 43 of the Industrial Property Act which provides that it is not infringement of a patent to curry out any act related to experimental use or research on the patented innovation whether scientific or commercial use.
Conclusively, the Bolar exemption was adopted globally however Uganda is still slow in the area of patents due to misconceptions, unawareness and limited investments in this area of intellectual property. It is my humble appeal for Ugandans to explore the advantages of patent protection for their inventions in any field due to the alarming numbers of patent applications.
BY: LUTAKOME IMRAN KIGONGO (LLM Fellow- MUK)
lutakomeimran@gmail.com
