Molecular Biotechnology: Principles and Applications - Glick B., Pasternak J. 2002

Research Control in Molecular Biotechnology and the Patenting of Biotechnological Inventions
Patenting Biotechnological Inventions
Patenting Inventions in Different Countries

Patent offices in different countries often reach completely different decisions regarding the exact same patent application. For instance, in 1989, the biotechnology company Genentech filed an application with the UK Patent Office, which included claims for a method of producing human tissue plasminogen activator (tPA) using Recombinant DNA technology. This protein, present in The Human Body in small quantities, is responsible for converting plasminogen into plasmin. Plasmin is an enzyme that breaks down the fibrin of Blood clots; consequently, human tPA can be used as a therapeutic agent for the Prevention and Treatment of coronary thrombosis. After numerous attempts, Genentech obtained the full-length nucleotide sequence complementary to the human tPA genomic DNA (cDNA) and cloned it into Escherichia coli with the intent of synthesizing large quantities of pure tPA. In its application, the company sought to patent human tPA synthesized via its proprietary biotechnological Procedures, as well as the cloning vector system and the genetically transformed microorganism. In addition, Genentech claimed rights to The Use of tPA as a pharmaceutical agent. The claims section in the initial application consisted of 20 items. Some of these were overly broad and vague, while others were quite narrow. The application was rejected by the UK Patent Office, prompting Genentech to appeal to the UK Court of Appeal, which, following a thorough review, found all the claims unpatentable. The court ruling noted that while the invention met the novelty requirement, certain experts concluded that the claimed technical solutions were obvious and therefore unpatentable.

In contrast, in the United States, Genentech was granted a patent for human tPA. This patent not only protected the specific form of human tPA that Genentech brought to market, but also granted the company exclusive rights to all similar, though non-identical, forms. Genentech successfully won lawsuits against two other biotech companies that were ruled to have infringed on Genentech's rights, even though they sold alternative forms of tPA distinct from Genentech's commercial product.

The patent granted for the very same application in Japan limited Genentech's claims to the specific Amino Acid Sequence of the cloned human tPA. Here, other companies retained the right to market alternative variants of human tPA. Thus, a single patent application met three entirely different fates across three different countries: in the first instance, it was rejected; In the second, it was approved, resulting in a patent with broad claims; and in the third, it was approved, yielding a patent with much narrower claims. Consequently, patent offices in different jurisdictions currently hold divergent Perspectives on the patentability of the exact same invention.