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Case 8 Commissioner of Patents v AbbVie Biotechnology Ltd Background

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Added on  2020-05-11

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Through this case, it was confirmed that it was not enough to be presented that the pharmaceutical substance was an integer of claim, which had been produced through the process which involved recombinant DNA technology and the claims of which were based on the patent term extension application. Under section 70(2) of the Patents Act, 1990 (Cth), a patent can be deemed as eligible for a patent term extension of a period of 5 years in which there was one or more of the provided substances and the same

Case 8 Commissioner of Patents v AbbVie Biotechnology Ltd Background

   Added on 2020-05-11

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Case 8Commissioner of Patents v AbbVie Biotechnology Ltd1BackgroundThe decision given in this case was an appeal decision made by the Full Federal court, and this was given unanimously. This case put an end to the controversy which was raised in AbbVie Biotechnology Ltd v Commissioner of Patents2, a decision which was presided over by the Administrative Appeals Tribunal. Through this case, it was confirmed that it was not enough to be presented that the pharmaceutical substance was an integer of claim, which had been produced through the process which involved recombinant DNA technology and the claims of which were based on the patent term extension application. It was stated that there was a need forthe pharmaceutical substance to be the subject matter of the claims and not the processes or methods involving or concerning the specific pharmaceutical substance3. Under section 70(2) of the Patents Act, 19904 (Cth), a patent can be deemed as eligible for a patent term extension of a period of 5 years in which there was one or more of the provided substances and the same has been disclosed in the entire specification which falls within the scope of these claims5. These substances are a per se pharmaceutical substance6 or a pharmaceutical substance which had been produced through a process involving the use of recombinant DNA technology7. Such goods which contain these pharmaceutical substances have 1 [2017] FCAFC 129 (18 August 2017)2 [2016] AAT 6823Austlii, Commissioner of Patents v AbbVie Biotechnology Ltd [2017] FCAFC 129 (18 August 2017) <http://www.austlii.edu.au/cgi-bin/viewdoc/au/cases/cth/FCAFC/2017/129.html?context=1;query=abbvie%20%5b2017%5d%20fcafc>4 Patents Act, 1990 (Cth)5 Patents Act 1990, s70(2)6 Patents Act 1990, s70(2)(a)7 Patents Act 1990, s70(2)(b)
Case 8 Commissioner of Patents v AbbVie Biotechnology Ltd Background_1
to be covered in the ARTG, i.e., the Australian Register of Therapeutic Goods. Apart from this, there is a need for 5 years to have been elapsed between the first regulatory approval date and thedate of the patent of such goods.In this case, there were three patents which included Swiss-style claims, which were directed to adalimumab’s use, which was an antibody produced through the use of recombinant DNA technology with regards to the manufacturing of medicament for treatment of diseases, which included rheumatoid spondylitis, ulcerative colitis, and Crohn's disease. Under the brand name ofHUMRIA ®, Adalimumab used to be marketed in the nation and had been included on December 10th, 2003 in the ARTG for the very first time, for treating rheumatoid arthritis. The patentee in this case was AbbVie Biotechnology Ltd who applied for extension on the term of the patent based on the regulatory approval attained subsequently for this drug for therapeutic indications which were covered through the respective patents claims8. The Lower Court held that section 70(2)(b) was applicable in this case as there was a use of recombinant DNA technology. As a result of which, the grant to the application of the plaintiff was refused by the Commissioner of Patents based on the claims being characterised by therapeutic use, which was new, which resulted in the product failing to fall in the scope of these claims. It was also held by the commissioner that the application could not be permitted as it wasnot based on the first approval date of the drug. This decision was appealed at the AAT where a controversial interpretation of this section occurred. They stated that this section encompassed use, application, method or process which involved the pharmaceutical substance which had been produced through the process involving the particular technology. Though, the decision of 8Allens, Patents & Trade Marks (11 September 2017) <https://www.allens.com.au/pubs/pta/cupta11sep17.htm>
Case 8 Commissioner of Patents v AbbVie Biotechnology Ltd Background_2

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