Legal Opinion Question: Mr. Philips, Director of Research at Garco Smix Klaine Ltd (GSK), a leading pharmaceutical company, seeks your advice on the following matter. Senior members of the Research team asked Leo, a young laboratory technician, to carry out experiments on the drug Aulix, a compound well known to be useful in treating lung cancer. The purpose of the experiments was to test the precise quantities of Aulix needed to reduce the spread of cancer. Leo’s employment contract states that his duties include “performing experiments, at the direction of his senior colleagues” and he is expected to work a standard 40 hours per week. While performing the experiments, Leo decided (without having been asked) to test the effectiveness of Aulix in treating leukaemia. He conducted these experiments outside his usual working hours because he was too busy with his large workload. Leo found out that Aulix was also useful in reducing the spread of leukaemia and told his senior colleagues about his discovery. GSK then applied for a UK patent on 1 January 2012, claiming priority from a US Patent filed in February 2011. The UK patent was granted in September 2013. The patent claimed a product, Aulix, “for the use in the manufacture of a drug suitable for treating leukaemia”. GSK has then marketed leukaemia Aulix tablets, the sales of which have been incredibly high. Optima Pharma Ltd, a competitor of GSK, is seeking to challenge the validity of GSK’s patent. They rely on the following: First is an article published in a Russian scientific journal in January 2011 referring to the “yet untested Aulix’s effects to treat a range of different diseases”. Second is an interview given by Leo to BBC 1 in June 2011 in which he says “Aulix has incredible benefits for leukaemia patients”. Third is evidence gathered in 2010 from Mr Bridge, who suffers from leukaemia and was accidentally prescribed Aulix. He said that he “felt much better after taking it”. Advise GSK, according to the Patents Act 1977 UK as to, the validity of their patent; and, making the assumption that there is a valid patent, whether they are entitled to ownership of it. Legal Opinion:
A patent is a right over the commercial exploitation of an invention granted by the state for a period of 20 years in return for detailed public disclosure of an invention. There is no set definition of an invention in statute, however per the Oxford dictionary it is creative ability, a new process or device that is fabricated or made up. Under s1(1) Patents Act 1977 (PA), a product or process patent can only be valid if it possesses novelty, an inventive step, can have industrial application and excluded subject matter under s1(2); s3; s4A; Schedule A2. Regarding the drug ‘Aulix’, which is a product patent, I am instructed to advise Garco Smix Klaine (GSK) according to the PA as to the validity of their patent; and, making the assumption that there is a valid patent, whether they are entitled to ownership of it. Novelty: S2(1) PA states that a patentable invention must be completely ‘new’, therefore it must not form part of the “state of the art”; this is later defined in s2(2) PA as all matter before the priority date which is available to the public anywhere in the world. The priority date (s5 PA) for the patent in the US was in February 2011 and this was claimed for the patent in the UK. This can be applied because the 12 months for claiming a date in a World Trade Organisation country had not passed. (s5(2) PA) An invention should not be ‘anticipated’, therefore, if it forms part of ‘state of the art’ it cannot be patented. As it was seen in (General Tire v Firestone), the prior disclosure should ‘plant a flag’ within the territory of the invention and thus, as we consider the Article published in the Russian Scientific Journal in January 2011- which gave light to the untested Aulix’s effects to treat a range of different diseases, we are unsure of further facts which may imply that said article did, in-fact state that Aulix can treat Leukaemia. Considering the date it was published was prior to the priority date, if the facts of said Journal did ‘plant a flag’ and if the disclosure was enabling (Synthon BV v Smithkline Beecham) meaning that it would in theory advise a person skilled in the art to assess the methodology involved in the creation of the product or process then the patent would fail on the grounds of novelty. Unfortunately, the facts relating to the Article was insufficient, it cannot be said with certainty whether there was an enabling disclosure, consequently, Lord Hoffmann’s two stage test is incomplete. Leo’s interview to BBC in June 2011 was after the priority date, there was no need to remain confidential. Lastly, Mr Bridge took Aulix in 2010 when he was accidently prescribed it for his Leukaemia and felt better after taking it may be similar to the case of (Lux Traffic v Pike Signals). Aulix was being used previously to the priority date as a drug which reduces the spread of cancer, it was already being used in the public domain even though it was patented for a different purpose it was being sold. In the case (Lux) it was held that public demonstration put the invention into the public domain, there was no need the prove anyone saw the disclosure. This can be emphasised in the case of (Merrell Dow Pharma. V HN Norton) where Lord Hoffmann said that if the recipe which inevitably produces the substance is part of the state of the art, so is the substance made by the recipe. At the time of Mr Bridge’s enlightenment, there was no enabling disclosure about Aulix treating specifically Leukaemia, however there was about it being a treatment for general cancer and lung cancer. Leukaemia is a form of cancer, so regardless, it would have been expected at that time that Mr Bridge would have “felt much better after taking it”. As seen in s.4A PA, a new use of a known product can be patented, therefore, Mr. Bridge’s evidence would be inadmissible. It can be concluded that Aulix would most likely not fail on the grounds of novelty, subject to the contents of the Journal Article. Inventive Step: S3 PA states that there must be an inventive step, therefore it must show a technical advance over existing technological understanding which is not obvious. (Biogen v Medeva) We are forced to ask whether it would have been ‘obvious’ to a person skilled in the art at the Priority Date. The test for the inventive step is the Windsurfing/Pozzoli approach to obviousness: 1A. Identify the person skilled in the art: Leo is a young laboratory technician. 1B. Identify the common general knowledge that person would have at the PD: The unimaginative technician may not think to conduct experiments on Aulix to treat Leukaemia. 2. Identify the inventive concept of the product or process: There was no amendment of the product itself, however experiments were conducted using the product to treat Leukaemia. 3. What differences are there between the inventive concept and the state of the art: The inventive concept is using Aulix for treating Leukaemia versus using Aulix for treating lung cancer or other types of general cancer. i.e. a new use for an existing product (Dyson v Hoover; Haberman v Jackal) 4. Without knowledge of the invention do these differences amount to steps that would have been obvious to a person skilled in the art?: The mere fact that the product was not used previous to the Priority date for the purpose it was patented (other than Mr Bridge which was accidental) despite favourable commercial factors, it would suggest that it is not obvious. After the application of the Windsurfing/Pozolli test it can be concluded that the product has an inventive step. Industrial Application: Per s.4 the invention is capable of industrial application if it is capable of being made or used in any kind of industry. This is not an issue; the invention can be applied industrially. Excluded Subject Matter: None of the statutory exceptions apply. Concluding, Aulix is likely to be patentable subject to the issues raised in the novelty examination. Sufficiency: Public disclosure must be obliged, and the patent specification must contain an enabling disclosure so a person skilled in the art would be able to perform said invention after interpreting the claim. (s.14(3) PA) If this isn’t satisfied then you run the risk of revocation. (s.72(1)(c) PA) Issues may arise here due to the claim being drafted widely and does not clearly identify steps which would enable a skilled man to recreate a product (Kirin-Amgen v Hoechst Marion Roussel Ltd) Assuming the patent is valid due to it being granted in September 2013 in the UK, we are to discuss whether GSK is entitled to ownership of said patent. Ownership: S.7 PA states that anyone can apply for ownership, it does not need to be the owner, but the person must be legally entitled. A patent is only granted to the inventor or the successor in title. The inventor is entitled to be named on the patent and must always be a person and not a corporate entity. Therefore, the patent granted to GSK, cannot have GSK named on their patent, rather, the name of the employer (Mr Philips) or the inventor (Leo). Expanding, if an employee invents a product or process during the course of their employment and they are contractually employed by their employer to invent- then the employer owns the developed product or process. (S.39 PA; Decision BL University of Warwick v Dr Geoffrey Graham Diamond) Issues arise because Leo’s contract stated that he was expected to work 40 hours per week to test the specific quantities of Aulix needed to reduce the spread of cancer, not to conduct experiments on Aulix relating to treating of other diseases. Due to a heavy workload he conducted the experiments outside of his usual working hours without the consent of his senior colleagues; he may argue that the invention is his intellectual property and he may be right. An employer would only be able to claim a product or process if it within their jurisdiction within the wording of their contractual agreement. Additionally, if Leo is aware that it was his IP and still gave it to his employer, then S.40 explains that an employer in certain circumstances may be obliged to pay compensation to an employee for their invention. (James Duncan Kelly & Kwok Wai Chiu v GE Healthcare) Finally, patents are only valid up to 20 years post Priority Date, their patent is only 5 years old, so it is still valid. I would advise GSK that it is unlikely they are the owners of the patent and if Leo was to claim ownership he would be successful. However, if Leo willingly gives his re-innovated product to GSK they should offer him sufficient consideration. Lastly, since they are on year 5, they must begin paying renewal fees for their patent.
0 Comments
|
AuthorKarina Samaroo Archives
September 2019
Categories
All
|