Intellectual Property Case Study

1. Intellectual Property Case Study

2. The Case • Prof. Andrews is a Professor within the School of Chemistry at the University of the East Midlands (UoEM). • During the study of his Ph.D., Mr. Evans tried to synthesise a new drug aimed at selectively killing cancer cells, under the supervision of Prof. Andrews. • Upon analysis of the product of this reaction, Mr. Evans noticed that the reaction had not in fact yielded the expected product, but had instead lead to another compound, compound X. • Compound X showed no activity against the cancer cells for which the original compound was designed.

3. Following the disappointment that compound X was inactive against cancer cells, the compound was screened against a wide range of other drug targets available within the Medical School of UoEM by a final year project student, Miss Fall, who was working in the group of Dr. Brown. • The results of this drug target screen were very positive identifying several drug targets against which compound X was active. • This prompted Miss Fall to conduct a literature review to establish other compounds which are active against the newly identified drug targets of compound X, which showed that compound X may act as a new treatment for HIV/AIDS.

4. Prof. Andrews has worked in close collaboration for many years with a group in Australia, which is lead by his friend Dr. Cairns, who is interested in retroviral diseases including AIDS. • Both Prof. Andrews and Dr. Cairns attended a conference in the USA in 2007, where, over dinner with their wives, they discussed aspects of the work relating to compound X. • Mr. Evans found that the exact structure of compound X proved difficult to establish. He therefore asked many people within his department to help him determine the correct structure of the compound. • Eventually, Dr. Davies, who is one of the other academics within the Chemistry Department of UoEM was able to reveal the structure of compound X, which proved particularly challenging to determine exactly.

5. Some months later, Dr. Cairns contacted Prof. Andrews by e-mail. Part of this email read: “With regard to the ‘unknown’ HIV/AIDS compound we discussed in L.A., I stumbled across some work in the French Journal of Chemistry from 1998 detailing some compounds which I thought were interesting – just thought you may be interested. The reference is....” • This e-mail prompted Prof. Andrews to conduct a more through literature review which revealed that the compounds published in the French journal disclosed compounds of similar structure to compound X, but that this article did not consider their potential use against HIV/AIDS, or any other biological targets. • These compounds were also synthesised by a different method to that used by Mr. Evans.

6. Prof. Andrews told his patent attorneys that they had found compounds similar in structure to compound X in the literature, and gave them the reference. • Subsequently the patent attorneys found that the French group had in fact been granted a patent in 2002 for the compounds they had made and their use as a herbicide. • UoEM filed for a provisional UK patent on the 1st of April 2007, which was followed up a year later with an international PCT patent application on the 1st of April 2008. • UoEM is now actively seeking to out-license the invention of compound X to a pharmaceutical company for development into a new treatment for HIV/AIDS.

7. Questions • On the following slides are a series of questions relating to the patent position and other considerations of this case • There may be more than one correct answer to each question, and where you think that this may be the case please chose ‘two or more of the above’ • Please use the handheld ‘KEEpad’ provided to answer… • 1 (or A) • 2 (or B) • 3 (or C)….etc. • Note: • You have to press the button firmly • The light on the KEEpad will flash green when your vote has been registered • You can only vote once (but can press the button as many times as you like!) • If your KEEpad flashes orange, hold it in the air and I will help you retune it

8. Test Question – What is your favourite colour? • Blue • Red • Yellow • Green • Other

9. The Scope of the Invention • Defining the scope of a new invention accurately is the key aspect of a patent and requires all the skills of a qualified patent attorney. • This is because the legal protection granted by the patent relies solely upon the claims defined by the patent attorney. • The strength and scope of the claims will determine the extent to which the inventor(s)/owners can pursue the full financial value of the monopoly granted under the patent, and avoid other parties questioning the validity of the invention for their own financial benefit.

10. In broad terms, what is the invention UoEM are trying to patent? • Compound Xper se • A method of producing Compound X • The fact that the reaction went wrong and gave the unexpected Compound X • Compound X for use as a drug • Compound X for treating HIV/AIDS • A method of treating HIV/AIDS • Two or more of the above

11. In broad terms, how should the patent attorney define Compound X? • Compound X defined by its exact structure • Compound X defined as broadly as possible by structure • Compound X defined as broadly as possible by structure, but so as not to overlap with that described in the French Journal of Chemistry or the French patent • Compound X defined by its application for the treatment of HIV/AIDS only • Two or more of the above

12. Patentability of an Invention • In order for a patent to be granted it must be new and it must contain an ‘inventive step’. • An idea is considered ‘inventive’ when it is “non-obvious to someone who is skilled in the art.” • Someone who is ‘skilled in the art’ may include a trained technician or a research student.

13. How could you argue that the claims of the UoEM patent application involve an ‘inventive step’? • Compound X has unexpected use as a drug • Compound X may be used to treat HIV/AIDS • The structure of Compound X is similar to that described in the French patent • The structure of Compound X was difficult to elucidate • Two or more of the above

14. Inventorship and Ownership of an Invention • It is necessary to name the inventors in a patent application and these names are published on the patent. • It is important that the inventors are correctly named.

15. Who are the “actual devisers” of the invention (i.e. the inventors)? • Prof. Andrews (he is Mr. Evans’ Ph.D. supervisor) • Mr. Evans (he carried out the reaction to synthesise X) • Prof. Andrews & Mr. Evans (who are both from the same research group at UoEM) • Dr. Brown & Miss Fall (the undergraduate Miss Fall conducted the screening of Compound X against other drug targets, under the supervision of Dr. Brown) • Prof. Andrews & Dr. Brown (who are the two UoEM supervisors for this work) • Prof. Andrews, Mr. Evans, Dr. Brown, Miss Fall & Dr. Davies (without all of these people a new invention would not have taken place) • Dr. Davis (he solved the structure of Compound X)

16. Who is the most likely owner of the intellectual property (i.e. the patent)? • Prof. Andrews (he is Mr. Evans’ Ph.D. supervisor) • Prof. Andrews & Dr. Brown (who are the two UoEM supervisors for this work) • Prof. Andrews, Mr. Evans, Dr. Brown, Miss Fall & Dr. Davies (without all of these people a new invention would not have taken place) • The University of the East Midlands

17. What is the most important concern to UoEM regarding the correct identification of the inventors on this patent before the invention is licensed? • UoEM needs to know to whom it needs to give the profits of the license • If UoEM does not correctly identify all of the inventors then it can invalidate the patent in Europe • If UoEM does not correctly identify all of the inventors then it can invalidate the patent in the US • Because UoEM knows that it is good for all of the named inventors to be able to claim recognition for being an inventor to further their careers and promote the University • Because an unnamed inventor may file their own application

18. Disclosure and Confidentiality • Avoiding disclosure of a new invention or technology is of key importance. • If the new invention is disclosed into the public domain or “made available to the public” this can affect whether a patent is granted. • What effect might the following scenarios have on the likelihood of UoEM’s patent being granted or on them finding a licensing partner?

19. Prof. Andrews discussed his work relating to Compound X with Dr. Brown and Dr. Davies at a UoEM staff Christmas lunch in December 2006 • The patent may be invalid • The patent may be invalid since Prof. Andrews and Dr. Brown are from different departments within UoEM • The disclosure has no effect on patent validity since all of the above are contracted employees of UoEM • The disclosure has no effect on patent validity because the disclosure was in an informal setting

20. The conference in L.A. at which Prof. Andrews discussed Compound X with Dr. Cairns took place in February 2007 before the exact structure of Compound X had been determined • The patent may be invalid • The disclosure has no effect on patent validity because the patent attorney was already preparing the patent application at this time, even though the application was not yet filed • The disclosure has no effect on patent validity because Dr. Cairns would have known to keep the information secret • The disclosure has no effect on patent validity because the conference was in L.A. • The disclosure has no effect on patent validity because Prof Andrews was unable to tell Dr. Cairns the structure of Compound X.

21. The conference in L.A. at which Prof. Andrews discussed Compound X with Dr. Cairns took place in March 2007 after the exact structure of Compound X had been determined • The patent may be invalid • The disclosure has no effect on validity because Dr. Cairns is Australian and does not live in the UK • The disclosure has no effect on validity because other people (the wives) who did not understand the discussion were present • The effect of the disclosure on patent validity depends on what was said

22. The conference in L.A. at which Prof. Andrews discussed Compound X with Dr. Cairns took place in May 2007 • The patent may be invalid • The disclosure has no effect on patent validity since the UK patent application was in place by this date • The patent is invalid because the disclosure took place before the PCT application was filed • The disclosure has no effect on the patent validity because Prof. Andrews and Dr. Cairns often collaborate on projects

23. How would a public disclosure of the invention affect the value of the licence UoEM may agree with a pharmaceutical company? • It would have no effect on the licence • It would increase the value of the licence since more people will be aware of the invention and want the new drugs produced • It would decrease the value of the licence since the patent may no longer be valid • It would depend on the timing of the public disclosure • It would remove all value of the licence

24. Freedom-to-Operate • A patent is a negative right (i.e. it stops others from using the technology detailed in the patent claims). • As such, you may not in fact be able to use your own invention or technology since parts of your invention may rely upon using other people’s patented technology. • This is called your ‘freedom to operate’.

25. As a potential licensee, what would concern you most about your freedom to commercialise Compound X in the future? • The fact that Dr. Cairns could file another patent in this area • The fact that UoEM could file another patent in this area • The content of the French patent • The content of the paper published in the French Journal of Chemistry

26. What is your best option to ensure that you have freedom to operate? • Obtain an infringement opinion from a patent attorney • Try and invalidate the French patent • Approach the French patent holders to ask for assignment of their patent rights • Approach the French patent holders to ask for a licence • Do nothing and hope the owners of the French patent don’t find out about your activities • Wait for the French patent to expire in 2022

27. Authors Dr. Rachel Oxley, Dr. Trevor Farren, Dr. Simon Mosey & Dr. William Drewe Organisations School of Chemistry, University of Nottingham, U.K. in association with Mewburn Ellis LLP Supported by:

29. Channel Setting Instructions for ResponseCard RF1. Press and release the "GO" or "CH" button.2. While the light is flashing red and green, enter the 2 digit channel code (i.e. channel 1 = 01, channel 21 = 21).3. After the second digit is entered, Press and release the "GO" or "CH" button. The light should flash green to confirm.4. Press and release the "1/A" button. The light should flash amber to confirm.