Intellectual Property

Case Study
 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.

This resource was downloaded from https://rsc.li/3niU8Bv

 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.
 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.
 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.
 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.
 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’
 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.
 In broad terms, what is the invention UoEM
are trying to patent?

1. Compound X per se
2. A method of producing Compound X
3. The fact that the reaction went wrong and gave the unexpected
Compound X
4. Compound X for use as a drug
5. Compound X for treating HIV/AIDS
6. A method of treating HIV/AIDS
7. Two or more of the above
 In broad terms, how should the patent attorney
define Compound X?

1. Compound X defined by its exact structure

2. Compound X defined as broadly as possible by structure
3. 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
4. Compound X defined by its application for the treatment of
HIV/AIDS only
5. Two or more of the above
 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.
How could you argue that the claims of the UoEM patent
application involve an ‘inventive step’?

1. Compound X has unexpected use as a drug

2. Compound X may be used to treat HIV/AIDS
3. The structure of Compound X is similar to that described in the
French patent
4. The structure of Compound X was difficult to elucidate
5. Two or more of the above
 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.

 Who are the “actual devisers” of the invention
(i.e. the inventors)?

1. Prof. Andrews (he is Mr. Evans’ Ph.D. supervisor)

2. Mr. Evans (he carried out the reaction to synthesise X)
3. Prof. Andrews & Mr. Evans (who are both from the same research
group at UoEM)
4. Dr. Brown & Miss Fall (the undergraduate Miss Fall conducted the
screening of Compound X against other drug targets, under the
supervision of Dr. Brown)
5. Prof. Andrews & Dr. Brown (who are the two UoEM supervisors for this
work)
6. Prof. Andrews, Mr. Evans, Dr. Brown, Miss Fall & Dr. Davies (without all
of these people a new invention would not have taken place)
7. Dr. Davis (he solved the structure of Compound X)
Who is the most likely owner of the intellectual property
(i.e. the patent)?

1. Prof. Andrews (he is Mr. Evans’ Ph.D. supervisor)

2. Prof. Andrews & Dr. Brown (who are the two UoEM supervisors for
this work)
3. Prof. Andrews, Mr. Evans, Dr. Brown, Miss Fall & Dr. Davies (without
all of these people a new invention would not have taken place)
4. The University of the East Midlands
 What is the most important concern to UoEM regarding
the correct identification of the inventors on this patent
before the invention is licensed?

1. UoEM needs to know to whom it needs to give the profits of the

license
2. If UoEM does not correctly identify all of the inventors then it
can invalidate the patent in Europe
3. If UoEM does not correctly identify all of the inventors then it
can invalidate the patent in the US
4. 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
5. Because an unnamed inventor may file their own application
 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?
 Prof. Andrews discussed his work relating to Compound X
with Dr. Brown and Dr. Davies at a UoEM staff
Christmas lunch in December 2006

1. The patent may be invalid

2. The patent may be invalid since Prof. Andrews and Dr. Brown
are from different departments within UoEM
3. The disclosure has no effect on patent validity since all of the
above are contracted employees of UoEM
4. The disclosure has no effect on patent validity because the
disclosure was in an informal setting
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

1. The patent may be invalid

2. 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
3. The disclosure has no effect on patent validity because Dr. Cairns
would have known to keep the information secret
4. The disclosure has no effect on patent validity because the
conference was in L.A.
5. The disclosure has no effect on patent validity because Prof
Andrews was unable to tell Dr. Cairns the structure of Compound X.
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

1. The patent may be invalid

2. The disclosure has no effect on validity because Dr. Cairns is
Australian and does not live in the UK
3. The disclosure has no effect on validity because other people
(the wives) who did not understand the discussion were present
4. The effect of the disclosure on patent validity depends on what
was said
The conference in L.A. at which Prof. Andrews discussed Compound X
with Dr. Cairns took place in May 2007

1. The patent may be invalid

2. The disclosure has no effect on patent validity since the UK
patent application was in place by this date
3. The patent is invalid because the disclosure took place before
the PCT application was filed
4. The disclosure has no effect on the patent validity because Prof.
Andrews and Dr. Cairns often collaborate on projects
How would a public disclosure of the invention affect the value of the
licence UoEM may agree with a pharmaceutical company?

1. It would have no effect on the licence

2. It would increase the value of the licence since more people will
be aware of the invention and want the new drugs produced
3. It would decrease the value of the licence since the patent may
no longer be valid
4. It would depend on the timing of the public disclosure
5. It would remove all value of the licence
 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’.

As a potential licensee, what would concern you most about
your freedom to commercialise Compound X in the future?

1. The fact that Dr. Cairns could file another patent in this area
2. The fact that UoEM could file another patent in this area
3. The content of the French patent
4. The content of the paper published in the French Journal of
Chemistry
 What is your best option to ensure that you
have freedom to operate?

1. Obtain an infringement opinion from a patent attorney

2. Try and invalidate the French patent
3. Approach the French patent holders to ask for assignment of
their patent rights
4. Approach the French patent holders to ask for a licence
5. Do nothing and hope the owners of the French patent don’t find
out about your activities
6. Wait for the French patent to expire in 2022
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: