1. Patenting strategy and commercialisation
Dr Michael Pears
8th May 2012

2. Overview What are patents? Why are patents important?
What can be patented?
What criteria must be met?
When & what needs to be done to get a patent?
Inventorship & Ownership?
Freedom to operate?

3. So what are patents? Patents protect technical inventions
Exclusive right for invention
it gives you the right to stop third parties using your invention
however, it does not give you the right to exploit your invention
Territorial right
Time limited: 20 years from filing (additional 5½ years for regulated products in some territories)
Patent infringement judged in the national court of the country
where infringement took place

4. Why are they important?
Encourage innovation by granting a monopoly in exchange for invention disclosure
Commercial assets (can be sold, licensed or mortgaged)
Significant commercial value (e.g. AZ’s patent for Nexium®)
Many uses…
- Attract investment?
- Spin-out from university?
- Generate income (licensing royalties)?
- As a bargaining tool in negotiations?
- Deter competitors?
- Create barrier to others to enter market?
- Raise organisation’s profile?
- Seeking a collaboration?
An IP strategy cannot be developed in a vaccuum. A sound IP strategy will assist your organisations to achieve its commercial goals effectively.
Four main areas of value – revenue contribution, margin contribution, marketing benefits and organisational value
However, if the commercial opportunity is small, a patent application may not be justified, even if the invention is eminently patentable.
A serious commercial opportunity is likely to require filing a patent application, even if ultimately obtaining patent protection may be challenging

5. Why are they important? Dictate Supports COMMERCIAL OBJECTIVES IP
STRATEGY
Dictate
Supports

6. What can be patented? Various products and processes
transgenic plants & animals
biological & chemical compounds
microorganisms
assays / diagnostic tests
drugs
What can be
patented?
Certain things excluded from patentability depending on territory (e.g. mere presentation of information or methods of doing business).
Biologics – polynucleotides, peptides and polypeptides,
dosage regimens/patient subgroups
isomers, salts, polymorphic forms etc
cell lines
Processes of manufacture
new medical uses of known compounds

7. Example: a biopharmaceutical
One or more of the following might be protectable:
The molecule per se
Method of making the molecule
Plasmid or cell line used in making the molecule
Apparatus or media for growing the cell line in
Formulation comprising the molecule; combinations with other therapeutics
Medical use claims, e.g. a method of making a medicament for treating X
Diagnostic/prognostic methods; treatment monitoring methods
Screening assay for further active molecules
Certain things excluded from patentability depending on territory (e.g. mere presentation of information or methods of doing business).
Biologics – polynucleotides, peptides and polypeptides,

8. What criteria must be met?
Novelty
Invention must be new at time of filing application
i.e. not made available to the public
by anyone at any time
at any place, in any language, in any way
Some examples:
journal/press articles
conference abstracts/presentations
PhD thesis in university library
earlier filed/published patent applications
journal/press articles
conference abstracts and presentations
PhD thesis made available in a university library
publications made available on the internet
a prior use of the invention

9. What criteria must be met?
Novelty
Confidentiality is key
Care needs to be taken in what is disclosed and what is kept secret (eg when promoting work, attracting funding, writing grant applications)
Checks in place to review proposed publications for potential patent opportunities before publication
Confidentiality agreements when discussing with third parties
If possible, err on side of caution and disclose nothing until patent application on file
The invention must be confidential before application filed
Be careful what you disclose and what you keep secret
Difficult in academia due to collaborations with other institutions
Take care when trying to attract funding, writing grant
proposals, and promoting your work
Always use a confidentiality agreement if disclosing to 3rd parties
Err on the side of caution and disclose nothing until a patent application has been filed

10. What criteria must be met?
Inventive step
Invention must not be obvious to a skilled person in the art in view of state of art at time of filing application
Not merely an obvious modification of what is known
Must exercise more skill/ability than ‘skilled person’
Surprising or unexpected result?
Not obvious to try or no reasonable expectation of success?
Overcame technical prejudice?
Always arguable
Skilled person is a skilled practitioner in field and aware of common general knowledge
How do you know if the technological advance you have made is obvious?
SEEK PROFESSIONAL ADVICE
need to consider what is known in the field
is there anything surprising or unexpected about what you have done?
have you solved a technical problem in the field?
Examples
Application of known measures: e.g. invention relates to a pump which differs from a known pump solely in that its motive power is provided by a hydraulic motor instead of an electric motor – would be obvious to use another kind of motor.
Mixture of medicines: known to be valuable to mix together a painkiller and a tranquiliser. Invention may reside in mixture of a known painkiller with a different tranquiliser. Found that using a particular tranquiliser (which intrinsically had no painkilling effect), the analgesic effect of the tranquiliser was intensified in a way that could not have been predicted.
Patent office search reports and examination reports - responses needed
Input from inventors
Do the documents say what the patent office thinks?
Why are any differences between the invention and the documents significant?
Is the invention still not an “obvious” development?

11. What criteria must be met?
Industrial applicability
Capable of being made or used in any kind of industry, including agriculture
Practical application and some profitable use
Low bar – must be plausible/credible
Must demonstrate at time of filing
Industry should be understood in a broad sense including any physical activity of “technical character”, i.e. an activity that belongs to the useful or practical arts rather than aesthetic arts
Must demonstrate at time of filing - You cannot have a patent for an invention when only years later you or someone else finds out what it is for.” The CoA upheld EPO case law, confirming that an applicant cannot rely on post-filing evidence of an effect; any effect must be at least plausible from the original patent application and common general knowledge at the filing date. 
the patent must disclose "a practical application" and "some profitable use" for the
claimed substance, so that the ensuing monopoly "can be expected [to lead to] some
... commercial benefit";
a "concrete benefit", namely the invention's "use ... in industrial practice" must be
"derivable directly from the description", coupled with common general knowledge;
a merely "speculative" use will not suffice, so "a vague and speculative indication of
possible objectives that might or might not be achievable" will not do; and
the patent and common general knowledge must enable the skilled person "to
reproduce" or "exploit" the claimed invention without "undue burden", or having to
carry out "a research programme".
Mere fact that it can be made is not enough – must have some practical application and some profitable use so that monopoly you get leads to commercial benefit

12. What criteria must be met?
Sufficiency of disclosure
Disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art without inventive skill
Addressing skilled person so description of known routine techniques less important than unknown non-routine techniques
Detail required can depend on breadth of claims
Need at time of filing
Must describe the invention clearly and completely
Must be an ‘enabling disclosure’
must enable a person skilled in the art to put the invention into practice
cannot withhold important features
the “best mode” must be included for the US
If not ‘enabling’ – a patent may not granted or may not be enforceable

13. What criteria must be met?
Support
Examples to support working of the invention
Experimental data – in vitro / in vivo
Need at time of filing
Generally, the more data the better
Most claims are generalisations from one or more particular examples. The extent of generalisation permissible is a matter which the examiner must judge in each particular case in the light of the relevant prior art. Thus, an invention that opens up a whole new field is entitled to more generality in the claims than one which is concerned with advances in a known technology.
A fair statement of claim is one which is not so broad that it goes beyond the invention nor yet so narrow as to deprive the applicant of a just reward for the disclosure of his invention.
Enough so that skilled person can extend the teaching of the description to the whole field claimed by using routine methods of experimentation or analysis
For example, the invention may relate to a certain treatment of plant seedlings to obtain specified results – shown for one type of plant. But well known that plants vary widely in properties, so well-founded reasons for believing that would not apply to all plants. Either need to provide convincing evidence why is applicable would need to restrict to one type of plant.

14. When and what needs to be done to get a patent?
Contents of a patent specification
Description – describe how to carry out invention
Claims – define scope of invention
Drawings
Preparing a patent specification
Professional help
The more information we have, the better the job we can do
Invention disclosure forms
Prepare draft with questions Review by inventors Filing

15. When and what needs to be done to get a patent?
File EPO application
(£4-5K)
File foreign applications (e.g. PCT)
(£4-6K)
File priority application
(£3-6K)
GRANTED PATENTS
Publication
File applications in territories of interest
(£1.5-10K each) 12 18
30/31
months
Two main issues
Want to know:
Is it going to work?
Is it going to be useful and commercially interesting?
Is it potentially patentable? - further searches
Strengthening application
Evidence that it works, and/or
Experimental support for why it ought to work
Confirmation/refinement of why it works
Search and preliminary opinion on patentability
Examination by national patent offices
Decision to proceed?
Decision to proceed?

16. International PCT application

17. Inventorship
Inventor is the “actual devisor” of the invention: Examples include:
Academics
Students
Consultants
External contractors
Inventorship vs authorship
May be more than one inventor
Important to get inventorship right
Enforcement
Ownership
The terms 'author' and 'inventor' are not synonymous.
Generally, an author should be the individual(s) who wrote or contributed to writing a particular work.
In the scientific world, authors of journal articles are typically those persons involved in designing or performing the experiments or in writing the resulting manuscripts. In addition, authorship is sometimes granted for the recognition of hard work or even for financial support.
In contrast, inventors of subject matter in patents have to be legally determined, according to the criteria of patent law, by their involvement in the original conception of the invention (not necessarily the same individual(s) involved in determining whether the invention works, or writing the analysis). 
The rules and guidelines for determining inventors are established by laws and judicial decisions and can differ from country to country.

18. Ownership Stems from inventorship
Usually, employer owns patent if invention made during course of normal employment
Be aware of contracts held by inventors – relevant to ownership
Important to ensure patent in name of rightful owner
Ensure have supporting documentation to establish/verify ownership (e.g. employment, consultancy, assignment documents…)
Important to register change of ownership at patent offices
In most European countries, ownership of an invention may pass from the inventor to their employer by rule of law if the invention was made in the course of the inventor's normal or specifically assigned employment duties, where an invention might reasonably be expected to result from carrying out those duties, or if the inventor had a special obligation to further the interests of the employer's company

19. Freedom to operate Distinct from patentability
Invention may be patentable but third parties may own IP that you would infringe by commercialising your invention
May be necessary to conduct searches to assess freedom to operate
If relevant third party IP identified, various options may be available
design around
licensing
cross-licensing
opposing/invalidating third party IP

20. Thanks for listening!

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