Patenting strategy and commercialisation Dr Michael Pears 8th May 2012

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?

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

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

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

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

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,

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

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

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?

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

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

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.

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

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?

International PCT application

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.

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

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

Thanks for listening!

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