mars best practices: ip best practices for life sciences companies - victoria heppell

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Discover why intellectual property is a critical asset to your company. Within the context of current economic uncertainty, this series covers cost-effective strategies for securing IP and patent rights to enhance the market value and competitive position of your life sciences or ICE company.


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2. IP Best Practices for Life Sciences Companies 3. 3 Introductory Remarks An IP portfolio can be used in a variety of ways to provide a tangible asset for a company. To be able to use your IP portfolio to carve out a niche, generate profit through royalties, or to attract potential investors, the patents must be well supported, provide coverage for any current or future commercial product/process and preferably also provide broad coverage. 4. 4 What Is Intellectual Property ? Patent Trademark Copyright Industrial Designs Trade Secret 5. 5 Patents Provides the right to exclude others from making, using, and selling a product or process during the term of the patent In exchange for a fully enabling disclosure of the best mode of practicing the invention Term of the issued patent is 20 years from date of filing Patent rights are territorial An issued patent does not necessarily grant you the right to practice your invention 6. 6 Why Patent? Patents may be used to generate value for a company Competitive advantage to prevent copying gain market share Blocking patents as barrier to market entry - force competitors from market Generate income via royalty stream Attract investment increase value of a company Negotiating for possible cross-licensing 7. 7 Value of IP Portfolio A viable start-up company usually has a small niche where they excel at a certain technology e. g. small molecules, medical devices. Companies, usually start-up companies, adopt a strategy to use their IP as a tangible asset for evaluation to investors or purchasers for a potential acquisition. Patents therefore form a large part of the value of the company. 8. 8 Deciding What to Patent As a business asset, value depends on other factors beyond simply technical merit: Is it so novel that broad claims are likely to issue? Can you block others - effectively preclude others from copying? Is it difficult for competitors to design around? Can infringement be easily detected? 9. 9 Filing Strategy what to think about Value = Validity + Scope of Claims Business Plan Vendible Product Claim Scope Market Analysis Patentability Analysis Ownership 10. 10 What is Involved? Information gathering Public disclosure? Determine inventorship Understand the invention Drafting the patent application Prosecution of the application 11. 11 Determine Inventorship Who contributed to the subject matter of the claims ? What is their relationship with the company/ institution, e.g. employee, contractor When was the invention created? Joint inventors anyone who contributed to at least one claim Naming the correct inventors is important a patent that fails to identify the true inventors may be held invalid and unenforceable 12. 12 Ownership Increased value when IP is owned by a single entity Employment Agreements/Contracts in place before IP is generated Assignment Agreements when research is done by third party Joint Collaborations IP considerations Grants/funding for research IP ownership by others All ownership of IP should be determined before the research is conducted and before patents are filed. 13. 13 Be Aware of Potential Bars to Patenting Public disclosure (e.g. publication, poster at a conference), public use or offer for sale may be a bar to obtaining a patent 1 -year grace period in US; Europe and most other jurisdictions require absolute novelty Any of bar actions start the clock ticking Use Non-Disclosure Agreements with appropriate description Using NDAs also avoids the potential for the other party filing for a patent on the same or similar ideas File the patent application early, if possible 14. 14 Patentability Analysis should you spend the money ? Identification of potential novelty and inventiveness Areas for investment of R&D Identification of competing technology Patents that need to be circumvented Identification of possible collaborations/partners Identification of possible license/cross-license options 15. 15 Prior Art Searching? No duty to search for prior art But must disclose relevant prior art of which you are aware Searching patent publications prior art may have implications related to willful infringement for patents found, since considered on notice 16. 16 Drafting the Patent Application Understand the invention both technically and in its commercial context Prepare a sufficient and enabling disclosure; beware of discussing the prior art Provide claims of varying scope; less vulnerable to prior art cited during prosecution and even after issuance, and thereby highly enforceable The claims of the issued patent define the legally enforceable scope of the patentees rights Draft different types of claims (product, i.e. compound, medical device, method, use) as appropriate to the invention 17. 17 Obtaining the Desired Claim Scope What is the vendible product? Support in the patent for the product itself, examples of synthesis of compounds, in vitro data, clinical trials, etc. What are the variants? When possible, allow some time to research variants of the product so that the scope of the patent specification can be expanded. What are your competitors doing? Ideally, the claims should both protect your product and exclude your competitors from working around the patent. This requires an expanded patent specification support by research. What is your niche? Do the claims of your patent build on your portfolio to carve out a niche? 18. 18 Claim Scope Claim Scope Product Variants Competitors Portfolio 19. 19 Scope of coverage - example Broad Scope Narrowing Scope for Group A Narrowing Scope for Groups A, X, Y, W, R4 20. 20 Obtaining Desired Claim Scope Filing of a full and complete disclosure You can only get protection for what you have done and shown in the description and what you can soundly predict based on what you have done. Disclosure of all contemplations of the invention. Demonstration of utility through test results whenever possible. Carrying out the right tests and trials to ensure broad coverage in the patent. Lack of full disclosure can lead to unduly narrow claims and possible invalidity of the patent. 21. 21 First Filing Typically, Canadians file first in US, many investors show preference to US filings Can file a Provisional application for lower fees while preserving early priority date; convert to Regular application within next 12 months; delays examination, however: The Specification of the Provisional application as filed must provide support for claims once converted 22. 22 Patent Applications options for filing U.S. Provisional Application To be filed when a disclosure is imminent Should be as detailed as possible or priority claim may be invalid Avoid unless necessary due to budget and publication constraints PCT (Patent Cooperation Treaty) Application International Application holding a filing date and place in nearly every country in the world 30 month deadline for selecting jurisdictions in which to obtain protection Search Report and Written Opinion/Report on Patentability issued European Application Single Examination for EU Member Countries Validation in selected jurisdictions 23. 23 Prosecution A well prepared specification and claims can make prosecution cleaner which can reduce costs Be aware of File Wrapper Estoppel in US Duty of candor in US applies during entire pendency of application 24. 24 Scope of Protection in all jurisdictions Market Analysis Value is increased if protection is obtained in all relevant jurisdictions Where is the market for the product? 20 year term Look to future markets and growing economies Where is the product manufactured? Prevent manufacture of product by others in strategic locations Import/Export Regulations Where are my competitors? Where is the R&D market? Which jurisdictions are more patent friendly? Importation Policing Litigation/Damages 25. 25 Scope of Protection Consumer Markets USA High Population, Disposable Income, Quality of Living Europe High Population, Disposable Income, Quality of Living Canada Disposable Income, Quality of Living Japan Disposable Income, Quality of Living China Highest Population, Increasing Disposable Income Producer Markets China Low cost manufacturing Competitors Russia/Eurasia Advanced Education, Natural resources Australia Advanced Education, Natural resources Enforcement China Emerging policing and government backing regarding enforcement 26. 26 Post-Filing Considerations Event Timeline for research and funding Maximizing Niche Protection cover your products Maximizing Maneuverability Freedom-to-Operate 27. 27 Post-Filing Timeline First application filed 12 Months PCT Application/Regular Application 18 Months Publication of First application 30 Months National Phase Entry of PCT Application 28. 28 Post-Filing Strategy Timeline for selecting jurisdictions: 1 year from priority date regular filed application 30 months from priority date PCT application Delay in time allows for: Funding Research/Test Results Partnering/Selling 29. 29 Maneuverability - Pending Applications Pending applications allows for amendment to scope of claims, providing support in application as filed Ability to amend claim scope may capture changes in research and/or product development When looking to use IP to increase value for acquisition, keep patent applications pending as long as possible. Allows for new owner/licensee to amend the claim scope of the pending application. Amending claims of allowed patent much more difficult and restricted. 30. 30 U.S. Strategy Consider continuation practice Obtain allowed claims to narrow scope and then file continuation patent directed to broader claim scope. Pending application provides for possible adjustment to the claims based on actions of competitors. Terminal Disclaimers/Double Patenting. Continuation-in-Part Applications for improvement


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