Ensuring intellectual property for melt extrusion Wouter Pors Bird & Bird, The Hague
Intellectual Property – the basics <ul><li>Never just rely on legal protection of intellectual property </li></ul><ul><li>...
Patents - scope versus validity <ul><li>Patent protection is a balance between broad protection and difference from prior ...
Patents – inventive step <ul><li>Inventive step is the real issue </li></ul><ul><li>Taking an active ingredient regardless...
Patent protection – the specifics <ul><li>Melt extrusion as such does not create a new active substance </li></ul><ul><ul>...
Patent protection – the specifics <ul><li>Patents for melt extrusion  are not basically different </li></ul><ul><li>Substa...
Patent protection – the specifics <ul><li>Process patents protect ways to produce a drug </li></ul><ul><ul><li>Process pat...
Best patent protection <ul><li>Claim for active ingredient regardless of form </li></ul><ul><ul><li>If the invention is th...
Best patent protection <ul><li>If active ingredient already claimed </li></ul><ul><ul><li>Claim various forms (if this inc...
See how far you can get <ul><li>Specific process and specific combination most likely to be strongest on validity </li></u...
Litigation strategy <ul><li>Which are the important markets for the competition? </li></ul><ul><li>Where can you litigate ...
Licensing <ul><li>Licensing follows patent protection </li></ul><ul><li>Do not extend beyond the scope of your patent </li...
Thank you! <ul><li>Wouter Pors </li></ul><ul><li>Bird & Bird The Hague </li></ul><ul><li>Van Alkemadelaan 700 </li></ul><u...
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2008 11 26 Melt Extrusion

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2008 11 26 Melt Extrusion

  1. 1. Ensuring intellectual property for melt extrusion Wouter Pors Bird & Bird, The Hague
  2. 2. Intellectual Property – the basics <ul><li>Never just rely on legal protection of intellectual property </li></ul><ul><li>Create a preferred market position </li></ul><ul><ul><li>Company reputation </li></ul></ul><ul><ul><li>Scientific publications (after protection) </li></ul></ul><ul><ul><li>Product range track record </li></ul></ul><ul><ul><li>Marketing efforts </li></ul></ul><ul><li>Trademark reputation </li></ul><ul><ul><li>Company </li></ul></ul><ul><ul><li>Range of products </li></ul></ul><ul><ul><li>Specific product </li></ul></ul>
  3. 3. Patents - scope versus validity <ul><li>Patent protection is a balance between broad protection and difference from prior art, needed for validity </li></ul><ul><li>Two basic requirements: novelty and inventive step </li></ul><ul><li>Novelty: invention not disclosed in one single prior publication or prior public application </li></ul><ul><li>Example of novelty: </li></ul><ul><ul><li>Active ingredient is known from prior art </li></ul></ul><ul><ul><li>No scientific publication on melt extrusion application </li></ul></ul><ul><ul><li>Prior patent for active ingredient claims active ingredient without (1) claiming the combination or process (2) without disclosing the combination or process in the patent specification </li></ul></ul>
  4. 4. Patents – inventive step <ul><li>Inventive step is the real issue </li></ul><ul><li>Taking an active ingredient regardless of form as starting point, how obvious is the melt extrusion production or combination to the man skilled in the art? </li></ul><ul><li>Can you add specifics of the process that make it inventive </li></ul><ul><ul><li>However, this of course limits the scope of protection </li></ul></ul>
  5. 5. Patent protection – the specifics <ul><li>Melt extrusion as such does not create a new active substance </li></ul><ul><ul><li>Patent protection may be claimed for the combination of an active substance and the excipients used in melt extrusion or </li></ul></ul><ul><ul><li>Patent protection may be claimed for the process of manufacturing the product through melt extrusion </li></ul></ul><ul><li>Nevertheless, specific market authorisation required </li></ul><ul><li>However, since no new active substance, no Supplementary Protection Certificate available </li></ul><ul><ul><li>Exclusivity only for term of the patent (20 years from filing) </li></ul></ul><ul><ul><li>No 5 year extension as for new substances </li></ul></ul>
  6. 6. Patent protection – the specifics <ul><li>Patents for melt extrusion are not basically different </li></ul><ul><li>Substance patents v. process patents </li></ul><ul><li>Substance patents protect active ingredient or specific form </li></ul><ul><ul><li>Melt extrusion form may be specific percentages or range of percentages of active ingredient versus polymer and versus plasticizer </li></ul></ul><ul><ul><li>This may further include the phase of the ingredients, such as amorphous form (however, stabilizing of amorphous forms through melt extrusion as such of course is no longer novel) </li></ul></ul><ul><ul><li>Further excipients, unless adding those is general knowledge of the man skilled in the art (to obtain certain characteristics) </li></ul></ul>
  7. 7. Patent protection – the specifics <ul><li>Process patents protect ways to produce a drug </li></ul><ul><ul><li>Process patents will only prevent competition from applying patented process </li></ul></ul><ul><ul><li>Burden of proof that the combination is produced through patented process is on the patentee (now available: raids on competition) </li></ul></ul><ul><ul><li>Different if combination is new and can be regarded as a “product”, but then why not claim the combination itself </li></ul></ul><ul><ul><li>Combination however may not include inventive step, whereas process might </li></ul></ul>
  8. 8. Best patent protection <ul><li>Claim for active ingredient regardless of form </li></ul><ul><ul><li>If the invention is the combination with the active ingredient, check if the ingredient as such is still available </li></ul></ul><ul><ul><li>If still available, do not fall into the pitfall of portrait claims of research results </li></ul></ul><ul><ul><li>If active ingredient is already known as such, it cannot be claimed anymore </li></ul></ul>
  9. 9. Best patent protection <ul><li>If active ingredient already claimed </li></ul><ul><ul><li>Claim various forms (if this includes inventive step) </li></ul></ul><ul><ul><li>Do not combine all possible forms in one patent </li></ul></ul><ul><ul><li>Claim logical bundles of forms </li></ul></ul><ul><ul><li>Do not invoke all patents simultaneously </li></ul></ul><ul><li>Claim broadest protection for melt extrusion </li></ul><ul><ul><li>Combination with a wide variety in range of active ingredient versus excipient (feeder accuracy) </li></ul></ul><ul><ul><li>But still needs to be novel and inventive </li></ul></ul><ul><ul><li>Maybe glass transition specifics can be included to render the process novel, since this is less usual outside pharma </li></ul></ul>
  10. 10. See how far you can get <ul><li>Specific process and specific combination most likely to be strongest on validity </li></ul><ul><li>Competition may have different process or different excipient </li></ul><ul><li>Balance of infringement and validity </li></ul><ul><li>Include range of claims in application </li></ul><ul><ul><li>Survival of examination </li></ul></ul><ul><ul><li>Survival of opposition </li></ul></ul><ul><ul><li>Survival of litigation </li></ul></ul>
  11. 11. Litigation strategy <ul><li>Which are the important markets for the competition? </li></ul><ul><li>Where can you litigate effectively? </li></ul><ul><ul><li>90% of European patents litigated in UK, Germany, Netherlands </li></ul></ul><ul><ul><li>UK most critical on novelty </li></ul></ul><ul><ul><li>Netherlands fair balance between patentee and competition </li></ul></ul><ul><ul><li>Germany has dual system: validity basically assumed </li></ul></ul><ul><ul><li>Other countries may have advantages based on specifics </li></ul></ul><ul><li>Do not patent if you are not prepared to litigate </li></ul><ul><ul><li>Unless purely done for tax purposes or abstract share value </li></ul></ul><ul><ul><li>External investors will want to have more comfort </li></ul></ul>
  12. 12. Licensing <ul><li>Licensing follows patent protection </li></ul><ul><li>Do not extend beyond the scope of your patent </li></ul><ul><ul><li>Do not guarantee or imply freedom to operate </li></ul></ul><ul><ul><li>Do not represent more than you can claim </li></ul></ul><ul><ul><li>Do not imply unsubstantiated generic marketing approval </li></ul></ul><ul><li>Carefully limit scope of license </li></ul><ul><li>Do not warrant properties you cannot guarantee </li></ul>
  13. 13. Thank you! <ul><li>Wouter Pors </li></ul><ul><li>Bird & Bird The Hague </li></ul><ul><li>Van Alkemadelaan 700 </li></ul><ul><li>[email_address] </li></ul><ul><li>+31 70 3538825 </li></ul><ul><li>+31 653 293896 </li></ul>
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