navigating your inhalation patents through the european patent office presented at: rdd europe 2015...
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Navigating Your Inhalation Patents Through the European Patent Office
Presented at:RDD Europe 2015 Respiratory Drug Delivery
Date:May 7, 2015
Presented by: Richard J. BasileMemberSt. Onge Steward Johnston & Reens LLCStamford, Connecticut, [email protected]
What is the European Patent Office
Created by International TreatyWent into Force in 1977Single Examination Good for 38 Contracting StatesMore Efficient and Predictable Than Prior System
Filing to Obtain a European Patent
Must be (1) New,(2) Involve Inventive Step, and (3) Involve Industrial Application
Official Languages EnglishFrenchGerman
Request for Grant of European Application
Description of the Invention
One or more Claims
Drawings (if referenced in the description)
Abstract
Parts of European Patent Application
Description must be “clear and complete”
Application shall disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person of skill in the art. Article 83 EPC
Parts of European Patent Application(cont.)
Filing European Patent Application
Applications can be physically submitted to EPOMunich, Berlin, The Hague
Industrial property office of contracting state
Vast majority of applications filed on linewww.epo.org
Less chance materials are lost or misplaced
Review and Grant ProcedureFirst Stage
(a)review of file for formalities
(b)preparation of search report and preliminary opinion on patentability
(c)publication of application with search report
End of first stage is good time to assess likelihood of getting patent granted
Review and Grant Procedure (cont.)
Second Stage
Substantive Examination by Examiner
Claims must satisfy three elements of patentability
May not amend claims to include subject matter beyond content of application.
Post Grant ProceedingsOpposition Proceeding
Filed within 9 months of patent grant
By Third party
Three Grounds as Basis for opposition
(1) Not patentable subject matter or inventive
(2) Invention not disclosed clearly and completely
(3) Claimed subject matter extends beyond content of application
Post Grant Proceedings (cont.)Revocation or Limitation Proceeding
Filed by Patent Proprietor
Done to correct known problems or weaknesses with patent
Often done with eye toward litigation
Boards of Appeal Decisions:Lack of Novelty
Claim: Particles suitable for use in pulmonary drug delivery by inhalation, which particles are spherical and crystalline, have a rough surface and incorporate an active agent, the particles being obtainable by a method according to any one of claims 1 to 8.
Lack of Novelty
Patent owner argued novelty based on (a) rough surface and (b) particle size distribution based on manufacturing process.
Board Finds No Novelty
Roughness not defined
No mention of particle size distribution in claim
Lack of Clarity
Claim: Particles suitable for use in pulmonary drug delivery by inhalation, which particles are spherical and crystalline, the relative degree of crystallinity being 90% or higher, have a rough surface and incorporate an active agent, the particles being obtainable by a method according to any one of claims 1 to 8
Lack of Clarity
To determine crystallinity description mentions
Use of x-ray powder diffraction
Use of reference powder, beclomethasone, having crystallinity of 79%
Lack of ClarityBoard rejects for lack of clarity because among other things, methodology for determining “relative degree of crystallinity” was not fully described in patent.
Missing: how relevant diffraction maxima selected; way estimation based on broadening of diffraction maxima is to be carried out; how reference sample is chosen
Lack of Clarity
“Under these circumstances, the skilled person is not in a position to determine whether a given sample meets the requirement ‘the relative degree of crystallinity being 90% or higher’”
Insufficiency of DisclosureClaim: Particles for use as a carrier in the preparation of
pharmaceutical formulations for the pulmonary administration of micronized active ingredients by means of a powder inhaler, wherein the median diameter of said particles is greater than 90µm, the surface rugosity is less or equal to 1.1 upon determination of the fractal dimension as described on page 14, line 15-page 15, line 11 and their surface is coated with an additive selected from lubricants, anti-adherents and soluble polymers.
Insufficiency of Disclosure
Claim included the location in description of methodology of how to measure rugosity
BUT, described a new method, adapted by inventors using SEM.
PROBLEM, Same particle could or could not meet claim requirement based on magnification used to acquire image of particle surface
Insufficiency of Disclosure
Board blamed proprietor for deliberately deciding to use own uncommon method
“In general terms, when the issue of sufficiency concerns the description of a method for determining a parameter, the less common the method the more accurate the information provided in the description should be.”
No Inventive StepClaim: A medication delivery apparatus (50) comprising an antistatic component made of a material having surface resistivity of between about 10E10 and 10E12 ohm/sq, wherein at least a portion of said component is see-through
Prior art device had see-through spacer for MDI made of antistatic material.
No Inventive Step
Auxiliary claim: A medication delivery apparatus (50) comprising an antistatic component made of a material having surface resistivity of between about 10E10 and 10E12 ohm/sq, wherein at least a portion of said component is see-through and wherein the antistatic property of the component is permanent.
No Inventive StepOnly feature missing from prior art was antistatic property was “permanent”
Proprietor argued “permanent” meant about one year
Board found that “permanent” meant for the useful/functional life of device and MDI’s are disposable
Extending Beyond Content of Application
Claim: A gaseous mixture containing nitric oxide, oxygen and less than 1 ppm NO2, for use in therapy.
Patent description limited to preventing or reversing acute pulmonary vasoconstriction
Claim as drafted covers ANY therapeutic use of nitric oxide
Extending Beyond Content of ApplicationClaim: Use of a gaseous mixture consisting of NO and N2 for the production of an inhalable medicament for treating pulmonary hypertension in a patient with persistent pulmonary hypertension of the newborn.
Description linked therapeutic treatment of PPHN to specific effect of pulmonary vasodilation.
Extending Beyond Content of Application
Effect of pulmonary vasodilation absent from claim so it would improperly encompass forms of treatment of PPHN not disclosed in application
Extending Beyond Content of Application
Third claim:Use of a gaseous mixture consisting of NO and N2 for the production of an inhalable medicament for reversing acute pulmonary vasoconstriction resulting from persistent pulmonary hypertension of the newborn.
Allowed