Transcript Navigating Your Inhalation Patents Through the European Patent

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. Basile
Member
St. Onge Steward Johnston & Reens LLC
Stamford, Connecticut, U.S.
[email protected]
What is the European Patent Office
Created by International Treaty
Went into Force in 1977
Single Examination Good for 38 Contracting
States
More 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
English
French
German
Parts of European Patent Application
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(cont.)
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
Filing European Patent Application
Applications can be physically submitted to EPO
 Munich, Berlin, The Hague
 Industrial property office of contracting state
Vast majority of applications filed on line
 www.epo.org
 Less chance materials are lost or misplaced
Review and Grant Procedure
First 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 Proceedings
Opposition 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 Clarity
Board 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 Disclosure
Claim: 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 Step
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 seethrough
Prior art device had see-through spacer for MDI
made of antistatic material.
Invention
Prior Art
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 Step
Only 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 Application
Claim: 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
Conclusion
Applications must include detailed descriptions
of the invention that are aligned with the scope
of the claims.