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, U.S.rbasile@ssjr.com

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.

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 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

Conclusion

Applications must include detailed descriptions of the invention that are aligned with the scope of the claims.