a start-up company’s perspective on patent prosecution carolina innovations seminar january 8,...

A Start-up Company’s Perspective on A Start-up Company’s Perspective on Patent ProsecutionPatent Prosecution

Carolina Innovations SeminarJanuary 8, 2009

www.liquidia.comwww.liquidia.com

Overview: A Start-up’s Perspective on Overview: A Start-up’s Perspective on Patent ProsecutionPatent Prosecution

• Overview of Liquidia’s Technology• Intellectual Property Perspective of Liquidia

At conception Today

• Start-up Patent Strategy Considerations• Prosecution Activities• Enforcement / Defense Considerations


Pattern Replication In Non-Pattern Replication In Non-wetting Templates (PRINTwetting Templates (PRINT®®))

“High Resolution Soft Lithography: Enabling Materials for Nano-Technologies”; Rolland, J. P.; Hagberg, E. C.; Denison, G. M.; Carter, K. R.; DeSimone, J. M. Angew. Chem. Int. Ed. 2004, 43, 5796-5799 .

Replicate

Master Template

Fluorocur® Mold

or

2 μm


PRINTPRINT®® Film Fabrication Film Fabrication


PRINTPRINT®® Particle Fabrication Particle Fabrication

Apply liquid to be molded

Form Fluorocur® mold


Control of Particle Size and Shape at Control of Particle Size and Shape at the Nanoscale the Nanoscale

d = 200 nm, L = 200 nmd = 113 nm, h = 36 nm d = 95 nm, h = 280 nm

Worm-like Flexible PRINT™ Particles: 80 nm x 2000 nm


PRINTPRINT®® Particle Therapeutics Particle Therapeutics

200 nm degradable particles with siRNA

3 μm drug particles for pulmonary delivery

2 μm vaccine particles 80 x 5000 nm particles for enhanced circulation


History of Liquidia – an IP PerspectiveHistory of Liquidia – an IP Perspective


Liquidia Today – an IP PerspectiveLiquidia Today – an IP Perspective

Films & Membranes Particles

Particle ApplicationsFilms & Membranes

Applications



Fluoropolymer Compositions of Matter

Trademarks

Trade Secrets



Manufacturing tools and techniques Methods of making and using

Mold materialsMethods of making and using

Compositions of MatterMethods of using

Trade Secrets



Films & Membranes

Micro & Nano-Patterned FilmsMicro & Nano ArraysMicrofluidic DevicesPhotovoltaic Devices

MoldsMedical Devices

Including: Methods of Making and Using



Particles

Micro & Nano-Particles

Harvesting, Collecting, & Purifying Particles

Molds

Including: Methods of Making and Using



Films & Membranes Applications

Applications: Optical Films, Nano Wire Grid Polarizer, Liquid Crystal Alignment Layer, Alternative Energy,

Photovoltaic Device Patterned Layers, Fuel Cell Membrane, Patterned Membrane

Including:Methods of making and using



Particle Applications

Applications:Drug Delivery Particles, Inhalation Particles, Protein Particles, Targeted Particles, Specific

Particle Compositions, Size and/or Shape Specific Particles

Including: Methods of making and using, Treating a patient,

Dosages, etc.


Choosing a Law Firm / RepresentationChoosing a Law Firm / Representation

• Considerations: Location

• Local can visit and become more comfortable and familiar with your technology, know reputation

Experience• Technical alignment

• Legal expertise

Cost Size

• Some law firms and/or groups are more tailored to working with small start-ups

• Larger firms typically offer more full serviceCorporate, licensing, employment…


Initial Patent FilingsInitial Patent Filings

• Highly Important Creation of value Establishes initial footprint of company Priority date for your technology

• Timing File early File prior to any disclosure to potential investors,

collaborators, and any third-party


Initial Patent Filings: DisclosureInitial Patent Filings: Disclosure

Bulk Filing Focused Filing

Pros: • establish early filing date for all your ideas and data• ability to mine the application for years to come• create value based on broad unknown quantity of ownership

Pros: • supported and enabled• cost effective • less blocking prior art against your later filing(s)

Cons:• may create prior art against your later filings (obviousness) • increased cost and complexity

Cons: • less subject matter to mine in future years• less mystery around scope of what you might eventually own


Follow on FilingsFollow on Filings

• Protect ongoing technical developments• Create value• Increase your licensing position

Foresee where customers / competitors are and how your technology may apply in their field

• Create layers of IP protection around your core background

• Enforceability Strategize to enforce your follow-on filings rather than

most core filings whenever possible If lose a follow on filing less damaging to the company


Route of Patent FilingsRoute of Patent Filings

• Timing Provisional application

• 12 months

• Very low filing fees

• No prosecution

• Must be converted

Patent Cooperation Treaty (PCT) application• 30 months

• Limited prosecution

• Relatively low filing fees

U.S. non-provisional application• Prosecution begins as soon as filed

• Filing fees can be high


Route of Patent FilingsRoute of Patent Filings

• Timing

IssuanceFiling Date

Example 1: Provisional PCT Non-Provisional

12 mo. 30 mo.

IssuanceFiling Date

Example 2: Non-Provisional

Time spent in Provisional and PCT status will delay time before issuance.

By not entering Provisional or PCT national stage, applications should issue quicker, however, larger fees will be incurred earlier.

36-48 mo.


Route of Patent FilingRoute of Patent Filing

• Strategy Cash is king in a start-up

• Filing provisional allows you to push off costs

• Provisional applications enable dynamic entrepreneurial environment by quickly and efficiently creating value

Caution – filing excessive cases without considering long term costs

• Abandonment of non-provisional cases results in the subject matter in that patent application being dedicated to the public if it’s not covered in another filing

Maintain confidentiality• File provisional application – if not converted to PCT or non-

provisional you can retain confidentiality Potential trap

• An incomplete provisional application can not be completed / updated upon conversion to Non-provisional or PCT without risking new-matter rejections / challenges


BudgetBudget

Sample budget for 1 patent filing

Country Fees Annuities Total

Australia 20,297 14,639 34,936

Canada 2,545 13,167 15,712

Europe 9,772 1,954 11,726

Japan 4,910 40,689 45,599

China 1,236 16,862 18,098

United States 1,990 7,800 9,790

$135,861

Drafting costsHourly fees v Flat rates

Filing feesWorld wide filings

Translation costsProsecution costs AnnuitiesPatent costs grow exponentially

Note: Translation fees and Prosecution costs are NOT included


Prosecution ActivitiesProsecution Activities

• Working with Counsel In-house counsel v outside counsel

In-house counsel Outside counsel

Pros:• cost effective for large / complex portfolio• closer to technology and developments• able to nurture the portfolio

Pros:• depth and breadth of experience• necessary for docketing cases, tracking deadlines, etc

Cons: • not cost effective for a small portfolio

Cons: • often not as connected with the technology


Prosecution Activities: Working with Prosecution Activities: Working with the Universitythe University

• A positive University representative can be your best asset

• Different models UNC: very collaborative with company, helps nurture technology Other Universities: different / less collaborative models

• Control prosecution University concerned with early stage companies Gain trust and common goal of commercial development as

company matures

• Interactions with University’s counsel Remember they do not represent the company Direct requests and comments through your University

representative


Prosecution ActivitiesProsecution Activities

• File History Watch Prosecution History Estoppel

• Leading countriesUS Europe

• Leading claimsCover productsQuick issuance Continue to pursue broader claims: costs, law changesEstoppel

Information Disclosure Statements• Across family members• Watch examiner cited cases – cross-reference• Policy with scientists: centralize all research materials


Enforcement / DefenseEnforcement / Defense

• Caution when asserting key background cases Serious blow to company Family of patents might fall victim

• Layered Portfolio Build cases beyond core background that are

independent of the core background and can be asserted

• Costs Patent litigation is very costly

a start-up company’s perspective on patent prosecution carolina innovations seminar january 8,...

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