BioEntrepreneurshipIntellectual Property Strategy

The Basics

Linda Kurdydyk

Branscomb LM, Frey Lecture, Duke University Law School, February 2004

Intellectual Property is an asset used to generate R&D funding Defines and sets your business apart from others Can be sold or licensed to form an important revenue stream Can be exploited through strategic alliances Forms part of marketing and branding Use to stop others using, making, selling or importing it without

your permission

Getting tothe Other Shore

IdentifyTechnology to Protect

Product Composition Method/use (1st) Process New use for known product Markers Screening methods Targets Software

Types of Protection

Patents Copyrights Trade secrets Trademarks

Major Forms of Protection:

Forms of protection may be used SIMULTANEOUSLY…

BUT DEPENDS ON TECHNOLOGY STAGE

SelectingType of Protection

Patents Trade secrets Copyrights

Early Stage Technology

Word, symbol, design, or slogan Identifies and distinguishes the source

of the goods or services Prevent against likelihood of confusion Potentially infinite term Mark must be used in commerce Symbols: TM or ®

Trademarks

Protects confidential information with commercial value (e.g. processes)

No legal formalities Use reasonable measures to keep secret

- confidentiality provisions in employment agreements etc. Provide notice on all confidential information Potentially infinite term

Trade Secrets

Protect original works of authorship Restricted to expression of an idea and

does not extend to the idea itself. Literary and artistic material, music, films,

sound recordings and broadcasts, including software and multimedia

Controls use of authors material such as by making copies, issuing copies to the public, performing in public, broadcasting and use on-line

Copyrights

Not effective to stop very similar works independently created

Can’t be used to stop programs that execute the same function or achieve the same result

Register commercially important works Copyright notice: Copyright © 2006 John Doe Term: Life of author + 50 years (US + 70 years)

Copyrights

Creator of the work owns the copyright

Work created in the course of employment belongs to employer unless agreement to the contrary

Ownership of Copyrights

Does a researcher infringe copyright by quoting works by other authors in articles and books?

• Canadian Copyright Act provides that any "fair dealing" with a work for purposes of private study or research, or for criticism, review or news reporting is not infringement

• BUT user must give the source and the author's name, if known

• Educational institutions can use copyrighted works if done on premises of educational institution for educational or training purposes, provided no suitable substitutes available in the commercial marketplace

Fair Dealing

New and improved products, processes, etc. that are capable of industrial application

Prevent others from performing certain acts • Make, Use, Sell or Import

Fixed term • 20 years from filing or 17 years from issue

Independent creation is not a defense

Patents

Why are you filing? (Academic versus Commercial Reasons)• Defensive filing• Offensive filing• Building up assets - improvements and modification

Why Not?• Costs money• Can take a long time to apply for - technology will be

obsolete before patent is granted (e.g., software)• Protection isn't automatic

Do You Really Need/Want a Patent

What type of invention? Utility

• Is the invention useful? Enabled

• Is the invention disclosed and described by the inventor in such a way as to enable others to make and use it

Is It Patentable?

"Anything Under the Sun that is Made by Man" (U.S. Supreme Court, 1980)

US05971829Motorized ice cream cone ...for imparting rotation upon the cup and rotationally feeding its contents against a person's outstretched tongue.

US05934226Bird diaper ...featuring an enclosed pouch... and apertures to accommodate both the wings and the tail of the bird.

Methods of medical treatment (Canada, Europe)

Use of human embryos for industrial or commercial purposes (EP, Canada)

Transgenic animals (Canada)

Scientific facts or principles -Upstream discoveries that amount to the mere identification of a functional biological relationship

Non-Patentable Subject Matter

LabCorp vs Metabolite - high homocysteine levels and the deficiency in the vitamins cobalamin or folate

Ariad v. Eli Lilly - U.S. Patent No. 6,410,516 claimed a functional relationship between a biochemical pathway (NF-kB) and gene expression and anything that acts to affect that relationship; Lilly's drug products were developed several years before the patent

http://cartoonstock.com/directory/P/Patentasp

Basic Scientific Principles, Laws of Nature and Natural

Phenomena

What’s Hot• Therapeutics, devices, diagnostics, vaccines

What’s Not• Screening methods and non-validated hits• Drug targets• Transgenic animals (trade secret - material

transfer agreements)

What YouShould/Shouldn’t Patent

VACCINES AND THERAPEUTICS

• Monoclonal Antibody for Treatment of RSV• AIDS Drug • Paclitaxel as a Cancer Treatment • Synthetic Thyrotropin as Adjuvant in Thyroid Cancer • Hepatitis A Vaccine (Strain HM-175) • Nutritional Supplement to Treat Macular Degeneration

Radioimmunotherapy for Non-Hodgkin’s Lymphoma • Proteosome Inhibitor for Treatment of Multiple Myeloma

NIH Top 20 Commercially Successful Inventions*

* for FY 2005, based on royalty income

DIAGNOSTICS

• Serological Detection of Antibodies to HIV-1

• DNA Probe for Breast Cancer Diagnosis

• Genoyping of HIV Protease Gene

• Serological Detection of Antibodies to HTLV-1

NIH Top 20 Commercially Successful Inventions

INSTRUMENTATION/DEVICES• Paclitaxel-Eluting Coronary Stent System

• Enhanced Magnetic Resonance Imaging Through Magnetization Transfer

• Laser Capture Microdissection

RESEARCH MATERIALS• Reconstituted Basement Membrane

• Neutrophil Chemotactic Factor (Interleukin-8)

• Transforming Growth Factor Beta (TGF-beta)

• Chemokine Receptors

NIH Top 20 Commercially Successful Inventions

Is there public prior art (e.g. publications) which precedes the invention in identical form?

U.S. and Canada - 1 year from publicly disclosed, used or offered for sale

Most Everywhere Else - NO GRACE PERIOD

• Foreign rights are compromised the instant the invention is made publicly available

Disclosure is OK if done correctly

(Confidentiality Agreements)

Novelty

Invention must not be obvious to a person skilled in the art

Is the invention a nontrivial extension of what was known?

Are there unexpected results/ advantages?

Inventive/Non-obvious

Things to Do

• Search scientific literature and patent databases for relevant publications and patent documents

• Prepare summary of background technology

• Organize scientific data, prepare description of protocol and results, create Tables/Figures illustrating results

• Speak to a patent agent

Preparing and Filinga Patent Applications

Patentability Patent databases

• http://www.uspto.gov/patft/index.html• http://www.european-patent-office.org/_new_sengi

nes/index.en.php

• http://www.wipo.int/pctdb/en/ • http://www.delphion.com/ • Scientific literature databases• http://www.ncbi.nlm.nih.gov/entrez/query.fcgi • The CAS Search Service (SciFinder, ChemPort)

http://www.scienceip.org/typesearch.html Right to Use/Freedom to Operate

• When? • Formal Opinion?• Due diligence?

Searches

First/Priority Filing - http://www.uspto.gov/

• US Provisional

Patent Cooperation Treaty - http://www.wipo.int/portal/index.html.en

• procedure for filing applications to protect internationally

• single filing results in single search with a written opinion (optionally a preliminary examination)

• examination (if provided by national law) and grant procedures are handled by national or regional authorities

• delay national or regional procedures associated filing fees and translation costs

Types of Patent Filings

File provisional applications to

• protect product, compositions, formulations, methods of treatment, uses, kits

• contemplate future development - new formulations, combinations, new uses

• experiments to support filings

One year later file PCT - with experimental data or defensive

Simultaneous PCT and US filings

Small Biotech Perspective

Negotiate rates with patent firms

Prepare a patent budget

Review portfolio regularly to ensure that only relevant patent applications are maintained

File in important jurisdictions

Reducing Costs

Ensure your IP is relevant to your business plan

Be prepared for due diligence - have organized files, tracking systems, charts, outside patent counsel

Police competitors for infringing activities

After You File

If someone infringes patent rights must use remedies available under the civil law e.g. seek injunctions and damages

Patent suits with between $1 -15 million under contention - median costs and fees about $3 million*

Insurance policy to cover costs of potential actions

Enforcement of Patent Rights

* American Intellectual Property Law Association, Report of the Economic Survey 2003 (Washington, DC: Fetzer-Kraus, Inc., 2003)

By the time of regulatory approval, the patent life for a product may be less than ½ the statutory 20-year patent term

In some jurisdictions you can extend the patent term

US

• Can extend for a period not exceeding 5 years, total extension must not result in an effective remaining patent life of greater than 14 years beyond the date of FDA approval

• Only one patent may be extended per approved product, the patent to be extended must be unexpired, and cover the approved product

Patent Term Extension

Avoid infringement

Right to use searches

Exceptions to Infringement

• Limited statutory experimental use exception for uses of patented drugs, devices, and biologics where the use is solely for purposes reasonably related to the development and submission of information to a regulatory authority

Third Party Patents

A new chemical entity (NCE) first approved as a drug under a New Drug Application (NDA), the sponsor is entitled to a 5 year exclusivity period that bars the submission of any generic drug application for a product that contains that NCE

If new clinical studies are essential to approval of certain changes to an already approved drug, e.g., a new indication, a new dosing regimen, a new patient population, a switch to over-the-counter marketing status, or other labeling changes, the sponsor is awarded a 3 year exclusivity period for the approved change

Regulatory Exclusivity

Data supporting NDA approvals is protected from public disclosure by laws, including the Federal Food, Drug, and Cosmetic Act (FDCA), the Freedom of Information Act (FOIA), and the Trade Secrets Act

7 year exclusivity for orphan drugs or biologics - those intended to treat rare diseases or conditions (less than 200,000 US patients) BUT does not block approval of the same drug for a different indication, approval of another version of the same drug if the new version offers clinical advantages over the prior product

Regulatory Exclusivity

6 month pediatric exclusivity when companies conduct FDA-requested studies of a drug in pediatric populations

Adds a six month approval delay for competing generic products, added to the end of any unexpired patent or regulatory exclusivity

Regulatory Exclusivity

Developing an IP portfolio and strategy are critical in crossing the Darwinian Sea BUT OTHER FACTORS SUCH AS STAGE OF PRE-CLINICAL/CLINICAL DEVELOPMENT, MARKET SIZE, ETC. NEED TO BE ADDRESSED

Are We There Yet?

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