NC State Bbs 201 Intro To Biopharmaceutical Science April 3 2009

Introduction to Biopharmaceutical Science
Intellectual Property
(BBS 201)
April 3, 2009

Presented by:
Stan Antolin
Smith Moore Leatherwood LLP
300 N. Greene St., Suite 1400
Greensboro, NC 27401
T: 336-378-5516
© 2009 Smith Moore Leatherwood LLP. ALL RIGHTS RESERVED.

Biotechnology & Intellectual Property

• A problem – osteoarthritis
• Intellectual property
• Osteoarthritis – finding a cure for
• Biology – a basic review
• Developing patent protection
• Summary

Osteoarthritis — Aggrecan
• Articular cartilage
– Cushions bones of the
knee
– Degradation  erosion
eventually bones of the
joint grind or rub
together
• Aggrecan
– Major extracellular
component of articular
cartilage
– Responsible for
providing
compressibility and
elasticity
– Loss implicated in the
degradation of articular
Deluzio, Queen's University, Kingston, ON. Canada cartilage
Peprotech Korea Limited.


Osteoarthritis — Aggrecanase

– Capable of cleaving
aggrecan at the
glu373-ala374 bond
– Could contribute to
aggrecan cleavage
in osteoarthritis
– Could be
synthesized by
osteoarthritic human
articular cartilage
J Biol Chem. 2008 Jan 18; 283(3):1501-7


Aggrecanase
– Difficult to isolate and purify
– Poor stability
– Generally low expression
levels
– Difficult to develop inhibitors
and treatment therapies to
treat diseases that involve
aggrecan cleavage

J Biol Chem. 2008 Jan 18; 283(3):1501-7



• Aggrecanase
– Identify novel forms with improved stability
– Develop ways to
• Produce large amounts
• Isolate aggrecanase
• Purify aggrecanase
• Investigate aggrecanase role in disease
states


• Aggrecanase
– Develop treatments involving aggrecan
cleavage
• Therapies
• Compositions

Intellectual Property: An Overview
Recognizing ownership in ideas generated by
creative thinkers.
– FDA Exclusivities
(US Food and Drug Administration)
– EMEA Exclusivities
(European Medicines Evaluation Agency)
– Trademark or Service Mark
– Copyright
– Trade Secret
– Patent

FDA Exclusivities — IND & NDA or BLA

Time to develop a drug = 10–15 year

Investigational New New Drug Application (NDA) /
Drug Application (IND) Biologic License Application (BLA)

Cost to develop a biologic Cost to develop a drug
2006 = $1.2 billion 2006 = $1.3 billion

Trademarks and
Service Marks
– Trademark (goods)
– Service mark (services)
– Words, names, symbols,
designs, or combinations
– Source and quality
– Standard:
• Priority of use and
• Likelihood of confusion
– Duration:
• Infinite life tied only to use


Trade Secrets
– Protect business or technical information
– Actual or potential commercial value
• unknown or unascertainable through
~ Independent development or
~ reverse engineering, and
– Maintained secret using reasonable effort under the circumstances

• Infinite protection as long as secret OR have tried to keep it that way
– Once out, no protection if no reasonable efforts.
• Need to have a confidentiality procedure in place, and follow that
procedure, before the trade secret is disclosed to ANYONE.

Copyrights
– Protect “original works of authorship”
– Idea expressed in a tangible form
– Life of author plus 70 years

Registration: Receive the exclusive right to:
• Protection is automatic but • Reproduce
registration allows you to sue • Create derivative works
infringers and receive statutory
• Distribute
damages plus attorneys’ fees
• Perform
• Easy and inexpensive
• Display the work publicly

Patents
– Protect inventions
• standard: useful, novel, and non-obvious
• Duration: 20 years from date of filing

What A patent protects: EXCLUDSIONARY right :
• Utility • EXCLUDE others from making,
– Machine using, selling, offering for sale,
– Process or importing in the U.S. The
product or process of the claim
– Article of manufacture
– Composition
Do not receive right :
– An improvement thereof
• To make or use the product or use
• Design (14 years from grant) the process of the claim
• Plant

The Patent Bargain
Inventor receives :
• Right to EXCLUDE others from making, using, selling,
offering for sale, or importing in the US
• Does NOT give the owner any right to make or use

Public receives:
• Disclosure of the best way to solve a problem
• Right to use that solution once the inventor’s rights are
exhausted

Design Patents
Protects the appearance of an invention
• Does not protect structural or functional features

Duration is fourteen years from grant date

There is only one claim


Plant Patents
• Protects asexually reproduced plant
varieties

• Duration is 20 years from date of
application

• There is only one claim in a plant
application

Utility Patents

“Anything under the sun that is made by man” (Almost)
– Machine
– Process
– Article of manufacture
– Composition
– An improvement thereof
Diamond v. Chakrabarty, 447 U.S. 303 (1980),

International Patent Protection
Patents are Territorial: Each Country Gets An Application.

Different Laws: Variations of the Same Application.

Treaties: PCT and Paris

Regional Patent Offices: WIPO, EPO, OAMPI, EAPO . . . .

United States: Everywhere Else:
– First to Invent – First to File
– Publication One Year – No Prior Publication
in Advance

Utility Patents

Utility patents are the most
common type of patent granted
by the USPTO.

Duration: 20 years from
date of application
(Plus Up to 5 years FDA
Exclusivity)

Aggrecan Monomer — Aggrecanase
• Aggrecanase
– Identify novel forms
with improved
stability
– Develop ways to
• Produce large
amounts
• Isolate
aggrecanase
• Purify
aggrecanase
• Investigate
aggrecanase role
in disease states
Peprotech Korea Limited. 18; 283(3):1501-7
J Biol Chem. 2008 Jan


Truncated Aggrecanase
Aggrecanase
X X

TSP TSP

partial or complete
thrombospondin (TSP)
deletion can
stabilize aggrecanase


Now What?


Courtesy: U.S. Department of Energy Genome Program

24

Primary (a), secondary
(b), tertiary and
quaternary (c) structure
of HCC

Nature Structural Biology 8, 316 - 320 (2001)


Eukaryotes Transcription  mRNA

Courtesy: National Human Genome Research Institute.


DNA is transcribed into RNA and
RNA is translated into Protein

Courtesy: National Human Genome Research Institute.


Degeneracy
of the Genetic
Code

Of the 64 codons, 61 specify one
of the 20 amino acids. The other
3 codons are chain-terminating
codons and do not specify any
amino acid. AUG, one of the 61
codons that specify an amino
acid, is used in the initiation of
protein synthesis.

28

Reverse Transcriptase (RT):
mRNA  cDNA

• Reverse transcriptase (RT)
& DNA polymerase used to
make a complimentary DNA
(cDNA) strand
– Contains no introns
– Complimentary to a
mRNA


X X

TSP TSP

partial or complete
thrombospondin (TSP)
deletion can
stabilize aggrecanase


X X TSP


Biopharmaceutical Production Process
Insert gene into
DNA vector

Transfer into host cell

Express desired protein

Grow cells in
bioreactors

Extract, Purify, Dilute
Kleinberg M, et al. Am J Health-Syst Pharm. 2004;61:695-708. protein therapeutic

Protecting Nucleic Acid Sequence

1. An isolated DNA comprising the sequence set forth
as SEQ ID NO: 33.
2. A cDNA comprising the sequence of
SEQ ID NO: 33.
3. An isolated nucleic acid comprising the nucleotide
sequence of SEQ ID NO: 33, or
a degenerate variant of SEQ ID NO: 33.


Protecting Amino Acid Sequence

1. A polypeptide comprising the amino acid
sequence of SEQ ID NO: 13.
2. A truncated aggrecanase comprising the
sequence set forth as SEQ ID NO: 13.
3. An amino acid comprising SEQ ID NO: 13,
wherein the polypeptide cleaves aggrecan.


Requirements for Patentability

• Patentability over the prior art
– Novelty
– Non-obviousness
• Disclosure requirements
– Utility
– Specification
• Enablement
• Best mode
• Written description

36

Patentability over the Prior Art —Novelty

• single reference
• discloses every element of
claimed invention


Abbaszade, I. et al. J. Biol. Chem. 1999;274:23443-23450


Patentability over the Prior Art —
Non-obviousness

• Multiple references
• Predictability
• Motivation to combine
• Teach or suggest claimed invention
• Reasonable expectation of success


Patentability over the Prior Art —
Non-obviousness
Sites of cleavage of aggrecan monomer by aggrecanase

Tortorella, M. et al. J. Biol. Chem. 2000;275:25791-25797


Patent Summary
Patentability over the prior art
– Novelty
– Non-obviousness
• Disclosure requirements
– Utility
– Specification
• Best mode
• Enablement
• Written description

Patent Summary
• Specification

– Best mode
– Enablement
• Teach one skilled in the art
• Make and use the claimed invention
• Without undue experimentation
• Disclose nascent technology

– Written description
• Demonstrate applicant’s possession of the claimed invention
• Provide disclosure of structure, formula, chemical name, or
physical properties

43

Ways of Recognizing Ownership in Ideas
Generated by Creative Thinkers:

– FDA exclusivities
(US food and drug administration)
– EMEA exclusivities
(European medicines evaluation agency)
– Trademark or service mark
– Copyright
– Trade secret
– Patent

Thank you

Stan Antolin
stan.antolin@smithmoorelaw.com
T: 336-378-5516
F: 336-433-7591


Intellectual Property Overview
Links
• United States Patent Office (USPTO):
– www.uspto.gov
– FAQs: http://www.uspto.gov/main/faq/index.html
– Trademark Search Engine:
http://www.uspto.gov/ebc/tess/index.html
– Patent Search Engine: http://www.patentfetcher.com/
– Patent Search Engine: http://www.google.com/patents
– Trademarks Basic Information:
http://www.uspto.gov/web/offices/tac/doc/basic/
• NC State Trademarks available at:
http://www.ncs.ncsu.edu/trademark/index.html


Why IP Is Important Links
• Bessen, James E. & Meurer, Michael J.,The Private
Costs of Patent Litigation, available at
http://ssrn.com/abstract=983736
• USPTO 2007 Annual Report available at
http://www.uspto.gov/web/offices/com/annual/index.html


Patent Primer Links
• USC: http://www.gpoaccess.gov/uscode/index.html
• CFR: http://www.gpoaccess.gov/cfr/index.html
• MPEP: http://www.uspto.gov/web/offices/pac/mpep/mpep.htm
• USPTO’s general design patent page
http://www.uspto.gov/web/offices/pac/doc/general/design.htm
• USPTO’s general plant patent page
http://www.uspto.gov/web/offices/pac/doc/general/plant.htm
• USPTO’s general treaties and foreign patents page
http://www.uspto.gov/web/offices/pac/doc/general/treaties.htm
• Bessen, James E. and Meurer, Michael J., The Private Costs of Patent
Litigation, available at http://ssrn.com/abstract=983736
• Article on the AIPLA survey regarding cost of litigation.
http://lawdepartmentmanagement.typepad.com/law_department_managem
ent/2005/03/costs_of_patent.html
• Ronald Schutz and Ken Hall, Strategies for Patent Holders Contemplating
Litigation, available at
http://www.rkmc.com/Strategies_for_Patent_Holders_Contemplating_Litigati
on.htm


Patent Update Links
• Licensing
– MedImmune v. Genentech, available at http://www.supremecourtus.gov/opinions/06pdf/05-
608.pdf
– O'Connor, Sean M., Using Stock and Stock Options to Minimize Patent Royalty Payment
Risks After Medimmune v. Genentech, available at http://ssrn.com/abstract=977342
– http://www.law.com/jsp/article.jsp?id=1169806049217
• Injunctions
– eBay v. MercExchange, available at http://www.supremecourtus.gov/opinions/05pdf/05-
130.pdf
– Eric Wesenberg & Peter O'Rourke, The Toll on the Troll: The Implications of 'eBay v.
MercExchange‘, available at http://www.law.com/jsp/article.jsp?id=1147943132930
• Obviousness
– KSR v. Teleflex, available at http://www.supremecourtus.gov/opinions/06pdf/04-1350.pdf
– J. Matthew Buchanan, KSR International v. Teleflex Inc., fedcirc.us, available at
http://www.fedcirc.us/case-reviews/ksr-international-v.-teleflex-inc.html
– USPTO guidelines on examination in light of the KSR decision,
http://www.uspto.gov/web/offices/com/sol/notices/72fr57526.pdf
– Jay Sandvos, How KSR v. Teleflex should change your patent strategies, available at
http://www.edn.com/index.asp?layout=article&articleid=CA6442383


Patent Update Links
• Patent Infringement:
– http://www.mwe.com/index.cfm/fuseaction/publications.nldetail/o
bject_id/2fc2350a-5379-42f7-a9f5-4faa65146c32.cfm
• Biotechnology:
– Janis K. Fraser, Ph.D., U.S. Gene Patents in Legal Limbo –– for
Now, available at
http://www.ipfrontline.com/depts/article.asp?id=18311&deptid=4
– Harold C. Wegner, Biotechnology Law Report, available at
http://www.liebertonline.com/doi/pdfplus/10.1089/blr.2007.9915


Patent Update Links
• Software/Business Methods:
– Hung H. Bui, In Re Bilski, No. 2007-1130 (Fed. Cir. Feb. 15, 2008,
available at
http://www.ipfrontline.com/depts/article.asp?id=20898&deptid=7
– USPTO guidelines November 22, 2005, available at
http://www.uspto.gov/web/offices/com/sol/og/2005/week47/patgupa.htm
– Foundation for a Free Information Infrastructure, http://www.ffii.org/
– Non profit: http://www.spi.org/home.jsp
– Deputy Commissioner’s May 18, 2008 memo:
http://www.uspto.gov/web/offices/pac/dapp/opla/preognotice/section_10
1_05_15_2008.pdf
– Anti-software patent: http://www.out-law.com/page-9447
– ecommerce patents, Arner, Erika Harmon, Yoches, E. Robert, Recent
Developments of E-Commerce Patents: The Ever Precarious Nature of
E-Commerce Patent Protection in the U.S., available at
http://www.finnegan.com/resources/articles/articlesdetail.aspx?news=d3
faffe2-c076-49bc-bffa-b1c74d37a6a0


Patent Update Links
• Evaluation:
– Intellectual Property valuation article:
www.ipmetrics.cc/IPVT.pdf
– Michael Fitzgerald, A Patent Is Worth Having, Right? Well,
Maybe Not, available at
http://www.nytimes.com/2007/07/15/business/yourmoney/15prot
o.html?_r=1&ref=yourmoney&oref=slogin
– Pro-trade secrets: http://www.jordasecrets.com/
– Checklist comparing trade secret and patent protection:
http://www.iphandbook.org/handbook/chPDFs/ch11/ipHandbook-
Ch%2011%2005%20Jorda%20Trade%20Secret%20Licensing.p
df
• Smith Moore Leatherwood, LLP: http://www.smithmoorelaw.com/


NC State Bbs 201 Intro To Biopharmaceutical Science April 3 2009

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NC State Bbs 201 Intro To Biopharmaceutical Science April 3 2009