from provisional patents to extending life of your patents...2014/01/30 · “ig nobel prizes for...
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Thursday, February 6, 2014
“Ig Nobel Prizes for Discoveries in
Chemistry – The Improbables”
Marc Abrahams,
Co-Founder and Editor, Improbable Research
Thursday, February 13, 2014
“Pheromones are in the Air:
Friends, Lovers or Foes”
Dr. George Preti and Dr. Charles Wysocki,
Monell Chemical Senses Center
5
From Provisional Patents to
Extending the Life of Your Patents
All recordings will be available to only ACS Members
http://acswebinars.org/extending-patents
®
Contact ACS Webinars ® at [email protected]
Brittany Syz, General Counsel,
Oberon Fuels
Marc Morley Patent Attorney and Partner
Foley & Lardner LLP
©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
From Provisional
Patents to
Extending the
Life of Your
Patents
Marc T. Morley
Partner
ACS Webinars
January 30, 2014
6
©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
Disclaimer
This presentation and Q&A discussion constitute an educational and
informational presentation of patent law issues and should not be construed as
individualized or group legal advice or representation.
The presentation of these materials does not establish an attorney-client
relationship. Representation can be initiated only upon completion of a
standard new client/new matter process, including completion of a conflicts
check, execution of an engagement agreement and payment of any applicable
retainer.
Any discussions are based solely upon non-confidential information provided by
the audience.
©2012 Foley & Lardner LLP © 2014 Foley & Lardner LLP 12
Marc T. Morley
Partner, Foley & Lardner LLP
Chem/Bio/Pharma intellectual property practice
15+ years industry and legal experience in chemical, pharmaceuticals, biotechnology, industrial microbiology and food and veterinary technology, plants, and medical devices
Adjunct Professor of Patent Law at the University of San Diego School of Law
Instructor of Biotechnology Patent Law at UCSD
President of the San Diego Intellectual Property Law Association
858-847-6700
www.linkedin.com/in/marcmorley/
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©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
Quiz:
Question
Have you ever been involved in a patent
application?
A. Yes, many
B. At least one
C. No, but will be in the future
D. No
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©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
Importance of Patents to our
Economy
“Intellectual Property in the U.S. Economy: Industries in
Focus” co-authored by the USPTO and the Economics and
Statistics Administration
– The entire U.S. economy relies on some form of IP, because virtually every
industry either produces or uses it.
– IP-intensive industries directly accounted for about 27 million American jobs in
2010, and indirectly supported an additional 13 million U.S. supply chain jobs.
This equals 40 million American jobs, or 27.7 percent of all U.S. employment.
– Jobs in IP-intensive industries pay well compared to other jobs. Average weekly
wages for IP-intensive industries were 42 percent higher than average weekly
wages in other private- sector industries in 2010. That wage differential was an
impressive 75 percent higher for jobs in the patent- and copyright-intensive
industries.
– IP-intensive industries accounted for just over $5 trillion dollars in value added
in 2010, or about 35 percent of U.S. gross domestic product.
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©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
USPTO Patent Statistics
FY 2012 Patents
Performance Overview
• Patent Application Backlog = 608,283
• Total UPR Applications Pending = 1,208,983
• Total UPR Filings = 533,308
• UPR Patents Issued = 247,868
• UPR Patent Examiners Onboard = 7,837
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15
©2012 Foley & Lardner LLP © 2014 Foley & Lardner LLP
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0
25,000
50,000
75,000
100,000
125,000
150,000
175,000
200,000
225,000
250,000
275,000
300,000
325,000
350,000
375,000
400,000
425,000
450,000
475,000
500,000
525,000
550,000
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Ap
pli
ca
tio
ns
Fiscal Year
Total UPR Filings (FY 2000 – FY 2012)
Fiscal Year 2012 UPR Filings = 533,308
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USPTO Patent Statistics
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©2012 Foley & Lardner LLP © 2014 Foley & Lardner LLP
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0
1000
2000
3000
4000
5000
6000
7000
8000
9000
2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012
Examiner Staff
Fiscal Year
T
o
t
a
l
Patent Examiner Staffing
FY 2001 – FY 2012
End of Fiscal Year 2012 Examiner Staff = 7,837
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USPTO Patent Statistics
©2012 Foley & Lardner LLP © 2014 Foley & Lardner LLP 18
Chem-Bio Statistics
Patent Office Technology Centers
– 1600 (Biotechnology & Organic Chemistry) and
– 1700 (Chemical and Materials Engineering)
TC 1600 and 1700 have approximately 20%
of Examiners and the Pending Applications
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©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
Some Patent Basics …
Requirements for a Patent:
– 35 U.S.C. §§:
101: Eligibility and Utility
102: Novelty
103: Obviousness
112: Enablement, Written Description and Best
Mode
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©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
From Provisional Patents to
Extending the Life of Your Patents
Today’s patent world requires greater
sophistication than ever before to fully protect
and maintain new innovation!
– Time pressure to file quickly (First-to-File)
– Pressure to adequately develop the technology
– Ease of inflicting “self harm”
– Domestic and foreign competition
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©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
From Provisional Patents to
Extending the Life of Your Patents
Provisional application lasts 1 year, then must be “converted”
to a nonprovisional application
– How much technology can and should you cover?
Nonprovisional Application Publication: 18 months from
earliest claimed priority
– Impact on downstream inventions? Novelty and
obviousness?
Patent Term: 20 years from earliest nonprovisional filing date
– Provisional applications don’t count (~21 years from first
provisional)
Ticking Clocks!
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©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
Provisional v. Nonprovisional
Applications
PROVISIONAL NON-PROVISIONAL
NotPublished Willpublishunlessnon-publicationrequested
Expiresafter12months Remainspendinguntilabandonedorissuesasapatent
Cannotbecomeapatent Canbecomeapatent
LenientFormattingGuidelines Strictformatting
Claimsnotrequired Requiresatleastoneclaim
ContributorsIdentified Inventorsidentifiedbaseduponclaims
PreparationCost:$500-$20,000 Preparationcost:~$9,000-$20,000
Lowerfilingfee-$90(smallentity) Higherfilingfees:~$700(smallentity)
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©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
An Example …
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©2012 Foley & Lardner LLP 24
Written Description
35 U.S.C. § 112, First Paragraph
– The specification shall contain a
written description of the invention,
and of the manner and process of
making and using it, in such full,
clear, concise, and exact terms as to
enable any person skilled in the art to
which it pertains, or with which it is
most nearly connected, to make and
use the same . . . .
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©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP 25
Ariad sued Eli Lilly for patent infringement based
upon Eli Lilly selling two drugs, Evista® and
Xigris®.
Ariad’s application was filed prior to Eli Lilly’s
drugs being discovered or made publicly known.
On May 4, 2006, Lilly was ordered by the district
court to pay ~$65 million in back royalties, and
2.3% royalties on future sales of the drugs.
Ariad Pharma., Inc. v. Eli Lilly and Co.
Written Description
©2012 Foley & Lardner LLP 26
Ariad Pharma., Inc. v. Eli Lilly and Co.
Sample claim:
95. [A method for reducing, in
eukaryotic cells, the level of
expression of genes which are
activated by extracellular
influences which induce NF-
κB-mediated intracellular
signaling, the method
comprising reducing NF-κB
activity in the cells such that
expression of said genes is
reduced], carried out on human
cells.
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©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP 27
Disclosure: 3 classes of molecules that reduce NF-κB
activity
– “Specific inhibitor molecules” (one example)
– “Dominantly interfering molecules” (no examples)
– “Decoy molecules” (only hypothetical examples)
. . . but, “no descriptive link between the table of
decoy molecules and reducing NF-κB activity”
Ariad Pharma., Inc. v. Eli Lilly and Co.
Written Description
©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
Quiz:
Question
The inventors of Ariad’s technology clearly discovered the role of
NFkB in causing inflammation, and therefore, as a target for
treating, preventing or reducing inflammation. A great discovery!
Does Ariad’s disclosure in its patent application justify a claim to
reducing NF-κB activity in the cells by any means? They did
disclose three of the primary strategies for inhibition, including
one specific inhibitor, IkB. Should Ariad be entitled to the claims
for all methods of inhibition of NF-kB based upon the written
description requirement (assume no prior art to prevent the
claim)?
A. Yes.
B. No.
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©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP 29
Written Description Requirement: “whether the
disclosure . . . reasonably conveys to those
skilled in the art that the inventor had
possession of the claimed subject matter as
of the filing date”
– Genus Claims: “requires the disclosure of either a
representative number of species . . . or structural
features common to the members of the genus so
that one of skill in the art can ‘visualize or recognize’
the members . . .”
Ariad Pharma., Inc. v. Eli Lilly and Co.
Written Description
©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP 30
Federal Circuit: claims to molecules that reduce NF- κB
activity are invalid for lack of written description
Conclusion: Test for written description (genus claims):
– Representative number of species within scope; OR
– Structural features in common for members of genus such that
one can visualize or recognize the members of the genus
Ariad Pharma., Inc. v. Eli Lilly and Co.
Written Description
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©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP 31
Comments:
– Great Discovery, but not enough to justify all desired patent
protection absent additional disclosure
– Need for more R&D for some inventions and discoveries,
but don’t we want to “file first?”
– Earlier published patent used as obviousness art against
later filings …
Ariad Pharma., Inc. v. Eli Lilly and Co.
Written Description
©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
What could Ariad have done?
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©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
Options (with pros and cons)
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Wait to file:
– Pros: allows greater development time to support broader claims
– Cons: a third party may file before you and have patent rights
(First-to-File)
File nonprovisional Application as soon as possible:
– Minimizes first-to-file risk
– But, will the application support all claims
File one or more provisional applications:
– Can file updated provisionals and claim priority to more than one
provisional
– Is there time to do enough R&D within the 1 year?
©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
“Serial” Provisional Applications
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©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
U.S. Patent No. 7,276,530
Filed April 29, 2005 “[3.2.0] Heterocyclic compounds and methods of using the same”
This application claims priority under 35 U.S.C. §
119(e) to U.S. Provisional Application Nos.
60/567,336, filed on Apr. 30, 2004; Ser. No.
60/580,838, filed on Jun. 18, 2004; Ser. No.
60/591,190, filed on Jul. 26, 2004; Ser. No.
60/627,462, filed on Nov. 12, 2004; Ser. No.
60/644,132, filed on Jan. 13, 2005; and Ser.
No. 60/659,385, filed on Mar. 4, 2005; each of
which is entitled [3.2.0] HETEROCYCLIC
COMPOUNDS AND METHODS OF USING THE
SAME; and each of which is incorporated herein
by reference in its entirety.
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©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
Additional Life Cycle Management
Strategies
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Second Generation Patent Applications:
– Analogs and derivatives (obviousness issues?)
– New uses / indications
– Methods of making
– Salts, racemates, polymorphs …
– New formulations
– New administration approaches
– New patient populations
– Downstream commercialization or R&D
Clinical endpoints
– New combinations
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©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
Timeline for New Drug (20 Years)
Pioneering Co. discovers drug
Patent filed
Patent granted
candidate identified
File IND
File NDA
NDA approved
clinical trials
Drug Enters Market
Original patent
expiration
Patent Term Extension
Restored Term “Lost” Patent Term Patent Exclusivity
Potential for Attack By Generics MFG
(“ANDA Attack”)
Generic
Prosecution of First Patent is Complete Long Before Any Profits!
Data Exclusivity
©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
Example of New Invention
Discovered During Development
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©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
U.S. Patent No. 7,915,307
“Methods of Improving the Pharmacokinetics of Doxepin”
Doxepin: tricyclic antidepressant for 30-40 years
Method of use patent for Insomnia issued in 1996
(expired 2013)
New Method related to insomnia administration:
– Provisionals filed 2006; Nonprovisional filed 2007
– 1. A method for providing sleep therapy comprising
administering a 3 mg or a 6 mg dose of doxepin to an
individual at least three hours after consuming a meal,
thereby providing a faster onset of action and reducing next
day residual effects.
– Much later expiration!
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©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
Good Housekeeping
Protecting your ownership and technology:
– Don’t “relax” once a provisional is filed (there is
more to do …)
– Avoid disclosing your technology as long as
possible (presentations, papers, talks, etc.)
– Identify and recognize new inventions
Don’t assume “this can’t be patented”)
– Care with collaborations and joint developments
– Proper employee agreements to avoid IP disputes
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©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
Don’t “relax” once a provisional is filed
Provisional filed on 1/15/2014 and discloses
inventions A and B
Invention C discovered on 1/22/2014
Inventions A, B and C disclosed at conference
on 1/25/2014
Invention C included in an patent application
on 1/28/2014
What impact does the conference disclosure
have on patentability of Invention C?
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©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
Don’t “relax” once a provisional is filed;
Avoid disclosing your technology as long as
possible
Provisional filed on 1/15/2014 and discloses
inventions A and B
Inventions A and B disclosed at conference on
1/20/2014
Invention C discovered on 1/22/2014: What
impact does the conference disclosure have
on your ability to patent Invention C?
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©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
Avoid disclosing your technology as long as
possible
Provisional filed on 1/15/2014 and discloses
inventions A and B
Inventions A and B disclosed at conference on
1/20/2014
Competitor attends conference and immediately goes
to the lab and discovers Invention C on 1/21/2014
Invention C discovered on 1/22/2014: What impact
does the conference disclosure have on your ability to
patent Invention C? Who will have patent rights to
Invention C?
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©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
Collaborations/Joint Development
Co-inventors own equally & can dispose unilaterally of the
invention
Beware of unintended co-inventors
– Jt. researchers, collaborators, contractors, etc.
Set up agreements where ownership of any rights is pre-
determined.
Leaving off inventor can render patent unenforceable
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©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP
Avoiding Self-Inflicted Harm
Protecting your ownership and technology: – File patent applications before presentations, talks, publishing in
journals, publishing a dissertation, meeting with collaborators,
licensees, investors, etc.
– Set up agreements where ownership of any rights is pre-determined.
– Do Not Disclose Invention Outside of Confidentiality
Use Confidential Disclosure Agreements (CDAs) for discussions
with potential collaborators, licensees, investors (when possible)
– Protect confidential information (e.g., mark it as “confidential” or don’t
disseminate it
– Maintain records of research and development (e.g., lab notebooks)
– Use caution with content of submissions and reports (assume they will be publicly available immediately)
– Minimize discussions without proper protection – don’t talk
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©2012 Foley & Lardner LLP © 2013 Foley & Lardner LLP 46
Thank you!
Marc T. Morley
Partner
Foley & Lardner LLP
Foley.com
www.linkedin.com/in/marcmorley/
858-847-6700
24
From Provisional Patents to
Extending the Life of Your Patents
All recordings will be available to only ACS Members
http://acswebinars.org/extending-patents
®
Contact ACS Webinars ® at [email protected]
Brittany Syz, General Counsel,
Oberon Fuels
Marc Morley Patent Attorney and Partner
Foley & Lardner LLP
Upcoming ACS Webinars www.acswebinars.org
48
®
Contact ACS Webinars ® at [email protected]
Thursday, February 6, 2014
“Ig Nobel Prizes for Discoveries in
Chemistry – The Improbables”
Marc Abrahams,
Co-Founder and Editor, Improbable Research
Thursday, February 13, 2014
“Pheromones are in the Air:
Friends, Lovers or Foes”
Dr. George Preti and Dr. Charles Wysocki,
Monell Chemical Senses Center
25
From Provisional Patents to
Extending the Life of Your Patents
All recordings will be available to only ACS Members
http://acswebinars.org/extending-patents
®
Contact ACS Webinars ® at [email protected]
Brittany Syz, General Counsel,
Oberon Fuels
Marc Morley Patent Attorney and Partner
Foley & Lardner LLP
Stay Connected…
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www.twitter.com/acswebinars
www.facebook.com/acswebinars
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Email ACS Webinars ® at [email protected]
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Be a featured fan on an upcoming webinar! Write to us @ [email protected] 51
“ACS Webinars gives me new information or
reinforces important information, skills, and points
of view. I feel like they are useful professional
development.”
Fan of the Week Sarah St. Angelo Ph.D.,
Assistant Professor of Chemistry
Dickinson College
How has ACS Webinars benefited you?
®
If you enjoy ACS Webinars every Thursday…
please support the program!
52
Find the many benefits of ACS membership!
www.join.acs.org
ACS Network (search for group acswebinars)
www.communities.acs.org
®
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ACS Webinars does not endorse any products
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the American Chemical Society.
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Contact ACS Webinars ® at [email protected]
®
Upcoming ACS Webinars www.acswebinars.org
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®
Contact ACS Webinars ® at [email protected]
Thursday, February 6, 2014
“Ig Nobel Prizes for Discoveries in
Chemistry – The Improbables”
Marc Abrahams,
Co-Founder and Editor, Improbable Research
Thursday, February 13, 2014
“Pheromones are in the Air:
Friends, Lovers or Foes”
Dr. George Preti and Dr. Charles Wysocki,
Monell Chemical Senses Center