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


“Pheromones are in the Air:

Friends, Lovers or Foes”

Dr. George Preti and Dr. Charles Wysocki,

Monell Chemical Senses Center


http://www.acswebinars.org/


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From Provisional Patents to

Extending the Life of Your Patents



®


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


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

[email protected]

www.linkedin.com/in/marcmorley/


http://www.linkedin.com/in/marcmorley/

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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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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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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


15

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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9


17

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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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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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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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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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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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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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 . . . .

13


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


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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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”


Written Description


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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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 . . .”


Written Description


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


Written Description

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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 …


Written Description


What could Ariad have done?

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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?


“Serial” Provisional Applications

34

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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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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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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


Example of New Invention

Discovered During Development

38

20


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!

39


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

40

21


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?

41


Don’t “relax” once a provisional is filed;

Avoid disclosing your technology as long as

possible


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?

42

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Avoid disclosing your technology as long as

possible


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?

43


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

44

23


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

45


Thank you!

Marc T. Morley

Partner

Foley & Lardner LLP

[email protected]

Foley.com

www.linkedin.com/in/marcmorley/

858-847-6700


http://www.foley.com/

http://www.linkedin.com/in/marcmorley/

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Oberon Fuels


Foley & Lardner LLP


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Marc Abrahams,










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Oberon Fuels


Foley & Lardner LLP

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“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?

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If you enjoy ACS Webinars every Thursday…

please support the program!

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Find the many benefits of ACS membership!

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presentation are those of the presenter and do

not necessarily reflect the views or policies of

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Marc Abrahams,










From Provisional Patents to Extending Life of Your Patents...2014/01/30 · “Ig Nobel Prizes for...

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