From Provisional Patents to Extending Life of Your Patents

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Thursday, February 6, 2014

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From Provisional Patents to Extending the Life of Your Patents

Brittany Syz,

Marc Morley

General Counsel, Oberon Fuels

Patent Attorney and Partner Foley & Lardner LLP




ACS Webinars January 30, 2014

Marc T. Morley Partner © 2013Foley Foley&&Lardner LardnerLLP LLP ©2012

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Disclaimer 

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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.

© 2013Foley Foley&&Lardner LardnerLLP LLP ©2012

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/ © 2014Foley Foley&&Lardner LardnerLLP LLP ©2012

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Quiz: Question  Have you ever been involved in a patent application? A. B. C. D.

Yes, many At least one No, but will be in the future 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. © 2013Foley Foley&&Lardner LardnerLLP LLP ©2012

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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 15


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Total UPR Filings Statistics (FY 2000 – FY 2012) USPTO Patent 550,000 525,000 500,000 475,000 450,000 425,000 400,000 375,000

Applications

350,000 325,000 300,000 275,000 250,000 225,000 200,000 175,000 150,000 125,000 100,000 75,000 50,000 25,000 0 2000

2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

2011

2012

Fiscal Year

Fiscal Year 2012 UPR Filings = 533,308 15 © 2014Foley Foley&&Lardner LardnerLLP LLP ©2012

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Examiner Staffing USPTOPatent Patent Statistics FY 2001 – FY 2012 Examiner Staff 9000 8000 7000

T o t a l

6000 5000 4000 3000 2000 1000 0 2001

2002

2003

2004

End of Fiscal Year 2012 Examiner Staff = 7,837

2005

2006

2007

2008

2009

2010

2011

2012

Fiscal Year 17

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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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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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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! 21


Provisional v. Nonprovisional Applications PROVISIONAL

NON-PROVISIONAL

Not Published

Will publish unless non-publication requested

Expires after 12 months

Remains pending until abandoned or issues as a patent

Cannot become a patent

Can become a patent

Lenient Formatting Guidelines

Strict formatting

Claims not required

Requires at least one claim

Contributors Identified

Inventors identified based upon claims

Preparation Cost: $500 - $20,000

Preparation cost: ~$9,000 - $20,000

Lower filing fee - $90 (small entity)

Higher filing fees: ~$700 (small entity)


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An Example …


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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 . . . . ©2012 Foley & Lardner LLP

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Ariad Pharma., Inc. v. Eli Lilly and Co. Written Description

 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.


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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 NFκB-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. ©2012 Foley & Lardner LLP

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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”

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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 . . .” © 2013Foley Foley&&Lardner LardnerLLP LLP ©2012

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 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


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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 …


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What could Ariad have done?


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Options (with pros and cons)  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? © 2013Foley Foley&&Lardner LardnerLLP LLP ©2012

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“Serial” Provisional Applications


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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. © 2013Foley Foley&&Lardner LardnerLLP LLP ©2012

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Additional Life Cycle Management Strategies  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 © 2013Foley Foley&&Lardner LardnerLLP LLP ©2012

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Timeline for New Drug (20 Years) File IND Pioneering Co. discovers drug

candidate identified

File NDA

NDA approved

Potential for Attack By Generics MFG (“ANDA Attack”)

clinical trials Data Exclusivity

“Lost” Patent Term Patent filed



Patent granted

Patent Exclusivity

Drug Enters Market

Restored Term

Original patent expiration

Generic

Patent Term Extension

Prosecution of First Patent is Complete Long Before Any Profits! © 2013Foley Foley&&Lardner LardnerLLP LLP ©2012

Example of New Invention Discovered During Development


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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 © 2013Foley Foley&&Lardner LardnerLLP LLP ©2012

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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? © 2013Foley Foley&&Lardner LardnerLLP LLP ©2012

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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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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? © 2013Foley Foley&&Lardner LardnerLLP LLP ©2012

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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 predetermined.  Leaving off inventor can render patent unenforceable


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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 © 2013Foley Foley&&Lardner LardnerLLP LLP ©2012

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Brittany Syz,

Marc Morley





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Brittany Syz,

Marc Morley





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How has ACS Webinars benefited you?

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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

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From Provisional Patents to Extending Life of Your Patents

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