French American Chamber of Commerce

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USPTO PROPOSED PATENT PRACTICE RULES
IP and Biotech Is There a Road Map?

• French American Chamber of Commerce
• of San Francisco
• Life Science Breakfast
• May 11, 2006
• Catherine C. Maresh
• Senior Patent Counsel
• Medtronic, Inc.

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USPTO PROPOSED PATENT PRACTICE RULES
IP and Biotech Is There a Road Map?

• Patent Overview
• Current patent strategy for Pharmaceutical,
  Biotech, and Medical Devices Industries
• Why change
• What is being changed
• How to prepare for the change

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USPTO PROPOSED PATENT PRACTICE RULES
IP and Biotech Is There a Road Map?

• Right to exclude others from making, using,
  offering for sale, or selling the invention in
  the U.S., or importing the invention into the
  U.S.
• Patents
• claims
• continuations

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USPTO PROPOSED PATENT PRACTICE RULES
IP and Biotech Is There a Road Map?

• Pharmaceutical Industry
• Patent Strategy
• drug substance, method of use, formulation and
  process
• Marketplace
• 4-15 patents
• minimal overlapping sets of patent rights
  between competitors
• Hatch Waxman Act
• Generics

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USPTO PROPOSED PATENT PRACTICE RULES
IP and Biotech Is There a Road Map?

• Biotech Industry
• Patent Strategy
• attract venture capital/capital markets
• rapid innovation and development
• multiple filings-offensive defensive
• continuations
• Marketplace
• freedom to operate
• licensing
• rapid innovation and development
• litigation
• Hatch Waxman

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USPTO PROPOSED PATENT PRACTICE RULES
IP and Biotech Is There a Road Map?

• Medical Device Industry
• Patent Strategy
• Innovation improvement
• Multiple filings-offensive and defensive
• Continuations
• Marketplace
• Freedom to Operate
• Litigation
• Licensing
• Hatch Waxman

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USPTO PROPOSED PATENT PRACTICE RULES
IP and Biotech Is There a Road Map?
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USPTO PROPOSED PATENT PRACTICE RULES
IP and Biotech Is There a Road Map?
Average 1st action pendency 27.7 months
Immunology, Receptor/ Ligands, Cytokines,
Recombinant Hormones, and Molecular
Biology 30.9 months Surgery Cutting,
Clamping, Suturing 52.1 months Finance
Banking, Accounting
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USPTO PROPOSED PATENT PRACTICE RULES
IP and Biotech Is There a Road Map?
Months of Inventory for a new application filed
in July 2005 at todays production 38-51 months
Drugs, Bio-affecting and Body Treatment 38-47
months Medical Instruments, Diagnostic
Equipment 22-136 months Business Methods
(Finance Banking, Accounting)
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USPTO PROPOSED PATENT PRACTICE RULES
IP and Biotech Is There a Road Map?

• Patent Office Objectives
• Quality Focused Examination
• Help the PTO get it right the first time
• Efficiency
• Create greater finality in examination
• Pendency
• help the Office turn to new inventions and
  create public certainty on patent protection

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USPTO PROPOSED PATENT PRACTICE RULES
IP and Biotech Is There a Road Map?

• Patent Office Funding
• FY1992-FY2003
• Congress diverted nearly 800 million in user
  fees from the Patent Office
• Improved funding since FY2003
• Hire and train examiners needed to improve
  quality and reduce backlog
• Time is needed, not a quick fix

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USPTO PROPOSED PATENT PRACTICE RULES
IP and Biotech Is There a Road Map?

• Proposed Changes to Practice for Continuing
• Applications, Requests for Continued
• Examination Practice, and Applications Containing
  Patentably Indistinct Claims
• 71 Fed. Reg. 48 (January 3, 2006)

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USPTO PROPOSED PATENT PRACTICE RULES
IP and Biotech Is There a Road Map?

• Continuations
• One continuation application
• always available as of right
• Additional continuation applications
• Petition, fee and showing that the amendment,
  argument or evidence could not have been
  submitted prior to the close of prosecution in
  the application

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USPTO PROPOSED PATENT PRACTICE RULES
IP and Biotech Is There a Road Map?

• PTO will refuse to enter, or will delete if
  present, any specific reference to a prior filed
  application that is not permitted
• Applicable to any application filed on or after
  effective date of the proposed rules or one in
  which a first office action on the merits was not
  filed before the effective date of the final rule

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USPTO PROPOSED PATENT PRACTICE RULES
IP and Biotech Is There a Road Map?

• Related application (filed on same day)
• If disclosure in any such related application
  substantially overlaps applicants disclosure,
  applicant must show that claims are patentably
  distinct or submit a terminal disclaimer and
  explanation why patentably indistinct claims
  should be maintained in the two or more such
  applications.

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USPTO PROPOSED PATENT PRACTICE RULES
IP and Biotech Is There a Road Map?

• Representative claims
• Initially examined
• All of the independent claims in an application,
  and only those dependent claims that are
  expressly designated by the applicant for initial
  examination.
• Up to 10 representative claims will get an
  initial examination.

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USPTO PROPOSED PATENT PRACTICE RULES
IP and Biotech Is There a Road Map?

• Examination Support Document
• Required if applicant submits more than 10
  independent claims, or designates more than 10
  representative claims to be initially examined

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USPTO PROPOSED PATENT PRACTICE RULES
IP and Biotech Is There a Road Map?

• Examination Support Document
• A pre-examination search
• An IDS
• Identification of limitations shown by cited
  references
• A patentability statement
• A utility statement
• A showing of how limitations are supported by
  disclosure.
• Litigation implications
• Burden on applicant

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USPTO PROPOSED PATENT PRACTICE RULES
IP and Biotech Is There a Road Map?

• Do your IP minders understand the proposals?
• Inform Commerce, Congress of your views
• Challenge the PTOs statutory authority to
• promulgate the rules

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USPTO PROPOSED PATENT PRACTICE RULES
IP and Biotech Is There a Road Map?

• Preparation, filing and prosecution strategies
• Size, scope and content of new applications and
  claims
• Related applications implications

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USPTO PROPOSED PATENT PRACTICE RULES
IP and Biotech Is There a Road Map?

• Prepare prosecution in any currently pending
  application for possible final opportunity to
  secure patent rights
• Look to implementation of rules this Fall or
  Winter