Mary C. Till Senior Legal Advisor

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The Life Sciences Lawyers Guide to PTA and PTE

• Mary C. TillSenior Legal Advisor
• Office of Patent Legal Administration

January 27, 2011
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PTE Laying the Groundwork for Patent Term
Restoration

• Eligibility requirements (patents, claim
  language)
• Eligibility Requirements
• Application Requirements
• Multiple Applications
• Combination Products
• Interim Extensions
• Calculating the restored term
• Regulatory review period
• Statutory caps
• Examples
• Reissue during PTE processing time
• Frequently asked questions

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PTE Laying the Groundwork for Patent Term
Restoration

• Eligible Patents
• 156(a)-the term of a patent which claims a
  product, a method of using a product, or a method
  of manufacturing a product, shall be extended. .
  .
• How must the product be recited in the claim?

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PTE Laying the Groundwork for Patent Term
Restoration

• Patent Claim Language
• Product Patents claim the small molecule (genus
  and/or species), antibody, sequence, device,
  pharmaceutical composition, etc.
• Use Patents method of treating disease X in a
  patient in need thereof, by administering an
  effective amount of substance Y.
• Method of Manufacturing Patents a process for
  preparing the substance Y comprising steps 1, 2,
  3, etc.

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PTE Laying the Groundwork for Patent Term
Restoration

• Eligibility Requirements
• Patent has not expired.
• Patent has never been extended before under
  (e)(1).
• An application is submitted by patent owner or
  his agent.
• The product was subject to a regulatory review
  period before its commercial marketing or use.
• The permission for the commercial marketing or
  use is the first permitted commercial marketing
  or use under the provision of law under which the
  regulatory review period occurred.

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PTE Laying the Groundwork for Patent Term
Restoration

• Relevant Regulatory Review Periods
• Section 505 of Federal Food Drug and Cosmetic Act
  (new drugs).
• Section 351 of the Public Health Services Act
  (human biological products).
• Section 515 of the Federal Food Drug and Cosmetic
  Act (medical devices).
• Section 512 of the Federal Food Drug and Cosmetic
  Act (new animal drugs).
• The Virus-Serum Toxin Act, 21 U.S.C. 151-159
  (veterinary biological products).
• Section 409 of the Federal Food Drug and Cosmetic
  Act (food additives and color additives).

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PTE Laying the Groundwork for Patent Term
Restoration

• Section 156(d)(1) sets forth the application
  requirements
• Identify the product and identify the statutory
  provision under which regulatory review occurred.
• Identify the patent and the claims of the
  patent that cover the product.
• Information to enable USPTO to determine
  eligibility and rights under the grant.
• Dates and activities during regulatory review.
• Any additional information.

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PTE Laying the Groundwork for Patent Term
Restoration
Timely filed section 156(d)(1) application Section
156(d)(1) defines the period within which to
file an application for term extension as,
within the sixty-day period beginning on the
date the product received permission under the
provision of law under which the applicable
regulatory review period occurred for commercial
marketing or use.
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PTE Laying the Groundwork for Patent Term
Restoration
Two situations can give rise to multiple
applications for PTE First, when multiple patents
claim the approved product, or a method of using
or manufacturing the approved product, patent
owners may file multiple applications and choose
the one to receive the extension at the end of
the PTE process (see 37 C.F.R. 1.785). Second,
multiple approvals for the same product on the
same day (35 U.S.C. 156(c)(4)).
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PTE Laying the Groundwork for Patent Term
Restoration
Combination Products Multiple active ingredients
drug products Arnold Partnership v. Dudas, 362
F.3d 1338 (Fed. Cir. 2004). Synergy? Drug/device
combination products
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PTE Laying the Groundwork for Patent Term
Restoration

• Interim Extension under 35 U.S.C. 156(d)(5)
• Section 156(d)(5) interim extension
• Product is not yet approved.
• Patent is expiring while product is undergoing
  continued review by the regulating agency.
• Clinical work is done, agency is conducting
  approval review.
• Statutorily set time frame for application
  submission.

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PTE Laying the Groundwork for Patent Term
Restoration
Timely filed section 156(d)(5) and subsequent
section 156(d)(5) interim extensions
156(d)(5)(A) defines the period within which to
file an application for interim extension as,
beginning 6 months, and ending 15 days before
such term is due to expire. 156(d)(5)(C)
defines the period within which to file a
subsequent application for interim extension as,
the period beginning 60 days before, and ending
30 days before, the expiration of the preceding
interim extension.
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PTE Laying the Groundwork for Patent Term
Restoration

• Interim Extension under 35 U.S.C. 156(e)(2)
• Section 156(e)(2) interim extension
• Product has been approved.
• Patent is expiring before certificate of
  extension can be granted.
• No statutorily set time frame for application
  submission.

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PTE Laying the Groundwork for Patent Term
Restoration

• Timely filed section 156(e)(2) interim extension
• Section 156(e)(2) does not contain a statutory
  time period for application submission.
• 37 C.F.R. 1.760 indicates that any request for
  interim extension under 156(e)(2) should be filed
  at least 3 months before the patent expires.

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PTE Laying the Groundwork for Patent Term
Restoration

• Calculating the restored term (35 U.S.C.
  156(c))
• Extended term is equal to the regulatory review
  period (RRP) for the approved product
• Which period occurs after the date the patent is
  issued (PG-patent pre-grant periods of regulatory
  review)
• RRP is reduced by the period during which the
  applicant for the extension did not act with due
  diligence (DD)
• RRP which is the testing phase as defined in
  156(g) includes only one-half of the days (TP).

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PTE Laying the Groundwork for Patent Term
Restoration

• Calculating the restored term (35 U.S.C.
  156(c))
• The extended term is one of three values
• Calculated RRP - PGRRP - DD - ½ (TP - PGTP)
• Days equal to 14 years of total exclusivity or
• Maximum of 5 years at the end of the 35 U.S.C.
  154 patent term.

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PTE Laying the Groundwork for Patent Term
Restoration

• Calculated extension example
• 156 Term RRP - PGRRP - DD - ½ (TP - PGTP)
• RRP 1,941 days
• DD 0 days
• Testing Phase (TP) 1,256 days (8/25/1999 thru
  1/31/2003)
• Patent grant date 9/3/2002
• PGRRP (pre-grant RRP days-all in TP) 1,106 days
  PGTP
• Approval Date 12/15/04, so 14 year limit is
  12/15/18 (2525 days).
• Original Expiration Date 1/16/12
• 156 Term (calculated) 1,941 - 1,106 - 0 - ½
  (1,256-1,106)
• 760 days
• Extension is always least number of days, so it
  is limited to 760 days.

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PTE Laying the Groundwork for Patent Term
Restoration

• 14 year limit example
• 156 Term (calculated) RRP - PGRRP - DD - ½ (TP
  - PGTP)
• RRP 2,224 days
• DD 0 days
• Testing Phase (TP) 1,920 days (6/22/1999 thru
  9/22/2004)
• Patent grant date 3/7/2000
• PGRRP (pre-grant RRP days-all in TP) 260 days
  PGTP
• Approval Date 7/22/2005, 14 year limit is
  7/22/2019
• Original Expiration Date 3/6/2017
• 156 Term (calculated) 2,224 - 260 - 0 ½
  (1,920-260)
• 1,134 days
• But extension is always least number of days, so
  it is limited to 868 days based on 14 year limit.

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PTE Laying the Groundwork for Patent Term
Restoration

• 5 year limit example
• 156 Term (calculated) RRP - PGRRP - DD - ½ (TP
  - PGTP)
• RRP 4,781 days
• DD 0
• Testing Phase (TP) 3,786 days (7/4/1991 thru
  11/13/2001)
• Patent grant date 6/11/1991
• PGRRP (pre-grant RRP days) 0 days
• Approval Date 8/3/2004, 14 year limit is
  8/3/2018 (extension would be more than 10 years)
• Original Expiration Date 6/11/2008
• 156 Term (calculated) 4,781-0-0- ½ (3,786-0)
• 2,888 days (7.9 years)
• Extension is always least number of days, so it
  is limited to 5 years based on section
  156(g)(6)(A).

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PTE Laying the Groundwork for Patent Term
Restoration

• Seeking or Pending Reissue during PTE Processing
• Once a product receives approval, the patent
  owner has a 60 day window within which to submit
  an application for term extension (35 U.S.C.
  156(d)(1)).
• Sometimes a reissue of the patent for which
  extension has been sought is undergoing
  prosecution.
• Sometimes during the processing of the patent for
  which extension has been sought, a reissue
  application is filed for the patent.

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PTE Laying the Groundwork for Patent Term
Restoration

• Effect of Reissue On PTE
• Section 251 states (in part), on the surrender
  of such patent and the payment of the fee
  required by law, reissue the patent for the
  invention disclosed in the original patent, and
  in accordance with a new and amended application,
  for the unexpired part of the term of the
  original patent.
• Section 252 states (in part), the surrender of
  the original patent shall take effect upon the
  issue of the reissued patent, and every reissued
  patent shall have the same effect and operation
  in law, on the trial of actions for causes
  thereafter arising, as if the same had been
  originally granted in such amended form. . . .

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PTE Laying the Groundwork for Patent Term
Restoration

• Frequent PTE Questions
• (1) Has U.S. Patent No. X,XXX,XXX been extended?
• (2) The patent owner and the marketing applicant
  before the agency are not the same entity, do we
  need to submit anything extra with our
  application?
• (3) Can a third party participate in the PTE
  process?
• (4) The FDAs Orange Book lists lots of patents
  for product X, why is only one patent listed on
  the USPTOs list of extended patents?
• (5) Our drug product has not received approval
  yet, but a medical device incorporating the drug
  product has been approved, can we extend one
  patent based on the medical device review and
  another patent based on the drug product review?

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PTE Laying the Groundwork for Patent Term
Restoration

• Answers to Frequent PTE Questions
• (1) Most PTE applications and grants are
  available for viewing in Public PAIR, check there
  first.
• (2) An authorization letter from the marketing
  applicant that the patent owner can rely on his
  activities before the regulating agency should be
  submitted with the application.
• (3) No.
• (4) Because of 35 U.S.C. 156(c)(4), only one
  patent may be extended per regulatory review
  period.
• (5) Yes, language of 156(a)(5)(A) and (c)(4)
  would permit this. Each was reviewed
  under a different regulatory provision.

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PTE Laying the Groundwork for Patent Term
Restoration

• Additional Frequent PTE Questions
• (6) Section 156(c)(1) indicates that any period
  of time that the patent owner did not act with
  due diligence during the regulatory review period
  is subtracted. Does the PTE applicant have to
  allege diligence?
• (7) During patent prosecution, there is a duty of
  disclosure under 37 C.F.R. 1.56. Is there a
  similar duty during PTE processing?
• How does the USPTO handle processing of a PTE
  application if the expiration date of the patent
  changes?
• If there is no challenge under section
  156(d)(2)(B)(i) to the determination of the
  regulatory review period by FDA following the
  Federal Register publication of the determination
  of the length, can the length of the extension
  granted be challenged later?
• What is the scope of the rights under section
  156(b)?

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PTE Laying the Groundwork for Patent Term
Restoration

• Answers to Additional Frequent PTE Questions
• (6) No.
• (7) Yes, see 37 C.F.R. 1.765. All such
  individuals who are aware, or become aware, of
  material information adverse to a determination
  of entitlement to the extension sought. . .must
  bring such information to the attention of the
  Office
• (8) If a terminal disclaimer is filed post grant
  and post PTE filing, but prior to certificate of
  extension grant, USPTO will calculate term based
  on that earlier expiration date. If there is
  additional PTA due, USPTO will calculate term
  based on that later expiration date.
• (9) No, see 35 U.S.C. 282. A due diligence
  determination under section 156(d)(2) is not
  subject to review in such an action.
• (10) The USPTO is not involved with enforcement
  of rights. However, the language in section
  156(b) is dependent upon the identity of the
  approved product as well as the type of claim
  which was extended.

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PTE Laying the Groundwork for Patent Term
Restoration

• Thank you!
• Contact Information
• Mary C. Till
• Senior Legal Advisor
• Office of Patent Legal Administration
• USPTO
• mary.till_at_uspto.gov
• 571-272-7755