patent term matters
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Patent Term Matters. Term and Scope AIPLA 14 May 2009. Patent Term Matters. James J. Kelley Ass’t General Patent Counsel Eli Lilly and Company Indianapolis, Indiana 46285 [email protected]. Vicki G. Norton Partner Duane Morris LLP San Diego, CA 92101-8285 [email protected]. - PowerPoint PPT PresentationTRANSCRIPT
Patent Term Matters
Term and ScopeAIPLA
14 May 2009
Patent Term Matters
James J. KelleyAss’t General Patent CounselEli Lilly and CompanyIndianapolis, Indiana [email protected]
Jeffrey P. KushanPartnerSidley Austin Brown & WoodWashington, D.C. [email protected]
Vicki G. NortonPartnerDuane Morris LLPSan Diego, CA [email protected]
Pamela PolitisPatent AttorneyEndo PharmaceuticalsChadds Ford, PA [email protected]
14 May 2009 2AIPLA Chemical and Biotechnology Sections
Motivation for This Session• Conference Speakers– “PTE = ½ day/day during testing phase + 1 day/day during
review phase (≤5, ≤14)”• Due diligence observations– premature filings– protracted, non-strategic prosecution
• RCEs, CIPs, TDs, extensions, late submissions• final rejections, not ready for appeal• pursuit of “scope”• no apparent concern about term
• How does pursuit of “scope” potentially jeopardize >14-year effective patent term for drugs?
14 May 2009 3AIPLA Chemical and Biotechnology Sections
How Much Does Term Matter?
• One extra day of exclusivity for a $1B/year drug is $2.75 million.
• Decisions that may affect patent term must be made carefully.– Example: • direct non-provisional US filing vs. • PCT followed 18 months later by US national filing
– NPV for $1B/year drug – up to ~$150 million.1
2assuming 8% discount rate, 9-month difference in patent term (18 months ÷ 2), and complete loss of market at end of term
14 May 2009 4AIPLA Chemical and Biotechnology Sections
Agenda
Discussion StartersJeff Kushan – PTAJim Kelley – PTE and PTAVicki Norton - Scope: Enemy of Term? The Impact of Recent DecisionsPam Politis – Strategy Questions
Panel and Audience DiscussionQuestions May be Asked at Any Time
14 May 2009 AIPLA Chemical and Biotechnology Sections 5
35 U.S.C. PTE Provisions
• PTE is applied after PTA - § 156 (a)• PTE accrues only after patent issues - § 156 (c)• Lack of diligence deduction; ½ day per day;
14-year limit - § 156 (c)• Regulatory review period = testing phase plus
review phase - § 156 (g)(1)(B)(i) and (ii), resp.• 5-year limit - § 156 (g)(6)(A)
14 May 2009 6AIPLA Chemical and Biotechnology Sections
PTE = PTR• Drug Price Competition and Patent Term Restoration Act• Must “lose” patent term before it can be “restored.”• PTE “credits”
Regulatory review period minus any time during which there was lack of diligence;
½ day per day from when the patent has issued and an IND has become effective until a complete NDA is submitted,
plus 1 day per day from when the patent has issued and the NDA is
complete until the NDA is approved,• Total patent term restored ≤ 5 yrs• Total period of Effective Patent Term (EPT) ≤ 14 yrs
14 May 2009 7AIPLA Chemical and Biotechnology Sections
Effective Patent Term (EPT)
Patent Term Starts
IND Effective
NDA Complete
D T
P
Patent Issues
R
NDA Approved
EPT (≤14 years)
Patent Expires
Inputs: P = time from beginning of patent term to patent issue (“pending phase”)D = time from beginning of patent term until IND effective date (“delay”)T = time from IND effective date until NDA complete (“testing phase”)R = time from NDA acceptance until NDA approval (“review phase”)
Output: EPT = time from NDA approval until patent expires
PTE “Credits”½ day
per day1 day
per day
Expiry of 17- or 20-year term
PTE (≤5 years)
14 May 2009 8AIPLA Chemical and Biotechnology Sections
Effective Patent Term (EPT)
Patent Term Starts
IND Effective
NDA Complete
D T
P
Patent Issues
R
NDA Approved
EPT (≤14 years)
Inputs: P = time from beginning of patent term to patent issue (“pending phase”)D = time from beginning of patent term until IND effective date (“delay”)T = time from IND effective date until NDA complete (“testing phase”)R = time from NDA acceptance until NDA approval (“review phase”)
Output: EPT = time from NDA approval until patent expires
PTE “Credits”½ day
per day1 day
per day
14 May 2009 9AIPLA Chemical and Biotechnology Sections
Patent Expires
Expiry of 17- or 20-year term
PTE (≤5 years)
Effective Patent Term (EPT)
Patent Term Starts
IND Effective
NDA Complete
D < 0T
P
Patent Issues
R
NDA Approved
EPT (≤14 years)
Inputs: P = time from beginning of patent term to patent issue (“pending phase”)D = time from beginning of patent term until IND effective date (“delay”)T = time from IND effective date until NDA complete (“testing phase”)R = time from NDA acceptance until NDA approval (“review phase”)
Output: EPT = time from NDA approval until patent expires
PTE “Credits”½ day
per day1 day
per day
14 May 2009 10AIPLA Chemical and Biotechnology Sections
Patent Expires
Expiry of 17- or 20-year term
PTE (≤5 years)
Attorney Influence Over EPT Variables
• No control: T, R• Some influence: D – time between start of
patent term and start testing phase• Most influence: P – time to issue patent
Patent Term Starts
IND Effective
NDA Complete
D T
P
Patent Issues
R
NDA Approved
EPT
Patent Expires
14 May 2009 11AIPLA Chemical and Biotechnology Sections
Survey
• 48 human drugs that qualified for PTE (no devices or animal products)
• Sources– USPTO site– US patents– Federal Register
Approval Year Number in Survey
1996 1
2000 1
2001 3
2002 3
2003 6
2004 6
2005 5
2006 14
2007 9
14 May 2009 12AIPLA Chemical and Biotechnology Sections
Survey Results – AveragesP D T R EPT
17-year (18) 5.9 5.9 5.5 0.9 12.820-year (30) 4.8 2.4 5.9 1.1 12.9Biotech (18) 6.1 3.7 5.3 1.3 13.2
Small Mol. (30) 4.7 3.6 6.0 0.9 12.6Total (48) 5.2 3.6 5.7 1.1 12.8
14 May 2009 13AIPLA Chemical and Biotechnology Sections
P = time from beginning of patent term to patent issue (“pending phase”)D = time from beginning of patent term until IND effective date (“delay”)T = time from IND effective date until NDA complete (“testing phase”)R = time from NDA acceptance until NDA approval (“review phase”)EPT = effective patent term, i.e., time from NDA approval until patent expires
Survey Results – RangesP D T R EPT
Minimum 1.5 -13.3 2.6 0.3 7.71st quartile 3.1 1.8 4.0 0.5 12.22nd quartile 4.6 3.0 5.5 0.8 14.03rd quartile 7.4 6.2 6.6 1.2 14.0Maximum 12.4 10.4 20 3.0 14.0
14 May 2009 14AIPLA Chemical and Biotechnology Sections
P = time from beginning of patent term to patent issue (“pending phase”)D = time from beginning of patent term until IND effective date (“delay”)T = time from IND effective date until NDA complete (“testing phase”)R = time from NDA acceptance until NDA approval (“review phase”)EPT = effective patent term, i.e., time from NDA approval until patent expires
An EPT “Mountain” – PTE Only
14 May 2009 AIPLA Chemical and Biotechnology Sections 15
Topographical View
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14 May 2009 AIPLA Chemical and Biotechnology Sections 17
EPT Observations
• The longer the testing (T), the smaller the “plateau.”
• Longer prosecution (P) and greater delay (D) lower likelihood for 14 years.
• Length of prosecution (P) has least effect when D=0, that is, when patent term starts at the same time that clinical testing starts.
• Length of review (R) has little to no effect when T = 4-6 years, but longer review (R) lowers likelihood for 14 years when T = 8-10 years.
14 May 2009 18AIPLA Chemical and Biotechnology Sections
PTE Summary
• Must have a patent before PTE “credits” accrue – therefore want to issue sooner than later.
• Realizing this will affect drafting, filing, and prosecuting strategies:– Longer prosecution => less EPT– Earlier patent filing => less EPT
• Longer development time => less EPT• If short development times (<~4-5 years), then less
concern about prosecution time.
14 May 2009 AIPLA Chemical and Biotechnology Sections 19
PTE and PTA§ 156 (c) The term … shall be extended by the time equal to the regulatory review period for the approved product which period occurs after the date the patent is issued, except that- …
(3) if the period remaining in the term of a patent after the date of the approval of the approved product … when added to theregulatory review period as revised under paragraphs (1) and (2) exceeds fourteen years, the period of extension shall be reduced so thatthe total of both such periods does not exceed fourteen years;
14 May 2009 AIPLA Chemical and Biotechnology Sections 20
156(c)(3), 154(b), 156(a)
Patent Term Starts
IND Effective
NDA Complete
Patent Issues
NDA Approved
Patent Expires
Expiry of 17- or 20-year term
PTE (≤5 years)
14 May 2009 21AIPLA Chemical and Biotechnology Sections
PTA
EPT (≤14 years)
156(c)(3) if the period remaining in the term of a patent after the date of the approval of the approved product … when added to the regulatory review period as revised under paragraphs (1) and (2) exceeds fourteen years, the period of extension shall be reduced so that the total of both such periods does not exceed fourteen years
Incorrect Interpretation of 156(c)(3)
Patent Term Starts
IND Effective
NDA Complete
Patent Issues
NDA Approved
EPT (≤14 years)
Patent Expires
Expiry of 17- or 20-year term
PTE (≤5 years)
14 May 2009 22AIPLA Chemical and Biotechnology Sections
PTA
156(c)(3) if the period remaining in the term of a patent after the date of the approval of the approved product … when added to the regulatory review period as revised under paragraphs (1) and (2) exceeds fourteen years, the period of extension shall be reduced so that the total of both such periods does not exceed fourteen years
PTE and PTA
• Does the 14-year limit apply to both PTE and PTA?– Statutory language seems clear – No. – But, will the USPTO take a different interpretation,
as in Wyeth?– No cases yet.– Some could be in process now.
14 May 2009 AIPLA Chemical and Biotechnology Sections 23
PTE and PTA
• PTA vs.PTE• PTE– want to issue sooner, to start accruing “credit”
sooner– only ½ day per day during testing phase
• PTE – want to issue later, but without incurring
deductions– 1 day per day
14 May 2009 24AIPLA Chemical and Biotechnology Sections
PTE and PTA• Poor correlation between pendency and PTA –
see Patently-O blog, March 14, 2008• Average PTA = ~1.1 years over-all– Longer for pharma & biotech patents covering
products? Longer for such patents that receive PTE?• No data yet (Wyeth and other cases)• No patents that obtained PTE also obtained PTA,
yet– PTE data are very delayed (2-3 years from approval)– Only 2 patents in survey were filed after May 29, 2000
and neither qualified for any PTA.
14 May 2009 25AIPLA Chemical and Biotechnology Sections
PTE and PTA Summary
• PTA will extend PTE-extended patent term beyond 14 years.– But, will USPTO take a different view?
• Must be very careful not to lose PTA after lengthy prosecution– e.g., lost appeal, RCE, TD– could jeopardize both PTE and PTA
14 May 2009 AIPLA Chemical and Biotechnology Sections 26
Back up Slides
14 May 2009 AIPLA Chemical and Biotechnology Sections 27
PTE and PTA
35 U.S.C. § 156 (a) The term of a patent … shall be extended … from the original expiration date of the patent, which shall include any patent term adjustment granted under section 154(b) if ….
14 May 2009 28AIPLA Chemical and Biotechnology Sections
Requirement for Patent Issue
35 U.S.C. § 156 (c) The term of a patent eligible for extension under subsection (a) shall be extended by the time equal to the regulatory review period for the approved product which period occurs after the date the patent is issued, except that-
14 May 2009 AIPLA Chemical and Biotechnology Sections 29
Deductions, Partial Credit, 14-year Limit
35 U.S.C. § 156 (c) …(1) each period of the regulatory review period shall be reduced by any period [in which diligence was not exercised];(2) after any reduction required by paragraph (1), the period of extension shall include only one-half of the time [described in 35 U.S.C. § 156 (g)(1)(B)(i) – i.e., from IND to NDA];(3) if the period remaining in the term of a patent after the date of the approval … exceeds fourteen years, the period of extension shall be reduced so that the total of both such periods does not exceed fourteen years
14 May 2009 AIPLA Chemical and Biotechnology Sections 30
“Regulatory Review Period”
35 U.S.C § 156 (g) For purposes of this section, the term "regulatory review period" has the following meanings: …(1)(B) The regulatory review period for a new drug, antibiotic drug, or human biological product is the sum of –– (i) the period beginning on the date [an IND] became
effective … and ending on the date an [NDA] was initially submitted, and
– (ii) the period beginning on the date the [NDA]was initially submitted and ending on the date such [NDA] was approved.
14 May 2009 AIPLA Chemical and Biotechnology Sections 31
5-year limit
35 U.S.C. § 156 (g)(6) A period determined under any of the preceding paragraphs is subject to the following limitations:(A) …, the period of extension determined on the basis of the regulatory review period … may not exceed five years.
14 May 2009 AIPLA Chemical and Biotechnology Sections 32