TOM ENGELLENNER Pepper Hamilton, LLP IP in Japan Committee Meeting AIPLA Annual Meeting, Washington...
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Transcript of TOM ENGELLENNER Pepper Hamilton, LLP IP in Japan Committee Meeting AIPLA Annual Meeting, Washington...
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TOM ENGELLENNERPepper Hamilton, LLP
IP in Japan Committee MeetingAIPLA Annual Meeting, Washington D.C.
October, 2015
USPTO Rule Changesand IPR Procedures
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Types of Post Grant ProceedingsRecap of IPR ProceduresOutcomes to DateRequest for comments – June 2014The Director’s Blog – Quick Fixes – March
2015PTO’s Proposed Rule Changes August 19,
2015PTO Responses to CommentsPTO Proposals for Statutory Changes
Presentation Overview
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Types of Post Grant Proceedings
Type Who Can Initiate?
What Patents Qualify?
When to File?
Grounds for Filing
Standard for Institution
IPR 3rd PartyAny
unexpired Patent
9 months after patent
grant, or termination
of PGR proceeding
§102 and §103 invalidity grounds; but only patents
or printed publications
Reasonable likelihood
petitioner would prevail on at least
1 of the challenged claims
PGR 3rd Party
Patents with a priority date of
3/16/2013 or later
During 9 month window
after grant
Any grounds for invalidity
More likely than not at least one
claim is unpatentable; or novel/unsettled legal question is
presented
CBM
3rd Party sued or charged
with infringeme
nt
Covered Business Method Patent
Only when PGR is not available
Any grounds for invalidity
More likely than not at least one
claim is unpatentable
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Filings as ofJuly 31, 2015
Over 3600 AIA proceedings have been filed to date-- (3277 IPRs, 368 CBMs, 10 PGRs)
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Recap of IPR procedures
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IPR Outcomes To Date
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Unintended Consequences?
“We are going to challenge and invalidate patents through the IPR process ... [and] we are not going to settle.”
“The companies that are expanding patents by simply changing the dosage or the way they are packaging something are going to get knee-capped.”
“The beautiful thing is this will lower drug prices for everyone.”
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Hedge Fund Challenges to Pharma
CAD Fund IPRs Filed
Target Drug Disease
I 5 Acorda Thera Ampyra Multiple Sclerosis
II 3 Shire PLC Lialda & Gattex
Short bowel syndrome
III 1 Jazz Pharma Xyrem narcolepsy
IV 1 Pharmacyclic Imbruvica lymphoma
V 3 Biogen Tecfidere Multiple Sclerosis
VI 5 Cellgene Revlimid Multiple Myeloma
VII 4 Pozen, Inc. Vimovo Pain & inflammation
VIII 1 Aegerion Juxtapid hypercholesterolemia
IX 1 Bristol Myer Eliquis Stroke / blood clots
X 3 Anacor Kerydin antifungal
XI 3 Insys Subsys Cancer pain
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The Director’s Blog
March 27, 2015:“We never envisioned that our rules or guidance would be perfect at the outset. . . . In June 2014 we asked for your input on how these proceedings were working. I am pleased to tell you about the feedback we collected and how that feedback is shaping the direction of our AIA trials going forward.”
PTO DirectorMichelle Lee
“This spring we plan to issue a first rule package containing what we call "quick fixes”. . . Later this summer, we will issue a second proposed-rule package.”
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Quick Fixes – May 19, 2015 Final Rules
Petition UNCHANGED 60 pages for IPRs80 pages for CBMs and PGRs
PO Prelim. Response UNCHANGED
60 pages for IPRs80 pages for CBMs and PGRs
PO Response UNCHANGED 60 pages for IPRs80 pages for CBMs and PGRs
Petitioner Reply UNCHANGED 15 pages
PO Motion to Amend Pages increased from 15 to 25 pages exclusive of any claim appendix
Petitioners Opposition to Motion to Amend
Pages increased from 15 to 25 pages
PO Reply to Opposition to Motion to Amend
Pages increased from 5 to 12 pages
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More Quick Fixes May 2015
Required Font 14-point, Times New Roman proportional font with normal spacing
Counsel Clarifies that more than one back-up counsel may be named.
Statements of Material Facts
Supplying a statement of a material fact is optional. However, when responding to a statement of material fact, "a listing of facts that are admitted, denied, or cannot be admitted or denied" must be included.
Discovery Clarification that routine discovery is limited to cross-examination and that either party is permitted to file testimony as an exhibit.
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August 19, 2015 Proposed New Rules
Testimonial Evidence (Expert Declarations) will be permitted in Patent Owner’s Preliminary Response (but the testimony will be considered in the light most
favorable to the petitioner when determining whether to institute an inter partes review proceeding)
Phillip-style claim construction standards for patents that “will expire” before final judgment (instead of broadest-reasonable-interpretation)
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August 2015 Proposed New Rules cont’d
New Rule-11 Requirement associated with all papers filed with the PTAB – giving the USPTO “a more robust means with which to police misconduct.”
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August 2015 Proposed New Rules cont’d
Word Count instead of page limits IPR Petitions: 14,000 words
CBM & PRG Petitions: 18,700 words
Exchange of demonstrative exhibits before Oral Hearing (7 days instead of 5 days)
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Lee’s Response to Public Comments
The Broadest Interpretation is not Appropriate for Issued Patent Claims “The Office appreciates the suggestions [but] will
continue to apply the broadest … interpretation standard”
Motions to Amend Should Be Liberally Allowed “These suggestions are not adopted.”
If a Motion to Amend is Denied, it should be converted to into A Request for Reexamination “This suggestion is not adopted.”
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Lee’s Report to Congress – Sept. 2015
Correction of Real Party in Interest “The USPTO recommends that the statute be amended
to allow for timely correction of real party in interest identification where the error identification arose without deceptive intent.”
Make Joinder Easier for Petitioners “The USPTO recommends clarifying the joinder
provisions to state that same party joinder is permitted.”
Ostensible to allow petitioners to challenge newly asserted claims from related district court litigation.
Pre AIA Patent Invalidity Challenges in District Courts:
Defendant Prevails on Invalidity 42% U.S. Personal Injury Litigation Generally
Plaintiff Prevails 52 %U.S. Contract Litigation Generally
Plaintiff Prevails 64 %Toxic Tort Litigation
Plaintiff Prevails 72%US Criminal Prosecutions
Government Prevails 84%IPR Challenges to Patent under Current PTO Rules:
Petitioner Prevails 96%
Comparative Success Rates Various Cases
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www.postgrant-counsel.com
THANK YOU
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TOM ENGELLENNERPepper Hamilton, LLP
High Street Tower, 19th Floor125 High Street
Boston, MA 02110+1-617-204-5189