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Presented by the Chemical Practice Committee
Tuesday, April 29, 2014
12:30 pm – 1:30 pm Eastern 1:30 pm – 2:30 pm Central
10:30 am – 11:30 pm Mountain9:30 am – 10:30 am Pacific
Chemical Practice at the ITC: Top Ten Considerations
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Sponsored by…
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Committee Leadership
AIPLA Chemical Practice Committee Leadership
Webinar Coordinator
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Jeffrey TownesChair
LeClair Ryan
Carol M NielsenVice Chair
Nielsen IP Law, LLC
Maximilienne Bishop, Ph.D.
AssociateFinnegan
Committee Leadership
AIPLA Online Programs Committee Leadership
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Stephen E. Belisle
Chair, Online ProgramsFitzpatrick Cella Harper & [email protected]
Jennifer M. K. Rogers
Vice Chair, Online ProgramsShumaker & Sieffert, [email protected]
How to submit a question
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Presented by…
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Jeffrey W. AbrahamFinnegan
Mareesa A. Frederick
Finnegan
Andrew Freistein (Moderator)
Chair, Citrix Training Subcommittee Online Programs Committee Wenderoth Lind & Ponack
© AIPLA 20147
Chemical Practice at the ITC: Top Ten Considerations
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Introduction
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“Facts and Trends Regarding USITC Section 337 Investigations,” April 15, 2013 Update, available at http://www.usitc.gov/press_room/documents/featured_news/sec337factsupdate.pdf
Introduction
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Chemical Practice at the ITC
1. Pace? FAST.
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Time to trial: 9 monthsTime to resolution at Commission: 18
monthsDiscovery: 6-8 monthsPercent of cases going to trial: 45%Percent of district court cases going to trial:
5%
1. FAST
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2. AIA: Inter partes review may drive patentees to the ITC.
Chemical Practice at the ITC
13 http://www.uspto.gov/aia_implementation/statistics.jsp
2. Inter Partes Review
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http://www.aiablog.com/post-grant-proceedings/district-courts-grant-post-institution-cbm-stays-100-of-time/
2. Inter Partes Review
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Is a stay likely in an ITC case after institution of an IPR?
2. Inter Partes Review
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2. Inter Partes Review
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Increasing IPR filings
Risk of a stay indistrict court
More ITC Investigations?
2. Inter Partes Review
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3. Defensive use of IPR.
Chemical Practice at the ITC
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• Not all roses for the patentee• Potentially impacts expert discovery• Inhibits patentee’s IPR amendments• While a stay is unlikely, the patentee could
amend its claims or the PTO could issue a decision within a timeframe that could significantly impact the outcome of an ITC decision.
3. Defensive use of IPR
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Settlement Pressure Example? Neptune (Omega-3 Products) District court, patent #1: filed October 4, 2011, stayed pending reexam District court, patent #2: filed October 2, 2012, stayed pending reexam District court, patent #3: filed February 28, 2013, stayed pending reexam
ITC: filed January 29, 2013 IPR, patent #2: filed October 1, 2013 IPR, patent #3: filed November 7, 2013 ITC: Settlement with IPR-filer, December 13, 2013 (4 days before trial) ITC: Other settlements pending
3. Defensive use of IPR
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4. Products made overseas? No safe harbor.
Chemical Practice at the ITC
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Safe harbor provision of 271(g):
No infringement of process patents if imported goods:(A) materially changed by a subsequent process, or (B) products are trivial and nonessential component of another product.
4. No Safe Harbor
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Minnesota Mining and Manufacturing Patent: method of making abrasive article Respondent argued that its imported
products were “materially changed” and thus did not infringe.
Result? Safe harbor does not apply in the ITC. Kinik Co. v. ITC, 362 F.3d 1359 (Fed. Cir.
2004).
4. No Safe Harbor
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How much additional processing?Tate & LylePatents: (1) methods of making intermediates
(2) method of recovering catalyst
4. No Safe Harbor
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OK
X
4. No Safe HarborHow much additional processing?Tate & LylePatents: (1) methods of making intermediates
(2) method of recovering catalyst
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5. Processes practiced in the US?
Chemical Practice at the ITC
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Products must infringe when imported. Inv. No. 337-TA-724.
Inducing infringement in the United States not sufficient when direct infringement occursafter importation. Suprema, Inc. v. ITC, (Fed. Cir. Dec. 13, 2013).
5. No processes performed in U.S.
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6. Jurisdiction: in rem.
Chemical Practice at the ITC
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In rem Products Imported by or on behalf of named respondentsRespondents subject to discovery, regardless of ties to the United States
6. In Rem Jurisdiction
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Eli Lilly and CompanyPatent: method of making gemcitabine
CanadaUnited Kingdom SingaporeDenmark AustraliaChinaUS district court (N.D. Ill.)US district court (D. Conn.)
Result? No manufacturing records
6. In Rem Jurisdicition
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Eli Lilly sued in the ITCResult? Chinese manufacturer produced batch
recordsLilly questioned authenticity. ALJ granted Lilly’s motion for a forensic
inspection (i.e., ink testing) of batch records.Inv. No. 337-TA-766, Order No. 10.
6. In Rem Jurisdicition
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7. No limits on joining unrelated respondents.
Chemical Practice at the ITC
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AIA restricts joinder of accused infringers to two situations:
(1) patentee seeks relief jointly, severally, or in the alternative with respect to or arising out of the same transaction, occurrence, or series of transactions or occurrences relating to the making, using, importing into the United States, offering for sale, or selling of the same accused product or process; and
(2) questions of fact common to all defendants or counterclaim defendants will arise in the action.
35 USC § 299(a). Allegation of infringement insufficient for joinder.
35 USC § 299(b).
7. AIA: Joinder
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ITC has no restrictions on joining unrelated defendants
Hitachi Metals sued for infringement of patents covering methods of making rare earth sintered magnets in Inv. No. 337-TA-855: 29 respondents listed in complaint 20+ settlements Withdrew complaint prior to trial
7. AIA: Joinder
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8. Domestic industry: what is it?
Chemical Practice at the ITC
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(1) Plant and equipment(2) Labor and capital(3) Exploitation
8. Domestic Industry
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Exploitation?
(1)Eli LillyPatent: making of gemcitabineDI: R&D, licensees activities Inv. No. 337-TA-766
(2)MerckPatents: use of METAFOLIN®DI: R&D, product support, packaging, products incorporating METAFOLIN®Inv. No. 337-TA-857
8. Domestic Industry
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Exploitation?(3) Neptune: Patent: krill extract DI: encapsulation
Harvested: Antarctic Ocean
Deep frozen in Uruguay
Extracted in QuebecEncapsulated in US
8. Domestic Industry
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How much is enough?No bright linesIn Certain Kinesiotherapy Devices, the ITC
concluded that domestic investments related to components amounting to 5% of product cost were sufficient. Comm’n Op., Inv. No. 337-TA-823.
8. Domestic Industry
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9. Remedy: no eBay.
Chemical Practice at the ITC
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Exclusion order Essentially an injunction eBay does not apply No irreparable harm requirement No consideration of the adequacy of
damages Public interest is considered Pursue damages later in district court
9. No eBay
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10. Remedy: exclusion order
Chemical Practice at the ITC
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Limited exclusion order: block imports by named respondents
General exclusion order: block imports by anyone when infringement is widespread, and it is difficult to determine the source of infringing products.
Certain Kinesiotherapy Devices, Inv. No. 337-TA-823 Wide-spread infringement Difficult to identify the source of infringing
goods
10. Remedies
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What does an exclusion order look like? Often, specific models are not identified “Products that infringe”
10. Remedies
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Inter Partes Review
Process Patents
Domestic Industry
Remedy
Conclusions
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Questions
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Finnegan, Henderson, Farabow, Garrett & Dunner, LLP901 New York Avenue, NWWashington, DC 20001-4413 Tel 1 202 408 4000Fax 1 202 408 4400
Maximilienne Bishop – Mareesa Frederick – Jeffrey Abraham
Thank you!
Thank you for participating in today’s program!
If you have any questions for today’s presenters that were not addressed or were stuck in the queue,
please e-mail them to:
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These materials are public information and have been prepared solely for educational and entertainment purposes to contribute to the understanding of U.S. intellectual property law. These materials reflect only the personal views of the authors and are not a source of legal advice. It is understood that each case is fact specific, and that the appropriate solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. Thus, the authors and Finnegan, Henderson, Farabow, Garrett & Dunner, LLP cannot be bound either philosophically or as representatives of their various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorney-client relationship with the authors or Finnegan, Henderson, Farabow, Garrett & Dunner, LLP. While every attempt was made to ensure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed.
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