1. 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 Mountain 9:30 am – 10:30 am Pacific Chemical Practice at the ITC: Top Ten Considerations 1

2. Sponsored by… 2

3. Committee Leadership AIPLA Chemical Practice Committee Leadership Webinar Coordinator 3 Jeffrey Townes Chair LeClair Ryan Carol M Nielsen Vice Chair Nielsen IP Law, LLC Maximilienne Bishop, Ph.D. Associate Finnegan

4. Committee Leadership AIPLA Online Programs Committee Leadership 4 Stephen E. Belisle Chair, Online Programs Fitzpatrick Cella Harper & Scinto Sbelisle@fchs.com Jennifer M. K. Rogers Vice Chair, Online Programs Shumaker & Sieffert, PA Rogers@ssiplaw.com

5. How to submit a question 5

6. Presented by… 6 Jeffrey W. Abraham Finnegan Mareesa A. Frederick Finnegan Andrew Freistein (Moderator) Chair, Citrix Training Subcommittee Online Programs Committee Wenderoth Lind & Ponack

7. © AIPLA 2014 7 Chemical Practice at the ITC: Top Ten Considerations

8. 8 Introduction

9. 9 “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

10. 10 Chemical Practice at the ITC 1. Pace? FAST.

11. 11 Time to trial: 9 months Time to resolution at Commission: 18 months Discovery: 6-8 months Percent of cases going to trial: 45% Percent of district court cases going to trial: 5% 1. FAST

12. 12 2. AIA: Inter partes review may drive patentees to the ITC. Chemical Practice at the ITC

13. 13 http://www.uspto.gov/aia_implementation/statistics.jsp 2. Inter Partes Review

14. 14 http://www.aiablog.com/post-grant-proceedings/district-courts-grant-post-institution-cbm-stays-100-of-time / 2. Inter Partes Review

15. 15 Is a stay likely in an ITC case after institution of an IPR? 2. Inter Partes Review

16. 16 2. Inter Partes Review

17. 17 Increasing IPR filings Risk of a stay in district court More ITC Investigations? 2. Inter Partes Review

18. 18 3. Defensive use of IPR. Chemical Practice at the ITC

19. 19 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

20. 20 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

21. 21 4. Products made overseas? No safe harbor. Chemical Practice at the ITC

22. 22 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

23. 23 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

24. 24 How much additional processing? Tate & Lyle Patents: (1) methods of making intermediates (2) method of recovering catalyst 4. No Safe Harbor

25. 25 OK X 4. No Safe Harbor How much additional processing? Tate & Lyle Patents: (1) methods of making intermediates (2) method of recovering catalyst

26. 26 5. Processes practiced in the US? Chemical Practice at the ITC

27. 27 Products must infringe when imported. Inv. No. 337-TA-724. Inducing infringement in the United States not sufficient when direct infringement occurs after importation. Suprema, Inc. v. ITC, (Fed. Cir. Dec. 13, 2013). 5. No processes performed in U.S.

28. 28 6. Jurisdiction: in rem. Chemical Practice at the ITC

29. 29 In rem  Products Ñ Imported by or on behalf of named respondents Ñ Respondents subject to discovery, regardless of ties to the United States 6. In Rem Jurisdiction

30. 30 Eli Lilly and Company Patent: method of making gemcitabine Canada United Kingdom Singapore Denmark Australia China US district court (N.D. Ill.) US district court (D. Conn.) Result? No manufacturing records 6. In Rem Jurisdicition

31. 31 Eli Lilly sued in the ITC Result? Chinese manufacturer produced batch records Lilly 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

32. 32 7. No limits on joining unrelated respondents. Chemical Practice at the ITC

33. 33 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

34. 34 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

35. 35 8. Domestic industry: what is it? Chemical Practice at the ITC

36. 36 (1) Plant and equipment (2) Labor and capital (3) Exploitation 8. Domestic Industry

37. 37 Exploitation? (1) Eli Lilly Patent: making of gemcitabine DI: R&D, licensees activities Inv. No. 337-TA-766 (2) Merck Patents: use of METAFOLIN® DI: R&D, product support, packaging, products incorporating METAFOLIN® Inv. No. 337-TA-857 8. Domestic Industry

38. 38 Exploitation? (3) Neptune: Patent: krill extract DI: encapsulation Harvested: Antarctic Ocean Deep frozen in Uruguay Extracted in Quebec Encapsulated in US 8. Domestic Industry

39. 39 How much is enough? No bright lines In 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

40. 40 9. Remedy: no eBay. Chemical Practice at the ITC

41. 41 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

42. 42 10. Remedy: exclusion order Chemical Practice at the ITC

43. 43 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

44. 44 What does an exclusion order look like? Often, specific models are not identified “Products that infringe” 10. Remedies

45. 45 Inter Partes Review Process Patents Domestic Industry Remedy Conclusions

46. 46 Questions

47. 47 Finnegan, Henderson, Farabow, Garrett & Dunner, LLP 901 New York Avenue, NW Washington, DC 20001-4413 Tel 1 202 408 4000 Fax 1 202 408 4400 Maximilienne Bishop – Mareesa Frederick – Jeffrey Abraham Thank you!

48. 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: Seminar_Questions@aipla.org 48

49. 49 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. Disclaimer