§ 337 Investigations  Shortcomings of district court litigation in dealing with infringing imports  Nature of § 337 investigations  Popularity of § 337 cases  Reasons to consider ITC  Stages of § 337 action  Timeline of § 337 investigation  In the Matter of Certain Recombinant Erythropoietin 1

District Court Suits & Infringing Imports  Scenario  You hold patent on tequila formulation  Your patent covers Patron Anejo  Importer/Distributor in AZ  Distributor just began selling in AZ  Could bring suit in district court for damages and injunction  What if you wanted to prevent Patron destined for AZ from entering country?  What if Patron uses different distributors for other states? 2

Nature of § 337 Investigation  What is the U.S. ITC?  Section 337 investigations  What does § 337 proscribe?  § 337(a)(1)(B): “The importation into the United States, the sale for importation, or the sale within the United States after importation by the owner, importer, or consignee, of articles that – (i) infringe a valid and enforceable United States patent... ; or (ii) are made... by means of a process covered by the claims of a valid and enforceable United States patent.” 3

Nature of § 337 Investigation cont’d  § 337 elements of proof  Existence of domestic industry  Importation of products by a respondent  Unfair act  Patent infringement  Remedy to which entitled if prevail 4

Nature of § 337 Investigation cont’d  Domestic industry requirements  Nexus between activities and patent at issue  Domestic industry exists in U.S. if there is either:  Significant investment in plant and equipment  Significant employment of labor or capital  Substantial investment in exploitation of patent  Manufacturing in U.S. not required  Unfair act  Laws pertaining to patent infringement apply 5

Nature of § 337 Investigation cont’d  Relief to which entitled if prevail  No monetary damages  Exclusion orders  Directed to U.S. Customs  General exclusion order  Limited exclusion order  Cease & desist orders 6

§ 337 Cases Have Increased  18 § 337 complaints filed in 2003  40 complaints in 2007  58 complaints in 2010  69 complaints in 2011  40 complaints in 2012  42 complaints in 2013  34 complaints in

Why Patentee Might Consider ITC vs. District Court  Expedited process  Opportunity for complainant to prepare case  One-stop relief available  No counterclaims  In rem jurisdiction  Bias of agency  Experienced ALJ’s 8

Stages of § 337 Action  Complaint filed with ITC  Investigation  ALJ phase  ITC phase  Presidential phase 9

Timetable of ITC § 337 Investigation  Non-TEO timetable  TEO timetable 10

In the Matter of Certain Recombinant Erythropoietin  Amgen  First to successfully clone EPO gene  Filed patent application that issued as ‘008 patent  Claim 2: A purified and isolated DNA sequence... encoding human erythropoietin  Claim 5: A... DNA vector including a DNA sequence according to... Claim 2...  Claim 23: A... [host] cells transformed... in a manner allowing the host cells to express [erythropoietin]  Amgen used host cells to produce rEPO  Chugai  Chugai Japan obtained host cells containing EPO gene  In Japan, Chugai used DNA sequence, DNA vector, and host cells to produce rEPO  Chugai imported rEPO into the U.S. 11

rEPO cont’d  Amgen filed complaint in ITC seeking exclusion  Amgen claimed articles used to make EPO, but none was imported  Use of patented article abroad does not constitute infringement  However, if a patented process is practiced abroad to produce a product, and that product is imported, then patent infringement  If Amgen could convince ITC that its claims were process claims practiced abroad to produce rEPO, then it could argue that importation of rEPO was violation of §

rEPO cont’d  Amgen contended that ‘008 patent claims were “hybrid” process claims  It said they covered both articles and intracellular processes  Based on claim construction, ALJ and ITC ruled that ‘008 patent does not claim a process  As filed, application contained process claims  Examiner rejected claims as obvious  Amgen then cancelled its process claims and rewrote its article claims  It stated that none of the rewritten claims corresponded to the cancelled process claims and, therefore, the issue of whether the process claims were patentable was no longer an issue  ITC relied on cases that patentee is precluded from obtaining a claim construction that would resurrect subject matter surrendered during prosecution  Because Amgen surrendered its process claims during prosecution, the surviving claims should not be construed in a way that would resurrect those claims 13