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Published byArnold Robinson Modified over 9 years ago
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§ 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
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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
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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
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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
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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
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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
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§ 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 2014 7
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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
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Stages of § 337 Action Complaint filed with ITC Investigation ALJ phase ITC phase Presidential phase 9
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Timetable of ITC § 337 Investigation Non-TEO timetable TEO timetable 10
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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
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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 § 337 12
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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
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