H311351

HQ H311351 August 19, 2020 OT:RR:BSTC:IPR H311351 JW/CBC/SEH CATEGORY: 19 U.S.C. § 1337; Unfair Competition VIA EMAIL: US-CLIENT-Jennewein-ITC@mayerbrown.com Mr. Gary M. Hnath Mayer Brown LLP 1999 K Street N.W. Washington, D.C. 20006-1101 RE: Ruling Request; U.S. International Trade Commission; Limited Exclusion Order; Investigation No. 337-TA-1120; Certain Human Milk Oligosaccharides and Methods of Producing the Same. Dear Mr. Hnath: Pursuant to 19 C.F.R. Part 177, the Intellectual Property Rights Branch (“IPR Branch”), Regulations and Rulings, U.S. Customs and Border Protection (“CBP”) issues this ruling letter. We find that Jennewein Biotechnolgies GmbH (“Jennewein”) has met its burden to show that the Human Milk Oligosaccharide, 2’-fucosyllactose (“2’-FL”), manufactured by Jennewein using the E. coli bacterial strain #1242 (“the articles at issue”) does not infringe claims 1–3, 5, 8, 10, 12, 18, and 24–28 of U.S. Patent No. 9,970,018. Thus, CBP’s position is that the articles at issue are not subject to the limited exclusion order issued by the U.S. International Trade Commission (“Commission” or “ITC”) in Investigation No. 337-TA-1120 (“the underlying investigation” or “the 1120 investigation”), pursuant to section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. § 1337 (“section 337”). In addition, with each entry of the articles at issue, CBP will require from persons importing the articles at issue (1) a certification, as approved by CBP; and (2) upon request by CBP, to furnish such records or analyses necessary to substantiate the certification. See Certain Human Milk Oligosaccharides and Methods of Producing the Same, Investigation No. 337-TA-1120, EDIS Doc. ID 710646, Limited Exclusion Order (May 19, 2020) (“1120 LEO”) at ¶ 4. We further note that determinations of the Commission are binding authority on CBP and, in the case of conflict, will by operation of law modify or revoke any contrary CBP ruling or decision. This ruling letter is the result of a request for an administrative ruling from CBP, which was conducted on an inter partes basis upon consent of the parties. The process involved the two parties with a direct and demonstrable interest in the question presented by the ruling request: (1) your client as named as a respondent in the underlying investigation, Jennewein; and (2) Glycosyn LLC (“Glycosyn”), the complainant in the underlying investigation. See, e.g., 19 C.F.R. § 177.1(c). The parties were asked to clearly identify confidential information, including information subject to the administrative protective order in the underlying investigation, with [[red brackets]] in all of their submissions to the CBP. See e.g., CBP Email to Parties dated June 8, 2020. If there is additional information in this ruling letter not currently bracketed in red [[ ]] that either party believes constitutes confidential information, and should be redacted from the published ruling, then the parties are asked to contact CBP within ten (10) working days of the date of this ruling letter. See, e.g., 19 C.F.R. § 177.8(a)(3). Please note that disclosure of information related to administrative rulings under 19 C.F.R. Part 177 is governed by for example, 6 C.F.R. Part 5, 31 C.F.R. Part 1, 19 C.F.R. Part 103, and 19 C.F.R. § 177.8(a)(3). See, e.g., 19 C.F.R. § 177.10(a). In addition, CBP is guided by the laws relating to confidentiality and disclosure, such as the Freedom of Information Act (“FOIA”), as amended (5 U.S.C. § 552), the Trade Secrets Act (“TSA”) (18 U.S.C. § 1905), and the Privacy Act of 1974, as amended (5 U.S.C. § 552a). A request for confidential treatment of information submitted in connection with a ruling requested under 19 C.F.R. Part 177 faces a strong presumption in favor of disclosure. See, e.g., 19 C.F.R. § 177.8(a)(3). The person seeking this treatment must overcome that presumption with a request that is narrowly tailored and supported by evidence establishing at least that: (1) it is information that is customarily kept private or closely; and either (a) the government provided an express or implied assurance of confidentiality when the information was shared with the government; or (b) there were no express or implied indications at the time the information was submitted that the government would publicly disclose the information. See, e.g., OIP Guidance: Step-by-Step Guide for Determining if Commercial or Financial Information Obtained from a Person is Confidential Under Exemption 4 of the FOIA (posted 10/3/2019). BACKGROUND ITC Investigation No. 337-TA-1120 Procedural History at the ITC The Commission instituted Investigation No. 337-TA-1120 on June 21, 2018, based on a complaint, as amended and supplemented, filed by Glycosyn LLC. Certain Human Milk Oligosaccharides and Methods of Producing the Same, Investigation No. 337-TA-1120, EDIS Doc. ID 712205, Commission Opinion (Public) (June 8, 2020) (“Comm’n Op.”) at 1 (citing 83 Fed. Reg. 28865–66 (June 21, 2018)). The complaint alleged violations of section 337 based upon the importation into the United States, the sale for importation, and the sale within the United States after importation of certain human milk oligosaccharides, by reason of infringement of certain claims of U.S. Patent Nos. 9,453,230 (“the ’230 patent”) and 9,970,018 (“the ’018 patent”). Id. The complaint also alleged the existence of a domestic industry. Id. The notice of investigation named Jennewein Biotechnologie GmbH as respondent in the investigation. Id. at 2. The Office of Unfair Import Investigations (“OUII”) was also a party to the investigation. Id. The Commission later terminated the investigation as to all asserted claims of the ’230 patent and certain asserted claims of the ’018 patent based on the withdrawal of the allegations pertaining to those claims. Id. (citations omitted). Claims 1–3, 5, 8, 10, 12, 18, and 23-28 of the ’018 patent remained pending in the investigation. Id. The presiding administrative law judge (“ALJ”) conducted an evidentiary hearing on May 14–17, 2019. Id. On September 9, 2019, the ALJ issued the final initial determination (“FID”) finding a violation of section 337 based on the infringement of claims 1-3, 5, 8, 10, 12, 18, and 24–28 of the ’018 patent. Id. (citation omitted). Based on a finding of non-infringement of claim 23 of the ’018 patent, the ALJ did not find a violation of section 337 for that claim. Id. (citation omitted). The FID also found that the domestic industry requirement was satisfied. Id. The FID also contained a Recommended Determination (“RD”) recommending, inter alia, that should a violation of section 337 be found, the Commission issue a limited exclusion order (“LEO”) barring entry of articles that infringe claims 1–3, 5, 8, 10, 12, 18, and 24–28 of the ’018 patent. Id. On September 23, 2019, Jennewein and the Commission’s Investigative Attorney (“IA”) filed petitions for review of the FID. Id. at 3. On October 1, 2019, Glycosyn and the IA filed responses to the various petitions. Id. On January 30, 2020, the Commission issued a notice determining to review the FID in part. Id. at 4 (citing 85 Fed. Reg. 6573–75 (Feb. 5, 2020)). Specifically, the Commission determined to review: (1) the FID’s infringement findings with respect to Jennewein’s bacterial strains adjudicated in the investigation, i.e., the #1540 bacterial strain and a derivative thereof, known as the #1540 derivative, or the #2410 strain; and (2) the FID’s decision not to adjudicate infringement as to Jennewein’s alternative bacterial strain, i.e., the TTFL12 strain. Id. (citation omitted); see also id. at 8; see also Certain Human Milk Oligosaccharides and Methods of Producing the Same, Investigation No. 337-TA-1120, EDIS Doc. ID 690229, Initial Determination on Violation of Section 337 and Recommended Determination on Remedy and Bond (Public) (October 13, 2019) (“FID”) at 7. The Commission determined not to review the remainder of the FID. Comm’n Op. at 4. On February 18,

at the ITCAccused StrainsThe ALJ found that Glycosyn showed by a preponderance of the evidence that the Accused Strains met the limitations of asserted claims 1–3, 5, 8, 10, 12, 18, and 24–28 of the ’018 patent either literally or under the doctrine of equivalents, and thus Jennewein directly infringed those claims. FID at 35. For those claims, the parties did not dispute, and the ALJ found, that most of the asserted claim limitations were met as compared to the Accused Strains. Id. at 36–8. The only claim limitation, and the only claim, disputed within those claims were:Disputed Claim 1 Limitation “an exogenous functional ß-galactosidase gene comprising a detectable level of ß-galactosidase activity that is reduced compared to that of a wild-type E. coli bacterium, wherein the level of ß-galactosidase activity comprises between 0.05 and 200 units” FID at 38-57.Disputed Claim 8 “the method of claim 1, wherein said exogenous functional ß-galactosidase gene comprises an E. coli lacZ gene” FID at 57-60.i. Disputed Claim 1 Limitation “an exogenous functional ß-galactosidase gene comprising a detectable level of ß-galactosidase activity that is reduced compared to that of a wild-type E. coli bacterium, wherein the level of ß-galactosidase activity comprises between 0.05 and 200 units”With respect to the disputed claim 1 limitation, “an exogenous functional ß-galactosidase gene comprising a detectable level of ß-galactosidase activity that is reduced compared to that of a wild-type E. coli bacterium, wherein the level of ß-galactosidase activity comprises between 0.05 and 200 units” (emphasis added); the ALJ first looked at the portion in bold and italics. FID at 38. The ALJ found that, that portion of the claim limitation was not literally met. Id. The ALJ stated that “the claim recites ‘a[] . . . functional ß-galactosidase gene,’ which Order 22 construed as ‘a functional sequence of DNA that encodes ß-galactosidase.’” Id. (citing Order No. 22 at 29). The ALJ noted the