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A Reminder of Doctrine of Equivalents in Biotechnology: Jennewein Biotechnologie GmbH v. International Trade Commission

Doctrine of equivalents (DOE) can be applied as a mechanism to hold a party liable for patent infringement even if the product or process does not literally infringe a patent claim, if the difference is “insubstantial”. Warner-Jenkinson Co. v. Hilton Davis Chem. Co. (1997) Findings of infringement under DOE, particularly in biotechnology related cases, have often been considered an exception rather than the rule. One such exception is the recent Federal Circuit nonprecedential decision in Jennewein Biotechnologie GmbH v. International Trade CommissionSeptember 17, 2020, Chen, R. (Glycosyn LLC, the patent owner, joined as an Intervenor). The Federal Circuit affirmed an exclusion order from the International Trade Commission (ITC) relying on an application of DOE to find infringement supported by substantial evidence.

Glycosyn’s ITC complaint under 19 U.S.C. § 1337, alleged that human milk oligosaccharides “HMOs” imported by Jennewein infringed Glycosyn’s U.S. Patent No. 9,970,018 (’018 patent). Claim 1 of the ‘018 patent is directed to a method for producing a fucosylated oligosaccharide in a bacterium and requires that, among other things, the bacterium contains “an exogenous functional β-galactosidase gene comprising a detectable level of β-galactosidase activity that is reduced compared to that of a wild-type E. coli bacterium, wherein the level of β-galactosidase activity comprises between 0.05 and 200 units”.

At the center of the dispute is whether Jennewein’s strains satisfy the claim limitations requiring “exogenous functional β-galactosidase gene” and “the level of β-galactosidase activity comprises between 0.05 and 200 units”. Jennewein argued that its strains do not have an “exogenous functional β-galactosidase gene” because they are engineered to express functional β-galactosidase only under certain temperature. More importantly, Jennewein argued that its strains express lacZα and lacZΩ, as separate gene fragments and lacZα is endogenous. Because the lacZΩ fragment is expressed at 42°C (but not at 30°C), the two fragments produce active β-galactosidase, only under these specific conditions and not throughout the process.

Jennewein also argued that negative control strains were required to determine the Miller values between 0.05 and 200 units and that such controls would demonstrate Jennewein’s strains have β-galactosidase activity outside the claimed range.

The Commission rejected Jennewein’s arguments finding infringement under DOE because Jennewein’s engineered β-galactosidase gene including an exogenous lacZΩ fragment is equivalent to an “exogenous functional β-galactosidase gene” required by the ’018 patent. Additionally, the claim language did not require that the E. coli demonstrate β-galactosidase activity between 0.05 and 200 units throughout the process and only at some point in time and no negative control was needed to correctly perform the Miller assay.

The CAFC affirmed the Commissions’ finding of infringement under DOE. Although nonprecedential, this case serves as a reminder that DOE still plays a significant role in biotech litigation and can change the outcome of the case.

© 2022 Proskauer Rose LLP. National Law Review, Volume XI, Number 308
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About this Author

Colin Cabral Los Angeles Corporate Intellectual Propert Lawyer Proskauer Rose LLP
Partner

Colin Cabral is a litigator and trial lawyer specializing in complex patent, intellectual property, and contract disputes.

Colin has wide-ranging experience litigating cases in federal district court. He has represented pharmaceutical companies in patent disputes relating to small molecule compounds and biosimilar drugs. He has also served as lead trial counsel in patent and trade secret matters involving computer software, electronic devices, and consumer products.

Recently, Colin has represented pharmaceutical...

310-284-611
Robert Cantone, Corporate Life Sciences Attorney, Proskauer Rose Law Firm
Partner

Robert A. Cantone, a partner in the Corporate Department, advises life science companies on their important transactional and securities matters. Robert has significant experience representing public and private companies, particularly in the life sciences sector, in acquisitions, divestitures, and other major corporate transactions, including domestic and cross-border collaborations, co-promotions, licenses, and distribution arrangements. Due to the breadth of his experience in structuring and negotiating mergers and acquisitions, strategic partnerships and commercial...

212.969.3235
Fangli Chen IP Lawyer Proskauer Law Firm
Partner

Dr. Fangli Chen is a partner in the Litigation Department and vice chair of the Life Sciences Patent Practice. She represents all types of companies in the biotech and pharmaceutical industries, and has deep scientific expertise and a strong business sense. Fangli effectively identifies and transforms technological developments into valuable intellectual property assets for her clients and specializes in the strategic development of complex IP portfolios for companies that align with their business goals.

Fangli’s practice also focuses on post-grant review before the USPTO,...

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Daryn Grossman, Proskauer Law Firm, Corporate, Media and Technology Attorney
Partner

Daryn A. Grossman is co-chair of Proskauer’s global Corporate Department, and serves as the co-head of the Technology, Media & Communications Group and head of the Life Sciences Group.

For over 20 years, Daryn has designed and negotiated complex technology and intellectual property transaction structures, including strategic alliances, licensing, technology development and outsourcing transactions. Her clients include a wide range of life sciences, cloud computing, digital media, Internet, software, electronics,...

212-969-3665
Sige Gutman IP Lawyer Proskauer
Partner

Siegmund (“Sige”) Gutman is chair of the Life Sciences Patent Practice, a partner in the Litigation Department, and a member of the Patent Law and Intellectual Property Groups.

Sige is an accomplished patent litigator, frequently representing clients before trial and appellate courts, as well as arbitration panels. In the life sciences area, his practice focuses on developing and executing market exclusivity and freedom-to-operate strategies, including patent office and FDA regulatory strategies, for leading biologics, pharmaceutical,...

310.284.4533
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