Case 1:17-cv-00421-UNA Document 1 Filed 04/13/17 Page 1 of 28 PageID #: 1
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`IN THE UNITED STATES DISTRICT COURT
`FOR THE DISTRICT OF DELAWARE
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`C.A. No. 17-_______
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`JURY TRIAL DEMANDED
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`)))))))))
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`BASF PLANT SCIENCE, LP,
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`NUSEED AMERICAS INC.,
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`
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` Plaintiff,
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`v.
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`
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`
`
`Defendant.
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`
`
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`COMPLAINT FOR DECLARATORY JUDGMENT
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`Plaintiff BASF Plant Science, LP (“BASF Plant Science”) brings this action against
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`Defendant Nuseed Americas Inc. (“Nuseed”) for Declaratory Judgment of Invalidity of United
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`States Patent Nos. 7,807,849; 7,834,250; 8,106,226; 8,288,572; 8,575,377; 8,809,559; 8,853,432;
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`and 9,458,410. BASF Plant Science alleges as follows:
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`THE PARTIES
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`1.
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`BASF Plant Science, LP is a Delaware registered limited partnership, having a
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`principal place of business at 100 Park Avenue, Florham Park, New Jersey.
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`2.
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`On information and belief, Nuseed Americas Inc. is a Delaware corporation with
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`a principal place of business at 11901 S. Austin Avenue, Alsip, Illinois.
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`JURISDICTION AND VENUE
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`3.
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`This action arises under the Declaratory Judgment Act and the patent laws of the
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`United States, 35 U.S.C. § 101 et seq. This Court has jurisdiction over the subject matter of this
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`action under 28 U.S.C. §§ 1331, 1338(a), 2201 and 2202.
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`4.
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`Nuseed is subject to personal jurisdiction in this District because it is incorporated
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`in the State of Delaware.
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`5.
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`Venue is proper in this District pursuant to 28 U.S.C. §§ 1391(b), (c) and/or
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`IPR Page 1/28
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`BASF Exhibit 2004
`Nuseed Americas Inc. v. BASF Plant Science GmbH
`IPR2017-02176
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`Case 1:17-cv-00421-UNA Document 1 Filed 04/13/17 Page 2 of 28 PageID #: 2
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`1400(b) because Nuseed resides in the State of Delaware.
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`BACKGROUND FACTS
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`6.
`
`On information and belief, United States Patent No. 7,807,849 (“the ‘849 Patent”)
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`is entitled “Synthesis of Long-Chain Polyunsaturated Fatty Acids by Recombinant Cells,” and
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`was issued by the United States Patent Office on October 5, 2010. The assignee identified on the
`
`face of the ‘849 Patent is Commonwealth Scientific and Industrial Research Organization
`
`(“CSIRO”). A copy of the ‘849 Patent is attached as Exhibit A.
`
`7.
`
`On information and belief, United States Patent No. 7,834,250 (“the ‘250 Patent”)
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`is entitled “Synthesis of Long-Chain Polyunsaturated Fatty Acids by Recombinant Cells,” and
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`was issued by the United States Patent Office on November 16, 2010. The assignee identified on
`
`the face of the ‘250 Patent is CSIRO. A copy of the ‘250 Patent is attached as Exhibit B.
`
`8.
`
`On information and belief, United States Patent No. 8,106,226 (“the ‘226 Patent”)
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`is entitled “Synthesis of Long-Chain Polyunsaturated Fatty Acids by Recombinant Cells,” and
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`was issued by the United States Patent Office on January 31, 2012. The ‘226 Patent is a
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`continuation of the ‘849 Patent. The assignee identified on the face of the ‘226 Patent is CSIRO.
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`A copy of the ‘226 Patent is attached as Exhibit C.
`
`9.
`
`On information and belief, United States Patent No. 8,288,572 (“the ‘572 Patent”)
`
`is entitled “Synthesis of Long-Chain Polyunsaturated Fatty Acids by Recombinant Cells,” and
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`was issued by the United States Patent Office on October 16, 2012. The ‘572 Patent is a
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`continuation of the ‘226 Patent, which in turn is a continuation of the ‘849 Patent. The assignee
`
`identified on the face of the ‘572 Patent is CSIRO. A copy of the ‘572 Patent is attached as
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`Exhibit D.
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`10.
`
`On information and belief, United States Patent No. 8,575,377 (“the ‘377 Patent”)
`
`2
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`is entitled “Synthesis of Long-Chain Polyunsaturated Fatty Acids by Recombinant Cell,” and
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`was issued by the United States Patent Office on November 5, 2013. The ‘377 Patent is a
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`continuation of the ‘572 Patent, which in turn is a continuation of the ‘226 Patent, which in turn
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`is a continuation of the ‘849 Patent. The assignee identified on the face of the ‘377 Patent is
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`CSIRO. A copy of the ‘377 Patent is attached as Exhibit E.
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`11.
`
`On information and belief, United States Patent No. 8,809,559 (“the ‘559 Patent”)
`
`is entitled “Enzymes and Methods for Producing Omega-3 Fatty Acids,” and was issued by the
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`United States Patent Office on August 19, 2014. The assignee identified on the face of the ‘559
`
`Patent is CSIRO. A copy of the ‘559 Patent is attached as Exhibit F.
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`12.
`
`On information and belief, United States Patent No. 8,853,432 (“the ‘432 Patent”)
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`is entitled “Synthesis of Long-Chain Polyunsaturated Fatty Acids by Recombinant Cell,” and
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`was issued by the United States Patent Office on October 7, 2014. The ‘432 Patent is a
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`continuation of the ‘377 Patent, which in turn is a continuation of the ‘572 Patent, which in turn
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`is a continuation of the ‘226 Patent, which in turn is a continuation of the ‘849 Patent. The
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`assignee identified on the face of the ‘432 Patent is CSIRO. A copy of the ‘432 Patent is
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`attached as Exhibit G.
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`13.
`
`On information and belief, United States Patent No. 9,458,410 (“the ‘410 Patent”)
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`is entitled “Synthesis of Long-Chain Polyunsaturated Fatty Acids by Recombinant Cell,” and
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`was issued by the United States Patent Office on October 4, 2016. The ‘410 Patent is a
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`continuation of the ‘432 Patent, which in turn is a continuation of the ‘377 Patent, which in turn
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`is a continuation of the ‘572 Patent, which in turn is a continuation of the ‘226 Patent, which in
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`turn is a continuation of the ‘849 Patent. The assignee identified on the face of the ‘410 patent is
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`CSIRO. A copy of the ‘410 Patent is attached as Exhibit H.
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`14.
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`Collectively, the ‘849 Patent, the ‘250 Patent, the ‘226 Patent, the ‘572 Patent, the
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`‘377 Patent, the ‘559 Patent, the ‘432 Patent, and the ‘410 Patent are referred to herein as the
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`“Patents-in-Suit.”
`
`15.
`
`On information and belief, Nuseed is the exclusive licensee of each of the Patents-
`
`in-Suit.
`
` See http://nuseed.com/corporate-news/australian-scientific-collaboration-set-break-
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`worlds-reliance-fish-long-chain-omega-3/.
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`16.
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`Nuseed has expressed an intent to enforce the Patents-in-Suit against BASF Plant
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`Science, if the parties do not enter into a negotiated license agreement. In September 2016, as a
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`predicate
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`to negotiations over
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`their
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`respective
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`technologies concerning
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`long chain
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`polyunsaturated fatty acids, the parties entered into a Confidentiality Agreement.
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`17.
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`Subsequently, between October 2016 and April 2017, the parties met by
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`teleconference or in person at least six times, and engaged in additional written correspondence.
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`The express purpose of these meetings and correspondence was to determine whether a
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`commercial agreement, including a patent license covering the United States and other
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`jurisdictions, could be negotiated, or whether litigation would be necessary.
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`18.
`
`In the course of those negotiations, Nuseed identified the Patents-in-Suit to BASF
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`Plant Science. Nuseed further made licensing demands, the terms of which were not acceptable
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`to BASF Plant Science. BASF Plant Science has repeatedly rejected Nuseed’s licensing
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`demands and has informed Nuseed that it believes the Patents-in-Suit are invalid. The parties
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`have reached an impasse in their negotiations, and there is now a real and immediate risk that
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`Nuseed will imminently commence patent infringement litigation against BASF Plant Science in
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`the United States. During the most recent telephone conference, on April 13, 2017,
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`representatives of Nuseed stated, “With the numbers you’re talking about, there is no path
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`forward.” BASF Plant Science’s representatives understood this to mean that litigation is
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`inevitable and imminent.
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`19.
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`A genuine dispute and actual controversy therefore exists about whether the
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`Patents-in-Suit are invalid.
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`20.
`
`As set forth in detail below, each claim of each of the Patents-in-Suit is invalid
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`under at least 35 U.S.C. §§ 102, 103 and/or 112.
`
`COUNT I: INVALIDITY OF THE ‘849 PATENT
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`21.
`
`BASF Plant Science refers to and incorporates by reference each of its allegations
`
`in paragraphs 1-20.
`
`22.
`
`An actual and justiciable case or controversy exists between BASF Plant Science
`
`and Nuseed regarding the validity of the ‘849 Patent.
`
`23.
`
`All claims of the ‘849 Patent are invalid under 35 U.S.C. § 112 at least because
`
`they lack adequate written description, lack enablement and/or are indefinite.
`
`24.
`
`Independent Claim 1 of the ‘849 Patent recites a process for producing oil by
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`obtaining a transgenic rape seed, transgenic cotton seed, or transgenic flax seed wherein the total
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`fatty acid content of the transgenic seed comprises at least 2.5% C20 ω3 fatty acids (w/w) and
`
`including EPA, DPA and DHA fatty acids.
`
`25.
`
`Claim 1 of the ‘849 Patent is invalid for lack of written description because the
`
`specification does not teach the preparation of any transgenic rape plant, cotton plant or flax
`
`plant, let alone any plant from the Brassica genus (an oil seed plant). The specification provides
`
`no examples of a plant from the Brassica genus capable of producing seeds having the claimed
`
`fatty acid content.
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`26.
`
`The specification of the ‘849 Patent further does not disclose any oil produced
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`from any transgenic oil seed plants that include the EPA, DPA and DHA fatty acids, let alone the
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`claimed amount of at least 2.5% C20 ω3 fatty acids (w/w). The specification of the ‘849 Patent
`
`does not contain representative examples of oil seed plants having the claimed fatty acid content.
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`Claim 1 of the ‘849 Patent recites a process for producing the oil but the specification does not
`
`provide any examples of preparing a transgenic oil seed plant capable of producing an oil
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`containing the recited fatty acids.
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`27.
`
`Thus, the specification does not provide written description support for producing
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`oil from all transgenic rape, cotton and flax plants having the claimed fatty acid content. The
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`specification lacks sufficient examples and does not describe which genes would need inserting
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`into the transgenic rape, cotton and flax plants to obtain the oil having the claimed fatty acid
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`content.
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`28.
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`Additionally, and/or in the alternative, Claim 1 of the ‘849 Patent is not enabled.
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`Claim 1 of the ‘849 Patent recites a process for producing oil by obtaining a transgenic rape seed,
`
`transgenic cotton seed, or transgenic flax seed wherein the total fatty acid content of the
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`transgenic seed comprises at least 2.5% C20 ω3 fatty acids (w/w) and including EPA, DPA and
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`DHA fatty acids. Claim 1 also recites that the plant cell has a total fatty acid content, which
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`includes 2.5% (w/w) C20 ω3 long-chain polyunsaturated fatty acids. Claim 1 and all dependent
`
`claims thus recite an open-ended range limitation containing a lower threshold without an upper
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`limit. Such a broad range is not enabled because the specification only provides one example –
`
`testing oil from a transgenic Arabidopsis plant cell - and this only produced three oils comprising
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`at least 2.5% (w/w) C20 ω3 long-chain polyunsaturated fatty acids at the lower end of the
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`claimed range (i.e. 3.8%, 3.8% and 4.1 %). Thus, all claims of the ‘849 Patent are not enabled
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`over the entire claimed range.
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`29.
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`The specification of the ‘849 Patent also does not enable one skilled in the art to
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`produce a transgenic seed having the claimed oil content as the specification provides no
`
`examples of oils produced from a transgenic rape seed, cotton seed or flax seed, let alone any an
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`oil seed in the Brassica plant genus including at least 2.5% C20 ω3 fatty acids (w/w).
`
`30.
`
`All claims of the ‘849 Patent are also invalid as they are not enabled for their full
`
`breadth of the claims as the specification does not enable a person skilled in the art to make the
`
`claimed inventions. The claims do not recite which genes are present in the transgenic plant cell
`
`that cause the plant cell to produce seeds having the recited long chain fatty acids. The claims
`
`conceivably cover any transgenic rape, cotton or flax seed that has the recited fatty acid content,
`
`but the specification does not provide sufficient guidance to enable one to make the transgenic
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`rape, cotton or flax plants capable of producing the oil covered by the scope of the claims. The
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`specification does not enable a person skilled in the art to make any and all transgenic constructs
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`that might be necessary to achieve a transgenic oil seed having the recited fatty acid content.
`
`31.
`
`Further, Claim 1 of the ‘849 Patent is indefinite because it would be unclear to
`
`one of ordinary skill in the art what the patentees meant by the term “C20 ω3 long chain fatty
`
`acids” and whether it includes only 20 carbon atoms in the carbon chain or whether it refers to
`
`omega-3 fatty acids including any amount of carbon atoms between 20-29 in the carbon chain.
`
`32.
`
`Each claim depending from Claim 1 of the ‘849 Patent, including without
`
`limitation Claims 2 through 11 of the ‘849 Patent, is invalid under 35 U.S.C. § 112 for the same
`
`reasons as Claim 1.
`
`33.
`
`Additionally, and/or in the alternative, at least Claim 1 of the ‘849 Patent is
`
`invalid as anticipated and/or obvious under 35 U.S.C. §§ 102 and/or 103 in view of at least
`
`Opsahl-Ferstad, et al., “Biotechnological approaches to modify rapeseed oil composition for
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`applications in aquaculture,” Plant Science, Vol. 165, pages 349-357 (2003) (“Opsahl-Ferstad”)
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`and/or PCT Application Publication No. WO 02/090493 A2 (Mukerji, et al.) (“Mukerji”), alone
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`and/or in combination, in view of the general knowledge of persons of ordinary skill in the art.
`
`34.
`
`Additionally and/or in the alternative, at least Claim 2 is obvious in view of at
`
`least Opsahl-Ferstad alone, Mukerji alone, and/or Opsahl-Ferstad combined with Mukerji, in
`
`view of the general knowledge of persons of ordinary skill in the art.
`
`35.
`
`Based on the foregoing, each claim of the ‘849 Patent is invalid.
`
`COUNT II: INVALIDITY OF THE ‘250 PATENT
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`36.
`
`BASF Plant Science refers to and incorporates by reference each of its allegations
`
`in paragraphs 1-35.
`
`37.
`
`An actual and justiciable case or controversy exists between BASF Plant Science
`
`and Nuseed regarding the validity of the ‘250 Patent.
`
`38.
`
`All claims of the ‘250 Patent are invalid under 35 U.S.C. § 112 at least because
`
`they lack adequate written description, are indefinite, and/or lack enablement.
`
`39.
`
`Independent Claim 1 of the ‘250 Patent recites a Brassica or Arabidopsis plant
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`cell having DPA (docosapentaenoic acid) and DHA (docosahexaenoic acid) fatty acids and a
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`total fatty acid content in the plant cell which includes 2.5% (w/w) C20 ω3 long chain fatty
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`acids, but the specification does not teach the preparation of any plant from the Brassica genus.
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`The specification provides no examples of a plant from the Brassica genus having the claimed
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`fatty acid content. The specification provides no examples showing a transgenic Brassica pant
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`cell.
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`40.
`
`Claim 1 of the ‘250 Patent recites that the plant cell comprises a polynucleotide
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`encoding a Δ5 elongase and a Δ4 desaturase. The specification does not provide adequate
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`written description support for the terms “Δ5 elongase” and a “Δ4 desaturase.” Claim 1 lacks
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`adequate written description and/or is indefinite because it is not clear which of the known Δ5
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`elongases and which of the known Δ4 desaturases are included in this claim. Further, the
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`specification does not provide sufficient examples of suitable Δ5 elongases and a Δ4 desaturases
`
`that would work in all Brassica or Arabidopsis plant cells to produce a plant cell having the
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`claimed fatty acids and the claimed percentage of C20 ω3 long chain fatty acids.
`
`41.
`
`Further, Claim 1 of the ‘250 Patent is invalid due to lack of enablement. Claim 1
`
`claims a Brassica or Arabidopsis plant cell having a certain claimed fatty acid content, but the
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`specification does not provide any examples of any species of plants from the Brassica genus
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`having been made or having this fatty acid content.
`
`42.
`
`Claim 1 of the ‘250 Patent also recites that the plant cell has a total fatty acid
`
`content, which includes 2.5% (w/w) C20 ω3 long-chain polyunsaturated fatty acids. Neither
`
`Claim 1 nor the claims depending therefrom claim an upper limit on this range. The claims thus
`
`recite an open-ended range limitation containing a lower threshold but no upper limit. Such a
`
`broad range is not enabled because the specification only provides one example – testing oil
`
`from a transgenic Arabidopsis plant cell - which produced three oils comprising at least 2.5%
`
`(w/w) C20 ω3 long-chain polyunsaturated fatty acids at the lower end of the claimed range (i.e.
`
`3.8%, 3.8% and 4.1 %). Thus, the claims are not enabled over the entire claimed range.
`
`43.
`
`Further, Claim 1 of the ‘250 Patent is indefinite because it would be unclear to
`
`one of ordinary skill in the art what the patentees meant by the term “C20 ω3 long-chain
`
`polyunsaturated fatty acid” and whether it includes only 20 carbon atoms in the carbon chain or
`
`whether it refers to omega-3 fatty acids including any amount of carbon atoms between 20-29 in
`
`the carbon chain.
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`44.
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`Additionally, and/or in the alternative, Claim 1 of the ‘250 Patent is invalid as not
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`enabled for their full breadth, because it does not recite which genes are present in the transgenic
`
`plant cell to provide the plant cell with the recited long chain fatty acids. The specification is not
`
`enabling for the use of any and all Δ5 elongases and Δ4 desaturases. The specification does not
`
`enable one skilled in the art to use any and all Δ5 elongases and Δ4 desaturases in all Brassica
`
`plants to obtain the transgenic plant cell having the fatty acid content recited in Claim 1.
`
`45.
`
`Each claim depending from Claim 1 of the ‘250 Patent, including without
`
`limitation Claims 2 through 16 of the ‘250 Patent, is invalid under 35 U.S.C. § 112 for the same
`
`reasons as Claim 1.
`
`46.
`
`Additionally, and/or in the alternative, at least Claim 1 of the ‘250 Patent is
`
`invalid as anticipated and/or obvious under 35 U.S.C. §§ 102 and/or 103 in view of at least
`
`Opsahl-Ferstad and/or Mukerji, alone and/or in combination, in view of the general knowledge
`
`of persons of ordinary skill in the art.
`
`47.
`
`Based on the foregoing, each claim of the ‘250 Patent is invalid.
`
`COUNT III: INVALIDITY OF THE ‘226 PATENT
`
`48.
`
`BASF Plant Science refers to and incorporates by reference each of its allegations
`
`in paragraphs 1-47.
`
`49.
`
`An actual and justiciable case or controversy exists between BASF Plant Science
`
`and Nuseed regarding the validity of the ‘226 Patent.
`
`50.
`
`All claims of the ‘226 Patent are invalid under 35 U.S.C. § 112 at least because
`
`they lack adequate written description, are indefinite, and/or lack enablement.
`
`51.
`
`Independent Claim 1 of the ‘226 Patent recites a process for producing oil by
`
`obtaining a transgenic Brassica or Arabidopsis seed, wherein the total fatty acid content of the
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`transgenic seed comprises at least 2.5% C20 ω3 fatty acids (w/w) and including EPA and DPA
`
`fatty acids. Claim 1 also requires that the level of DPA present is based on a conversion ratio of
`
`EPA to DPA of at least 5%.
`
`52.
`
`Claim 1 of the ‘226 Patent is invalid for lack of written description because the
`
`specification does not teach the preparation of any plant from the Brassica genus (an oil seed
`
`plant). The specification provides no examples of a plant from the Brassica genus having the
`
`claimed fatty acid content, let alone a Brassica plant having DPA converted from EPA at a ratio
`
`of at least 5%.
`
`53.
`
`The specification of the ‘226 Patent does not disclose any oil produced from any
`
`Brassica oil seed plant that include the EPA and DPA fatty acids, let alone the claimed amount of
`
`at least 2.5% C20 ω3 fatty acids (w/w). The specification contains no representative examples of
`
`oil seed plants having the claimed fatty acid content. Claim 1 of the ‘226 Patent recites a process
`
`for producing the oil but the specification lacks adequate written description because it does not
`
`provide any examples of preparing a transgenic Brassica oil seed plant capable of producing an
`
`oil containing the recited fatty acids.
`
`54.
`
`The specification does not provide written description support for producing oil
`
`from all transgenic Brassica plants having the claimed fatty acid content. The specification lacks
`
`sufficient examples and does not describe which genes would need to be inserted into the
`
`transgenic Brassica plants to obtain a transgenic seed capable of having the claimed fatty acid
`
`content.
`
`55.
`
`Additionally, the claims of the ‘226 Patent are invalid for lack of enablement.
`
`Claim 1 of the ‘226 Patent recites a process for producing oil by obtaining a transgenic Brassica
`
`or Arabidopsis seed, wherein the total fatty acid content of the transgenic seed comprises at least
`
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`2.5% C20 ω3 fatty acids (w/w) and including EPA and DPA fatty acids. Claim 1 also requires
`
`that the level of DPA present is based on a conversion ratio of EPA to DPA of at least 5%.
`
`56.
`
`Claim 1 (and all dependent claims) recite two open-ended range limitations
`
`containing a lower threshold but no upper limit. Such a broad range is not enabled because the
`
`specification only provides one example – testing oil from a transgenic Arabidopsis plant cell –
`
`which only produced three oils comprising at least 2.5% (w/w) C20 ω3 long-chain
`
`polyunsaturated fatty acids at the lower end of the claimed range (i.e. 3.8%, 3.8% and 4.1 %).
`
`Further, the specification does not provide any examples of an oil seed plant that produces DPA
`
`as a result of a conversion ratio of EPA to DPA of at least 5%. Thus, the claims are not enabled
`
`over the entire claimed range.
`
`57.
`
`All claims of the ‘226 Patent are also invalid as they are not enabled for their full
`
`breadth as the specification does not enable a person skilled in the art to make the claimed
`
`invention. The claims do not recite which genes are present in the transgenic plant cell that
`
`cause the plant cell to produce seeds having the recited long chain fatty acids. The claims
`
`conceivably cover all processes for producing oil from all transgenic Brassica seeds that have the
`
`recited fatty acid content, but the specification does not provide sufficient guidance to enable one
`
`to make the transgenic Brassica seed plants capable of comprising the fatty acids required by the
`
`claims.
`
`58.
`
`Further, the ‘226 Patent is indefinite because it would be unclear to one of
`
`ordinary skill in the art what the patentees meant by the term “C20 ω3 fatty acids” and whether it
`
`includes only 20 carbon atoms in the carbon chain or whether it refers to omega-3 fatty acids
`
`including any amount of carbon atoms between 20-29 in the carbon chain.
`
`59.
`
`Each claim depending from Claim 1 of the ‘226 Patent, including without
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`limitation Claims 2 through 18 of the ‘226 Patent, is invalid under 35 U.S.C. § 112 for the same
`
`reasons as Claim 1.
`
`60.
`
`Additionally, and/or in the alternative, at least Claim 1 of the ‘226 Patent is
`
`invalid as anticipated and/or obvious under 35 U.S.C. §§ 102 and/or 103 in view of at least
`
`Opsahl-Ferstad and/or Mukerji, alone and/or in combination, in view of the general knowledge
`
`of persons of ordinary skill in the art.
`
`61.
`
`Based on the foregoing, each claim of the ‘226 Patent is invalid.
`
`COUNT IV: INVALIDITY OF THE ‘572 PATENT
`
`62.
`
`BASF Plant Science refers to and incorporates by reference each of its allegations
`
`in paragraphs 1-61.
`
`63.
`
`An actual and justiciable case or controversy exists between BASF Plant Science
`
`and Nuseed regarding the validity of the ‘572 Patent.
`
`64.
`
`All claims of the ‘572 Patent are invalid under 35 U.S.C. § 112 at least because
`
`they lack adequate written description, are indefinite, and/or lack enablement.
`
`65.
`
`Independent Claim 1 of the ‘572 Patent recites a process for producing oil by
`
`obtaining a transgenic seed of an oil seed plant wherein the total fatty acid content of the
`
`transgenic seed comprises at least 2.5% C20 ω3 fatty acids (w/w) and including EPA
`
`(eicosapentaenoic acid), DPA and DHA fatty acids. The claims also require that the level of
`
`DPA present is based on a conversion ratio of EPA to DPA of at least 5%.
`
`66.
`
`Claim 1 of the ‘572 Patent is invalid for lack of written description because the
`
`specification does not teach the preparation of any plant from the Brassica genus (an oil seed
`
`plant), let alone provide working examples of a plant in the Brassica genus capable of producing
`
`seeds having the claimed fatty acid content.
`
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`Case 1:17-cv-00421-UNA Document 1 Filed 04/13/17 Page 14 of 28 PageID #: 14
`
`67.
`
`The ‘572 Patent does not disclose any oil produced from any oil seed plants that
`
`include the EPA, DPA and DHA fatty acids, let alone the claimed amount of at least 2.5% C20
`
`ω3 fatty acids (w/w). The specification contains no representative examples of oilseed plants
`
`having the claimed fatty acid content. Claim 1 of the ‘572 Patent recites a process for producing
`
`the oil but the specification does not provide any examples of preparing a transgenic oil seed
`
`plant capable of containing the recited fatty acids.
`
`68.
`
`The specification does not provide written description support for producing oil
`
`from all transgenic oil seed plants having the claimed fatty acid content. The specification lacks
`
`sufficient examples, and does not describe which genes are needed for insertion into the oil seed
`
`plants to obtain the oil having the claimed fatty acid content.
`
`69.
`
`Additionally, and/or in the alternative, Claim 1 of the ‘572 Patent is also invalid
`
`for lack of enablement. Claim 1 of the ‘572 Patent recites a process for producing oil by
`
`obtaining a transgenic seed of an oil seed plant wherein the total fatty acid content of the
`
`transgenic seed comprises at least 2.5% C20 ω3 fatty acids (w/w). Claim 1 also require that the
`
`level of DPA present is based on a conversion ratio of EPA to DPA of at least 5%.
`
`70.
`
`Claim 1 and all dependent claims recite two open-ended range limitations
`
`containing a lower threshold without an upper limit. Such broad ranges are not enabled because
`
`the specification only provides one example – testing oil from a transgenic Arabidopsis plant cell
`
`- which only produced three oils comprising at least 2.5% (w/w) C20 ω3 long-chain
`
`polyunsaturated fatty acids at the lower end of the claimed range (i.e. 3.8%, 3.8% and 4.1 %).
`
`Further, the specification does not provide any examples of an oil seed plant that produces DPA
`
`as a result of a conversion ratio of EPA to DPA of at least 5%. Thus, all claims of the ‘572
`
`Patent are invalid as they are not enabled over the entire claimed range.
`
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`Case 1:17-cv-00421-UNA Document 1 Filed 04/13/17 Page 15 of 28 PageID #: 15
`
`71.
`
`The specification of the ‘572 Patent does not enable one skilled in the art to
`
`produce a transgenic seed of an oil seed plant having the claimed fatty acid content because the
`
`specification provides no examples of oils produced from an oil seed in the Brassica plant genus
`
`including at least 2.5% C20 ω3 fatty acids (w/w).
`
`72.
`
`All claims of the ‘572 Patent are also invalid as they are not enabled for their full
`
`breadth because they do not recite which genes are present in the transgenic plant cell to cause
`
`the plant cell to produce the recited long chain fatty acids. The claims conceivably cover any
`
`transgenic seed of any oil seed plant that has the recited fatty acid content, but the specification
`
`does not provide sufficient guidance to enable one to make the transgenic oil seed plants capable
`
`of producing an oil covered by the scope of the claims. The specification does not enable a
`
`person skilled in the art to make any and all claimed transgenic constructs that might be
`
`necessary to achieve a transgenic oil seed having the recited fatty acid content.
`
`73.
`
`Further, Claim 1 of the ‘572 Patent is indefinite because it would be unclear to
`
`one of ordinary skill in the art what the patentees meant by the term “C20 ω3 fatty acids” and
`
`whether it includes only 20 carbon atoms in the carbon chain or whether it refers to omega-3
`
`fatty acids including any amount of carbon atoms between 20-29 in the carbon chain.
`
`74.
`
`Each claim depending from Claim 1 of the ‘572 Patent, including without
`
`limitation Claims 2 through 20 of the ‘572 Patent, is invalid under 35 U.S.C. § 112 for the same
`
`reasons as Claim 1.
`
`75.
`
`Additionally, and/or in the alternative, at least Claim 1 of the ‘572 Patent is
`
`invalid as anticipated and/or obvious under 35 U.S.C. §§ 102 and/or 103 in view of at least
`
`Opsahl-Ferstad and/or Mukerji, alone and/or in combination, in view of the general knowledge
`
`of persons of ordinary skill in the art.
`
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`Case 1:17-cv-00421-UNA Document 1 Filed 04/13/17 Page 16 of 28 PageID #: 16
`
`76.
`
`Based on the foregoing, each claim of the ‘572 Patent is invalid.
`
`COUNT V: INVALIDITY OF THE ‘377 PATENT
`
`77.
`
`BASF Plant Science refers to and incorporates by reference each of its allegations
`
`in paragraphs 1-76.
`
`78.
`
`An actual and justiciable case or controversy exists between BASF Plant Science
`
`and Nuseed regarding the validity of the ‘377 Patent.
`
`79.
`
`All claims of the ‘377 Patent are invalid under 35 U.S.C. § 112 at least because
`
`they lack adequate written description, are indefinite, and/or lack enablement.
`
`80.
`
`Independent Claim 1 of the ‘377 Patent is invalid for lack of written description.
`
`Claim 1 of the ‘377 Patent recites a process for producing oil by obtaining a transgenic seed of
`
`an oil seed plant wherein the total fatty acid content of the transgenic seed comprises at least
`
`2.5% C20 ω3 fatty acids (w/w) and including EPA and DPA fatty acids in an esterified form as
`
`part of a triglyceride. Claim 1 also recites that the transgenic plant comprises a microalgal fatty
`
`acid desaturase. Claim 1 also requires that the level of DPA present is based on a conversion
`
`ratio of EPA to DPA of at least 5%.
`
`81.
`
`Claim 1 of the ‘377 Patent is invalid for lack of written description because the
`
`specification does not teach the preparation of any plant from the Brassica genus (an oil seed
`
`plant), let alone provide working examples of a plant in the Brassica genus capable of producing
`
`seeds having the claimed fatty acid content.
`
`82.
`
`The specification of the ‘377 Patent does not disclose any oil produced from any
`
`oil seed plants that include the EPA and DPA fatty acids, let alone the claimed amount of at least
`
`2.5% C20 ω3 fatty acids (w/w). The specification of the ‘377 Patent contains no representative
`
`examples of oilseed plants having the claimed fatty acid content. Claim 1 of the ‘377 Patent
`
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`Case 1:17-cv-00421-UNA Document 1 Filed 04/13/17 Page 17 of 28 PageID #: 17
`
`recites a process for producing the oil but does not provide any examples of preparing a
`
`transgenic oil seed capable of producing an oil containing the recited fatty acids covered by the
`
`scope of the claim.
`
`83.
`
`Claim 1 of the ‘377 Patent is also indefinite and/or lacks adequate written
`
`description in claiming that the transgenic