BASF Plant Science, LP v. Commonwealth Scientific and Industrial Research Organisation (Fed. Cir. 2022)

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The consequences of joint development agreements, particularly under circumstances where later development is pursued independently by the parties, can create, inter alia, allegations of improper ownership and infringement if the agreements do not contemplate these possibilities and account (or attempt to account) for them.  Such was the case in the Federal Circuit's recent decision in BASF Plant Science, LP v. Commonwealth Scientific and Industrial Research Organisation.

The lawsuit involved a complicated set of licenses and co-development activities between the Commonwealth Scientific and Industrial Research Organisation (CSIRO), a research branch of the Australian government, and BASF.  CSIRO is assignee of U.S. Patent Nos. 9,926,579; 9,951,357; 9,970,033; and 9,994,880 (termed Group A patents), as well as Nos. 9,994,792 and 9,932,541, all of which involve genetic engineering of plants to produce oils, such as canola oil, non-native to these plants.  These claims were directed generally to production of Omega-3 long chain polyunsaturated fatty acids (abbreviated LC-PUFAs in the opinion) and specifically to eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), both known to be beneficial to human heart health.  The commercial goal of the research was to produce oils to be used in farm-raised salmon and other fish to improve their nutritional value and flavor to be closer to free-range fish.  CSIRO and BASF (in collaboration in part and independently in part) pursued this effort beginning around the turn of the century, specifically introducing certain genes encoding enzymes in biosynthetic pathways (derived in microorganisms) for LC-PUFAs into plants including Brassica napus or rapeseed (that naturally produced canola oil).  At all relevant times, CSIRO's efforts were limited to introducing these enzymes into a laboratory strain called Arabidopsis thaliana; according to the Federal Circuit opinion CSIRO had not introduced these enzymes into commercially relevant species.  BASF, on the other hand, had introduced enzymes from the biosynthetic pathway into tobacco and linseed as well as Arabidopsis and a plant closely related to rapeseed, Brassica juncea.  Although during some of the time relevant to this lawsuit CSIRO and BASF were working together on a "focused research project," the opinion states that the parties were working on introducing different enzymes from the pathway.  Thereafter, the parties each developed collaborations with other commercialization partners; in BASF's case the partner was Cargill and their joint efforts resulted in BASF depositing recombinant seeds with the American Type Culture Collection (ATCC) in support of its own patent applications.

Licensing negotiations aimed at BASF obtaining a license to CSRIO's patents were not fruitful and BASF sued CSIRO (and other defendants no longer in this lawsuit) for a a declaratory judgment that it did not infringe (related to patents other than the ones in this lawsuit).  BASF thereafter filed an amended complaint naming only CSIRO.  In its answer, CSIRO asserted infringement of the six patents named in this lawsuit; claims 1, 31, 32, and 33 of the '357 patent were deemed representative and reproduced in the Federal Circuit's opinion:

1.  A recombinant plant cell which synthesizes eicosapentaenoic acid (EPA), comprising more than one heterologous polynucleotide, wherein said polynucleotides encode:
    a) a Δ6 desaturase, a Δ6 elongase and a Δ5 desaturase; or
    b) a Δ5/Δ6 bifunctional desaturase and a Δ5/Δ6 bifunctional elongase;
    wherein the more than one polynucleotides are operably linked to one or more promoters that are capable of directing expression of said polynucleotides in the cell, wherein the enzymes encoded by said polynucleotides comprise at least one desaturase which is able to act on an acyl-CoA substrate, and wherein the synthesis of EPA requires the sequential action of said enzymes.

31.  The plant cell of claim 1 which is a Brassica napus cell or Arabidopsis thaliana cell, wherein the heterologous polynucleotides encode a Δ6 desaturase, Δ6 elongase and a Δ5 desaturase.

32.  The cell of claim 31, comprising a heterologous polynucleotide encoding a Δ5 elongase which catalyzes the conversion of EPA to DPA [docosapentaenoic acid] in the cell.

33.  The plant cell of claim 32, wherein said cell is capable of synthesizing DHA.

(It was important for BASF's allegation that CSIRO's asserted claims did not satisfy the written description requirement that claim 1 was not limited to Brassica napus nor Arabidopsis thaliana cells while claims 31-33 were so limited.  Other asserted claims shared this pattern, wherein, inter alia, claim 5 of the '579 patent, claim 5 of the '033 patent, claim 1 of the '792 patent, and claims 15 and 20 of the '541 patent were limited to Brassica cells, whereas asserted claims 2 and 10 of the '880 patent were not.)

CSIRO's complaint also named Cargill, a BASF commercialization partner, as co-defendant.  BASF countered by asserting it owned the patents-in-suit through the co-development agreement with CSIRO entered into in 2008.  Cargill moved the trial court to dismiss them from the suit for lack of personal jurisdiction; the trial court denied the motion and the case went to trial.  The parties stipulated to infringement of all but the '541 patent, which the jury found was infringed.  The jury also found that BASF had not established the patents lacked adequate written description support but did find BASF co-owned the '792 patent due to the earlier co-development agreement.  The District Court ruled CSIRO had adduced insufficient evidence of willful infringement and precluded the jury from considering enhanced damages on this basis.  In addition, the Court dismissed the jury from hearing evidence of damages but held a separate bench trial in which the District Court denied an injunction and awarded an ongoing royalty on the infringed patents but no damages for past infringement.  Somewhat predictably, the parties appealed on those grounds where they lost at trial.

The Federal Circuit, in an opinion by Judge Taranto joined by Judge Chen and (in part) by Judge Newman ruled as follows:

First, we affirm the district court's determination that venue as to Cargill was proper in the Eastern District of Virginia.  Second, regarding the jury's verdict rejecting the written-description challenge to the asserted Group A patent claims, we affirm as to the claims that are limited to canola plants (the only ones either side meaningfully discusses), but we reverse as to the broader genus claims.  Third, we affirm the jury's verdict that five patents were not co-owned by BASF but reverse the contrary verdict as to the sixth, with the result that infringement of all valid claims of the six patents at issue is now settled.  Finally, on the remedy issues, we affirm the district court's refusal to submit willfulness to the jury and its decision on the evidentiary issue concerning past damages.  But we remand for reconsideration of the remedy, while leaving the current remedy in place pending such reconsideration.

On Cargill's venue challenge, the Federal Circuit agreed with the District Court that there was proper assertion of personal jurisdiction (which Cargill did not appeal) and venue.  Factors favoring venue included a "partnership" between BASF and Cargill, BASF's deposit of seed with the ATCC (which was within the trial court's jurisdiction and was deemed an infringing "use"), and it filing its declaratory judgment action in the District (these activities being "central to the partnership").  The panel rejected Cargill's reliance on Home Depot U.S.A., Inc. v. Jackson, 139 S. Ct. 1743 (2019), which related to the removal statute (28 U.S.C. § 1441(a)) based on "textual similarity" to 28 U.S.C. § 1400(b).  The issue in Home Depot involved removal rights to third party defendants, the position Cargill was in here.  While there was some force to Cargill's argument by analogy, the Federal Circuit held that Cargill had not provided "sufficient justification for departing from the ordinary meaning of the term 'defendant'" and thus venue was proper ("[i]n short, to hold that § 1400(b) covers third-party counterclaim defendants would require us to determine that, for patent suits only, two civil actions can exist in one lawsuit, with the counterclaim qualifying as a 'civil action for patent infringement' that triggers the protections of § 1400(b) for counterclaim defendants—except for the original plaintiffs who under General Electric [Co. v. Marvel Rare Metals Co., 287 U.S. 430 (1932)] would be held to have forfeited venue protection.").  And on the facts here upon which the District Court made its decision, the Federal Circuit found no basis for disturbing it.

Turning to the merits, the panel considered and affirmed the District Court's distinction that the asserted claims satisfied the written description requirement when limited to canola oil-producing species and related plants, but not satisfied more broadly for all plants.  Not required were "commercially desirable or other specific levels of production," however.  But the panel asserts that the evidence from the specification is focused on canola oil-producing plants and related species, as well as being supported by expert testimony from both parties, and provides working examples in Arabidopsis which "a very reliable model for Brassica napus" wherein "LCPUFA production in Arabidopsis was highly predictive of positive results in canola."

In this way the panel distinguished as being "materially different" the factual circumstances here with Nuvo Pharmaceuticals (Ireland) Designated Activity Co. v. Dr. Reddy's Laboratories Inc., 923 F.3d 1368 (Fed. Cir. 2019).  BASF's expert testimony to the contrary, that the skilled worker would not accept the Arabidopsis results as being predictive provided "no sound reason" in support of BASF's position that the patents-in-suit all failed to satisfy the written description requirement.  Moreover, the panel found CSIRO's "failure" to produce LCPUFA's in Brassica napus occurred due to focus on optimizing production in Arabidopsis thaliana rather than lack of possession of the claimed invention when limited to canola oil-producing species.

The genus claims presented a different story to the panel, which held that these claims were invalid for failure to satisfy the written description requirement.  The parties had "not given [the Court] much to work with" on this question according to the opinion, with disclosure and testimony being "focused" on canola oil-producing species.  The panel understood that "BASF has argued for the inadequacy of the written description as to all the asserted Group A claims on a common ground—that the magnitude of the leap from success in producing LC-PUFA in Arabidopsis to success in any other plant is too great for the written description to support claims to any other plant" (emphasis in opinion).  The panel agreed that CSIRO's disclosure was insufficient to show description beyond the narrow limitations of canola oil-producing plants.  (While the Court's reasons for coming to this conclusion are couched in whether CSIRO had possession of the invention outside the scope of canola oil-producing plants, the rationale blends here somewhat into the question of whether the disclosure enabled production in other plant species, bolstered by reference to experts' testimony regarding whether the skilled worker would have believed disclosure of the former would indicate possession of the latter.)

Regarding the patent ownership question, the Federal Circuit's opinion notes that BASF did not base its ownership claim on co-inventorship or sole inventorship by an inventor obliged to assign her rights to BASF.  The argument was limited to co-ownership and, according to the opinion, was based "entirely" on the prior co-development agreement between the parties.  The Court found this inadequate because, as a matter of contract interpretation BASF's ownership's claims were not supported.  The opinion cites to specific sections of the agreement, the Court finding three categories of ownership:  "(1) constructs that were developed under the Evaluation if they contained both CSIRO and BASF genes; (2) results, data, or information derived from the Evaluation respecting the CSIRO-BASF-gene-combination constructs developed under the Evaluation; and (3) Intellectual Property subsisting in the first two categories."  The panel appreciated BASF's co-ownership claims to rest solely on the third category, but the Court rejected this argument, saying that a reasonable jury could only find no co-ownership for any of the patents-in-suit.  But even though "none of the six patents claim the BASF-CSIRO-gene-combination constructs or properties of them or uses of them" BASF contended that CSIRO obtained the claims of these patents "by drawing on the lessons it learned from the experiments involving both BASF and CSIRO's materials" (emphasis in opinion).  This argument makes no legal sense to the panel because CSIRO's inventions would need to be considered inherent in the "results, data, or information" from the joint work for which BASF was not (and did not claim to be) a joint inventor.  Nor did it make commercial sense, because interpreting the agreement in this way would "create an ever-threatening cloud over independent post-[agreement] work and the investments in such work."  The opinion then dissected the claims of the patents-in-suit and affirmed the jury's verdict for all but one of them that BASF is not a co-owner.  And for the one patent where the jury found to the contrary (the '792 patent) the Court finds BASF's evidence for co-ownership equivalently lacking and relying on "an impermissible level of speculation."

With regard to the remedies decided by the District Court, the Court affirmed the District Court's decision that CSIRO could not submit its assertion of willful infringement to the jury nor that CSIRO was entitled to damages for past infringement.  Otherwise, the Court remanded based on the changes in the substantive determinations regarding infringement, invalidity, and ownership (albeit including in the opinion extensive assessments of the allegations by CSIRO of error, or lack of it, for consideration on remand).

Judge Newman's dissent was based solely on the co-inventorship issue for the '792 patent, the Judge being persuaded that the jury had substantial evidence with which to come to its conclusion that BASF was a co-owner of this patent.

BASF Plant Science, LP v. Commonwealth Scientific and Industrial Research Organisation (Fed. Cir. 2022)
Panel: Circuit Judges Newman, Taranto, and Chen
Opinion by Circuit Judge Taranto; opinion dissenting in part by Circuit Judge Newman

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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