A Joint Venture Research Agreement

Naturally harvested seafood typically contains high levels of omega-3 fatty acids obtained from their diet, with three of the more important variants in human physiological being linolenic acid (ALA), eicosapentaenoic acid (EPA) and docosahexanoic acid (DHA).1 Humans are incapable of synthesizing these fatty acids, despite their importance in maintaining physiological health, and require regular consumption of these nutrients.2 However, farm-raised seafood requires supplements be fed to the fish to elevate the fatty acid levels to those of naturally-caught seafood.3 The industry researched avenues to supplement fish FA levels, with BASF and CSIRO looking into synthesizing the desired compounds from the canola plant (Brassica napus),4 which could be fed to farm-raised seafood.5 Both BASF and CSIRO looked into introducing enzymes into canola to use alpha-linolenic acid, which was naturally made by the plant, as a starting molecule for EPA and DHA.6

The two companies entered into a joint venture research agreement, allowing analysis of using genes from both companies.7 The year following expiration of the research agreement, BASF developed a canola line capable of synthesizing EPA and DHA, and licensed the technology.8 Shortly thereafter, in the mid-2010’s, CSIRO filed patent applications that claimed priority to provisional applications filed prior to the JV, which it licensed.9 BASF attempted to secure a license from CSIRO, and after negotiations broke down, filed a declaratory action against CSIRO and its licensees,10 arguing that the patents were invalid for lack of written description, or jointly owned based on the research agreement.11

The Court addressed the lack of written description, noting that numerous sections of the specification discussed using canola, specific examples of fatty acid-producing Arabidopsis crops- a commonly accepted model for canola, and scientific rationale supporting the likelihood of canola producing the fatty acids, showing that a skilled practitioner in the field would understand that CSIRO had invented what was claimed.12 The fact that CSIRO did not actually produce the fatty acids until after the provisional filing was dismissed by the court, noting actual reduction to practice is not required, and that the work in the Arabidopsis model as a highly predictive indicator of success in canola, was critical to the written description determination.13 However, the Court also found that claims to a broader group of crops was not supported.

On the issue of joint ownership of the patents, the Court noted the claim relied solely on the research agreement, and analyzed the agreement terms to determine the validity of the claim.14 The Court took a narrow view of the terms, finding that the joint ownership applied only to inventions that include gene constructs from both BASF and CSIRO, information and data that originated from evaluating the BASF-CSIRO gene combinations, and IP that comprises the gene constructs or information above.15 After concluding the CSIRO patents did not claim any combinations of BASF and CSIRO gene combinations, the Court found BASF’s position- that the CSIRO patents were obtained by drawing on the experiments from the joint research, was unreasonable and declined to overrule the finding that CSIRO was the sole owner of its patents,16 highlighting the importance of terms in a contract.

 

1 BASF Plant Science, LP v. Commonwealth Scientific and Industrial Research Organization, No. 2020-1415, p5 (Fed. Cir. Mar. 15, 2022); Hishikawa, et al., Metabolism and functions of docosahexaenoic acid-containing membrane glycophospholipids. FEBS Lett. 2017 Sep; 591(18):2730-2744.

2 Hishikawa, et al. FEBS Lett. 2017.

3 BASF Plant Science, LP, p5.

4 Id. at 6.

5 Id. at 5.

6 Id. at 6.

7 Id. at 7.

8 Id. at 8.

9 Id. at 7,9, 11-12.

10 Id. at 8.

11 Id. at 14.

12 Id. at 26-29.

13 Id. at 30-33.

14 Id. at 35.

15 Id. at 36-37.

16 Id. at 38.

Invention Disclosures

At some point during a consultation with each patent client, the potential client asks, “So what information do you need from me?” Not only is this a common question, but also a complex one.  The simple answer is taken directly from the rules governing the patent application process- enough for someone in the field to make and use the invention and know exactly what it is you want to protect. Additionally, the application must provide different versions of the invention that the inventor deems covered by the application or wants protection in the application.

However, that answer belies the complexity of patent law, because there is no one way to describe an invention- it depends on the technology and the available information. For devices, the application needs to describe the parts and how those parts work- with one another and to accomplish the end goal of the device. For example, in a bone screw patent application, the way the floating head of the screw connected to the body of the screw, and locked into a set orientation with the body.  For pharmaceutical applications, the synthesis of the compound, animal studies, possible prophetic studies, SAR analysis, metabolism, distribution, dosing regimens, and toxicity can all be helpful or critical to the application.[1]

The prior art must also be considered when determining how much information is needed- because the amount of information needed is not determined in a vacuum.  Prior art is the information known by the field at the time the invention is made.  This includes trade or journal articles (both print and online), web postings, manuscripts, sales documents, and products, though this is not an exhaustive list.  The prior art cuts both ways, since the more information known in the field that relates to the invention means the disclosure needs less information, but also increases the requirement to distinguish the invention from what is already known.

Getting back to the initial question- what is needed for a patent application; the answer is as much information as you can provide, but at a minimum enough information for me to figure out your invention.

[1] For example, the Federal Circuit recently analyzed animal studies and prophetic studies to uphold patent infringement in Novartis Pharma. Corp. v. Accord Healthcare, Inc. No. 2021-1070; p5-7, 10-12 (Fed. Cir. January 3, 2022).