Joint Inventorship of a novel compound may exist even if co-inventor only developed method of making

Bernadette McGann | January 25, 2012

Falana v. Kent State University and Alexander J. Seed

January 23, 2012

Panel:  Linn, Prost and Reyna.  Opinion by Linn.

Summary

The CAFC held that a putative inventor who envisioned the structure of a novel chemical compound and contributed to the method of making that compound is a joint inventor of a claim covering that compound.  One may be a joint inventor even if co-inventor’s contribution to conception is merely a method of making the claimed product and said co-inventor does not synthesize the claimed compound.

Details

Kent Displays Inc. (hereinafter KDI) is a spin-off technology company from Kent State that designs and manufactures liquid crystal displays.  In 1997, KDI began a research program to develop a temperature independent, high helical twisting power chiral additive which would improve the performance characteristic of LCDs.  A chiral compound is a compound that contains an asymmetric center (chiral atom or chiral center) and thus can occur in two nonsuperimposable mirror-image forms (enantiomers), designated as an R-form or an S-form.  Dr. Doane of KDI hired Dr. Seed of Kent State to work on this research project.  Dr. Seed, who was unable to dedicate a sufficient amount of time to the research project, hired Dr. Falana to work on the research project.  Dr. Seed expected Dr. Falana to work independently and to have his own ideas.  All three individuals were located in Kent Ohio and interacted with one another regularly on the research projection.  Dr. Seed described the interaction of Dr. Doane, Dr. Falana and himself as “very much a team project.”

In March 1999, Dr. Falana developed a synthesis protocol for making a novel class (genus) of compounds.  Using the synthesis protocol, Dr. Falana synthesized Compound 7, an SS enantiomer that showed great improvement and represented significant progress but did not completely satisfy the goals of the project.  In September 1999, Dr. Falana resigned from KDI and Kent State.  In early 2000, Dr. Seed synthesized Compound 9, an RR enantiomer, which satisfied the goals of the research project.  Compound 9 was synthesized using the synthesis protocol of Dr. Falana.

On June 9, 2000, KDI and Kent Stated filed a provisional application that led to the ‘789 Patent.  Dr. Falana was not named as an inventor.

Claim 1 of the ‘789 Patent recites:

1. An optically active compound of the formula:

 

 

 

 

 

where the R2 and R3 groups are a lower alkyl group or an aryl or biaryl unit while the R1 groups independently each are a hydroxyl, alkoxyl, aryloxy, or arylalkoxy group, the R groups each represent a group as follows:

A1—[—Z—]q -A2

where A1 is an aromatic group, an acyclic aliphatic group, or an alicyclic group, and A1 can be a substituted or unsubstituted, Z is a group selected from —O—,—OCO—, or —S—, and the coefficient q is 0 or 1 or Z is (CH2)nO where the coefficient n is 0 to 5 and the coefficient q is 1, and A2 is a bivalent radical of a naphthalene group, and the cyclic structure of A2, or A1 if it is cyclic, can be heterocyclic.

The ‘789 Patent discloses Falana’s synthesis protocol as the protocol used to synthesize the claimed compound.  Dr. Falana was not named as an inventor in the ‘789 Patent.

Dr. Falana filed a §256 action to correct the inventorship of the ‘789 Patent.  In June 2008, Dr. Doane and Dr. Khan filed signed statements with the court that “[they] have no disagreement with the addition of Olusegun Falana as a named co-inventor” and that these statements may be filed with the USPTO to request correction of inventorship.  At trial Dr. Doane and Dr. Khan testified that they signed the statement “not because they thought, as scientists, that Dr. Falana actually had been a joint inventor, but instead because they wanted out of the lawsuit.”  KDI, Dr. Doane and Dr. Khan moved to be dismissed from the suit and the motion was granted by the district court.

The Defendants, Kent State and Dr. Seed, argued that the claims of the ‘789 Patent should be construed as to require an RR enantiomer that provides a substantially temperature independent helical twisting power (hereinafter HTP), wherein substantially temperature independent HTP is further defined as having a maximum change in peak reflection of 30 mm or less across a temperature range of +10oC to +50oC.  (Compound 9 has a substantial temperature independence between -20 and +70 oC)

The District Court construed claims 1 and 25 to require an RR enantiomer but refused to read limitations into claims 1 and 25 concerning a substantially temperature independent HTP.  The District Court held that Falana contributed to the conception of the claimed invention by the development of the synthesis protocol.  Further, the District Court ruled the case exceptional and awarded attorney fees to Falana.

Defendants appealed arguing that the District Court erred in its claim construction, abused its discretion in excluding certain exhibits, erred in concluding that Falana was an omitted joint inventor and erred in ruling the case exceptional.

Claim Construction

Defendants argued that when “the specification makes clear at various points that the claimed invention is narrower than the claim language might imply, it is entirely permissible and proper to limit the claims.”  Defendants argued that the specification describes the inventive compounds as possessing a HTP that is substantially independent of temperature and that “without this limitation the claimed compounds ‘would be commercially worthless’.”

Falana argued that the plain language of the claims does not suggest a limitation regarding temperature independent HTP, and moreover does not recite the specified range of +10 to +50oC.  Falana cites to the specification as disclosing that HTP relative to temperature is simply a modifiable characteristic of the inventive class of compounds.  Further, Falana argued that while the preferred embodiment may exhibit a temperature independent HTP, the only reasonable conclusion is that the patentee meant to claim the entire class of compounds covered by the plain language of the claim.

The CAFC cited Laitram Corp., and held that “it is the claims, not the written description, which define the scope of the patent right.”  Laitram Corp. v NEC Corp., 163 F.3d 1342, 1347 (Fed. Cir. 1998).  The CAFC held that “there is no suggestion in the intrinsic record that the applicant intended the claims to have the limited scope suggested by Defendants and ‘[a]bsent such clear statements of scope, we are constrained to follow the language of the claims, rather than that of the written description’.”  Teleflex, Inc. v. Focosa N. Am. Corp., 299 F.3d 1313, 1327-28 (Fed. Cir. 2002).

Exclusion of Evidence

District Court excluded the admission of Defendants’ evidence, a United Kingdom patent application filed by Dr. Seed and a scientific article published in 2000 by Dr. Seed and others.  Defendants argued that the District Court erroneously excluded this evidence and had this evidence been considered, it would have shown that the synthesis protocol developed by Dr. Falana was already known in the art.  Falana asserted that even if the District Court abused its discretion, any error was harmless as Seed failed to testify that these exhibits mentioned the naphthyl substituted TADDOLs (hereinafter the previously unknown genus) let alone the complete synthesis protocol developed by Falana.

The CAFC held that “[a]lthough the district court may have erred in excluding these exhibits without providing any explanation, any such error in this case was harmless.”  The CAFC noted that while Defendants attempted to admit these exhibits to establish that the Falana synthesis protocol was known in the art, the Defendants only demonstrated that certain portions of the synthesis protocol were within the prior art.  Further, these exhibits would only have been cumulative to the testimony of Seed that explained the portions of the synthesis protocol that was known in the art at the time of invention.

Joint Inventorship

“The burden of showing misjoinder or nonjoinder of inventors is a heavy one and must be proved by clear and convincing evidence.”  Bd. of Educ. v. Am. BioSci., Inc., 333 F.3d 1330, 1337 (Fed. Cir. 2003).  “The critical question for joint conception is who conceived, as that term is used in the patent law, the subject matter of the claims at issue.”  Ethicon, Inc. v. U.S. Surgical Corp., 135 F.3d 1456, 1460 (Fed. Cir. 1998).   Each joint inventor “must contribute in some significant manner to the conception of the invention.” Fina Oil & Chem. Co. v Ewen, 123 F.3d 1466, 1473 (Fed. Cir. 1997).  Conception of a chemical compound “requires knowledge of both the specific chemical structure of the compound and an operative method of making it.”  Id.

The District Court held that the synthesis protocol was sufficient contribution to the conception of the claimed compound as to render Falana a joint inventor of the ‘789 Patent.

Defendants argued that even if Falana contributed to the synthesis protocol, that contribution was insufficient to render him a joint inventor of the ‘789 Patent, as the ‘789 Patent claimed chemical compounds, and not method claims.  Defendants also argued that Falana merely synthesized Compound 7, which is not within the scope of the claims of the ‘789 Patent.

Falana argued that he developed the synthesis protocol which made it possible to synthesize a previously unknown genus of compounds and that without his synthesis protocol, Dr. Seed could not have synthesized Compound 9.  Further, only his synthesis protocol is disclosed in the specification as a method of making the claimed compound.  Falana argued that “because he contributed to the method of making the novel class of compounds claimed in the ‘789 Patent, his contribution to conception was sufficient to make him a joint inventor.”

The case law holds that the conception of a chemical compound necessarily requires knowledge of a method of making that compound Fina Oil & Chem. Co. v Ewen, 123 F.3d 1466, 1473 (Fed. Cir. 1997).  A determination of what was known in the prior art and the level of skilled needed to make a compound will determine if the method of making a compound arises to conception.  “When…a method of making a compound with conventional techniques is a matter of routine knowledge among those skilled in the art, a compound has been deemed to have been conceived when it was described, and the question of whether the conceiver was in possession of a method of making it is simply not raised.”  Oka v Youssefyeh, 849 F.2d 581, 583 (Fed. Cir. 1988).  In the case at hand, the CAFC held that “[w]here the method requires more than the exercise of ordinary skill…the discovery of that method is as much a contribution to the compound as the discovery of the compound itself.”

The CAFC held that “a putative inventor who envisioned the structure of a novel genus of chemical compounds and contributes to the method of making that genus contributes to the conception of that genus.”

A joint inventorship arises only “when collaboration or concerted effort occurs – that is, when the inventors have some open line of communication during or in temporal proximity to their inventive efforts.”  Eli Lilly & Co. v. Aradigm Corp., 376 F.3d 1352 (Fed. Cir. 2004).

The District Court found the following to be evidence of the collaboration or concerted effort: Falana’s development of the synthesis protocol to synthesize Compound 7; the development of the Falana synthesis protocol was not “simply following the teachings of others”; Compound 7 is a species within the previously unknown genus; Compound 7 was considered a great improvement by KDI; the team (Doane, Khan, KDI and Seed) continued to research compound within the previously unknown genus; using the Falana synthesis protocol, See synthesized Compound 9 and Compound 9 is similar to Compound 7.

The Defendants argued that Falana is not a joint inventor, as Falana had left the team prior to the synthesis of Compound 9. However, the claims of the ‘789 Patent are not limited to Compound 9, but rather claim a subset of the previously unknown genus, i.e. the RR enantiomers.

The CAFC held that “Falana contributed to the conception of this genus by providing the team of which he was a part with the method for making these novel compounds.  Falana’s lack of contribution to the discovery of Compound 9 itself does not negate his contribution of the method used by the other inventors to make the genus of compounds covered by the claims at issue.”

Exceptional Case

The District Court held the case to be exceptional due to the inequitable conduct by the defendants, the Defendants’ untenable position in defending the case and their defense lacked credibility and veracity and bordered on bad faith.  The District Court awarded unquantified attorney fees against the Defendants, leaving the amount to be determined in further proceedings.

A decision to award attorney fees under 35 U.S.C. §285 is not final and appealable before the award has been quantified.  Special Devices, Inc. v. OEA, Inc., 269 F.3d 1340, 1343 (Fed. Cir. 2001).

In the present case, the decision regarding joint inventorship is final and reviewable but the exceptional case determination is a separately appealable judgment which is not yet appealable.

The CAFC held that the District Court’s decision finding the case exceptional and awarding attorney fees that remain as of yet unquantified is not final and thus, not appealable.  A non-final decision does not become final simply because it is issued in the same order as a final decision.

PROSECUTION TIPS

Review inventorship to ensure that all inventors are named to a patent application.  Particularly for chemical cases, an individual who solely contributed to method of making a claimed product may be a joint inventor.  This is true even if no method of making claims is presented.

LITIGATION TIPS

An exceptional case ruling is not appealable until an award has been issued.

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