Infringement, Indefiniteness, and Tobacco Curing Invention

See STAR SCIENTIFIC v. RJ REYNOLDS

Issue(s):  Was the district court correct in denial of Appellant’s Star Scientific, Inc. (“Star”) motion for judgment as a matter of law (“JMOL”) and in the alternative a new trial after a jury verdict of non-infringement and invalidity of U.S. Patent Nos. 6,202,649 (“’649 patent”) and 6,425,401 (“’401 patent”) (collectively, “Williams patents”)?

STAR SCIENTIFIC, INC., Plaintiff-Appellant, v. R.J. REYNOLDS TOBACCO COMPANY, Defendants-Appellees. (2010-1183) Appeal from the United States District Court for the District of Maryland in consolidated case nos. 01-CV-1504 and 02-CV-2504, Senior Judge Marvin J. Garbis. (Decided: August 26, 2011); Before RADER(Author), LINN, and DYK (dissenting-in-part),

Facts:       Star is the exclusive licensee of the Williams patents, which claim tobacco curing methods. Curing dries the tobacco leaves before shipment to tobacco companies. One prior art curing method—“air curing”—places tobacco leaves in a barn to dry without any added heat. In the United States, curing is generally performed in heated curing barns through a method called “flue curing,” which uses diesel gas or propane gas heaters.  Until the 1970s, most curing occurred in indirect-fired barns that heated and dried the tobacco in an environment separated from the exhaust gases released by the heaters. In the 1970s, in an effort to save money, tobacco farmers switched to direct-fired barns, which mixed the combustion exhaust with the curing tobacco. The combustion gases (including carbon monoxide, carbon dioxide, and water vapor) can create an anaerobic, or oxygen-free, environment. This anaerobic environment in direct-fired barns can lead to the formation of a family of chemical compounds called tobacco-specific nitrosamines (“TSNAs”) on curing tobacco leaves. Tobacco can acquire four varieties of TSNAs, known by the abbreviations NNN, NNK, NAB, and NAT.

These TSNAs arise because anaerobic conditions stimulate microbes on tobacco plants to produce the enzyme, nitrate reductase, which converts nitrate to nitrite and nitric oxide. Nitric oxide reacts with precursor tobacco alkaloids to form TSNAs.

Because some TSNAs are known carcinogens, tobacco companies have long sought curing methods that minimize or eliminate TSNA formation on cured tobacco plants. The Williams patents claim a tobacco curing method that “substantially prevent[s]” the formation of at least one TSNA during curing. Star employee Jonnie Williams (“Williams”) is the named inventor.  Williams developed the “StarCure” process, the commercial embodiment of the invention. The parties  agree the StarCure process is the best mode of practicing the claimed invention.

The Williams patents work with air curing and both indirect and direct flue curing methods.  In general, the Williams patents posit that sustaining an aerobic environment during tobacco curing will prevent TSNA formation. For purposes of infringement, the parties agreed that the combined elements of claims 4 and 12 of the ’649 patent were representative.

From 1998 through 2001, Star had agreements with Brown & Williamson to cure low-TSNA tobacco using Williams’ patented method. Star made millions of dollars in licensing fees for rights to the Williams patents. However, defendants-appellees R.J. Reynolds Tobacco Company (“RJR”) terminated those agreements with Star upon acquisition of Brown & Williamson.

On May 23, 2001, Star filed a complaint against RJR, alleging infringement of the ’649 patent, and subsequently filed an amended complaint further alleging infringement of the ’401 patent. RJR denied infringement and claimed both patents were unenforceable for inequitable conduct, and invalid for anticipation, obviousness, indefiniteness, and failure to disclose the inventor’s best mode.

Lower Court’s Decision:  After a bench trial, the district court held the Williams patents unenforceable for inequitable conduct and granted summary judgment of invalidity for indefiniteness. Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., (D. Md. June 26, 2007) (finding the Williams patents unenforceable for inequitable conduct based on the nondisclosure of a document (“Burton letter”)); Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., (D. Md. June 22, 2007) (finding the Williams patents invalid for indefiniteness). Additionally, the district court granted summary judgment to RJR on the filing date question.

On appeal, this court reversed the findings of unenforceability and invalidity. Star Scientific, Inc., v. R.J. Reynolds Tobacco Co., 537 F.3d 1357 (Fed. Cir. 2008) (reh’g en banc denied Oct. 22, 2008) (“Star I”). This court held that the claim term “anaerobic condition” was not indefinite and consequently reversed the district court’s grant of summary judgment of invalidity. court also found that the Williams patents were not unenforceable for inequitable conduct. In reversing the district court’s inequitable conduct finding, this court held that RJR failed to show the withheld prior art, including the Burton letter, renders either of the Williams patents unenforceable.  At that time, this court did not review the district court’s priority date determination. This court also did not address anticipation and best mode because the trial court denied RJR’s summary judgment motions on those grounds. Therefore, this court remanded this case to the district court for proceedings on infringement (“Star II”).

A June 16, 2009 special verdict, based on the September 15, 1999 priority date assigned by the court in Star I, found RJR’s curing process to be non-infringing and the Williams patents invalid as anticipated, obvious, failing to disclose best mode, and indefinite.  After oral argument in this case, the Patent Office, in light of an ex parte reexamination request by Star, confirmed that the claims of the Williams patents deserve the priority date of the provisional application, namely September 15, 1998. The Patent Office also found that claims 4, 12, and 20 of the ’649 patent, and claim 41 of the ’401 patent, were obvious over Tohno, Wiernik, and several other references asserted by RJR. Because of the earlier effective filing date, the Patent Office did not consider the Peele reference as prior art.

Findings on Appeal: Claims deserve the provisional application’s earlier filing date so long as that application contains adequate written description under 35 U.S.C. § 112. Trading Techs. Int’l. Inc. v. Espeed Inc., 595 F.3d 1340,  In this case, the asserted claims deserve the September 15, 1998 priority date of the provisional application. The provisional application’s written description discloses that the minimum air flow “may be about 28,000 CFM at 1” static pressure in a typical curing barn,” but that the “minimum flow of air may vary according to conditions and may be determined on a routine basis.” Claim 3 of the provisional application further clarifies that the claimed invention covers a “flow . . . sufficient to prevent an anaerobic condition” around the curing tobacco. Because the provisional application teaches one of ordinary skill that a minimum air flow “may vary,” one of ordinary skill would know that the conditions in a curing barn could demand an air flow of 25,000 CFM. The district court’s reliance on specifically disclosed air flow rates improperly narrowed the scope of the provisional application based on an added example in the later-filed non-provisional application that discloses a process for curing using an “air flow of approximately 25,000 CFM.” Indeed, the Patent Office’s recent reexamination confirms that September 15, 1998 is the proper priority date.

Star contends that the trial court committed numerous reversible evidentiary errors. Star seeks reversal and remand for a new trial based on the court’s exclusion of proffered data, failure to exclude the Burton slide, reproduced above, failure to exclude arguments made by RJR about failure to produce the Burton letter to the Patent Office, and other arguments made by RJR during trial.  The district court did not commit reversible error in its evidentiary rulings. Because inequitable conduct was not at issue in the trial, this court finds the presentation of the Burton slide troubling. The Burton slide, showing a shadowy figure conspicuously holding a piece of paper behind his back, does not support any claim at issue in this case. As a practical matter, however, Star did not show the presentation of the Burton slide affected its substantive rights.

A. Best Mode:   RJR concedes that Williams had not yet contemplated a best mode as of September 15, 1998. As discussed above, September 15, 1998 is the proper priority date for the asserted claims of the Williams patents. Therefore, at the time of filing, the record shows no best mode violation. Without evidence that Williams had possession of a best mode of practicing the claimed invention at the time of filing, the record cannot support invalidity under the best mode requirement. This court reverses the district court’s finding that the Williams patents are invalid for failure to disclose the best mode of practicing the claimed invention.

B. Indefiniteness:  A construed claim can be indefinite if the construction remains insolubly ambiguous, meaning it fails to provide sufficient clarity about the bounds of the claim to one skilled in the art.   The district court construed the claim term “controlled environment” to mean “controlling one or more of humidity, temperature and airflow in the curing barn, in a manner different from conventional curing, in order to substantially prevent the formation of TSNAs.”

Here, indefiniteness requires a showing that a person of ordinary skill would find “controlled environment” to be insolubly ambiguous.  From that perspective, this record does not present reasonable grounds for showing that “controlled environment” is indefinite. The jury’s verdict assumes that a person of skill in the art would not recognize a “controlled environment” because the Williams patents do not give exact numbers measuring humidity, temperature, and airflow in a conventional curing barn. However, the record repeatedly shows that a person of skill in the art of tobacco curing would possess adequate understanding to manipulate these variables to create a controlled environment. Indeed, because conventional curing varies depending on the conditions for each cure, specific numerical values are not needed for one skilled in the art to implement conventional curing.

C. Obviousness:  Whether prior art invalidates a patent claim as obvious is determined from the perspective of one of ordinary skill in the art.

Dr. Otten testified that a combination of two prior art references, Tohno and Wiernik, rendered the ’649 patent obvious. Specifically, he testified that a person of ordinary skill in the art would combine Wiernik’s teaching (that TSNAs form from high humidity, optimal temperature, and anoxia) with Tohno’s teaching (that an increased airflow helps avoid an oxygen deficient condition) to generate the claimed curing methods.

Even if the record showed some motivation or suggestion to combine these references, the combination of Tohno and Wiernik would still not present a clear and convincing instance of obviousness. Tohno describes an alternative quick bulk curing method.

Tohno does not mention TSNAs and does not provide a link between the oxygen levels (inherent in increasing air flow) and precursor tobacco alkaloids or the activation or inhibition of nitrate reductase—both critical targets of the Williams patents.

Wiernik’s general teachings also produce little to render the Williams patents obvious. Wiernik speculates that microorganisms are influenced by environmental factors during the end of yellowing or the beginning of the browning stage of curing to potentially facilitate the production of TSNAs. Wiernik’s speculative and tentative disclosure of what “might” or “may” lead to nitrite and TSNA production does not sufficiently direct or instruct one of skill in this art.

Moreover, the record contains many secondary considerations that support nonobviousness. The record shows a substantial need in the industry for curing methods that minimized or eliminated the formation of TSNAs. The record also contains numerous scientific articles counseling that eliminating or minimizing carcinogens in tobacco has been a longfelt industry need. To that end, the record showed decades of unsuccessful attempts at reducing TSNA levels to the extent achieved by the Williams patents.

D. Anticipation:  The jury verdict did not identify which prior art reference supplied clear and convincing evidence to anticipate the Williams patents. Because Dr. Otten testified that three pieces of prior art anticipated the Williams patents, this court considers those prior art references: the Peele method and the alleged public uses at Spindletop and Brown.

A jury could not reasonably find by clear and convincing evidence that Brown’s method of curing met the claim limitation “substantially prevent the formation of . . . at least one nitrosamine,” ’649 patent, more than a year before the Williams patents’ September 15, 1998 priority date.

No reasonable juror could conclude that a series of tests from 1998, less than a year prior to the patents’ priority date, let alone one test from 1996, with readings of “ND” or “0.00” can serve as clear and convincing evidence that Brown’s curing techniques anticipate the Williams patents, which require TSNA levels below 0.05 ppm or 0.10 ppm, where a “0.00” or “ND” result only provides that the concentration of TSNAs is below the 0.15 ppm detection threshold. Accordingly, this court finds that no reasonable juror could find the Williams patents anticipated.

E. Infringement;  The jury returned a special verdict finding that Star did not show infringement of the Williams patents by a preponderance of the evidence. The district court denied Star’s motions for JMOL and, in the alternative, a new trial.

Star’s expert testimony was dispositive in this case. The record shows that Star presented Dr. Lee as its “primary evidence of infringement[.]”. In fact, upon the court’s threat to conditionally limit or exclude Dr. Lee’s testimony, Star conceded that “for all practical cases” there would be no case of infringement. Indeed, the district court remarked that the jury “as it most certainly should have, rejected Dr. Lee’s opinion altogether.” In fact, the district court indicated that, had the jury not discredited Dr. Lee, the court “would now exclude Dr. Lee’s testimony as not meeting the Daubert standard.”

Star advances several arguments for a new trial. However, Star’s arguments need not be addressed because this court’s grant of JMOL of validity moots any alleged errors pertaining to validity. This court notes that correction of any alleged error would not have changed the result in this case because there was substantial untainted evidence before the jury to support a verdict of non-infringement. See Verizon, 602 F.3d at 1342 (“We may affirm the jury’s findings on infringement if substantial evidence in the record appears in the record supporting the jury’s verdict and if correction of alleged errors would not have changed the result given the evidence presented.”(citations omitted)). It was not an abuse of discretion for the district court to deny Star’s motion for a new trial.

DYK, Circuit Judge, concurring-in-part and dissenting-in-part:  Although I agree with the majority with respect to infringement, I would find the patents-at-issue invalid for indefiniteness, and respectfully dissent from the majority’s contrary holding. Because I would hold the patents invalid for indefiniteness, I find it unnecessary to reach any of the other invalidity challenges.  Here, the district court construed the term “controlled environment” to mean “controlling one or more of humidity, temperature, and airflow in the curing barn, in a manner different from conventional curing, in order to substantially prevent the formation of TSNAs.”

The specifications elsewhere directly contradict the majority’s conclusion, explaining that the claimed “controlled environment” is something different from conventional curing methods. The specifications criticize conventional curing processes on the ground that they “do not provide suitable conditions (e.g., adequate oxygen flow) and fail to prevent an anaerobic condition in the vicinity of the tobacco leaves.”  In sum, the patents describe the claimed “controlled environment” as something different from conventional curing methods, but fail to explain those differences in a way that would permit a skilled artisan to determine the bounds of the claims. To add to the confusion, the patents define conventional curing methods as air-curing or flue-curing “without the controlled conditions” required by the claims. Under this court’s established test for definiteness, such circularity is insufficient to inform skilled artisans of the bounds of the claims.

Allen’s Observations:   Thank goodness someone figured out how to reduce those pesky carcinogens introduced during the tobacco curing processes.  Anyway, there is not much here that can be generalized, with one exception.  The best mode was not known at the time the provisional was filed, but later found during development.  This should help inventors rest easy when filing.  It makes sense that more testing might be required after a provisional is filed.  While technically it would be better to disclose at least a subjective belief as to the best mode, not venturing to guess what it might be is not going to be punished.

 

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About C. Allen Black, Jr.

I am a practicing patent attorney with a technical background in molecular biology and vaccinology. I have a Ph.D. in Immunology and teach the Biotechnology Law class at the University of Pittsburgh Law School as an adjunct professor.
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2 Responses to Infringement, Indefiniteness, and Tobacco Curing Invention

  1. Izof_texas says:

    If anyone cares, I believe it was RJR who asked for the ex parte patent exam (on 12/30/2008) and then asked Garbis (district court judge) to grant a stay of trial until the results were in.

    MOST unfortunately for Star (but at Star’s request to go ahead with trial), Garbis, having so screwed up the first trial (throwing in a completely unjustified and unexplained 2+ year delay in rendering an opinion), was afraid to grant RJR that delay, much as one may assume he would like to have done so.

    Also, I think it is clear that Judge Dyk’s dissent was based on a misunderstanding of the term “controlled environment” … thinking it to be, as I had been writing for months I feared would happen, “the curing barn”.

    In fact, I believe that everyone connected with the case, to RJR’s advantage, has been horn-wrestled into the view favoring RJR’s case … that “the barn” is “the controlled environment”. IT IS NOT.

    I have written several long writeups explaining this, but I will try to be very brief, and less explanatory, here and see if it works.

    The patents’ claims carefully specify that “the controlled environment” is a SMALL VOLUME “around each plant portion” of the load of tobacco within the curing barn. They teach that the conditions IN THE BARN have to be manipulated so that ALL OF THOSE little “controlled environments” around each plant portion maintain an aerobic condition.

    Thus the patents teach that one should control the variables temperature, humidity, air flow [both within the barn and between the barn and "ambient" air], and [in the specification] the arrangement of the tobacco leaves themselves within the barn overall such that each little “controlled environment” around each “plant portion” is at all times aerobic (meaning with characteristics, in terms of oxygenation, etc., equal to that of “ambient air” outside the vicinity of the curing barn).

    One skilled in the art realizes that it is like a “weakest link in the chain” situation. He/she realizes that one must manipulate those variables (with)IN THE BARN so that the small “controlled environment” around the tobacco plant portion that is the LEAST WELL VENTILATED within the barn remains “aerobic”.

    Seeing that, it is perfectly clear, it seems to me, what makes the Williams method “different from conventional curing”: THAT PROCESS.

    In “conventional curing” it has never been suggested that one ensure (by manipulating barn parameters overall) that every “microenvironment” within a curing barn … around EACH PLANT PORTION … be maintained in an “aerobic state” in order to substantially prevent the formation of one or more tobacco specific nitrosamines (per the court’s construction of the latter term). Though a bit complex, the language seems appropriately concise, and completely explanatory when carefully read.

    In fact, the (Judge) Michel panel in the first appeal, of the initial I.C. trial result, seemed to appreciate this process/concept MARVELOUSLY. Oddly, Judge Dyk was a part of that Michel panel, and I had counted on him to carry forward that understanding. It is strange (and a bit scary … a close call for Star) the way things work out some times.

  2. Izof_texas says:

    If I may comment further, more in the form of a question, on a separate topic …

    Regarding

    “As a practical matter, however, Star did not show the presentation of the Burton slide affected its substantive rights.”

    Though I am not an attorney, I know a bit about law, I have followed this matter since the suit was filed in 2001 (actually before), and I have to wonder if Star may not have “lost” on this point simply because it did not expressly state that it, Star, had the right to a fair trial.

    Discussions I have read of the term “due process” … a Constitutional guarantee … state that due process conveys to one basic, substantive rights among other things. (Thus, it seems to me, that “substantive rights” FLOW FROM “due process”, and that lack of the former IMPLIES lack of the latter.)

    Many say this, in fact or essence, about “due process”:

    “A fundamental, constitutional guarantee that all legal proceedings will be fair and that one will be given notice of the proceedings and an opportunity to be heard before the government acts to take away one’s life, liberty, or property”.

    http://legal-dictionary.thefreedictionary.com/Due+Process+of+Law

    I think Star’s Phillips made an EXCELLENT argument that the showing of the slide in question, PLUS a number of other things

    (allowing RJR to argue that it practiced it’s own “Peele patent” and [implying] to the jury that, therefore, it was not practicing Star’s patent … impermissible in the context of an infringement trial, if I understand correctly; not allowing Star to introduce in an effective manner the fact that RJR’s own defense firm opined formally in 2001 that indeed RJR was infringing on Star’s patents, ETC.)

    very unfairly prejudiced the jury’s whole impression of Star … painting a picture of Star to be a company who didn’t deserve the patents in question, having lied to the PTO, and one which was prosecuting “poor RJR” for practicing Star’s patents WHEN INSTEAD RJR was practicing its own patents, etc.

    The appeals panel found these things disturbing. I felt sure they would also find disturbing how the jury found for RJR on EVERYTHING, even things Star technincally couldn’t lose (like “best mode”, etc.).

    I though SURELY CAFC would ask itself why the jury panel acted as if it hadn’t heard a word spoken by Star’s attorneys in the whole trial. How could CAFC miss that this jury acted precisely as if Star didn’t even belong in the courtroom (and thus neither did poor RJR)? Why did not CAFC understand that what troubled it ALSO very much troubled … prejudiced … the jury??

    Can it be that CAFC denied Star a new, fair trial simply because Star did not state that its substantive right to a fair trial … one where trial procedure would have cured these ills AT THE TIME OF THE TRIAL by correct handling of the appropriate timely objections … had been most decidedly abridged in the Garbis court?

    After 3.5 weeks of trial, the jury hardly deliberated at all. Even accepting that Star’s direct evidence of infringement was weak at best, how is it that in “no time” the jury just checked every box “against” Star, no matter what the evidence per issue in this very complx matter?

    Is it not OBVIOUS that the trial was not FAIR … that RJR’s “side” of things (all things) was given extraordinary voice (highly prejudicial voice, in fact), and Star’s side of things (all things) substantially choked off?

    Was all of that lost on CAFC … or is CAFC saying that the problem was merely that Star never said (that I know of), “Thus we did not get our Constitutionally guaranteed fair trial …”?

    Did Phillips consider that to be understood? Is it? If one fact logically implies another, MUST one state “the corollary” result to get justice?

    I think the trial was clearly and categorically unfair (strongly and impermissibly prejudiced jury), by reason of several matters, carefully detailed by Phillips in favor of Star on appeal … matters that CAFC stated it “found disturbing” (I think CAFC found more than “the slide” disturbing … surely “the slide” combined, as Phillips clearly illustrated, with the other factors like those mentioned above, to be very disturbing, taken together).

    Star had a right to a fair trial, and one did not obtain, and therefore “the government” in the person of CAFC has wrongfully deprived Star of property by not granting a new, hopefully fair, trial, it seems to me.

    Does one actually have to state … plead … “unfair trial” (THE lost … “affected” … “substantive right”) to tie all those factors together? Did Phillips do so? If not, is that why Star did not get a new trial … a try at a fair trial?

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