217-1. Board’s Decision to Expunge Full Deposition Transcript Affirmed; Board Erred in Analyzing Diligence in Reduction to Practice
The United States Court of Appeals for the Federal Circuit recently issued a ruling which addressed issues including timeliness in filing a full deposition transcript, limitations found in preambles, and diligence in reduction to practice. Specifically, the Court held (1) a submission of a full deposition transcript can be unauthorized by being untimely, (2) preambles do not provide limitations to a claim unless the preambles are “necessary to give life, meaning and vitality” to the claim, and (3) pauses in reduction to practice for testing may not amount to unreasonable delay. See Arctic Cat Inc. v. GEP Power Prods. Inc., Nos. 2018-1520, 2018-1521, 2019 U.S. App. LEXIS 8964 (Fed. Cir. Mar. 26, 2019) (Before Prost, Chief Circuit Judge, Reyna and Taranto, Circuit Judges) (Opinion for the court, Taranto, Circuit Judge).
Arctic Cat, Inc. (Arctic Cat) is the owner of U.S. Patent Nos. 7,072,188 (the ’188 patent) and 7,420,822 (the ’822 patent). Both patents relate to an electrical connection box used to supply power to various electrical components, such as the electrical components of a personal recreation vehicle. Of particular importance to the case was language in the preambles of certain claims in the ’188 and ’822 patents. Two independent claims of the ’188 patent included a preamble reciting: “A power distribution module for a personal recreation vehicle comprising.” Similarly, an independent claim of the ’822 patent recited: “A personal recreation vehicle comprising.”
In July 2016, GEP Power Products, Inc. (GEP) petitioned for inter partes review of the ’188 and ’822 patents. For the ’188 patent, the Board instituted review on three grounds: (1) anticipation of certain claims by Boyd, (2) obviousness of certain claims over Boyd and Svette, and (3) obviousness of certain claims over Svette alone. For the ’822 patent, the board instituted review on three grounds: (1) anticipation of certain claims by Boyd, (2) obviousness of certain claims over Boyd and Svette, and (3) obviousness of all independent claims over Svette and Matsuoka.
The Board made three determinations that led to the current appeal. In the Patent Owner Response, Arctic Cat relied on an April 3, 2017 deposition by the sole inventor on the ’188 and ’822 patents, Mr. Janisch. GEP cross examined Mr. Janisch on May 25, 2017 and subsequently filed its replies in June 2018, submitting only the portions of the deposition transcript that GEP cited in the replies. Three months later, on September 20, 2017, Arctic Cat submitted the full deposition transcript “without any request for permission.” Relying on 37 C.F.R. § 42.7(a), the Board expunged the full deposition transcript from the record as “not authorized.” The Board noted that Arctic Cat “‘did not seek authorization’ to file the transcript, nor did Arctic Cat ‘explain why . . . the transcript could not have been filed earlier (for example, by the due date in the Scheduling Order for Motions for Observation).’”
The Board’s final decision found all claims of the ’188 and ’822 patents invalid. In so holding, the Board first rejected Arctic Cat’s argument that the preambles recited limitations for the claims. The Board also concluded Boyd was a proper prior art reference, having been filed seven months before the parent application in the present case (the ’188 patent). Arctic Cat appealed, arguing the Board erred by (1) rejecting the full deposition transcript, (2) construing the preambles as not providing limitations for the claims, and (3) finding Boyd as a proper reference for §§ 102 and 103 rejections.
Arctic Cat’s first challenge was against the Board’s rejection of Arctic Cat’s submission of the full transcript of its inventor’s deposition. Arctic Cat relied on 37 C.F.R. § 42.53, which addresses taking and using depositions before the Board, which states, “Except where the parties agree otherwise, the proponent of the testimony must arrange for providing a copy of the transcript to all other parties. The testimony must be filed as an exhibit.” Arctic Cat argued that the express language means that, “when a party submits some testimony from a deposition, that party (the proponent) must submit the transcript of the entire deposition, or that, in any event, the adversary party may submit the entire transcript if the proponent of the testimony does not.”
The Court, however, did not decide whether Arctic Cat’s reading of the regulation was accurate. According to the Court, regardless of the meaning of the regulation, the Board has discretion to decide when a filing is late. Accordingly, the Court held that there was no basis to determine that the Board abused its discretion by rejecting Arctic Cat’s submission of the full transcript
Arctic Cat next challenged the Board’s determination that certain language in the preambles of the challenged claims did not impose limitations. In particular, Arctic Cat focused on the preambles that recited a “personal recreation vehicle.”
The Court began its analysis by reciting three “canons of construction in statutory interpretation”:
(1) “In general, a preamble limits the invention if it recites essential structure or steps, or if it is ‘necessary to give life, meaning, and vitality’ to the claim.” Citing Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808 (Fed. Cir. 2002);
(2) “Whether to treat a preamble as a limitation is ‘determined on the facts of each case in light of the overall form of the claim, and the invention as described in the specification and illuminated in the prosecution history.’”Citing Deere & Co. v. Bush Hog, LLC, 703 F.3d 1349, 1357 (Fed. Cir. 2012); and
(3) “This court has recognized that as a general rule preamble language is not treated as limiting.” Citing Aspex Eyewear, Inc. v. Marchon Eyewear, Inc., 672 F.3d 1335, 1347 (Fed. Cir. 2012).
The Court agreed with the Board’s determination that the bodies of the claims “describe structurally complete inventions,” and reference to a recreational vehicle is only a reference to an intended use. The bodies of the challenged claims did not recite a “personal recreation vehicle,” though the claims did recite the specific features of the housing, electrical harness, etc. The Court held the intended use of the power distribution modules did not limit the body of the claims.
Finally, Arctic Cat challenged the Board’s decision to find U.S. Patent No. 6,850,421 to Boyd as prior art applicable against the challenged patents. Arctic Cat took two positions on the issue: (i) that under Pre-AIA § 102(a)(2), the inventor on the ’188 and ’822 patents invented the subject matter before Boyd’s filing date, and (ii) the disclosures in Boyd relevant to patentability of the ’188 and ’822 patent claims were not invented “by another.” Although Mr. Boyd was the only named inventor in the Boyd reference, Arctic Cat argued Mr. Boyd was hired to reduce Mr. Janisch’s conception to practice. The Court did not address the “by another” argument but instead discussed the priority argument.
To antedate Boyd, Arctic Cat was required to show that Mr. Janisch “(1) conceived of the inventions at issue before April 1, 2002, and (2) diligently reduced the conceptions to practice.” Citing Perfect Surgical Techniques, Inc. v. Olympus America, Inc., 841 F.3d 1004, 1007 (Fed. Cir. 2016). At issue in the case was diligence between April 1 and April 29, 2002, and between August 16 and October 18, 2002. The Board held that the evidence did not support diligence between those periods. The Court, however, held that “the Board’s analysis rested on too rigid a standard.” The standard requires that the inventor “was reasonably diligent during the critical period so as not to have abandoned his invention or unreasonably delayed its reduction to practice.”
During the time periods at issue, the invention was subject to testing and validation by Mr. Boyd’s employer, Tyco. Arctic Cat hired Tyco to complete the testing. The device “went through five revisions in only five months.” Mr. Janisch sent emails to Tyco asking, “How soon can we expect to receive … the decals” and asking to be updated on the results “as they are completed.” The Court stated:
Lack of diligence cannot be inferred from putting the invention into someone else’s hands for needed testing and awaiting test results for a short period commensurate with the testing need, at least where oversight was diligent. That course of action, as a way of reducing an invention to practice, does not give rise to an inference of unreasonable delay or abandonment of the invention.
Citing Perfect Surgical, 841 F.3d at 1009. Reviewing the Board’s determination under a substantial evidence standard, the Court held that Mr. Janisch was reasonably diligent in reducing his invention to practice. Accordingly, the Court held that the Boyd reference “is not available as prior art against the ’188 and ’822 patents.”
The result of the Court’s holding on the prior art was that the Board’s decision was reversed in part and vacated in part with respect to the ’188 patent. Two instituted grounds against the patent relied upon Boyd as a reference, and the Court reversed on these grounds. The third ground did not rely on Boyd as a reference, but the Board applied Boyd as background knowledge. The Court vacated on this ground and remanded for further proceedings.
As for the ’822 patent, Boyd was not relied upon as a reference for one ground, so the Court affirmed the Board’s prior art holding for the patent. Accordingly, the Court affirmed the Board’s decision with respect to invalidity of the ’822 patent.
Although a proponent of deposition testimony may be required to submit the full transcript, the issue of timeliness of the submission is at the Patent Trial and Appeal Board’s discretion. Thus, the Board has discretion to expunge a subsequent filing of the full transcript if the submission is untimely, for example after a due date in a Scheduling Order. Also, practitioners should note that diligent reduction to practice may include pauses if the product is being tested and the pause is commensurate with the testing needed.
217-2. New Trial on Validity Ordered by Federal Circuit in Sealant Systems International and TEK Global Tire Repair Kit Patent Dispute
The Federal Circuit recently granted a new trial on invalidity to Sealant Systems International (“SSI”) with respect to a patent for a tire repair kit held by TEK Corporation (“TEK”). The Court, however, also affirmed a finding of infringement against SSI that resulted in a $2.78 million jury verdict, which will stand if the tire kit patent is not found invalid. See TEK Global, S.R.L. v. Sealant Sys. Int’l, No. 2017-2507, 2019 U.S. App. LEXIS 9301 (Fed. Cir. Mar. 29, 2019) (Before Prost, Dyk, and Wallach, J.) (Opinion for the court, Prost, J.).
The patent at issue, U.S. Patent No 7,789,110 (the ’110 patent), is directed to an emergency kit for repairing punctured tires. SSI and TEK were competitors for the sale of tire repair kits. TEK sued SSI for patent infringement, but the district court initially granted summary judgment to SSI on invalidity in light of its claim construction and based on two asserted references. TEK appealed, challenging the district court’s grant of summary judgment. The Federal Circuit reversed the district court’s construction, and remanded because SSI did not have the opportunity to make a case for invalidity in light of the corrected claim construction.
On remand, SSI again moved for summary judgment of invalidity. This time, however, the district court interpreted the Federal Circuit’s decision to mean that the Federal Circuit had already considered and rejected obviousness in light of the two previously asserted references. As a result, the district court denied summary judgment. The case proceeded to trial, where a jury found that SSI infringed the valid ’110 patent and awarded $2.78 million in lost profits and reasonable royalties to TEK.
SSI moved for a new trial on damages and for judgment as a matter of law (“JMOL”) on damages, invalidity, and noninfringement. The district court denied the motion for a new trial and denied JMOL on invalidity and noninfringement. The district court did, however, grant JMOL on damages with respect to the reasonable royalty award of approximately $255,000. The district court also granted TEK’s motion for a permanent injunction. SSI appealed.
On appeal, SSI argued that the ’110 patent was invalid, and that had the district court allowed SSI to present an additional obviousness theory based on the previously asserted references, but in light of the correct claim construction, the jury would have found the ’110 patent invalid. The Federal Circuit noted the district court instructed the jury, based on the district court’s interpretation of the Federal Circuit’s earlier opinion, that the jury was “not permitted to conclude that the [previously asserted references], alone or in combination with one another, disclose[d]” a certain claim limitation.
The Federal Circuit clarified, however, that its prior opinion did not foreclose all obviousness theories based on the asserted references, only the previous one based off the incorrect claim construction. While the Court declined to reverse the district court’s denial of JMOL on invalidity, it held the district court should not have barred SSI from presenting to the jury other preserved obviousness theories based on the asserted references. Thus, the Court granted a partial new trial on invalidity.
The Court, however, affirmed the district court’s denial of JMOL on noninfringement. The district court did not misconstrue any claim terms challenged on appeal, so the Court did not re-evaluate whether the accused product infringed the ’110 patent under those constructions. SSI also argued that the district court erred by allowing TEK to compare the SSI accused product to TEK’s commercial embodiment of the ’110 patent during closing arguments. While it is an error to compare the accused product with a patentee’s commercial embodiment, rather than the claims of the patent itself, in an infringement analysis, the Court found that the district court properly instructed the jury against such a comparison to determine infringement and therefore did not abuse its discretion. The Court also affirmed the district court’s denial of JMOL with respect to the jury’s lost profits award of approximately $2.5 million and found the district court did not err by granting a permanent injunction to TEK.
A determination by the Federal Circuit that a combination of references do not teach a particular limitation under a certain claim construction does not bar other possible obviousness theories raised by combining those same references.
217-3. Ineligible Subject Matter Under 35 U.S.C. § 101 Leads to a Rule 12(b)(6) Dismissal of ChargePoint’s Patent Infringement Suit
The Federal Circuit recently affirmed the U.S. District Court of Maryland’s grant of SemaConnect’s Rule 12(b)(6) motion based on 35 U.S.C. § 101. In reaching its determination, the Federal Circuit noted, “a claimed invention’s use of the ineligible concept to which it is directed cannot supply the inventive concept that renders the invention ‘significantly more’ than that ineligible concept.” See ChargePoint Inc., v. Semaconnect, Inc., No. 2018-1739, 2018 U.S. Dist. LEXIS 49026 (Fed. Cir. Mar. 29, 2019) (Before Prost, Reyna, and Taranto, J.).
The case originated when ChargePoint, Inc. (“ChargePoint”) brought suit in district court alleging patent infringement of eight claims from amongst four of its patents, U.S. Patent Nos. 8,138,715 (the ’175 patent), 8,432,131 (the ‘131 patent), 8,450,967 (the ‘967 patent), and 7,956,570 (the ’570 patent), which all share the same specification. The technology at issue pertains to charging stations for electric vehicles. At the time the first application was filed, problems in the technology included long charging times and electric power grids lacking sufficient electricity to meet demands. To solve the aforementioned problems, the asserted patents claim network charging stations allowing drivers to locate charging stations in advance and allowing all users to interact intelligently with the electricity grid (e.g., allowing electric vehicles to supply electricity to the grid).
More specifically, ChargePoint alleged infringement of claims 1 and 2 of the ’715 patent directed to an apparatus controlled by a remote server, where the server controls whether electricity is flowing. Claim 2 adds a component that physically connects the charging station to an electric vehicle that can activate or deactivate charging at the connection. As for the ʼ131 patent, ChargePoint asserted claims 1 and 8, directed to an apparatus modifying electricity flow based on demand response communications received from the server. With respect to the ʼ967 patent, ChargePoint asserted claims 1 and 2, directed to method claims related to using the network-controlled charging stations. They also incorporate the idea of demand response. Finally, regarding the ʼ570 patent, ChargePoint asserted claims 31 and 32, directed to a network-controlled charging station system.
The Federal Circuit began its analysis by noting “[s]ubject matter eligibility under 101 may be determined at the Rule 12(b)(6) stage of a case . . . ‘only where there are no factual allegations that, taken as true, prevent resolving the eligibility question as a matter of law.’” Aatrix Software, Inc. v. Green Shades Software, Inc., 882 F.3d 1121, 1125 (Fed. Cir. 2018). The Court then began its analysis by applying the two-step Alice analysis.
At step one, the Court determined whether the claims were directed to judicial exception (e.g., a law of nature, natural phenomena, or an abstract idea). The Court analyzed each of the asserted claims and, although claim construction was not at issue in this case, the Court looked to the specification to determine “the problem facing the inventor.” Based on the claims and the specification, the Federal Circuit then determined there was no indication that the invention was intended to improve particular components of a device or that the inventors viewed the claimed components as their invention. Therefore, the Court determined the asserted claims were directed to the abstract idea of communicating over a network for device interaction. Further, the Federal Circuit noted “the broad claim language would cover any mechanism for implementing network communication on a charging station, thus preempting the entire industry’s ability to use networked charging stations.”
At step two of the Alice inquiry, the Court determined whether an inventive concept exists. The inquiry requires an examination of the elements of each claim both individually and as an ordered combination to determine whether the additional elements transform the nature of the claim into a patent-eligible application. ChargePoint argued its patents provide network control to charging stations, which are an unconventional solution to technological problems in the field, and thus contain an inventive concept sufficient to transform the claims to “significantly more” than an abstract idea. ChargePoint identified the problems in the art as: sparse availability of charging stations and the need for more widespread stations; the need for a communication network that facilitates finding an available charging station, controlling the station, and paying for electricity; and the need for real-time communication to effectively implement demand response and vehicle-to-grid transfer. ChargePoint further argued that it solved these problems in an unconventional way by: (1) turning an electric supply on based on communications from a remote server; (2) a “network-controlled” charging system; and (3) a charging station that receives communication from a remote server, including communications made to implement a demand response policy.
The Federal Circuit found ChargePoint’s argument unconvincing holding that its alleged inventive concept, network control, is also the ineligible abstract idea. Because “a claimed invention’s use of the ineligible concept to which it is directed cannot supply the inventive concept that renders the invention ‘significantly more’ than that ineligible concept,” ChargePoint’s claims failed step two of Alice.
Finally, the Federal Circuit declined to vacate the district court’s dismissal with prejudice because ChargePoint never sought leave to amend pre-judgment, never filed a proposed amended complaint pre-judgment, never sought leave to amend post-judgment, and did not submit facts sufficient to withstand a § 101 challenge.
Under step-two of Mayo/Alice analysis, the inventive concept must be distinct from the ineligible concept to render the invention “significantly more” than the ineligible concept.
217-4. Claims Directed to a “Specific Method of Treatment for Specific Patients Using a Specific Compound at Specific Doses to Achieve a Specific Outcome” Held Patent Eligible, Mirroring Vanda
The Federal Circuit recently reversed the District of Delaware’s decision holding the claims of the patent-in-suit ineligible under 35 U.S.C. § 101 as directed to a natural law. The Federal Circuit, reviewing the motion to dismiss and patent eligibility determination de novo, concluded that the claims were “directed to a patent-eligible method of using oxymorphone or a pharmaceutically acceptable salt thereof to treat pain in a renally impaired patient.” Endo Pharm. Inc. v. Teva Pharm. USA, Inc., Nos. 2017-1240, 2017-1455, 2017-1887, 2019 U.S. App. LEXIS 9189 (Fed. Cir. Mar. 28, 2019) (Before, Wallach, Clevenger, and Stoll, J.) (Opinion for the court, Stoll, J.).
Endo owns the patent-in-suit that covers a method of using oxymorphone to treat pain in patients with impaired kidney function. More specifically, the inventor developed a method that allowed renally impaired pain patients to be treated safely and effectively notwithstanding their impaired kidney function. The steps of the method of treatment consisted of providing a controlled release dosage of oxymorphone, measuring the patient’s kidney function by its creatinine clearance rate, orally administering depending on the creatinine clearance rate a lower dosage to provide pain relief based upon the concentration of the drug within the patient’s bloodstream (specifically, less than 21 ng hr/mL).
Endo Pharmaceuticals Inc. and Mallinckrodt LLC (collectively “Endo”) sued Actavis LLC, Actavis South Atlantic LLC, Actavis Pharma, Inc., Actavis Elizabeth LLC, Actavis Holdco U.S., Inc. (collectively, “Actavis”) for infringement of the patent-in-suit. Actavis moved to dismiss Endo’s claims, arguing that the patent claims were ineligible under § 101. The magistrate judge recommended granting Actavis’s motion. The magistrate judge reasoned that the claims are directed to the natural law that the bioavailability of oxymorphone is increased in people with severe renal impairment and the “administering step” of the claims merely instructed physicians to dispense oxymorphone for the treatment of pain in a well-known manner, while utilizing a natural law to manage the dosage. The district court agreed with the magistrate judge, held the patent ineligible, and dismissed Endo’s claims. Endo properly appealed.
The Court quickly concluded that the claims were not directed to patent-ineligible subject matter, identifying three recent cases the district court did not have the benefit of considering: Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd, 887 F.3d 1117 (Fed. Cir. 2018), Rapid Litig. Mgmt. Ltd. v. CellzDirect, Inc., 827 F.3d 1042, 1050 (Fed. Cir. 2016), and natural Alternatives International v. Creative Compounds, LLC, No. 2018-1295, 2019 WL 1216226 (Fed. Cir. Mar. 15, 2019).
The Court continued that “[t]he claims at issue here are legally indistinguishable from the representative claim in Vanda.” Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd, 887 F.3d 1117 (Fed. Cir. 2018). Walking through the similarities step-by-step, the Court stated that both claims “are directed to a specific method of treatment for specific patients using a specific compound at specific doses to achieve a specific outcome.” See Vanda, 887 F.3d at 1136. Or more specifically, the patent-in-suit “claimed an application of [the identified] relationship—specifically, a method of treatment including specific steps to adjust or lower the oxymorphone does for patients with renal impairment.”
Additionally, the Court distinguished Mayo based upon the “orally administering” step of the patent-in-suit – stating that the step “describes giving a specific dose of the drug based on the results of kidney function testing” contrasting that with the Mayo step that “simply describes giving the drug to a patient with a certain disorder.” See Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 77 (2012). The Court continued that Mayo merely used the metabolite level in blood to “indicate” a need to increase or decrease dosage, failing to prescribe a specific dosage regimen or other added steps to take as a result of that indication. On the contrary, the patent-in-suit recites the steps of “carrying out a dosage regimen based on the results of kidney function testing.”
The Court then continued on to dismiss Actavis’s remaining arguments. Notably, the Court, in Vanda and here, held that the patent-in-suit’s method directed to “specific patients” was sufficient, or stated differently, the Court would not require the precise methods used to identify the renal impaired patients to be claimed. Additionally, the Court held that the wherein clause identifying the 21 ng hr/mL threshold was a sufficient limit on the scope of the orally administering step – dismissing Actavis’s arguments that the patent-in-suit did not specify an amount or frequency of oxymorphone to be administered. Finally, the Court addressed Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015) and Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743 (Fed. Cir. 2019) concluding neither required a different outcome.
The Court reversed the district court’s decision, finding that the patent-in-suit’s claims were not directed to patent ineligible subject matter.
Claims can be directed to a new treatment for an ailment, albeit using a natural law or phenomenon, without claiming the natural law. Therefore, when the claims are not directed to the ineligible subject matter itself, the claims can be patent eligible.
217-5. Cross-Appeals Denied Regarding ANDA Applications
The Federal Circuit recently reviewed a challenge to the district court’s finding that U.S. Patent No. 7,994,364 was not invalid for obviousness and that Hikma did not infringe U.S. Patent No. 8,536,130 in its ANDA application. The Federal Circuit denied both challenges because: 1) the reference relied on did not make a sufficient teaching to invalidate (treating tapentadol hydrochloride with a solvent to induce recrystallization and form a polymorph); and 2) Hikma did not infringe because it was accused of indirect infringement and its proposed label did not include the relevant treatment (treating polyneuropathic pain). See Grunenthal GmbH v. Alkem Labs. Ltd., Nos. 2017-1153, 2017-2048, 2017-2049, 2017-2050, 2019 U.S. App. LEXIS 9187 (Fed. Cir. Mar. 28, 2019) (Before Reyna, Taranto, and Chen, Circuit Judges) (Opinion for the court, Reyna, Circuit Judge).
The Court started its analysis with the challenge to non-infringement (induced and contributory infringement) of the ’130 patent. According to the Court, “the question of induced infringement turns on whether Hikma and Actavis have the specific intent, based on the contents of their proposed labels, to encourage physicians to use their proposed ANDA product to treat polyneuropathic pain.” “In other words, we ask whether the label encourages, recommends, or promotes infringement.” Appellant argued that since Hikma’s label indicated it could be used for “severe chronic pain, the labels will cause at least some users to infringe.” The Court found that, based on expert testimony, even if Hikma’s drug would sometimes treat polyneuropathic pain, it would also treat mononeuropathic and other types of pain outside the protected scope of the ’130 patent and therefore Hikma “do[es] not specifically encourage use of tapentadol hydrochloride for treatment of polyneuropathic pain.” Regarding contributory infringement, the Court found no error with the district court’s findings that experts provided credible testimony that there were substantially non-infringing uses for Hikma’s ANDA drug, such as treatment of nociceptive or mononeuropathic pain.
Alkem’s challenge to the finding that the ’364 patent was not invalid required it show that there was “a reasonable expectation of success in arriving at Form A [of tapentadol hydrochloride] or, relatedly, it would have been obvious to try to find a polymorph of Form B of tapentadol hydrochloride.” The Court found no clear error in the district court’s analysis of the single reference relied on. First, the Court noted that, at the time of filing of the ’364 patent, “polymorphism of tapentadol hydrochloride was unknown” (i.e., “Form B was the only crystal structure of tapentadol hydrochloride known”). Further, the Court noted the uncertainty in determining the polymorphism of a compound. For example, one of the steps in determining polymorphism is determining the recrystallization of the compound using different solvents. The Court noted that the prior art “does not disclose when it would be appropriate to use particular solvents or a particular mixtures of solvents,” and does not provide specific teachings of how to modulate other variables that can be important during the recrystallization process. Thus, the district court did not clearly err in its conclusion that the prior art “provides insufficient guidance” on recrystallization. For the same reasons (i.e., the large number of variations resulting from the large number of recrystallization variables), the district court did not err in its finding that it was not “obvious to try” the formation of the relevant polymorph.
The mere possibility of infringing use is insufficient to establish induced infringement – the patent holder must show specific intent. When arguing invalidity, the fact that a reference teaches a generic method may be insufficient to establish a reasonable expectation of success if the reference does not clearly describe how to modulate variables to achieve certain results in the performance of the method.