Thanks for visiting! Welcome to a new way to research case law. You are viewing a free summary from Descrybe.ai. For citation and good law / bad law checking, legal issue analysis, and other advanced tools, explore our Legal Research Toolkit — not free, but close.
Bayer AG v. Dr. Reddy's Laboratories, Ltd.
Citations: 518 F. Supp. 2d 617; 2007 U.S. Dist. LEXIS 79108; 2007 WL 3120794Docket: Civ. 04-179-SLR
Court: District Court, D. Delaware; October 25, 2007; Federal District Court
Bayer AG, Bayer Healthcare AG, and Bayer Pharmaceuticals Corporation (collectively, Bayer) initiated a legal action against Dr. Reddy's Laboratories, Ltd. and Dr. Reddy's Laboratories, Inc. (collectively, Reddy) following Reddy's submission of an Abbreviated New Drug Application (ANDA) to market a generic version of the antibiotic AVELOX, which contains moxifloxacin hydrochloride. Bayer claims that Reddy's ANDA infringes U.S. Patent Nos. 4,990,517 (the '517 patent) and 5,607,942 (the '942 patent). Reddy acknowledges infringement but counters with claims that both patents are invalid or unenforceable due to reasons including obviousness, double patenting, and inequitable conduct. A bench trial took place from August 7 to August 15, 2006, to evaluate these defenses and counterclaims. The court has jurisdiction under 28 U.S.C. §§ 1331, 1338(a), and 1400(b). Findings highlight Bayer's corporate structure, with Bayer AG and Bayer Healthcare AG based in Germany and Bayer Pharmaceuticals Corporation incorporated in Delaware. Reddy comprises a corporation from India and a New Jersey corporation. The case centers on quinolone antibacterial compounds, particularly the structural variations of their core molecular framework, including monocyclic and bicyclic substituents.
The '517 patent and the '942 patent belong to the same patent family known as "Le A 26 108," with the initial application filed in Germany on July 15, 1988. The U.S. Patent Application No. 07/375,434, filed on June 30, 1989, claims priority to this German application and was issued as the '517 patent on February 5, 1991. The '942 patent, filed as a divisional application on March 20, 1995, claims priority to the '517 patent and was issued on March 4, 1997. Claims 1 and 2 of the '517 patent broadly cover numerous quinolone compounds characterized by a generic formula featuring a 5/5 or 5/6 bicyclic substituent at the 7-position; moxifloxacin, a compound mentioned in the specification, had not yet been synthesized at the filing date. The '942 patent specifically addresses moxifloxacin and its stereoisomers, with moxifloxacin hydrochloride being the active ingredient in AVELOX.
The prosecution history of the '434 application notes that it initially comprised 189 pages and contained 20 claims. On March 23, 1990, a conversation between patent counsel and the examiner led to a provisional election to prosecute a designated Group IV invention. Following an office action on April 4, 1990, which outlined a restriction requirement and rejections of several claims, a formal response was filed on July 19, 1990, affirming the election of Group IV claims. An examiner interview on August 10, 1990, resulted in the cancellation of non-elected claims, and two notices of allowance were issued on August 27, 1990, for the elected claims. A divisional application (No. 07/580,906) was filed on September 10, 1990. The issue fee for the '434 application was paid on October 31, 1990, and a European search report was issued on November 7, 1990, highlighting three significant prior art references relevant to the pending claims.
The claims of the EPO application differed from those in the '434 application, with the European search report received by Bayer on November 9, 1990, and transmitted to Mr. Horn's law firm shortly thereafter. Dr. Petersen, an inventor, provided comments on the same day. On November 28, 1990, Mr. Horn submitted an Information Disclosure Statement (IDS) to the PTO for the '434 application, noting that the references were cited in the EPO search report. The '434 application was issued as the '517 patent on February 5, 1991. Following this, on February 11, the examiner mailed the November IDS with initials beside each reference, accompanied by a "Notice of Allowability" cover sheet, although the title was crossed out by the examiner. The references were considered on February 8, 1991, just days after the patent issuance.
On February 19, 2001, Mr. Horn filed an IDS for the '906 divisional application, again citing the X references and providing additional commentary on specific documents. After a restriction requirement on February 25, 2001, Mr. Horn selected a subset of claims related to specific compounds, with the X references not leading to any anticipation or obviousness rejections. The '906 divisional application was allowed on May 17, 1991, and issued as U.S. Patent No. 5,059,597 on October 22, 1991, followed by additional divisional applications, one of which became the '942 patent.
Regarding obviousness, a patent cannot be granted if the differences between the claimed invention and prior art would render the invention obvious to someone skilled in the field at the time of invention, as outlined in 35 U.S.C. § 103(a). This determination involves assessing the scope and content of prior art, evaluating differences, and understanding the ordinary skill level in the relevant field. Secondary considerations such as commercial success and unsolved needs may also inform the analysis. Patents are presumed valid, thus, an alleged infringer must prove obviousness with clear and convincing evidence.
Reddy's case for obviousness involves several key assertions: (1) a person of ordinary skill would be motivated to modify the 7-position of monocyclic compounds AT-3295 and Sankyo 1-130, both disclosed in prior art; (2) such a person would opt for a diazabicyclo octane (DBO) substituent at this position; and (3) through routine experimentation, this individual could create bicyclic versions of these compounds using the Bayer 5/5 bicycle, which are encompassed by the claims in question. To substantiate this claim, Reddy must demonstrate not only the motivation to combine these elements but also a reasonable expectation of success, as established in PharmaStem Therapeutics, Inc. v. Via-Cell, Inc.
Bayer's expert, Dr. Taylor, supported the idea that modifying the 7-position substituents in quinolone compounds would be a logical step. The Bayer 5/5 bicycle is identified as a DBO, a bicyclic structure consisting of eight atoms, including two nitrogen atoms. Additionally, inventors Dr. Petersen and Dr. Schenke had previously worked on quinolone compounds with specific 7-position substituents, which showed comparable or superior activity to ciprofloxacin, although their bridged piperazines were noted to have toxicity not disclosed in prior art.
The debate also centers on whether Reddy must justify the selection of AT-3295 or Sankyo 1-130 as lead compounds for modification. Bayer contends that Reddy needs to prove that a skilled person would choose these compounds, while Reddy claims that the selection is evident due to the prominence of AT-3295 and the acknowledgment by Bayer’s expert that Sankyo 1-130 is among the top three significant compounds in the Sankyo application. However, Reddy fails to provide testimony supporting why a skilled person would specifically select Sankyo 1-130 for modification.
Reddy fails to establish a connection between the Dainippon abstract or the Sankyo application and the issue addressed by the '516 patent. Although Reddy references Dr. Petersen's cross-examination testimony suggesting that AT-3295 could have been a potential lead compound for Bayer, the lack of evidence explaining its desirability undermines this claim. Reddy did not provide evidence to indicate that a person skilled in the art would have sought to modify AT-3295 or Sankyo 1-130 in developing an antibiotic to rival ciprofloxacin. In contrast, Bayer presented expert testimony indicating that, as of June 1988, clinafloxacin and its 8-fluoro analog were being targeted for their superior activity. The court found insufficient evidence from Reddy to support a motivation for 7-position modifications on AT-3295 or Sankyo 1-130 compared to other quinolone compounds, aligning with precedent that emphasizes the need for specific motivation to select a lead compound from a broad array of prior art.
Furthermore, Reddy did not demonstrate motivation to modify AT-3295 or Sankyo 1-130 with DBO at the 7-position. While Reddy cited various references regarding bicyclic use at this position, no substantive testimony was provided for three of these references. The Tone patent, which presents a quinolone compound with a bicyclic 7-position substituent, claims superior antimicrobial activity, though it only includes a single comparative analysis without a positive control. The corresponding European patent application, Tone EP, reveals that monocyclic compounds sometimes outperformed bicyclic compounds, indicating variability in effectiveness. Additionally, DTX-299, a Japanese patent abstract, describes a quinolone with a bicyclic 7-position substituent noted for antibacterial action but lacks data or relevant comparisons, rendering it ineffective in advancing the research in this domain.
European Patent Application No. 106,489 (the "Culbertson application") presents quinolones featuring three types of 7-position substituents: monocycles, fused bicycles, and spirocycles. Dr. LaVoie acknowledges that those skilled in the art would find monocycles and spirocycles to be the most effective substituents. However, the Tone patent, Hokuriku abstract, and Culbertson application do not convincingly demonstrate that bicyclic substituents are preferable, and Reddy failed to provide testimony to support this claim. The court concludes that these references do not sufficiently indicate that a person skilled in the art would be motivated to modify AT-3295 or Sankyo 1-130 with DBO 7-position substituents with a reasonable expectation of success.
Drs. Schenke and Petersen's findings in DTX-161 suggest that bridged piperazine substituents at the 7-position enhance activity compared to ciprofloxacin, but this does not imply a broad endorsement of DBO substituents. Their testimony does not characterize their findings in general terms, and Reddy did not submit its own supporting testimony. Bayer inventors clarified that bridged piperazine and 5/5 pyrrolidine bicycles are distinct entities, despite similar nomenclature.
The court recognizes that DTX-161 may motivate experimentation with DBOs as 7-position substituents but finds no clear indication that a skilled person would use the Bayer 5/5 bicycle. Reddy's argument hinges on Dr. Taylor's acknowledgment that a skilled individual could derive a DBO substituent from 3-amino 4-methyl pyrrolidine, which does not suffice to demonstrate independent motivation. Additionally, Reddy referenced a statement from a poster by the inventors of the '517 patent regarding systematic variation of 7-amino substituents, but no expert testimony was provided to substantiate the routine experimentation theory. Dr. Taylor indicated that a skilled person would not be inclined to create a DBO over other bicyclic structures. Therefore, the court declines to conclude that the claimed compounds are obvious as a matter of law based solely on the inventors' mention of "systematic variation" without further context.
Reddy failed to prove, by clear and convincing evidence, that a person of ordinary skill would have had motivation or a reasonable expectation of success in modifying the claimed compositions from the prior art quinolones, specifically AT-3295 or Sankyo 1-130, with a DBO substituent at the 7-position. Consequently, the asserted claims of the '517 patent remain valid. Reddy also alleged that the '517 and '942 patents are unenforceable due to inequitable conduct, claiming that the applicants did not disclose four relevant references during the '434 application’s prosecution. These references include specific articles and applications deemed material to the patent's examination.
The law mandates that patent applicants and their representatives maintain a duty of candor, good faith, and honesty with the PTO, which includes submitting truthful information and disclosing material information. A breach of this duty results in inequitable conduct, rendering the entire patent application unenforceable if proven for any claim. Findings of inequitable conduct rest with the trial court's discretion and require clear and convincing evidence that (1) omitted or false information was material to patentability, (2) the applicant was aware of this information and its relevance, and (3) there was intent to deceive the PTO. Determining inequitable conduct involves a two-step analysis focusing on materiality and intent, referencing different standards of materiality that existed before and after 1992.
Misstatements or omissions are considered material if they meet the criteria under the current Rule 56 standard, which defines materiality as information that is not cumulative and either establishes a prima facie case of unpatentability or contradicts the applicant's arguments regarding patentability. Under the previous "reasonable examiner" standard, materiality hinged on whether a reasonable examiner would find the omitted information significant. The older three tests for materiality include: (1) the objective "but-for" standard, where the misrepresentation is so significant that the patent should not have been issued; (2) the subjective "but-for" test, where the misrepresentation directly influenced the examiner's approval; and (3) the "but it may have" standard, where the misrepresentation could have affected the examiner's decision.
Establishing that an applicant withheld material information leads to an inquiry into whether there was intent to mislead the PTO. Intent cannot be presumed solely from nondisclosure; it requires a factual basis and an assessment of all evidence, including indications of good faith. A "smoking gun" is not necessary for proving intent.
Once both materiality and intent are established, the trial court must evaluate their balance to determine if inequitable conduct occurred; a lesser showing of intent may suffice with high materiality, while a greater showing is required with low materiality. As patents are presumed valid, inequitable conduct must be demonstrated by clear and convincing evidence.
Regarding the X references, an applicant cannot be found guilty of inequitable conduct if those references were submitted to the examiner, irrespective of whether they contributed to a rejection. Bayer contends that since the X references were submitted to the PTO after the Notice of Allowance and fee payment, they should not serve as grounds for inequitable conduct. The MPEP from 1988 indicates that prior art cited after a Notice of Allowance is typically not considered unless accompanied by a specific amendment, timely affidavit, or a statement asserting the materiality of the information.
After all claims are marked as allowable, the examiner is not obligated to consider citations that do not meet specified criteria. Reddy contends that Mr. Horn's omission of the X references, lacking the necessary explanation, amounts to constructive withholding and supports a claim of inequitable conduct. Examiner Dentz acknowledged the X references but only reviewed them on February 8, 1991, after the '517 patent had already issued on February 5, 1991. There is no evidence that the X references were available to or considered by the examiner during the prosecution of the '517 patent, leading the court to reject the notion that these references were disclosed to the PTO in a manner that would negate their use in an inequitable conduct claim.
The materiality of the X references in relation to claims pending when the European search report was obtained is questioned. A reference deemed material solely to withdrawn claims cannot substantiate a finding of inequitable conduct, resulting in the affirmation of partial summary judgment against Reddy. The originally-filed claims of the '434 application encompassed broad structures that included compounds mentioned in the X references, but these claims were withdrawn from prosecution prior to the alleged act of withholding the European search report received on November 9, 1990. The anticipation of claims by the withheld prior art is irrelevant to materiality since the claims were no longer under examination at the time Reddy argues disclosure should have occurred.
The X references were pertinent to the pending claims of the European counterpart at their citation, and they were material to the originally-filed genus claims in the '434 application. However, Reddy did not provide a comparison between the originally-filed and issued claims of the '434 patent. Reddy claimed that Mr. Horn acknowledged the relevance of the X references to the elected subject matter, indicating structural unity among the compounds. Mr. Kurt Briscoe, a Bayer patent attorney, characterized Horn's statements as signaling unity of invention to the examiner, facilitating the prosecution of distinct subject matters within the same application. No opposing evidence was presented by Reddy, and such arguments appear to be a reasonable response to a restriction requirement.
The X references feature monocycles at the 7-position, while the closest prior art to the '517 patent involves quinolones with fused bicycle substituents, as testified by Dr. Taylor.
The Culbertson patent and its U.S. counterpart were referenced by the examiner during the initial office action regarding the '517 patent. The court emphasizes that a mere comparison of references does not suffice to establish their cumulativeness; a detailed analysis is necessary. Bayer's evidence did not convincingly demonstrate that the references were cumulative, and Reddy failed to present counter-evidence. Under Rule 56, the X references could be deemed material if they, alongside other evidence, suggest a prima facie case of unpatentability. Two X references—the Dainippon abstract and the Sankyo application—disclosed monocycles that could potentially modify the Bayer 5/5 bicycle to create compounds within the claims of the '517 patent. While quinolones were recognized as effective antibacterial agents prior to the patent, the core innovation of the '517 patent was the introduction of a unique 7-position pyrrolidine ring substituent, which led to novel combinations. The court determined that Reddy did not establish a prima facie case of obviousness based on the potential modifications of the X references, thus ruling out their use in supporting unpatentability claims.
Regarding the Liebigs reference, which does not mention quinolones, Reddy contends that it was crucial for the originally filed claim 19, which claimed the Bayer 5/5 bicycle. However, since claim 19 was withdrawn before any rejection from the examiner, the focus should be on whether the Liebigs reference is material to any current issued claims rather than withdrawn ones. Reddy argues that the examiner could have rejected issued claim 7 of the '517 patent based on a combination of the Liebigs reference and DTX-341, suggesting that attaching the Bayer 5/5 bicycle to Compound II would yield the compound of claim 7.
The examiner relied on representations indicating that a compound was patentable, leading to the conclusion that any compound incorporating the Bayer 5/5 bicycle would also be patentable. Reddy presented Dr. LaVoie's testimony regarding the prior art quinolones, but it was confirmed that the Liebigs reference does not discuss quinolones related to the '517 patent. However, it is acknowledged that the Bayer 5/5 bicycle disclosed in Liebigs can be integrated with Compound II of DTX-341 to yield a compound claimed in issued claim 7. The court determined that the Liebigs reference meets the materiality threshold for inequitable conduct, suggesting it could have influenced the examiner's decisions during the prosecution of claim 7 and could form a basis for an obviousness rejection when combined with DTX-341.
The court contrasted the materiality of the Liebigs reference with the X references, noting that Reddy did not establish a prima facie case of obviousness based on the X references nor used Liebigs in an obviousness argument. The Liebigs reference is deemed more material due to its disclosure of the Bayer 5/5 bicycle, one of two critical pyrrolidine ring structures relevant to the claims, whereas the X references pertain to a broader range of quinolone compounds.
Additionally, prior to the filing of the '434 application, Dr. Schenke drafted a memo highlighting the Bayer 5/5 bicycle's significance, which Reddy argues serves as "smoking gun" evidence of Dr. Schenke's awareness of its importance. Despite this, Dr. Schenke did not disclose the bicycle, even though it was originally claimed in the application and he affirmed understanding its content in the inventors' declaration. Dr. Petersen, who also signed the declaration, was primarily responsible for drafting the claims and specification, while Dr. Schenke focused on the synthesis portion, which did not include the Bayer 5/5 bicycle, claiming that this was the responsibility of a deceased co-inventor, Dr. Krebs.
Dr. Schenke stated that Dr. Krebs used a different method to synthesize the Bayer 5/5 bicycle than what was described in the Liebigs reference. Both inventors were unaware of the Liebigs reference when filing the Le A 26 108 application in Germany and the '434 application in the U.S. They only learned of it while Dr. Schenke was working on the Le A 26 686 application, which was related to quinolone intermediates, distinct from the quinolones in the '434 application. The inventors relied on their review of the German application rather than the English version before signing their declaration. Upon recognizing the overlap between the Liebigs reference and the divisional patent claims in 1990, Dr. Petersen informed Bayer’s patent department, leading to a preliminary amendment being filed before any office action. The Liebigs reference was disclosed in the divisional application, and Dr. Schenke ensured that the claims excluded the Bayer 5/5 bicycle.
The court found the circumstantial evidence insufficient to establish inequitable conduct. Although Dr. Schenke's memo indicated awareness of the Bayer 5/5 bicycle's relevance to the '434 application, there was no evidence that either inventor knew the bicycle was disclosed in the Liebigs reference before original claim 19 was withdrawn. Once they became aware, they disclosed it in the divisional case, indicating a lack of intent to deceive the PTO. Reddy claimed that Mr. Horn intended to deceive by submitting the Liebigs reference only for the divisional application, arguing he either failed to investigate its relevance to claim 7 or intentionally withheld it. However, with Mr. Horn deceased and unable to clarify his actions, the court found both scenarios equally probable and did not favor Reddy's argument without further evidence.
Examiner Dentz reviewed both the divisional and '434 applications, where amendments in the divisional application revealed the Liebigs reference before the issuance of the '517 patent. To establish inequitable conduct, a significant level of intent to deceive is required, with the degree of materiality influencing the necessary intent; less culpable intent is needed for more material omissions. The court determined that Reddy failed to prove inequitable conduct regarding Dr. Schenke, Dr. Petersen, or Mr. Horn, resulting in the '517 and '942 patents being enforceable.
The double patenting doctrine prohibits a patentee from obtaining two patents for the same invention, divided into two forms: statutory ("same invention") double patenting and non-statutory ("obviousness-type") double patenting. Statutory double patenting is based on 35 U.S.C. § 101, which allows only one patent for a single invention. If two claimed inventions are identical in scope, the second patent cannot be granted. Non-statutory double patenting prevents claims that, while not identical, are so similar that granting both would unduly extend patent protection. This analysis involves a two-step process: comparing claims from earlier and later patents to identify differences, and assessing whether these differences render the claims patentably distinct.
Reddy contends that the '942 patent is invalid for double patenting over the '517 patent, asserting each claim of the '942 patent infringes on at least one claim of the '517 patent. Reddy also claims the '942 patent is invalid for obviousness-type double patenting concerning claims 4 and 5 of the '517 patent. Reddy's argument hinges on the assertion that Bayer should not benefit from failing to include specific claims related to the later '942 patent in the earlier '517 patent.
The analysis focuses on the claims of the '517 and '942 patents rather than their disclosures. Claims 1 and 2 of the '517 patent are genus claims that include moxifloxacin, while claim 1 of the '942 patent specifically claims moxifloxacin. Although it is suggested that the '517 patent may dominate the '942 patent, this does not inherently constitute double patenting. The case of In re Schneller is referenced, where double patenting was affirmed due to the patentee attempting to extend protection of claims covering similar compounds without justification. However, the court distinguishes this case from the current matter, stating that Schneller does not introduce a new legal standard for double patenting and emphasizes the importance of the independence of the inventions claimed. Reddy, the appellant, did not argue that the claims of the '942 patent are not patentably distinct from those of the '517 patent. The parties' agreement that claims from the '942 patent overlap with the '517 patent does not imply a lack of patentable distinction. The court concludes that the '942 patent is valid and not invalidated by In re Schneller. During the prosecution of the '942 patent, claims were initially rejected for double patenting over the '517 patent, but the applicants successfully argued that their claims represented a separate invention, leading to the eventual allowance of their application.
Unexpected results were sufficient to overcome an obviousness-type rejection, according to the interview summary record. Reddy seeks the court's reconsideration of this decision and contends that the validity of the '942 patent claims hinges on whether unexpected desirable properties are relevant to obviousness-type double patenting. However, the court found that Reddy failed to provide clear and convincing evidence establishing that the '942 patent claims are obvious variants of the '517 patent claims, as per the Eli Lilly two-prong test. The sole distinction between the '942 and '517 patents is the 8-position substituent: claims 1 and 2 of the '942 patent contain a methoxy group, while claims 4 and 5 of the '517 patent contain fluorine and chlorine, respectively. The court examined whether the claims are patentably distinct based on these substituents.
Reddy argued that the Sankyo application indicated a preference for methoxy at the 8-position, supported by Dr. LaVoie's testimony regarding preferred compounds. However, the court deemed this evidence insufficient to prove that the compounds are obvious variants, noting the lack of evidence regarding the interchangeability or chemical similarities between halogen and methoxy groups. Furthermore, Reddy did not provide a rationale for a skilled person’s choice of methoxy as an equivalent substituent. Consequently, Reddy did not meet the burden of proof required to establish that the patents were too similar to allow for both exclusive rights.
The court concluded that Reddy failed to demonstrate, by clear and convincing evidence, that: 1) the '517 and '942 patents are unenforceable due to inequitable conduct; 2) the '517 patent is invalid for obviousness; or 3) either patent is invalid for double patenting. As a result, the effective date for any approval of Reddy's ANDA is set for no earlier than March 4, 2014, which is the later expiration date of the '517 and '942 patents. The court will also grant appropriate injunctive relief. An order was issued on October 25, 2007, affirming these decisions.
Reddy is prohibited from manufacturing, using, selling, or importing moxifloxacin hydrochloride or any related compounds covered by claims 1 or 2 of the '942 patent within the United States before March 5, 2014. The parties must submit a joint proposed order of judgment by November 23, 2007. Submitting an application under the Federal Food, Drug, and Cosmetic Act for a drug claimed in a patent constitutes infringement. Various claims from the '942 patent have faced rejections under 35 U.S.C. 102(a) for anticipation and 103 for obviousness, as well as non-enablement under 35 U.S.C. 112. Reddy's inequitable conduct argument is limited to three "X" references. Reddy contends that combining certain prior art would have led a person skilled in the field to develop compounds covered by the asserted claims of the '517 patent. Additional patent references, including German and Japanese patents, are cited in relation to the claims. The court finds that Reddy's characterization of a bridged piperazine as a DBO is accepted, as Bayer does not challenge this description.
Dr. Zhanel, during cross-examination, stated that six compounds from the Sankyo '206 application were identified based on their poor performance against one type of bacterium, indicating that a person of ordinary skill would not select these compounds due to a preference for broad-spectrum antibacterial effects. Dr. Petersen noted that AT-3295 was not pursued as a lead compound by Bayer at that time, despite its potential. Dr. LaVoie, Reddy's expert, suggested that modifications to AT-3295 might be made by someone interested in developing effective antibacterial agents, but did not establish why either compound would be selected from prior art. There was insufficient motivation for a skilled person to modify AT-3295 or Sankyo 1-130 with any reasonable expectation of success. Testimony not cited was stricken from the record, and the court provided context for Bayer's counterarguments. Dr. Remmel expressed skepticism regarding the pharmacokinetic data, citing concerns about the experimental methods. The court referenced established unpredictability in chemical arts and found insufficient evidence to demonstrate a lack of motivation to combine references or a reasonable expectation of success. The existence of numerous DBO compounds and the unpredictability surrounding the Bayer 5/5 bicycle compound led to the conclusion that the evidence did not support obviousness. Reddy's claims of reasonable expectation of success were deemed unconvincing, despite some expert testimony suggesting otherwise.
The court concluded that Bayer's inventors' "systematic variation" of the 7-position substituent could be considered inventive, as they utilized previously unutilized substituents in quinolone development, a fact underscored by Reddy's failure to present an invalidity defense based on anticipation. A prima facie case of unpatentability arises when the evidence suggests that a claim cannot be patented under the preponderance of evidence standard, which requires broad construction of claim terms consistent with specifications, without considering contrary evidence. The Kimberly-Clark case emphasized that claims must be examined regarding materiality and intent in relation to known prior art, particularly when addressing allegations of fraud based on nondisclosure of prior art related to abandoned claims rejected for reasons unrelated to the uncited art. Defendants did not demonstrate how nondisclosure affected the allowance of the claims. Reddy's argument centered around intent, while the court dismissed Reddy's assertion regarding the materiality of the Liebigs reference. Additionally, Reddy could not successfully argue that Dr. Schenke's awareness of prior art at the time of signing the declaration was relevant to the case. The court found no justification for allowing Reddy to introduce a new theory of inequitable conduct based on a false inventors' declaration at this late stage.
Schenke, Petersen, and Mr. Horn may not have established the connections suggested by Reddy. Reddy claims, without evidence, that the divisional application was assigned to the same examiner only after the '517 patent was issued. However, there is no record indicating when examiner Dentz was assigned to the divisional application, and Reddy does not dispute that the usual procedure is to assign divisional cases to the same examiner as the parent application. Both applications were assigned to examiner Dentz and were copending as of the October 1, 1990 preliminary amendment. Claims 1, 2, 3, 4, 5, and 7 of U.S. Patent 5,607,942 cannot be practiced without infringing at least one claim of U.S. Patent 4,990,517. The concept of "domination" exists when a broader claim in one patent encompasses a narrower claim in another patent, but this does not constitute double patenting. Reddy's proposed "Schneller" test, which evaluates if the later patent's subject matter was disclosed in the earlier patent and if the later subject matter is covered by earlier claims, is not recognized by any court and contradicts established precedent that only the claims of the patent can be considered for double patenting rejections. An examiner cited concerns regarding the applicants' ability to claim a purified moxifloxacin enantiomer that was not explicitly depicted in the earlier patent. There appears to be a conflict between the Federal Circuit's definitions of obviousness under 35 U.S.C. 103 and nonstatutory double patenting, particularly regarding the need for evidence of unexpected properties. Claim 1 of the '942 patent pertains to one of the four stereoisomers in claim 2, specifically referencing the methoxy functional group. Reddy did not contest Bayer's request for an injunction if the court sides in Bayer's favor.