04/22/2014

Sanofi-Aventis Deutschland v. Glenmark Pharma.: Mere Existence of Combination of Classes, by itself, not Enough to Make Finding of Obvious to Try


Category: 103  
 
 
 
 
By: Jesus Hernandez, Blog Editor/Contributor  
 
TitleSanofi-Aventis Deutschland GMBH v. Glenmark Pharma. Inc., No. 2012-1489 (Fed. Cir. April 21, 2014).
Issues
[Obviousness] Glenmark argues that the verdict cannot stand, as a matter of law, on the premise that if a combination of classes of components is already known, all selections within such classes are obvious to try, as a matter of law. Glenmark argues that it is irrelevant that the combination is ultimately found to have unpredicted or superior properties if those properties, though unknown in the prior art, could be attributed to one of the prior art components of the combination.
Sanofi-Aventis Deutschland GMBH at *6-7.
[Spoliation/Jury Instructions] Glenmark argues that the district court’s instruction was improper and prejudicial […] for the statement that prejudice occurs when “there is a reasonable possibility” that the error affected the result. Glenmark argues that the Plaintiffs did not show that any deleted emails contained relevant evidence [pertaining litigation of the ANDA generic drug].
Id. at *13 (text added, internal citations omitted).
Holdings
[Obviousness] [Because in the medical arts potential solutions are less likely to be genuinely predictable, as compared with other arts such as the mechanical devices,] [t]he jury could reasonably have relied on the testimony of the Plaintiffs’ expert, that persons skilled in the art in 1986 would not have predicted the longer-lasting hypertension control demonstrated by the double-ring structures of quinapril and trandolapril in combination with calcium antagonists, because of the widespread belief that double-ring inhibitors would not fit the pocket structure of the ACE.
Id. at 11 (text added).
[Spoliation/Jury Instructions] The destroyed records were from the period that was acknowledged to include discussion of the generic drug, marketing in the United States, preparation of the ANDA, and the Paragraph IV Certification challenging the patent. Glenmark did not negate the reasonable inference that the destroyed emails related to relevant issues. […] Absent any reasonable negation of this inference, the district court’s finding that the documents were likely to be relevant was not clearly erroneous, and informing the jury of the destruction program was not an abuse of discretion. […].
Id. at *14-15 (internal citations omitted).
 
Procedural HistoryThe New Drug Application (NDA) for the Tarka® product was approved by the Food and Drug Administration in 1996 and acquired by Abbott Laboratories in 2001. In 2007 the defendants Glenmark Pharmaceuticals Inc. and Glenmark Pharmaceuticals Ltd. (collectively “Glenmark”) filed an abbreviated new drug application (ANDA) for the generic counterpart of this product. Since the ’244 patent had not expired, Glenmark filed a Hatch-Waxman “Paragraph IV Certification,” leading to the filing by Plaintiffs of this infringement suit. Launch of Glenmark’s generic product was stayed for 30 months, as the statute provides. 21 U.S.C. §355(j)(5(B)(iii). After the stay expired in 2010, Plaintiffs moved for a preliminary injunction, which the district court denied. In June 2010 Glenmark launched its generic product “at-risk,” while this litigation proceeded in the district court.
Sanofi-Aventis Deutschland GMBH at *2-3.
 
 
 
 
Legal Reasoning (Newman, Linn, Wallach)
Background
Claim at Issue1. A pharmaceutical composition comprising: (a) an angiotensin-converting enzyme inhibitor (ACE inhibitor) . . . , and (b) a calcium antagonist or a physiologically acceptable salt thereof; where- in said ACE inhibitor and said calcium antagonist are present in said composition in amounts effective for treating hypertension; . . .

3. A composition according to claim 1, wherein said ACE inhibitor is trandolapril [formula omitted] or a physiologically acceptable salt thereof, or quinapril [formula omitted] or a physiologically acceptable salt thereof.

Sanofi-Aventis Deutschland GMBH at *6.
FactsThe New Drug Application (NDA) for the Tarka® product was approved by the Food and Drug Administration in 1996 and acquired by Abbott Laboratories in 2001. In 2007 the defendants Glenmark Pharmaceuticals Inc. and Glenmark Pharmaceuticals Ltd. (collectively “Glen- mark”) filed an abbreviated new drug application (ANDA) for the generic counterpart of this product. Since the ’244 patent had not expired, Glenmark filed a Hatch-Waxman “Paragraph IV Certification,” leading to the filing by Plaintiffs of this infringement suit.
Id. at *2.
[Obviousness]: '244 Patent not Invalid under Obvious to try
Legal Standard: Obvious to TryIn KSR International Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) the Court explained that “obvious to try” may apply when “there are a finite number of identified, predictable solutions” to a known problem. The Court explained that when the path has been identified and “leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.” Id. This court has elaborated that the identified path must “present a finite (and small in the context of the art) number of options easily traversed to show obviousness.” […] As illustrated in In re O’Farrell, 853 F.2d 894, 903 (Fed. Cir. 1988), it would not be “obvious to try” when “the prior art gave either no indication of which parameters were critical or no direction as to which of many possible choices is likely to be successful.”
Sanofi-Aventis Deutschland GMBH at *9 (some internal citations omitted).
Tarka® productThe trandolapril ACE inhibitor in the Tarka® product is distinguished from the class of previously known ACE inhibitors in that trandolapril is a “double-ring” compound, whereas the prior art had studied primarily “single-ring” compounds. At the time the ’244 patent application was filed in 1986, the single-ring ACE inhibitors enalapril and captopril were the only ACE inhibitors approved by the FDA, and both of these drugs had a short duration of action.
Id. at *7.
Battle of the Experts
Points of DisagreementAt trial Glenmark’s expert agreed that quinapril and trandolapril are of the class of double-ring ACE inhibitors, and that neither of these double-ring compounds was suggested for use in combination with a calcium channel blocker in any prior art reference. He opined that the number of rings on the ACE inhibitor was not an im- portant consideration for his analysis. This view was challenged by the testimony of Plaintiffs’ expert, who testified that persons skilled in this field at the time of the patent generally believed that double-ring ACE inhib- itors were not more effective than single-ring inhibitors to control hypertension because single-ring structures were believed to fill the “pocket” of the ACE enzyme to inhibit the enzyme’s activity, and that the double-ring inhibitors would not fit in the pocket as effectively. Plaintiffs’ expert also explained that as a mode of treatment, combination therapy was not favored in 1986 as compared to “stepped care,” in which physicians were instructed to use one drug at a time.
Id. at *7-8.
Points of Agreement[T]here was not disagreement that the previously tested combinations of ACE inhibitors and calcium chan- nel blockers required more than once daily dosing, and that the longer-lasting effectiveness of the Tarka® combination, along with its improved kidney and blood vessel function, were not provided by, or predicted or suggested by, the prior art.
Id. at *8.
Not Obvious to TryGlenmark argues that the inventors’ selection of the double-ring ACE inhibitors for testing in combination with calcium antagonists is of itself evidence that it was obvious to try this combination. Patentable invention does not require that inventors work from ignorance. Technologic advance flows from knowledge, experience, insight—perhaps hunch or curiosity. Patentability does not turn on how the invention was made, but on whether it would have been obvious to a person of ordinary skill in the field. In Eisai Co. v. Dr. Reddy’s Laboratories, Ltd., 533 F.3d 1353 (Fed. Cir. 2008), the court observed that in the medical arts “potential solutions are less likely to be genuinely predictable,” id. at 1359, as compared with other arts such as the mechanical devices in KSR.
Id. at 9.
[Spoliation / Jury Instructions]: District Court's Jury Instruction was not Improper
Legal StandardThe district court applied Third Circuit law, under which spoliation occurs when “the evidence was in the party’s control; the evidence is relevant to the claims or defenses in the case; there has been actual suppression or withholding of evidence; and the duty to preserve the evidence was reasonably foreseeable to the party.” Bull v. United Parcel Serv., Inc., 665 F.3d 68, 73 (3d Cir. 2012).
Sanofi-Aventis Deutschland GMBH at *12.
Jury InstructionsYou may make an adverse inference in this case against Glenmark. In this case, I have determined that Glenmark systematically overwrote the emails on its email server between February 23, 2006 and mid-2007 and that some of these documents were relevant to the claims in suit.

An adverse inference permits you, the jury, to infer that the destroyed emails and attached documents might or would have been unfavorable to the position of Glenmark. However, you are not required to draw such an inference, and the weight to be given such an inference is your decision.

Id. at *13.

Destroyed Emails were related to ANDA process and Litigation

Glenmark’s witnesses stated that email was a mode of communication used during the relevant time frame. Terrance Coughlin, Glenmark’s President and CEO, stated that he communicated by email with Dr. Soni (Vice President of Intellectual Property) and Mr. Dutra (head of marketing) when they were unable to meet in person. Dr. Soni testified that he communicated with the research and development department in India concerning the decision to develop a generic version of Tarka®, and acknowledged that Glenmark used email to communicate with the team in India during the development. It was pointed out to the district court that attorney work product claims were made relative to this period, before Glenmark’s later institution of a litigation hold. It was reasonable for the district court to infer that some destroyed emails related to issues for which litigation was expected by Glenmark.
Id. at *14.
Jury Instruction ProperAlthough the district court declined to impose the sanction of forfeiture as requested by Plaintiffs, the court was well within its discretion in informing the jury that it may draw an inference that the destroyed documents may have been unfavorable to Glenmark. The courts are not required to tolerate acts in derogation of the integrity of judicial process. […] The destruction of documents in the course of preparation for litigation has no entitlement to judicial protection, and need not be concealed from the jury. A new trial on this ground is not warranted.
Id. at *15.
Conclusion
The rulings and judgment of the district court are affirmed. We remand to the district court for the reserved accounting of any post-verdict damages.
Sanofi-Aventis Deutschland GMBH at *19.
 
 
 
Editor Note
This case also had brief discussions of Jurisdiction and Standing. For further reading on these issues, click here.
 
 
Image Attribution Statement: Illustration from U.S. Patent No. 5,721,244. 
 
 
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