abbreviated new drug application

By Memorandum Order entered by The Honorable Gregory M. Sleet in Amgen Inc. v. Macleods Pharmaceuticals, Ltd., Civil Action No. 17-817-GMS (D.Del. December 19, 2017) (consolidated), the Court denied the Motion for Judgment on the Pleadings of defendants Macleods Pharmaceuticals, Ltd. and Macleods Pharma USA, Inc. (collectively, “Macleods”).

Plaintiff Amgen filed the patent infringement action against Macleods s for infringement of one or more claims of Amgen’s U.S. Patent No. 9,375,405 (“the ‘405 patent”) after Macleods filed its Abbreviated New Drug Application (“ANDA”) seeking approval to manufacture, use and/or sell of a generic version of Amgen’s Sensipar® product prior to the expiration of the ‘405 patent. In its Motion for Judgment on the Pleadings, Macleods claimed that its ANDA products do not contain any of the listed excipients required by the ‘405 patent; thus, Amgen could only assert a claim under the doctrine of equivalents. Id. at *2. Macleods also asserted that any claim by Amgen under the doctrine of equivalents was barred by the doctrine of prosecution history estoppel. Id.

In response, among other things, Amgen argued that Macleods motion should be converted into a motion for summary judgment because it required resolving factual issues and, if converted, should be denied because there are material facts in dispute. Id. at *3. The Court agreed that the motion should have been brought as a motion for summary judgment given the presence of material factual disputes, but decided not to convert the motion into a motion for summary judgment. Id. Instead, the Court found that there are material disputes of facts between the parties concerning the prosecution history of the ‘405 patent and denied Macleods’ Motion for Judgment on the Pleadings. Id. at *3-5.

A copy of the Memorandum Order is attached.

By Memorandum Order entered by The Honorable Leonard P. Stark in Reckitt Benckiser LLC v. Aurobindo Pharma Limited et al., Civil Action No. 14-1203-LP (D.Del. October 16, 2017), the Court denied Defendants motion for attorneys’ fees and expenses under 35 U.S.C. § 285. 35 U.S.C. § 285 provides that, in “exceptional” patent cases, a Court may award “reasonable attorney fees” to the “prevailing party.” “An exceptional case under § 285 is ‘simply one that stands out from others with respect to the substantive strength of a party’s litigating position (considering both the governing law and the facts of the case) or the unreasonable manner in which the case was litigated.” Nova Chems. Corp. (Canada) v. Dow Chem. Co., 856 F.3d 1012, 1016 (Fed. Cir. 2017) (quoting Octane Fitness, LLC v. ICON Healthy & Fitness, Inc., 134 S. Ct. 1749, 1756 (2014)).

In the instant action, following claim construction, the Court allowed Defendants to file a motion for summary judgment of non-infringement. Reckitt Benckiser LLC at *1. After full briefing and a hearing, the Court granted Defendants’ motion for summary judgment of non-infringement finding that “no reasonable factfinder could find that [Defendants’] proposed ANDA product contains two distinct formulations, as required by the asserted claims.” Id. Defendants thereafter sought attorneys’ fees under 35 U.S.C. § 285 contending the case was “exceptional.” Id. at *2.

In considering the motion for attorneys’ fees, the Court noted as follows:

In one way, this case stands out from others: it is an ANDA case that was resolved on summary judgment, a rare occurrence in this Court, which often does not allow summary judgment motions to be filed in an ANDA case. But this fact alone does not make this case per se “exceptional.” That the nature of the narrow dispute presented by the parties turned out to be amenable to summary judgment does not inevitably correlate to an exceptionally weak substantive position or an unreasonable manner of litigation.  Id. at *3. 

Ultimately, after concluding the totality of the circumstances, the Court concluded that the factors weighing against finding the case exceptional outweighed those in favor. Id. at *7. Accordingly, the Court exercised its discretion to deny the request for attorneys’ fees. Id. at *8.

A copy of the Memorandum Order is attached.

Following a three-day bench trial in the matter on June 5-7, 2017 and after having considered the entire record in the case and the applicable law, the Court, through Trial Opinion, entered by The Honorable Richard G. Andrews in Orexigen Therapeutics, Inc. v. Actavis Laboratories FL, Inc., Civil Action No. 15-451-RGA (D.Del. October 13, 2017), found that (1) Defendant failed to prove by clear and convincing evidence that claims 26 and 31 U.S. Patent No. 7,462,626 (“the ‘626 patent”), claim 1 of U.S. Patent No. 7,375,111 (“the ‘111 patent”), and claim 11 of U.S. Patent No. 8,916,195 (“the ‘195 patent”) are invalid; and (2) Plaintiff proved by a preponderance of the evidence that Defendant’s ANDA product directly infringes claim 1 of the ‘111 patent and indirectly infringes claims 26 and 31 of the ‘626 patent and claim 11 of the ‘195 patent.

A copy of the Trial Opinion is attached.

Following a five-day bench trial in the matter in February 2017 and after having considered the entire record in the case and the applicable law, the Court, through Memorandum, entered by The Honorable Gregory M. Sleet in Tris Pharma, Inc. v. Actavis Laboratories FL, Inc., Civil Action No. 14-1309-GMS (consolidated) (D.Del. September 6, 2017), entered judgment in favor Defendant Actavis Laboratories FL, Inc. (“Actavis”) after concluding that all asserted claims of the patents-in-suit are invalid due to obviousness. The patents-in-suit in the action are U.S. Patent Nos. 8,465,765 (“the ‘765 patent”), 8,563,033 (“the ‘033 patent”), 8,778,390 (“the ‘390 patent”), 8,956,649 (“the ‘649 patent”) and 9,040,083 (“the ‘083 patent”).

After assessing the four considerations of an obviousness analysis – (1) the scope and content of the prior art; (2) the level of ordinary skill in the art; (3) the differences between the claimed subject matter and the prior art; and (4) secondary considerations of nonobviousness, such as commercial success, long-felt but unsolved need, failure of others, acquiescence of others in the industry that the patent is valid, and unexpected results – the Court concluded that the asserted claims are invalid as obvious under 35 U.S.C. §103. Id. at 26-45.

Copies of the Memorandum and Order are attached.

By Memorandum Order entered by The Honorable Leonard P. Stark in UCB, Inc., et al. v. Watson Laboratories, Inc. et al., Civil Action No. 14-1083-LPS-SRF (D.Del., May 19, 2017), the Court denied Defendants’ motion for reargument of its Order entered on December 5, 2016, in which the Court denied Plaintiffs’ request for a stay, but ordered Defendants liable for the costs of the litigation from that point forward if either (a) their Abbreviated New Drug Application (“ANDA”) was rejected due to the major deficiencies identified by the FDA or (b) they changed the ANDA formulation in contradiction of the repeated representations to the Court that no such alteration is required.

The Court explained that it denied the motion for reargument for a couple reasons. First, Defendants failed to comply with their obligation to meet and confer with Plaintiffs before filing their motion. Id. at *2. Second, Defendants failed to meet their burden to demonstrate that reargument of the Court’s prior Order was appropriate. Id. Defendants did not point to any change in the controlling law or any new evidence, and defendants’ contentions that the Court made a decision outside of the issues presented by the parties, committed a clear error of law, and created manifest injustice were found to be incorrect. Id. at *2-4.

A copy of the Memorandum Order is attached.

The general takeaway is that motions for reargument are sparingly granted by Courts and, when they are, the movant was able to convince the Court that granting reargument is appropriate because of some intervening change in the controlling law, some new evidence not available at the time the Court made its decision, or there was a need to correct some clear error of law or fact to prevent manifest injustice.

By Memorandum Opinion entered by The Honorable Leonard P. Stark in Reckitt Benckiser LLC v. Aurobindo Pharma Ltd., Civil Action No. 14-1203-LPS (D.Del. March 6, 2017), the Court granted Defendants’ motion for summary judgment of non-infringement of the asserted claims of U.S. Patent No. 6,955,821 (“the ‘821 patent”) and U.S. Patent No. 7,838,032 (“the ‘032 patent”) with respect to Defendants’ proposed generic version of Mucinex® DM, an extended-release tablet that contains dextromethorphan hydrobromide and guaifenesin. The claim limitations of the patents-in-suit require the claimed drug product to include both an immediate-release formulation and a sustained release formulation of the drug guaifenesin. Id. at *6. Defendants moved for summary judgment on the basis that Plaintiff failed to present sufficient evidence that Defendants’ proposed product has two distinct formulations, as required by each asserted claim. Id. at *6-7.

The Court agreed with Defendants that summary judgment was warranted. Id. at *7. The Court explained that, on the record created by the parties and taking all of the evidence in the light most favorable to Plaintiff and drawing all reasonable inferences in Plaintiff’s favor, no reasonable factfinder could find that Defendants’ proposed product contains the two distinct formulations required by the asserted claims. Id.

A copy of the Memorandum Opinion is attached.

By Memorandum Opinion entered by The Honorable Gregory M. Sleet in Recro Gainesville LLC v. Actavis Laboratories FL, Inc., Civil Action No. 14-1118-GMS (D.Del. February 24, 2017)(consolidated), the Court, following a three-day bench trial and having considered the entire record in the case and the applicable law, concluded that Actavis’ proposed ANDA products infringe all of the asserted claims of U.S. Patent No. 9,132,096 (“the ‘096 patent”) and U.S. Patent No. 6,902,742 (“the ‘742 patent”). As a result, the Court ordered that, pursuant to 35 U.S.C. §271(e)(4)(A), the effective date of any FDA approval of Actavis’ proposed ANDA products shall not be earlier than the later expiration date of the ‘096 and ‘742 patents. Id. at *28. The Court, pursuant to 35 U.S.C. §271(e)(4)(B), also enjoined Actavis, its officers, agents, attorneys, and employees, and those acting in privity or concert with any of them, from engaging in the commercial manufacture, use, offer to sell, or sale within the United States, or importation into the United States of Actavis’ ANDA products prior to the expiration of the ‘096 and’742 patents. Id.

A copy of the Memorandum Opinion is attached.

By Memorandum Opinion entered by The Honorable Sue L. Robinson in Merck Sharp & Dohme Corp. v. Teva Pharmaceuticals USA, Inc., Civil Action No. 14-874-SLR (D.Del., November 16, 2016), the Court found the asserted claims of U.S. Patent No. 6,127,353 (“the ‘353 patent”) are valid but that defendant does not infringe the asserted claims of the ‘353 patent with its ANDA product.[1] Specifically, the Court found in favor of plaintiff Merck and against defendant as to defendant’s asserted affirmative defenses of invalidity of the ‘353 patent based on obviousness-type double patenting and alleged lack of an adequate written description of the invention as required by 35 U.S.C. § 112, ¶ 1. Id. at *2-7. The Court found in favor of defendant and against plaintiff Merck as to the infringement of the ‘353 patent after finding that plaintiff had not established, by a preponderance of the evidence, the presence of mometasone furoate monohydrate (“MFM”) in defendant’s ANDA product during its two-year shelf life. Id. at *8-24.

A copy of the Memorandum Opinion is attached.

[1] The ‘353 patent is listed in the Food and Drug Administration’s publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, which is known as the “Orange Book”, for the nasal spray, Nasonex®. This action arose out of the filing of an Abbreviated New Drug Application (“ANDA”) by defendant Teva seeking to produce and market a generic mometasone furoate nasal spray.

By Memorandum Opinion entered by the The Honorable Sue L. Robinson in Takeda Pharmaceuticals U.S.A., Inc. v. West-Ward Pharmaceutical Corp., et al., Civil Action No. 14-1268-SLR (D.Del., May 18, 2016), the Court granted Defendants’ motion to dismiss Plaintiff’s first amended complaint pursuant to Federal Rule of Civil Procedure 12(b)(6) after finding that Plaintiff’s claims for indirect infringement failed to state a plausible claim for relief.  In reaching its conclusion, the Court, among other things, found that the Mitigare™ label does not infringe and is not a sufficient catalyst to constitute active steps to encourage direct infringement. Id. at 16-17.  The Court reasoned that (1) like the generic in AstraZeneca Pharmaceuticals LP v. Apotex Corp., 2010 WL 5376310 (D.Del., December 22, 2010) aff’d, 669 F.3d 1370 (Fed. Cir. 2012), Defendant specified that Mitigare™ is for the prevention of gout flares and warned that its drug is not indicated for the treatment of acute gout flares, and (2) allowing Takeda to proceed with its claims would be akin to allowing Takeda to expand the scope of its exclusivity over the treatment of gout with colchicine. Id. at 15.

A copy of the Memorandum Opinion is attached.

By Memorandum Order entered by the Honorable Leonard P. Stark in Cumberland Pharmaceuticals Inc. v. InnoPharma, Inc., Civil Action No. 12-618-LPS (D.Del., November 1, 2013), the Court granted Defendant InnoPharma’s Motion to Dismiss the Complaint of Plaintiff Cumberland Pharmaceuticals Inc. after agreeing that InnoPharma’s ANDA product could not infringe Cumberland’s U.S. Patent No. 8,148,356 (the “’356 patent”) because all of the claims of the patent-in-suit cover only a formulation “free from a chelating agent,” yet the Complaint admitted that InnoPharma’s product contains EDTA, which is a chelating agent. The Court found that no formal process of claim construction was necessary to make that determination under the circumstances and Cumberland’s attempts to avoid that conclusion were unavailing. Id. at 2-5.

A copy of the Memorandum Order is attached.