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Recent Events in Pharmaceutical Litigation – January 17 – 24, 2019

Posted on Jan 29, 2019 in Blog

New ANDA Cases Filed

Esbriet® (pirfenidone capsules) – NDA No. 022535

Genentech, Inc. and Intermune, Inc. v. Aurobindo Pharma Limited and Aurobindo Pharma USA, Inc., U.S.D.C. Del., Case No. 1:19-cv-00103.  Genentech and Intermune, in a complaint filed on January 17, 2019, seek to block approval of Aurobindo’s ANDA products (267 mg pirfenidone capsules) prior to the expiration of U.S. Patent Nos. 7,566,729; 7,635,707; 7,767,700; 7,816,383; 7,910,610; 8,013,002; 8,084,475; 8,318,780; 8,383,150; 8,420,674; 8,592,462; 8,609,701; 8,648,098; 8,754,109; 8,778,947; 7,696,236; 7,767,225; 7,988,994; and 8,753,679 – Orange Book listed patents for Esbriet® capsules which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Genentech, Inc. and Intermune, Inc. v. Lupin Ltd. and Lupin Pharmaceuticals, Inc., U.S.D.C. Del., Case No. 1:19-cv-00109.  Genentech and Intermune, in a complaint filed on January 18, 2019, seek to block approval of Lupin’s ANDA products (267 mg pirfenidone capsules) prior to the expiration of U.S. Patent Nos. 7,566,729; 7,635,707; 7,767,700; 7,816,383; 7,910,610; 8,013,002; 8,084,475; 8,318,780; 8,383,150; 8,420,674; 8,592,462; 8,609,701; 8,648,098; 8,754,109; 8,778,947; 7,696,236; 7,767,225; 7,988,994; and 8,753,679 – Orange Book listed patents for Esbriet® capsules which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Genentech, Inc. and Intermune, Inc. v. Apotex Inc. and Apotex Corp., U.S.D.C. Del., Case No. 1:19-cv-00120.  Genentech and Intermune, in a complaint filed on January 22, 2019, seek to block approval of Apotex’s ANDA products (267 mg pirfenidone capsules) prior to the expiration of U.S. Patent Nos. 7,566,729; 7,635,707; 7,767,700; 7,816,383; 7,910,610; 8,013,002; 8,084,475; 8,318,780; 8,383,150; 8,420,674; 8,592,462; 8,609,701; 8,648,098; 8,754,109; 8,778,947; 7,696,236; 7,767,225; 7,988,994; and 8,753,679 – Orange Book listed patents for Esbriet® capsules which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Genentech, Inc. and Intermune, Inc. v. ScieGen Pharmaceuticals Inc. and Bactolac Pharmaceutical, Inc., U.S.D.C. Del., Case No. 1:19-cv-00132.  Genentech and Intermune, in a complaint filed on January 23, 2019, seek to block approval of ScieGen’s/Bactolac’s ANDA products (267 mg pirfenidone capsules) prior to the expiration of U.S. Patent Nos. 8,383,150; 8,420,674; 7,767,225; 7,988,994; and 8,753,679 – Orange Book listed patents for Esbriet® capsules which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Esbriet® (pirfenidone tablets) – NDA No. 208780

Genentech, Inc. and Intermune, Inc. v. Laurus Labs Ltd. and Laurus Generic Inc., U.S.D.C. Del., Case No. 1:19-cv-00104.  Genentech and Intermune, in a complaint filed on January 17, 2019, seek to black approval of Laurus’ ANDA products (267, 534, and 801 mg pirfenidone tablets) prior to the expiration of U.S. Patent Nos. 7,566,729; 7,635,707; 7,767,700; 7,816,383; 7,910,610; 8,013,002; 8,084,475; 8,318,780; 8,383,150; 8,420,674; 8,592,462; 8,609,701; 8,648,098; 8,754,109; and 8,778,947 – Orange Book listed patents for Esbriet® tablets which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Genentech, Inc. and Intermune, Inc. v. Aurobindo Pharma Limited and Aurobindo Pharma USA, Inc., U.S.D.C. Del., Case No. 1:19-cv-00105.  Genentech and Intermune, in a complaint filed on January 17, 2019, seek to block approval of Aurobindo’s ANDA products (267, 534, and 801 mg pirfenidone tablets) prior to the expiration of U.S. Patent Nos. 7,566,729; 7,635,707; 7,767,700; 7,816,383; 7,910,610; 8,013,002; 8,084,475; 8,318,780; 8,383,150; 8,420,674; 8,592,462; 8,609,701; 8,648,098; 8,754,109; 8,778,947; and 9,561,217 – Orange Book listed patents for Esbriet® tablets which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Genentech, Inc. and Intermune, Inc. v. Lupin Ltd. and Lupin Pharmaceuticals, Inc., U.S.D.C. Del., Case No. 1:19-cv-00110.  Genentech and Intermune, in a complaint filed on January 18, 2019, seek to block approval of Lupin’s ANDA products (267 and 801 mg pirfenidone tablets) prior to the expiration of U.S. Patent Nos. 7,566,729; 7,635,707; 7,767,700; 7,816,383; 7,910,610; 8,013,002; 8,084,475; 8,318,780; 8,383,150; 8,420,674; 8,592,462; 8,609,701; 8,648,098; 8,754,109; and 8,778,947 – Orange Book listed patents for Esbriet® tablets which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Genentech, Inc. and Intermune, Inc. v. Micro Labs Ltd. and Micro Labs USA Inc., U.S.D.C. Del., Case No. 1:19-cv-00111.  Genentech and Intermune, in a complaint filed on January 18, 2019, seek to block approval of Micro Labs’ ANDA products (267 and 801 mg pirfenidone tablets) prior to the expiration of U.S. Patent Nos. 7,566,729; 7,635,707; 7,767,700; 7,816,383; 7,910,610; 8,013,002; 8,084,475; 8,318,780; 8,383,150; 8,420,674; 8,592,462; 8,609,701; 8,648,098; 8,754,109; and 8,778,947 – Orange Book listed patents for Esbriet® tablets which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Genentech, Inc. and Intermune, Inc. v. Aptoex Inc. and Apotex Corp., U.S.D.C. Del., Case No. 1:19-cv-00123.  Genentech and Intermune, in a complaint filed on January 22, 2019, seek to block approval of Aptoex’s ANDA products (267 and 801 mg pirfenidone tablets) prior to the expiration of U.S. Patent Nos. 7,566,729; 7,635,707; 7,767,700; 7,816,383; 7,910,610; 8,013,002; 8,084,475; 8,318,780; 8,383,150; 8,420,674; 8,592,462; 8,609,701; 8,648,098; 8,754,109; 8,778,947 and 9,561,217 – Orange Book listed patents for Esbriet® tablets which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Genentech, Inc. and Intermune, Inc. v. Shilpa Medicare Limited and Maia Pharmaceuticals, Inc., U.S.D.C. Del., Case No. 1:19-cv-00130.  Genentech and Intermune, in a complaint filed on January 23, 2019, seek to block approval of Shilpa’s/Maia’s ANDA products (267 and 801 mg pirfenidone tablets) prior to the expiration of U.S. Patent Nos. 8,383,150 and 8,778,947 – Orange Book listed patents for Esbriet® tablets which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Genentech, Inc. and Intermune, Inc. v. ScieGen Pharmaceuticals Inc. and Bactolac Pharmaceutical, Inc., U.S.D.C. Del., Case No. 1:19-cv-00131.  Genentech and Intermune, in a complaint filed on January 23, 2019, seek to block approval of ScieGen’s/Bactolac’s ANDA products (267 and 801 mg pirfenidone tablets) prior to the expiration of U.S. Patent Nos. 8,383,150 and 9,561,217 – Orange Book listed patents for Esbriet® tablets which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Genentech, Inc. and Intermune, Inc. v. Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd, U.S.D.C. Del., Case No. 1:19-cv-00136.  Genentech and Intermune, in a complaint filed on January 24, 2019, seek to block approval of Teva’s ANDA products (267 and 801 mg pirfenidone tablets) prior to the expiration of U.S. Patent Nos. 7,566,729; 7,635,707; 7,767,700; 7,816,383; 7,910,610; 8,013,002; 8,084,475; 8,318,780; 8,383,150; 8,420,674; 8,592,462; 8,609,701; 8,648,098; 8,754,109; and 8,778,947 – Orange Book listed patents for Esbriet® tablets which are indicated for the treatment for idiopathic pulmonary fibrosis (IPF).

Jublia® (efinaconazole topical solution) – NDA No. 203567

Valeant Pharmaceuticals North America LLC, Valeant Pharmaceuticals Ireland Ltd., Dow Pharmaceutical Sciences, Inc. and Kaken Pharmaceutical Co., Ltd. v. CIPLA Ltd. and CIPLA USA Inc., U.S.D.C. N.J. Case No. 3:19-cv-00988.  Valeant and Dow, in a complaint filed on January 23, 2019, seek to block approval of CIPLA’s ANDA products (efinaconazole topical solution) until expiration of U.S. Patent No. 10,105,444 – an Orange Book listed patent for Jublia® which is indicated for the treatment of onychomycosis of the toe nail.

Valeant Pharmaceuticals North America LLC, Valeant Pharmaceuticals Ireland Ltd., Dow Pharmaceutical Sciences, Inc. and Kaken Pharmaceutical Co., Ltd. v. Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd., U.S.D.C. N.J. Case No. 3:19-cv-00990.  Valeant and Dow, in a complaint filed on January 23, 2019, seek to block approval of Teva’s ANDA products (efinaconazole topical solution) until expiration of U.S. Patent No.– 10,105,444 – an Orange Book listed patent for Jublia® which is indicated for the treatment of onychomycosis of the toe nail.

Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumerate) – NDA No. 203100

Japan Tobacco Inc. v. Mylan Pharmaceuticals Inc., U.S.D.C. N.D. W. Va. Case No. 1:19-cv-00012.  Japan Tobacco, in a complaint filed on January 24, 2019, seeks to block approval of Mylan’s ANDA products (elvitegravir 150 mg dosage strength, cobicistat 150 mg dosage strength, emtricitabine 200 mg dosage strength, tenofovir disoproxil fumerate 300 mg dosage strength fixed-dose combination tablets) until expiration of U.S. Patent No. 8,633,219 – an Orange Book listed patent for Gilead Sciences Inc.’s Stribild® which is indicated for the treatment of HIV-1 infections.

Ovide®(malathion lotion) – NDA No. 018613

Taro Pharmaceutical Industries Ltd., Taro Pharmaceuticals North America, Inc. and Taro Pharmaceuticals U.S.A., Inc. v. Novitium Pharma, LLC, U.S.D.C. N.J. Case No. 3:19-cv-01028.  Taro, in a complaint filed on January 24, 2019, seeks to block approval of Novitium’s ANDA products (malathion lotion, 0.5%) until expiration of U.S. Patent Nos. 7,560,445 and 7,977,324–Orange Book listed patents for Ovide® (malathion lotion, 0.5%) which is indicated for the treatment of patients infected with Pediculus humanus capitis (head lice and their ova) of the scalp hair.

New Declaratory Judgment Cases Filed

Isosulfan Blue – ANDA No. 090874

Beloteca, Inc. v. Apicore US LLC and Mylan Institutional LLC., U.S.D.C. N. Ill., Case No. 1:19-cv-00360.  Beloteca, in a complaint filed on January 17, 2019, seeks a declaratory judgment of non-infringement of U.S. Patent Nos. 7,662,992; 8,969,616; and 9,353,050, which allegedly encompass processes for preparing and isolating isosulfan blue which is indicated for use in delineating lymphatic vessels.

Chantix® (varenicline tartrate) – NDA No. 021828

Par Pharmaceutical, Inc.  v. Pfizer Inc., Pfizer Products Inc., and C.P. Pharmaceuticals International C.V., U.S.D.C. S.D. N.Y., Case No. 1:19-cv-00615.  Par, in a complaint filed on January 22, 2019, seeks declaratory judgments of non-infringement and invalidity of U.S. Patent Nos. 6,890, 927 and 7,265,119 – two of three Orange Book listed patents for Chantix® which is indicated as an aid to smoking cessation treatment.

Recent Case Law

District Court Denies Motions in Limine in Run Up to Aczone® Trial

Almirall LLC v. Taro Pharmaceutical Industries Ltd., No. 1:17-cv-663-JFB-SRF, 2019 U.S. Dist. LEXIS 11539 (D. Del. Jan. 24, 2019).  Visiting Senior Judge Joseph F. Bataillon (U.S.D.C. D. Ne.) denied both parties motions in limine deferring to hear the parties’ objections and determining the weight of the evidence at trial.  The case arose from Taro’s filing of an ANDA seeking FDA approval of a generic equivalent of Allergan Inc.’s (Almirall’s predecessor in interest) Aczone® (dapsone, 7.5% gel product) which is indicated for use in the treatment of acne vulgaris.  Id. at *1.  Almirall asserts that Taro’s ANDA products would induce infringement of U.S. Patent No. 9,517,219 (“the ’219 patent”) under the doctrine of equivalents, more specifically Almirall alleges that Taro’s product includes “a polymeric viscosity builder, or PVB, equivalent to Sepineo P600, the PVB used in Aczone®.”  Id.

Six motions in limine were pending before the Court.  The first motion, by Almirall, sought to preclude testimony by Taro’s expert, Dr. Amiji, on the issue of prosecution estoppel as to the amendment of claim 1 during the prosecution of the ’219 patent because Dr. Amiji’s report relied exclusively on prosecution events related to original claim 14 of the application that lead to the issuance of the ’219 patent.  Id. at *2.  Almirall went on to argue that it would be prejudiced by any testimony regarding Dr. Amiji’s opinions as to claim 1 because it had not had the opportunity to respond to these opinions nor to probe these opinions at deposition.  Id.  Taro argued that Dr. Amiji had explicitly referred to the amendment to claim 1; his anticipated testimony on this issue would be a permissible elaboration of the opinions contained in his expert report; Almirall had sufficient notice of his opinion; and Almirall had an opportunity to address Dr. Amiji’s expected testimony in their reply expert report and during his deposition but chose not avail itself of these opportunities.  Id.

The Court was inclined to believe that Dr. Amiji’s testimony as to the amendments to claim 1 was based on an unduly narrow reading of his expert report; that his testimony on the issue would be a natural outgrowth of his testimony as to claim 14; and that Almirall had notice of the gist of his testimony.  Id. at *3.  The Court, therefore, denied Almirall’s motion relying, in part, on First Am. State Bank v. Cont’l Ins. Co., 897 F.2d 319, 328 (8th Cir. 1990) (the trial court, in a non-jury case, is presumed to consider only competent evidence); Leonard v. Stemtech Health Scis., Inc., 981 F. Supp. 2d 273, 276 (D. Del. 2013) (evidentiary rulings, especially those encompassing broad classes of evidence, should generally be deferred until trial); and In re Paoli R.R. Litig., 35 F.3d 717, 791-92 (3rd Cir. 1994) (exclusion of critical evidence is an extreme sanction that should not be imposed where an untimely or improper expert disclosure amounts to only a slight deviation from pre-trial notice requirements or occasions only slight prejudice on the movant).  Almirall LLC v. Taro Pharmaceutical Industries Ltd.,  LEXIS 11539 at *3.

The second motion, by Taro, sought to exclude evidence, arguments and opinions comparing the accused ANDA product to Almirall’s NDA and/or its commercial product to prove infringement.  Id. at *4.  Taro argued that such comparisons are contrary to precedent since the language of the asserted claims, not the patent holder’s commercial products define the infringement inquiry.  Id.  Almirall argued that Federal Circuit case law does not contain such a prohibition; Taro does not dispute that its Aczone® product meets all of the limitations of the asserted claims; and whether an excipient, not explicitly recited in the claims, can form part of a PVB is a question of fact.  Id.

The Court held that “a comparison to the patentee’s commercial product may be relevant to infringement in on a proper showing” and that the parties could be assured that the Court would compare the ANDA described product to the asserted claims as construed.  Id.  As such, the Court denied the motion based in part on Adams Respiratory Therapeutics, Inc. v. Perrigo Co., 616 F.2d 1283, 1289 (Fed. Cir. 2010) (“When a commercial product meets all of the claim limitations, then a comparison to that product may support a finding of infringement.”).  Almirall LLC v. Taro Pharmaceutical Industries Ltd.,  LEXIS 11539 at *4.

The third motion, a Daubert motion by Taro, sought to exclude Almirall’s expert’s (Dr. Majella E. Lane) testimony based on her focus on Almirall’s commercial product and because her conclusions are based on a conclusory analysis that fails to apply established principles.  Id. at *5.  Almirall, on the other hand, argued that Taro’s arguments relate to the weight, not the admissibility, of their expert’s testimony and was contrary to the Court’s claim construction.  Id.

The Court found that Taro’s motion reflected a disagreement with Dr. Lane’s conclusions and not a challenge to her qualifications or methods.  Id. at *6.  As such, Taro’s criticisms go to the weight not the admissibility of her opinions, which can be addressed in cross-examination.  Id.  The Court, therefore, denied the motion to exclude Dr. Lane’s testimony relying, in part on, i4i Ltd. P’ship v. Microsoft Corp., 598 F.3d 831, 852 (Fed. Cir. 2010) (when an expert’s methodology is sound, and the evidence relied upon is sufficiently related to the case at hand, disputes about the degree of relevance or accuracy may go to the testimony’s weight, but not its admissibility.) and Intendis GMBH v. Glenmark Pharm. Inc., USA, 822 F.3d 1355, 1362 (Fed. Cir. 2016) (when the claims and specifications of a patent are silent as to the result of a claim limitation … we should turn to the ordinary skilled artisan); and Graver Tank & Mafg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 609-10 (1950) (proof of equivalence can be made in any form, including, testimony of experts, documents, including texts and treatises and disclosures of the prior art, and, like any other issue of fact, requires a balancing of credibility, persuasiveness and weight of the evidence).  Almirall LLC v. Taro Pharmaceutical Industries Ltd.,  LEXIS 11539 at *5-*6.

The fourth motion, by Taro, sought to exclude evidence of infringement under the doctrine of equivalents because this theory cannot be asserted if it will encompass/ensnare the prior art.  Id. at *6.  Almirall argued that the motion was nothing more than an attempt to seek a merits-based ruling on an equitable defense.  Id.  The Court found that it could not address Taro’s arguments in the context of a motion in limine and the arguments should be reasserted at the close of evidence at the end of trial or in a posttrial motion.  Id. at *7.  The Court, therefore, denied the motion based on DePuy Spine, Inc. v. Medtronic Sofamor Danek, Inc., 567 F.3d 1314, 1322 (Fed. Cir. 2009) (ensnarement, a policy oriented limitation on the doctrine of equivalents is applied as a question of law and limits the scope of equivalency that a patentee is allowed to assert); id. at 1323 (an ensnarement determination can be made by the court either on a pretrial motion for partial summary judgment or on a motion for judgment as a matter of law at the close of evidence); and id. at 1324 (the district court, in an ensnarement context, may hear expert testimony and may consider other extrinsic evidence).  Almirall LLC v. Taro Pharmaceutical Industries Ltd.,  LEXIS 11539 at *6-*7.

The fifth motion, by Taro, sought to exclude evidence or testimony regarding a lead compound obviousness analysis.  Id. at *7.  Taro contended that a lead compound analysis was not applicable in this case because the asserted claims were method of treatment claims.  Id.  Almirall argued that “evidence that a skilled artisan would not have obviously selected dapsone as the pharmaceutical agent in developing an improved treatment for acne or rosacea is relevant and admissible for determining whether Taro’s obviousness analysis falls prey to hindsight bias.”  Id.  The Court found that evidence of hindsight bias may be relevant but found it difficult to determine the relevance of the challenged evidence in the context of a motion in limineId.  As such, it denied the motion based, in part on, In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063, 1078-79 (Fed. Cir. 2012) (a court is required to consider secondary considerations of nonobviousness as a check against hindsight bias); and Dystar Textilfarben GmBH & Co. Deutschland KG v. C.H. Patrick Co., 464 F.3d 1356, 1367 (Fed. Cir. 2006) (“Our suggestion test is in actuality quite flexible and not only permits, but requires, consideration of common knowledge and common sense.”).  Almirall LLC v. Taro Pharmaceutical Industries Ltd.,  LEXIS 11539 at *7.

The sixth motion, by Taro, sought to exclude Almirall’s medical expert (Dr. Julie Harper) from testifying on the issue of obviousness given that she had admitted that she was not a person of ordinary skill in the art (“POSA”).  Id. at *7-8.  Almirall argued that Dr. Harper was qualified to testify on the issue of obviousness because she was a board certified dermatologist with approximately twenty (20) years of experience who had conducted research, published, and presented extensively regarding acne and rosacea treatment; because both parties definition of a POSA included “consultation or collaboration with” someone with her expertise; and because the patent examiner had defined a POSA being “at least a medical doctor with several years of experience in the art.”  Id. at *8.  The Court found that Taro did not dispute that Dr. Harper’s testimony was based on sufficient facts/data or that she had reliably applied the principles and methods of the case.  Id.  The Court also found that she possessed technical expertise on a relevant aspect of the pertinent art and that her qualifications were sufficient to make her testimony helpful to an understanding of the evidence.  Id.  The Court, therefore, denied Taro’s motion and would allow Dr. Harper to offer testimony from a clinical perspective to rebut evidence of obviousness based on Calhoun v. Yamaha Motor Corp., U.S.A., 350 F.3d 316, 321 (3d Cir. 2003) (the Third Circuit interprets qualification liberally) and Pindea v. Ford Motor Co., 520 F.3d 237, 244 (3d Cir. 2008) (an engineer was allowed to testify as to the inadequacy of a waring in a service manual for an automotive rear liftgate despite that fact that the engineer was not substantially qualified in the design of automobile rear liftgates or the drafting of service manual warnings).  Almirall LLC v. Taro Pharmaceutical Industries Ltd.,  LEXIS 11539 at *8-*9.

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