Pharmaceutical Law & Industry Report® Index-Summary

PANCREASE

– Pancreatic enzyme product approved, 500

PATENTS

– AIDS/HIV drug evaluation methods (U.S., rev grant), 1394
– Allergan settlement (E.D. Tex.), 747
– Analysis of obviousness by courts, BNA Insights, 1197
– Angiomax

See ANGIOMAX

– Antidepressant process patent invalid for obviousness (S.D.N.Y.), 809
– Aricept

See ARICEPT

– Arzerra

See ARZERRA

– Backlog at PTO, 1254
– Bardoxolone methyl, 1260
– Benicar patent not invalid for obviousness, 1175; (U.S., rev sought), 1615
– Biologics, Filigrastim infringement suit (E.D. Pa.), 1498
– Boniva infringement claim (D.N.J.), 1087
– Business methods, machine-or-transformation test (U.S.), 847; industry and practitioners react, 850
– Calculations for extended patent terms challenge (Fed. Cir.), 57
– Carbetocin, 1162
– Cefaclor infringement claim (Fed. Ct. App.), 1327
– Cenestin infringement claim (S.D.N.Y.), 776
– Cialis inventorship (Fed. Cir.), 487
– Cipro antitrust settlement challenge (2nd Cir.), 579; rehearing sought, 675; amended, 853
– Concerta patent invalid (Fed. Cir.), 549
– Copaxone infringement claim (S.D.N.Y.), 1212
– Cozaar exclusivity upheld (D.D.C.), 349; FDA supports, 414
– Crestor patent upheld, 883
– Criteria for injunctions, BNA Insights, 870
– Decline in international findings, 221
– Delivery device patent extension (D.D.C.), 233
– Detrol nonobviousness (D.N.J.), 156; patent upheld, 230
– Diagnostic test patents (Fed. Cir.), 1608
– Diovan patent extension denial in Brazil, 26
– Enforcing drug patents, BNA Insights, 1447
– Evista patent upheld (Fed. Cir.), 1133
– Examination quality, PTO procedures, 1317
– Fabrazyme

See FABRAZYME

– Fee-setting authority for PTO, 653
– Focalin infringement claims dismissal (D.N.J.), 156
– Fuzeon infringement settlement (E.D.N.C.), 1246
– Gemzer

See GEMZER

– Generic drugs

See GENERIC DRUGS

– Gianvi

See GIANVI

– Gleevec Brazilian patent decision, 1382
– Helixate FS settlement (E.D. Tex.), 273
– Human rights concerns on drug access, 530
– Humira

See HUMIRA

– Hyzaar exclusivity upheld (D.D.C.), 349; FDA supports, 414
– Incentivizing technologies, PTO seeks comments, 1227; criticized, 1512
– India, drug patents, Analysis & Perspective, 46
– Inequitable conduct test, Special Report, 1595
– Intermezzo, 401
– Levaquin patent extension (Fed. Cir.), 617; BNA Insights, 762; rehearing denied, 976
– Licensing

– – Amigal, 1416
– – Antibiotics, 1529
– – Cancer drugs, 760
– – Danoprevir, 1326
– – Esmya, 1637
– – QPI-1002, 1097
– – Seasonale, 623
– – Seroquel, 623

– Lipitor

See LIPITOR

– Metvixia patent extension, 617; BNA Insights, 762
– Mirapex patent extension limits (Fed. Cir.), 619
– Mircera settlement (D. Mass.), 5
– Miscalculation of term extension (D.D.C.), 202
– Mydicar, 434
– Naropin infringement ruling vacated (Fed. Cir.), 1463
– Orange Book listing, Hatch-Waxman application, 512; rehearing denied, 1016
– Plavix infringement, stay denial (S.D.N.Y.), 514; damage award, 1339
– Purdue Pharma pain relief drugs settlement (W.D. Va.), 987
– Qnexa patents, 331
– Ranexa infringement alleged (D.N.J.), 947
– Recalculation of patent term adjustments (D.D.C.), 917
– Reform, Leahy's efforts, 282; substitute amendment, Special Report, 336; patent community support, Special Report, 339; industry concerns, 396; manager's amendment, 495; questions raised, Special Report, 798
– Rosuvastatin infringement claims (Fed. Ct. App.), 604
– Russia, collaboration with PTO, 796
– Skelaxin method patent invalid as obvious (Fed. Cir.), 1014
– Sleeping pill generic, inequitable conduct claims (D.N.J.), 774
– Surfaxin patent extension, 1354
– Sxpertise at district courts

See LEGISLATION, FEDERAL, HR 628

– Taxotere patent invalid for obviousness (D. Del.), 1245
– Temodar

See TEMODAR

– Three-track exam system, 751
– Ultram ER patent obviousness (Fed. Cir.), 743
– Updated obviousness guidelines from PTO, 1165
– Venture capital and Hatch-Waxman, BNA Insights, 535
– Viagra

See VIAGRA

– Viread, 173
– Vyvanse exclusivity decision challenge (D.D.C.), 311; exclusivity upheld (D.C. Cir.), 1425
– Written description requirement upheld (Fed. Cir.), 381
– Xopenex infringement alleged (D. Del.), 945
– Xyrem, 1636
– Zenvia, 219
– Zetia

See ZETIA

– Zometa infringement suit (D. Del.), 982
– Zymar patent invalid (D. Del.), 851
– Zyprexa validity, rehearing ordered (Fed. Cir.), 1036

PAXIL

– Birth defects

– – Antidepressant, no summary judgment (N.D. Okla.), 10
– – Confidential settlements (Pa. Ct. Com. Pl.), 865
– – Fatal heart defect, limitations period (S.D. Ohio), 522
– – Fraudulent joinder claim (E.D. Ky.), 1185
– – Most suits settled, 959

– Generic, TRO denied (D.N.J.), 1340; no injunction, 1395
– Suicide risk

– – Appeal dismissed (10th Cir.), 587; rehearing sought, 648
– – Catholic priest's death, no summary judgment (S.D. Ind.), 490
– – Failure-to-warn of suicide risk, no preemption (7th Cir.), 271
– – Inadequate warning, verdict for maker (11th Cir.), 319
– – Remand suits (10th Cir.), 744
– – Venue change denied (E.D. Pa.), 11

PDUFA (PRESCRIPTION DRUG USERS FEE ACT)

See USER FEES

PENNSYLVANIA

– Bristol-Myers Medicaid AWP case (Pa. Commw. Ct.), 1305
– J&J Medicaid AWP reporting (Pa. Commw. Ct.), 1612

PERSONALIZED MEDICINE

– Holistic approach pushed by FDA chief, 284
– R&D effects, 1475

PHARMACISTS AND PHARMACIES

– CEO for association, 1380
– Database of patient services, 171
– FEHBP, CVS generic drug prices, 217
– Medicaid reimbursement

– – Cuts challenge dismissal (D.D.C.), 1580
– – False claims (D. Mass.), 1187
– – GAO report, 18
– – Walgreens Wash. decision postponement, 213

– Merger of CVS Caremark, antitrust issues, 1472
– Privacy

– – Protected health information, CVS alleged misuse (S.D. Tex.), 1307
– – Rite Aid HIPAA settlement, 992

– Specialty pharmacy teams, CVS survey, 567

PHARMACY BENEFITS MANAGEMENT (PBM)

– D.C. law preempted (D.C. Cir.), 913
– Express Scripts, brand name drug pricing suit dismissal (11th Cir.), 646
– Genetic benefit management, 758
– Medicaid savings, changes, 1592
– Transparency

– – Grassley seeks feedback, 360
– – Rectification of PBMs, 1323

– Utah, itemized forms, 1284
– Walgreens out of CVS network, 756; CVS announcement, 792; new agreement, 826

PHENSERINE

– Alzheimer's drug, class securities fraud claim dismissal (2nd Cir.), 419

PHILIPPINES

– Lipitor generic retail sales, 221; reconsideration sought, 258

PHOSLO GELCAPS

– Generic challenge (D. Mass.), 1145

PIRFENIDONE

– IPF drug priority review, 43

PIXUVRI

– Cancer drug application, 397; appeal, 1561

PLAVIX

– Antiplatelet drug effectiveness, boxed warning, 367
– BCBS placement in highest tier (3rd Cir.), 779
– Patent infringement, stay denial (S.D.N.Y.), 514; damage award, 1339

POTIGQ

– Partial-onset seizure drug, FDA panel vote, 1095

PRADAXA

– Stroke drug, FDA panel vote, 1232; approved, 1354

PRANDIN

– Anticompetitive conduct suit (D. Minn.), 1580
– Diabetes drug purchaser class action (E.D. Mich.), 715
– Patents

– – Claims dropped (S.D.N.Y.), 1616
– – Infringement claim (E.D. Mich.), 1303
– – Orange Book listing, Hatch-Waxman application, 512; rehearing denied, 1016

PREGABALIN

– Anticonvulsant, no declaration of confidentiality, 571; notice of allegation, 906

PREMARIN

– HRT blamed for breast cancer (E.D. Ark., D. Minn.), 1219
– Transfer of breast cancer suit (D. Minn.), 1433

PREMPRO

– Class action not time-barred (E.D. Va.), 857
– Expert witnesses (D.P.R.), 1556
– Foust breast cancer suit (Pa. C.P.), 278
– Mich. fraud exception (E.D. Mich.), 1309
– Singleton breast cancer suit (Pa. C.P.), 278
– Torkie-Tork breast cancer suit (E.D. Va.), 1583
– Wilson breast cancer suit (E.D. Ark.), 1583

PRESCRIPTION DRUG USERS FEE ACT (PDUFA)

See USER FEES

PREVNAR 13

– Biologics application, 44

PRICING

– AIDS drug pricing suit (C.D. Cal.), 1502
– ASP, late data from firms to CMS, 211
– AstraZeneca settlement, 826
– Brand-name drugs price hikes, 659; generics effect, 757
– Brazil drug price control adjustment, 372
– Cardinal Health overcharges settlement, 930
– Ceiling prices

– – Federally funded medical clinics (9th Cir.), 34; (U.S., rev grant), 1243; (brief filed), 1618
– – TRICARE, implementation of Federal Ceiling Prices, 210

– Conn. pricing settlement (D. Mass.), 1340
– Consolidated suit, inflated pricing claims, N.Y. law violations (D. Mass.), 154
– Dispute resolution, HRSA seeks comments, 1226
– Exclusivity and drug costs, 1441
– Expediting Bristol-Myers settlements (D. Mass.), 1503
– FEHBP

– – CVS generic drug prices, 217
– – Transparency

See LEGISLATION, FEDERAL, HR 4489

– Health reform effects, CBO report, 1437
– India, price controls, 1163
– J&J

– – Overcharging suit (C.D. Cal.), 1621
– – Reporting prices (Pa. Commw. Ct.), 1612

– Massachusetts

– – Actavis inflated settlement (D. Mass.), 314
– – False claims overcharging settlement (N.D. Ill.), 1213
– – Merck false reporting (D. Mass.), 1274
– – Mylan inflated settlement (D. Mass.), 1430
– – Par settlement (D. Mass.), 1613
– – Watson settlement (D. Mass.), 208
– – Workers comp overcharges settlement (Mass. Super. Ct.), 1156

– Medicaid

– – Idaho

– – – Actavis settlement (Idaho Dist. Ct.), 714
– – – Sandoz settlement (Idaho Dist. Ct.), 1341

– – Iowa AWP suit dismissal (D. Mass.), 1465
– – Mass. overcharging settlement (N.D. Ill.), 1213
– – Merck settlements with U.S., Cal., Fla., 21
– – Mich. overcharging settlement (N.D. Ill.), 1213
– – N.Y. AWP suit dismissal (D. Mass.), 1465
– – Part B price substitution, 1407
– – Protonix overcharges (D. Mass.), 646
– – Teva settlements, 189
– – U.S. trade policy and negotiation limits, 290
– – Wis., Boehringer settlement (Wis. Cir. Ct.), 553
– – Withdrawal of pricing rules proposed, 1149; final rule, 1435

– Medicare inflated AWP settlements, 1549
– Qatar price control relief, 1356
– Russia, vitally important drugs, 1446
– Steep hikes, GAO report, 68
– Switzerland, price cuts for health insurance system, 295
– Watson inflated price reporting, Mass. settlement (D. Mass.), 208

PRILOSEC

– Extra damages denied (S.D.N.Y.), 811
– Heartburn drug infringement by generic (Fed. Cir.), 5

PRIVACY AND CONFIDENTIALITY

– HITECH Act privacy rules and drugmakers, BNA Insights, 1038
– Protected health information, CVS alleged misuse (S.D. Tex.), 1307
– Rite Aid HIPAA settlement, 992
– State restrictions

– – Me. prescribing data sales limits (1st Cir.), 1049
– – Vt. data mining law unconstitutional (2nd Cir.), 1496; (U.S., rev sought), 1614; BNA Insights, 1643

PROCRIT

– Anemia drug, qui tam suit partial dismissal (U.S., rev sought), 37; Solicitor Gen. input sought, 231; (rev den), 810
– J&J consumer claims (D. Mass.), 1209
– Recall, 1258

PRODUCT LIABILITY

– Accutane

See ACCUTANE

– Antibiotics, generic and vision loss (M.D. Ga.), 355
– Avandia

See AVANDIA

– Baycol and muscle damage, exclusion of expert (8th Cir.), 354
– Bisphosphonates

– – Jawbone deterioration (M.D.N.C.), 1400
– – Osteonecrosis (N.J. Super. Ct.), 1310

– Cymbalta suicide warning claim (D.S.D.), 1310; summary judgment for maker, 1364
– Darvocet and heart attack (E.D. La.), 1624
– Digitek

See DIGITEK

– Duragesic wrongful death claim (Tex. App.), 457
– Effexor and suicide, learned intermediary (W.D. Pa.), 277
– Embeda, 239
– Fentanyl

See FENTANYL

– Fosamax

See FOSAMAX

– Hepatitis after colonoscopy (Nev. Dist. Ct.), 625
– HRT

See HORMONE REPLACEMENT THERAPY (HRT)

– Infusion pump pain drugs (D.R.I.), 783
– Lamisil and skin disease (D.N.J.), 1218
– Learned intermediary defense, BNA Insights, 832
– Levaquin

See LEVAQUIN

– Metoclopramide

See METOCLOPRAMIDE

– Metoprolol, preemption of liability claims (E.D. Mo.), 66
– Motrin labeling, preemption of Tex. law (N.D. Tex.), 157
– Neurontin and suicide, widow's suit (M.D. Tenn.), 322; expert testimony, 627; settlement, 682
– Nsaid design defect (D.N.H.), 986
– Ortho-Evra patch labeling (N.D. Ohio), 160
– Pain patch

– – Alza, fatal overdose (S.D.N.Y.), 237
– – Mylan, blamed for death (E.D. Mo.), 555

– Pain pumps

– – Cal. suit dismissal (C.D. Cal.), 488
– – Continuous infusion of anesthetics (D. Minn.), 890
– – Exemplary damages permitted (D. Colo.), 1365
– – Fraudulent concealment claims (W.D. Pa.), 1366
– – Summary judgment for anesthetic makers (S.D. Ind.), 321
– – Vt. suit dismissal (D. Vt.), 161

– Paxil

See PAXIL

– Phenylpropanolamine and neurological ailments (Iowa), 235
– Preemption of failure-to-warn claims (6th Cir.), 1501
– Prempro

See PREMPRO

– Provera and breast cancer (Pa. Super. Ct.), 64
– Prozac suicide warning claim against generic (C.D. Cal.), 455
– Public disclosure, draft FDA proposal, BNA Insights, 1068
– Redux and valvular heart disease (Pa. Super. Ct.), 1022
– Reglan

See REGLAN

– Remicade direct advertising, no learned intermediary (Tex. App.), 317
– Requip blamed for gambling (5th Cir.), 386
– Risperdal and diabetes (La. Parish Ct.), 1342
– Seizure drug and skin reaction (S.D. Miss.), 1277
– Seroquel

See SEROQUEL

– Sulindac blamed for blindness and skin reaction (D.N.H.), 1183
– Transdermal system, Okla. consumer law (S.D. W.Va.), 718
– Trasylol

See TRASYLOL

– Vioxx not fit for purpose, Australia, 372
– Wellbutrin side effects, no preemption (E.D. Pa.), 745; failure-to-warn claim, 854
– Zyprexa

See ZYPREXA

PROLIA

– Osteoporosis drug approved, 729

PROMACTA

– ITP drug and liver disease, 659

PROPOFOL

– Anesthetic withdrawn, 730

PROPOXYPHENE

– Pain drug withdrawal, 1523

PROPYLTHIOURACIL

– Hyperthyroidism drug and liver damage, 566

PROSCAR

– Prostate cancer drug, new indications, 1561

PROTONIX

– Acid suppressant drugs, Medicaid overcharges suit (D. Mass.), 646
– False advertising suit dismissal (E.D. Mich.), 313
– Generic blocked (D.N.J.), 1105; ANDA accepted, 1355
– Heartburn drug patent valid (D.N.J.), 584; upheld, 941

PROTOPAM CHLORIDE

– Poisoning treatment pediatric use approval, 1194

PROVENGE

– Medicare

– – CMS panel supports, 1515
– – National coverage analysis, 896

– Prostate cancer drug approval, 598

PROVERA

– HRT and breast cancer (Pa. Super. Ct.), 64

PROVIGIL

– Discovery ordered (D.D.C.), 942
– Narcolepsy generic, subpoena upheld (D.D.C.), 1080
– Settlements in antitrust suit challenge (E.D. Pa.), 412
– Sleep disorder drug antitrust suit (N.D. Ohio), 748

PROZAC

– Suicide warning claim against generic (C.D. Cal.), 455

PTO (PATENT AND TRADEMARK OFFICE)

See generally PATENTS

PUERTO RICO

– Tax on foreign firms, 1410

PULMICORT

– Respiratory generic blocked (Fed. Cir.), 1391