Pharmaceutical Law & Industry Report® Index-Summary

PATADAY

– Allergy eye drug ANDA, infringement claimed (S.D. Ind.), 63
– Eyedrop ANDA, infringement alleged (S.D. Ind.), 202

PATANOL

– Eye treatment generic, infringement alleged (S.D. Ind.), 202

PATENTS

– Acular patent upheld (U.S., rev den), 117
– ADX-N05, In Brief, 570
– Alheimer's treatment patent invalid (Fed. Cir.), 1128
– Amrix infringement claim split from antitrust and patent misuse claims (D. Del.), 1192
– Antara, Lupin gets marketing rights (D. Md.), 1194
– Anti-interleukin antibiotics, infringement alleged (D. Mass.), 939
– Antidepressant competing patents, two claims invalidated by prior art (S.D.N.Y.), 673
– Appointments, PTO chief confirmed, 949
– Azopt maker alleges infringement (E.D. Tex.), 119
– BiTE antibody, In Brief, 77
– BNA plans audioconference, In Brief, 190
– Brazil, pipeline law challenged, 597
– Cabilly II, PTO confirms claims of validity, 270
– Calibrating proper dosage for treating certain diseases, method is patentable (Fed. Cir.), 1066; Analysis & Perspective, 1209
– Carvedilol, infringement claim settled (D.N.J.), 587
– Celexa competing patents, two claims invalidated by prior art (S.D.N.Y.), 673; jury awards royalty, 1247
– Cephem compound double patent challenge, summary judgment vacated (Fed. Cir.), 433
– Cipro

See CIPRO

– Clarinex patent suit settled (D.N.J.), 437
– Clobel patent infringement alleged (N.D. Tex.), 63
– Detrol maker did not mislead PTO in prosecuting patent (D.N.J.), 461
– Enbrel, non-infringement ruling affirmed (Fed. Cir.), 635
– Enforcement focused on drug patent settlements, Analysis & Perceptive, 1006
– Exclusivity, FDA delisting rule challenged (D.D.C.), 792; upheld, 964; Analysis & Perspective, 979
– Expiration of patent does not increase use, report finds, 1264
– Focalin, infringement claim dismissed (D.N.J.), 95
– Fosrenol maker alleges infringement (S.D.N.Y.), 312
– Generic drugs

See GENERIC DRUGS

– High priority changes urged at PTO, In Brief, 19
– Humira

See HUMIRA

– “Imminent importation” of allegedly infringing drugs, revised opinion issued (Fed. Cir.), 524
– Infringement

– – AIDS therapy, Stanford lacks standing to make infringement claim (Fed. Cir.), 1167

– Levaquin

See LEVAQUIN

– Lexapro

See LEXAPRO

– Licensing

– – Antibody license, In Brief, 192
– – Aricept licensing, In Brief, 299
– – Assay licensing, In Brief, 77
– – AV513 license, In Brief, 25
– – Axomadol licensing, In Brief, 272
– – Blinatumomab licensing, In Brief, 324
– – Budesonide license, In Brief, 838
– – Caerulomycin A license, In Brief, 238
– – Campath, Genzyme buys rights, 384
– – CDA-1 and CDB-2 license, In Brief, 486
– – Cimzia licensing, In Brief, 191
– – Daxas, In Brief, 952
– – Depression drugs licensing, In Brief, 191
– – DI-Leu16-IL2 license, In Brief, 323
– – DOTPA chloride license, In Brief, 238
– – Elinogrel rights, In Brief, 213
– – Fanapt, In Brief, 1208
– – Fortesta, In Brief, 1004
– – Heart drug licenses, In Brief, 627
– – IDX889 licensing, In Brief, 191
– – JAK2 inhibitors licensed to Onyx, 48
– – JP-1730/fipamezole U.S.-Canadian rights purchased, 1003
– – Lupuzar license, In Brief, 163
– – OpRA III licensing, In Brief, 1116
– – Pain drug licensing, In Brief, 191
– – POT-4, In Brief, 1265
– – Relistor, In Brief, 1238
– – Reloxin license, In Brief, 450
– – RNA-based compounds, In Brief, 1207
– – Tetrabenazine licensing, In Brief, 595
– – UCB drug rights, In Brief, 77
– – VIA licenses, In Brief, 24
– – Wellbutrin, U.S. rights purchased, In Brief, 540
– – Zevalin licensing, In Brief, 78

– Lipitor

See LIPITOR

– Lotrel

See LOTREL

– Lovenox patent not enforceable (U.S., rev sought), 171; (rev den), 495
– “Machine or transformation” test questioned (U.S., briefs filed), 939
– Messenger protein, patent invalid for lack of adequate written description (Fed. Cir.), 399
– Milestone payments, In Brief, 77
– Naprelan infringement suit dismissed (S.D. Fla.), 284
– Oforta, In Brief, 570
– Pataday

See PATADAY

– Plavix active ingredient, patent not invalid for anticipation or obviousness (U.S., rev sought), 912
– Prosecution process, PTO may issue rules changing (Fed. Cir.), 337; rehearing sought, 669; rehearing granted, 789; stay of en banc review sought, 879; PTO to rescind rules, 1201; challenge proceeds, 1224
– Reform

– – Conditions for patentability

See LEGISLATION, FEDERAL, S 610

– – Congress urged to scale back controversial proposals, 186
– – CRS publishes analysis, 128
– – First-to-file

See LEGISLATION, FEDERAL, HR 1260, S 515

– – Urged at PTO, 43

– Reversing patent settlements, Analysis & Perspective, 749
– Risk evaluation and mitigation strategy patents, Analysis & Perspective, 28
– Rythmol SR patent dispute settled (D. Del.), 463
– Skelaxin method patents invalid (E.D.N.Y.), 92
– Solodyn

See SOLODYN

– Tarcera infringement suit dismissed in India, 543
– Truvada V drug ANDA infringes patent (S.D.N.Y.), 10
– Ultracet patent invalidity ruling partially reversed (Fed. Cir.), 1025
– Ultram ER patent invalid for obviousness (D. Del.), 963; appealed, 1034
– Unenforceable patents, direct buyer plaintiffs have standing to bring antitrust claim (2nd Cir.), 1217
– Unpatentable law of nature, gene expression at issue (Fed. Cir.), 172; rehearing granted, 988
– Yasmin patent invalid for obviousness (Fed. Cir.), 937

PAXIL

– Antidepressant product liability settlement approved (D.P.R.), 282
– Birth defects

– – Production of study correspondence ordered (D. Mass.), 1101

– Failure-to-warn of suicide risk, no preemption (E.D. Wis.), 910
– Generic, supply and license contract dispute, $70M awarded for breach (N.D. Ill.), 201
– Venue change sought in product liability suit (E.D. Pa.), 1032; severance sought, 1066
– Wrongful death action by stepchildren barred (Tex. App.), 800

PBM

See PHARMACY BENEFITS MANAGEMENT (PBM)

PEGINTRON

– Melanoma drug cleared by FDA panel, 1176

PENNSYLVANIA

– Price database launched, 293

PERAMIVIR

– H1n1 virus treatment, FDA clears for emergency use, 1261

PERSONALIZED MEDICINE

– Comparative effectiveness discussed at conference, 1265
– Key trend in biotech industry, 568
– Merck CEO urges, 566
– R&D advocates push, 538

PHARMACISTS AND PHARMACIES

– CVS accused of failing to protect patient data (FTC), 199; pharmacists seek probe, 351
– Electronic prescriptions

See E-PRESCRIPTIONS

– Health care reform, Senate bill includes PBM transparency, 1128
– Medicare accreditation

See LEGISLATION, FEDERAL, HR 3663

– N.Y. chains agree to free language services, 474
– Ore. adverse event reporting system, few pharmacies participating, 950
– “Pill mill,” pharmacist convicted (Kan. Dist. Ct.), In Brief, 617
– Plan B, pharmacists challenge to Ill. contraceptive dispensing requirement may proceed (Ill.), 7
– Rhabdomyolsis blamed on drug interaction, pharmacy had no duty to warn (N.D. Ind.), 857
– Tenn., disclosing drug cost information, bill passed, 621
– Wal-Mart settles recordkeeping charges, 46
– Walgreens accused of fraudulently switching dosage forms, dismissed (N.D. Ill.), 1030

PHARMACISTS AND PHARMACISTS

– New york

– – Language assistance required in N.Y.C., 1080

PHARMACY BENEFITS MANAGEMENT (PBM)

– Antitrust, Internet pharmacy denied access to PBM networks, claim time-barred (5th Cir.), 527
– D.C. PBM disclosure law preempted (D.D.C.), 333
– Express Scripts to buy WellPoint PBMs, 448
– Transparency

See LEGISLATION, FEDERAL, HR 3200

PHENERGAN

– Anti-nausea drug “IV push” blamed for gangrene and loss of guitar player's arm, failure to warn claim not preempted (U.S.), 249; Analysis & Perspective, 353; preemption limits, Analysis & Perspective, 388; discussed at conference, 564; effect on preemption defense, Analysis & Perspective, 658

PHYSICIANS

– Conflicts of interest

– – AstraZeneca to disclose payment to health care professionals who speak on its behalf, 623
– – Codes of conduct urged by industry group, 236
– – Gifts

See Gifts, this heading

– – Harvard Medical School to revise policy, 161
– – Increased disclosure sought by IOM, 511
– – Industry ties to MDs, MedPAC reports, 266
– – Medical students

– – – Industry funding under Senate scrutiny, 887
– – – Promotional items may influence unconscious attitudes, 569

– – Naval Medical Center MDs, Grassley (R-Iowa) probes industry payments, 890
– – Pfizer to disclose payments to health care professionals for consulting, speaking engagements, clinical trials, 189
– – Professional medical associations urged to reject industry funding, 380
– – Stanford med school to post MD-industry ties, 416

– Gifts

– – Conn. ban urged, 293
– – Federal reporting bill

See LEGISLATION, FEDERAL, S 301

– – Iowa Senate approves ban, 349
– – Mass. limits criticized, 71; conferences moved from Boston, 129; creates controversy, 158; final rules adopted, 292
– – Minn. bill to ban withdrawn, 378
– – N.Y. budget proposal includes industry gift ban, 20
– – Sunshine act, passages in 2009 predicted, 289

– Pondimin, prescribing MD is not seller entitled to indemnity from maker (Tex. App. Ct.), 641

PLAN B

See CONTRACEPTION

PLAVIX

– Active ingredient, patent not invalid for anticipation or obviousness (U.S., rev sought), 912
– Antiplatelet drug, less effective in some patients, FDA reports, 133
– Antitrust, former executive pleads guilty to false statements (D.D.C.), 401
– Independence Blue Cross placement of Plavix in highest tier upheld (E.D. Pa.), 707
– Infringement settlement (D.N.J.), In Brief, 972

POLYHEME

– Red blood cell substitute, maker shuts down, 594

PONDIMIN

– Diet drug, prescribing MD is not seller entitled to indemnity from maker (Tex. App. Ct.), 641

PRANDIN

– Diabetes drug patent validity, summary judgment denied (E.D. Mich.), 733

PRASUGREL

– Antiplatelet drug, FDA panel favors approval, 159; consumer group opposes, 649

PREMPRO

– HRT blamed for breast cancer, damage amount sealed (Pa. Ct. Com. Pl.), 1252

PRICING

– Ala. pharmacies suit over reimbursement, summary judgment denied (M.D. Ala.), 312
– Antitrust, Community Medical suit against drug maker over price may proceed (D. Minn.), 1218
– Brand name prices up in 2008, 481
– Canada

See CANADA

– EU, cheaper drugs, drug makers suspected of blocking, 813
– International developments

– – Brazil authorizes price hikes, 387
– – Mexico, Kaletra price cut, 387
– – Switzerland, erectile dysfunction drugs price-fixing alleged, 214

– Isentress price cut sought, 892
– Lamictal sold at discount, no settlement breach (D.N.J.), 763
– Lundbeck pricing suit may proceed (D. Minn.), 851
– McKesson settles price inflation claims (D. Mass.), 909
– Medicaid

See MEDICAID

– Medicare

– – Part B, changes to save money urged by HHS IG, 17
– – Price comparison tool at CMS criticized, 864

– Minn. generic pricing law, union funds sue pharmacy chains (D. Minn.), 1029
– Norvir

See NORVIR

– RICO suit brought by third-party payer over prices, settlement approved (D. Mass.), 307; appeal planned, 500; challenged, 553; upheld (1st Cir.), 1022
– State developments

– – Cal. counties denied class certification in suit against drug firms (N.D. Cal.), 611
– – Pa. price database launched, 293
– – Wis. Atty. Gen. settles with drug firms (Wis. Cir. Ct.), 11

PRILOSEC

– Food poisoning, maker accused of failure to warn (S.D. Ohio), 680
– Impax generic infringed valid patent (U.S., rev sought), 147; (rev den), 282
– Ulcer drug, generic did not infringe (S.D.N.Y.), 309

PRIVACY AND CONFIDENTIALITY

– CVS accused of failing to protect patient data (FTC), 199; pharmacists seek probe, 351
– Data mining

See DATA MINING

– De-identified health information and state regulation, Analysis & Perspective, 422
– State developments

– – N.H. considers requiring shredding of health records, 184
– – N.M. considers requiring notification of E-health breaches, 184
– – Trends, more states consider limits on health data marketing, 184
– – Va. considers requiring notification of health data breaches, 184

PROCRIT

– Anemia drug, qui tam suit against maker partially dismissed (1st Cir.), 968

PRODUCT LIABILITY

– Accutane blamed for inflammatory bowel disease, new trial ordered (N.J. Super. Ct.), 313
– Accutane, jury verdict for plaintiff thrown out (Fla. Dist. Ct. App.), 1252
– Aldara blamed for severe skin symptoms, claim time-barred (D. Utah), 257
– Aredia blamed for osteoporosis, summary judgment denied (M.D. Tenn.), 995
– Avandia

See AVANDIA

– Blood factor concentrates, Taiwanese hemophiliacs suits may proceed in Cal. (N.D. Ill.), 96
– Chantix

See CHANTIX

– Cholesterol drug unfavorable trial results, class action settled (D.N.J.), 908
– Digitek

See DIGITEK

– Effexor blamed for suicide, jury verdict for drug maker upheld (7th Cir.), 230
– Elidel suits remanded (D.N.J.), 734
– Etodoloc contamination blamed for death, summary judgment granted for maker (E.D. Pa.), 708
– Expert witnesses

See EXPERT WITNESSES

– Federal preemption in drug and device suits, Analysis & Perspective, 106
– Fosamax

See FOSAMAX

– Heparin adverse reaction, suit remanded to state court (S.D. Ala.), 255
– HRT

See HORMONE REPLACEMENT THERAPY (HRT)

– Injection devices, injuries blamed on continuous use (C.D. Cal.), 528
– Ketek, concealment of hazards alleged, depositions blocked (E.D.N.Y.), 557
– Legal outlook 2009, 79
– Methamphetamine costs incurred by government entities, ephedrine and pseudoephedrine makers not liable (8th Cir.), 39
– Metoclopramide

See METOCLOPRAMIDE

– Minocin, failure-to-warn claim not preempted (N.D. Ill.), 364
– Neo-Synephrine addiction, suit time-barred (N.D. Ill.), 177
– Neurotonin

See NEUROTONIN

– Nuvaring, defendants barred from conducting ex parte interviews with treating MDs (E.D. Mo.), 367
– Obama preemption memo reviewed, 841
– Outlook 2009, 135
– Pain patch

– – Design defect claim, strict liability does not apply (D. Utah), 912
– – Fatal dose, suit may proceed (S.D. W.Va.), 1228

– Pain pump

– – Access to settlement agreement ordered (S.D. Ind.), 1104
– – Cause of action not stated, drugmakers dismissed as defendants (D. Colo.), 1196
– – Expert witnesses

See EXPERT WITNESSES

– Paxil

See PAXIL

– Phenergan blamed for gangrene and loss of guitar player's arm, failure to warn claim not preempted (U.S.), 249; Analysis & Perspective, 353; preemption limits, Analysis & Perspective, 388; discussed at conference, 564; effect on preemption defense, Analysis & Perspective, 658
– Pondimin, prescribing MD is not seller entitled to indemnity from maker (Tex. App. Ct.), 641
– Prilosec, maker accused of failure to warn of food poisoning risk (S.D. Ohio), 680
– Redux, FDA approval preempts failure-to-warn claim (N.D. Ohio), 366
– Reglan

See REGLAN

– Remicide, blamed for pulmonary fibrosis, key expert excluded (11th Cir.), 203
– Seroquel

See SEROQUEL

– State developments

– – Ga. governor proposes protection for drug and device makers, 209
– – Mich. House approves repeal of immunity for drug firms, 378

– Sulindac blamed for SJS, federal law no bar to suit (D.N.H.), 1190
– Trasylol suit remanded to state court (S.D. Ill.), 1227
– Trileptal blamed for multi-organ sensitivity, suit dismissed (S.D. Ohio), 970
– Ulcer drug recall, plaintiff had no side effects denied, claim dismissed (N.D. Cal.), 529
– Vioxx

See VIOXX

– Vytorin misrepresentation claims, makers submit FDA evaluation on effectiveness (D.N.J.), 176
– Yasmin blamed for blood clots, consolidation of suits sought (J.P.M.L.), 882
– Zometa

See ZOMETA

– Zyprexa

See ZYPREXA

PROLIA

– Osteoporosis treatment, approval recommended by FDA panel, 808

PROPOXYPHENE

– Pain drug risks, FDA panel recommends taking off market, 155
– Pain drugs, FDA orders boxed warning, 803

PROPYLTHIOUACIL

– Hyperthyroidism drug, liver risk cited, 646

PROTONIX

– Acid suppressant drugs, Medicaid overcharges alleged (D. Mass.), 582
– Generic

– – Erosive esophagitis treatment, motion to enjoin generic denied (Fed. Cir.), 585
– – Gastroesphageal reflux drug, generic advertising challenged (E.D. Mich.), 554

PROVENGE

– Prostate cancer drug application planned, 1147
– Prostate drug, politically-motivated delay in approval alleged, dismissal affirmed (U.S., rev den), 61

PROVIGIL

– Narcolepsy drug off-label marketing, dismissal denied (E.D. Pa.), 996

PULMICORT

– Asthma drug maker seeks to block generic (D.N.J.), 436; blocked, 461; preliminary injunction, 610

PURCHASING POOLS

– Savings for group purchasing organizations reported, 539