Orange Book Blog

OBB News Briefs

• Teva announced Friday that it is acquiring Barr Pharmaceuticals for $7.5 billion plus $1.5 billion in debt.  For more:  AP; Reuters; WSJ.
• Zentiva, the Czech generic drug maker, announced Friday that it rejected a takeover bid from Sanofi-Aventis.  Sanofi already owns 25% of the company.
• Meanwhile, the WSJ Health Blog recently reported that the CEOs of GSK and Roche have no interest in getting into the generics business.
• FDA Law Blog recently reported on two interesting USPTO decisions denying Patent Term Extension requests under 35 U.S.C. § 156.  In both cases, AstraZeneca was the applicant:  July 8 (Symbicort); July 16 (Prilosec OTC).
• On July 16, Impax and Wyeth announced a settlement of their litigation over Impax's generic version of Effexor XR.  Under the agreement, Impax may launch its capsule formulation of Effexor XR on June 1, 2011, and possibly as early as January 1, 2011.
• On July 11, Momenta Pharmaceuticals announced the filing of an ANDA with a paragraph IV certification for a generic version of Copaxone, Teva's $500 million multiple sclerosis drug.  According to Pharmalot, Teva's CEO is not concerned.
• The Baltimore Sun recently reported that the brand-name pharmaceutical industry has been successfully pushing legislation at the state level requiring pharmacists to inform doctors or get their permission before substituting a generic drug for a brand-name drug.
• The FDA announced on July 9 that it is revising the way it communicates to drug companies when a marketing application cannot be approved as submitted.  CDER will no longer issue "approvable" or "not approvable" letters.  For more:  Pharmalot; WSJ Health Blog.
• The WSJ Health Blog had an interesting post recently about a report from the HHS Inspector General, finding that FDA typically takes longer than the 180 days allowed under law to review a generic drug application.
• The Mircera case between Amgen and Roche is attracting a great deal of attention, particularly because of the "public interest" factor of the injunction analysis.  Pharmalot has more on the case.
• Insmed recently announced that it has developed a biosimilar version of Amgen's Neupogen, a $1 billion drug for the treatment of Neutropenia.  Pharmalot has more.

OBB News Briefs

• The Federal Trade Commission announced the release of its FY 2007 Summary of Pharmaceutical Company Settlement Agreements.  For commentary, see FDA Law Blog, Pharmalot.
• Wyeth sued Sandoz over a generic version of Protonix I.V.  The WSJ Health Blog recapped all the Protonix ANDA litigation.
• India's drugmakers recently threatened to stop production of 33 bulk drugs, Pharmalot reports.
• The Washington Legal Foundation announced that it filed an amicus brief urging the Federal Circuit to rehear the Caraco v. Forest Labs case.

OBB News Briefs

• As reported by FDA Law Blog, FDA determined on May 7 that Cobalt forfeited its 180-day exclusivity on acarbose and Cobalt sued FDA on May 8 for injunctive relief.  Last Friday, for some reason, Cobalt voluntarily dismissed its suit against FDA.
• Also last Friday, FDA appealed the D.C. district court's decision requiring relisting of Janssen's patent on Risperdal (risperidone).
• Ivax recently filed a declaratory judgment complaint against AstraZeneca, reportedly seeking to trigger Ranbaxy's 180-day exclusivity on esomeprazole.  AstraZeneca and Ranbaxy settled their esomeprazole litigation last month.
• The district court in Washington, D.C. recently transfered the FTC v. Cephalon "reverse payment" antitrust case to the Eastern District of Pennsylvania, Reuters reported, possibly throwing a wrench into the FTC's plans to get a "reverse payment" case before the Supreme Court.
• Pharmalot had an interesting post last week on the coming wave of generic drugs from Chinese generic drug companies.

OBB News Briefs

• Last Thursday, FDA Law Blog reported on the Lupin v. Abbott case scheduled for oral argument at the Federal Circuit on Wednesday.  The case concerns a very unusual situation, where Abbott obtained two patent term extensions under 35 U.S.C. § 156 for a single drug product.
• In what is being reported as a setback for the prospects of a biosimilars industry in the United States, the FDA recently denied Genzyme's request to change the manufacturing site of its drug Myozyme.  For more: Boston Globe, Pharmalot, WSJ Health Blog.
• The L.A. Times published an interesting op-ed last week about safety concerns with biotech drugs.
• The New York Times reported last week on a lobbying fight between the brand-name and generic drug industries over inequitable conduct provisions in patent reform legislation.
• FDA Law Blog recently updated their coverage of two interesting cases: Teva vs. FDA, concerning 180-day exclusivity on Risperdal, in which Apotex filed a motion to intervene; Nu-Pharm v. FDA, Nu-Pharm's ANDA for generic Depakote, in which the D.C. Circuit summarily affirmed the district court's decision in favor of FDA.
• On April 16, a district court denied Perrigo's motion for summary judgment that its generic version of Olux (clobetasol propionate foam), a treatment for scalp psoriasis, does not infringe Connetics' U.S. Patent No. 6,126,920.
• On March 19, a district court denied Ranbaxy's motion for summary judgment that Roche's patent on Valcyte (valganciclovir HCl), U.S. Patent No. 6,083,953, is invalid due to incorrect inventorship.  Numerous other summary judgment motions are still outstanding in the case.

OBB News Briefs

• Earlier this week, FDA Law Blog provided an update on Teva's suit against the FDA, seeking relisting of Janssen's patent on Risperdal (risperidone) and confirmation of Teva's 180-day exclusivity on a generic version of the drug.
• Last week, FDA Law Blog reported on a recent FDA determination that Watson Labs forfeited its 180-day exclusivity on generic Camptosar (irinotecan HCl) because it failed to obtain tentative approval of its ANDA within 30 months of filing, as required by the MMA.
• Pharmalot and the WSJ Health Blog recently ran posts on a series of articles in the Los Angeles Times examining whether generic drugs are as good as brand-name drugs.
• Eighteen states recently sued Abbott Labs for antitrust violations, alleging that Abbott made trivial changes to the formulation of its TriCor cholesterol drug, thereby delaying generic competition.  Statements were released by the Attorneys General from Florida and Iowa.
• William Kovacic was appointed the new Chairman of the Federal Trade Commission this week, succeeding Deborah Platt Majoris.  The Wall St. Journal reported that Mr. Kovacic has been a strong proponent of FTC action against "reverse payment" settlements.

OBB News Briefs

• Last Friday, Rep. Anna G. Eshoo (D-CA) announced that she and Rep. Joe Barton (R-TX) introduced H.R. 5629, the "Pathway for Biosimilars Act" (click here for summary; click here for text of bill).  BIO immediately applauded the bill, while GPhA immediately denounced it.  For more, visit FDA Law Blog; Pharmalot; or the WSJ Health Blog.
• Barr Labs and Teva are two of the world's largest, and most litigious, generic drug companies.  Their CEO's gave extensive interviews to separate newspapers last week: Barr's CEO Bruce Downey to Investor's Business Daily and Teva's CEO Shlomo Yanai to Globes.
• We reported in January that Teva filed a citizen petition asking FDA to relist J&J's patent on Risperdal and to grant it 180-day exclusivity on the generic.  Recently, FDA law blog and Patent Baristas reported that FDA denied Teva's petition on February 26, and Teva responded by filing suit against FDA on March 4.  Also see: Reuters and Teva press release.
• The Wall St. Journal reported last week that Thailand is poised to disregard patents on several cancer drugs.  The WSJ Health Blog has a summary of the article.
• Teva announced last month that it received approval for the first biosimilar G-CSF in Europe.

OBB News Briefs

• The New York Times had another article Thursday on the investigation into the Chinese supply of heparin.  Pharmalot had this related post Friday.
• FTC Commissioner Jon Leibowitz wrote an editorial for the Washington Post Monday on "reverse-payment" settlements (or "pay-for-delay" settlements), and the FTC's recently filed case against Cephalon, in particular.
• Dow Jones reported Monday that Apotex and Pfizer settled their patent litigation over generic Neurontin (gabapentin).  Pfizer's cases against Eon Labs, Purepac and Teva are continuing.
• FDA Law Blog had an interesting post on a long-shot citizen petition filed by Apotex, who is seeking to recover its 180-day exclusivity on generic Plavix (clopidogrel).
• Also last week, FDA Law Blog posted a draft of Rep. Eshoo's biosimilar's bill.  Word on the street is that it has little chance of passing.
• Pharmalot reported last week that growth in sales of generic drugs slowed to just 3.8% last year, largely due to increased competition.

OBB News Briefs

• The Biotechnology Industry Organization CEO, Jim Greenwood, spoke with reporters and bloggers Thursday morning about follow-on biologics and patent reform.  Mr. Greenwood sounded optimistic that a forthcoming bill sponsored by Reps. Eshoo and Barton will represent a reasonable compromise between earlier proposals that stalled in Congress last year.  Patent Docs has two posts summarizing the call.  The AP was there too.
• The Federal Trade Commission announced Wednesday that it has sued Cephalon "for a course of anticompetitive conduct that is preventing competition to its branded drug Provigil."  According to the FTC's complaint, Cephalon paid four generic drug companies a total of more than $200 million to abandon their paragraph IV patent challenges.  Cephalon responded with a press release.  For more information, see: Antitrust Review; Pharmalot; and WSJ Health Blog.
• Reuters reported Wednesday that AstraZeneca has no plans to settle its Hatch-Waxman cases concerning Nexium and Seroquel.
• After the FDA announced Monday that Baxter's heparin has been linked to severe allergic reactions, reports surfaced in the Wall St. Journal, New York Times and Capital Times implicating the Chinese plant that manufactures the drug's active ingredient.  Thursday, Pharmalot posted an interview with a Rutgers business professor, who thinks the pharmaceutical industry should stop doing business with China entirely.
  

OBB News Briefs

• Fosamax, Merck's blockbuster osteoporosis drug, went generic on Wednesday.  The In Vivo Blog posted an interesting report on the unusual steps Merck took to promote Fosamax in the last month, before its patents expired.
• The WSJ Health Blog posted an interesting story this week on contributions from the pharmaceutical industry to the presidential candidates.  Apparently drug company employees are not fans of John McCain.
• FDA Law Blog reported Tuesday that the Bush Administration announced, as part of its FY2009 budget proposal, that it will seek new statutory authority to allow FDA to approve follow-on biologics in abbreviated applications.  In response to the budget announcement, Insmed, Inc., a developer of follow-on biologics and biopharmaceuticals, announced that it is launching a "national awareness" campaign on follow-on biologics.
• FDA Law Blog reported last week that the district court in D.C. dismissed Nu-Pharm's lawsuit against the FDA, in which Nu-Pharm sought to force FDA to grant final approval to its ANDA for a generic version of Abbott Labs' Depakote.  Nu-Pharm, a former subsidiary of Apotex, has appealed the decision to the D.C. Court of Appeals.
• On Feb. 1, FDA posted a new comprehensive list of FDA Guidance Documents, which could come in handy for FDA-regulated companies.
• Wyeth recently launched of an authorized generic version of Protonix, as Pharmalot and the WSJ Health Blog reported.  The WSJ Health Blog also reported on speculation about why Teva declined to ship any additional generic Protonix.

OBB News Briefs

• Earlier this week, FDA released its highly anticipated response concerning granisetron 180-day exclusivity.  This marks the first time that FDA has interpreted the "failure to market" forfeiture provisions of the 2003 MMA.  FDA Law Blog posted a nice summary of FDA's response.
• FDA Law Blog also posted on a very interesting case recently filed by Nu-Pharm against FDA, in which Nu-Pharm seeks to force FDA to grant it final approval to market generic Depakote (divalproex sodium).
• The Wall St. Journal had an interesting article yesterday on health plans that pay doctors $100 each time they switch a patient to a generic drug.  The WSJ Health Blog posted this summary of the article.
• A district court in New York recently held that three Purdue Pharma patents on Oxycontin are not unenforceable for inequitable conduct.
• Cypress Pharmaceutical announced today that it has settled patent litigation with GSK concerning its generic version of Zantac (ranitidine) syrup.