Orange Book Blog

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.

OBB News Briefs

• Teva announced last week that it was granted 180-day exclusivity for its generic Kytril injection product (granisetron HCl, 1 mg/mL in 1 mL vials).  Thus, it appears the FDA decided the 180-day exclusivity issue raised in Teva's citizen petition--namely, whether Teva's failure to market its generic product within 30 months of ANDA submission caused forfeiture of its exclusivity.  FDA is expected to release a formal response to Teva's petition in the near future.
• King Pharma and CorePharma settled their patent litigation over generic Skelaxin (metaxalone).  According to this AP story, however, analysts disagreed over the impact of the settlement.
• Taro Pharma and Breckenridge Pharma announced settlements with Novartis of their patent cases concerning generic Trileptal (oxcarbazepine).  According to their press releases, Taro and Breckenridge are sharing 180-day exclusivity for the product.
• Bloomberg published an interesting article earlier this week about the faltering biotechnology industry in China.
• Both Pharmalot and the WSJ Health Blog had posts this week about a Bloomberg story that reported the FDA approved only 19 new drugs last year, the fewest since 1983.
• Pharmalot also posted this week on a new report from Cutting Edge Information entitled "Combating Generics 2008," which found that 66 percent of brand name drug companies do not begin strategizing against generics until at least two years after product launch.

Pharma News Briefs

• Eisai announced yesterday that the district court in New Jersey recently dismissed its lawsuit against Mutual Pharma concerning Aricept ODT.  The case was dismissed on jurisdictional grounds because Mutual has not challenged Eisai's patent.
• The Wall St. Journal had an interesting article Wednesday about Sun Pharma's generic version of Wyeth's blockbuster antidepressant Effexor XR.  AP published this related story last week.
• On Monday, Teva announced that it launched generic Protonix (pantoprazole).  In response, Wyeth announced that it will pursue monetary damages from Teva.  For more, see Pharmalot and the WSJ Health Blog.  As we previously reported, in September a district court denied Wyeth's motion for a preliminary injunction against Teva.
• FDA Law Blog reported last week that the district court in Washington, D.C. enjoined the federal government's Average Manufacturer Price (AMP) rule for pharmaceutical reimbursement.
• Pharmalot had an interesting post last week about a recent report on the various types of pharmaceuticals in Phase I studies.
• Depomed announced on December 13 that a district court in California granted summary judgment of infringement in its patent case against IVAX concerning generic Glumetza.
• AstraZeneca announced on December 12 that it filed patent infringement suits against seven generic drug makers who filed ANDAs for generic versions of Crestor (rasuvastatin calcium).  See also this Reuters article.

Pharma News Briefs

• Prof. Chris Holman, who has contributed to this blog in the past, recently started his own blog: Holman's Biotech IP Blog.  Formerly in-house counsel at a biotech company, Chris offers valuable insights on biotech IP law.
• "Big Pharma Faces Grim Prognosis" was the top story on the front page of the Wall Street Journal Thursday.  It proclaims: "Over the next few years, the pharmaceutical business will hit a wall."  Summaries of the article appear on the WSJ Health Blog and Pharmalot.
• Watson Pharmaceuticals announced Thursday that it settled patent litigation with Novartis concerning its generic version of Novartis's Exelon.
• Sun Pharma also announced a settlement with Novartis on Thursday, concerning its own generic version of Exelon.  On October 23, Sun announced that the FDA granted final approval to its ANDA for generic Exelon.
• On Tuesday, Watson announced that it settled litigation with Biovail over its generic version of Cardizem LA.  Biovail also put out its own press release.
• King Pharmaceuticals announced Monday that the Federal Circuit denied its petition for rehearing and rehearing en banc of the Federal Circuit's September 11 decision invalidating the patent on Altace.