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

• Last Monday, the Federal Circuit affirmed a district court decision in McNeil-PPC v. Perrigo, concerning a generic version of Pepcid Complete.  The decision was affirmed without an opinion, under Rule 36.
• Tuesday, AstraZeneca and Ranbaxy announced a settlement of their patent litigation over generic Nexium (esomeprazole), with Astra granting Ranbaxy exclusive rights to sell a generic version of Nexium in 2014, six months before the first patent expires.  Teva and Dr. Reddy's plan to continue challenging Astra's patents.  Astra press release; Ranbaxy press release; AP; Bloomberg; Pharmalot; WSJ Health Blog.
• In a very surprising decision, a D.C. district court recently ruled in favor of Teva in a case in which Teva alleged that the FDA wrongfully delisted a patent on Risperdal (risperidone) from the Orange Book, depriving Teva of 180-day exclusivity.  FDA Law Blog has a full report.
• Earlier this month, Depomed announced a settlement of patent litigation against Teva over generic Glumetza (metformin HCl).  Depomed press release; AP story.
• Pharmalot recently had two interesting posts about biosimilars: the first suggested, based on a report about the Food and Drug Law Institute's annual meeting, that biosimilars legislation may actually be passed this year; the second reported on lobbying for a biosimilars bill.
• FDA Law Blog recently updated their coverage of the generic Depakote (divalproex sodium) litigation between Nu-Pharm (a former subsidiary of Apotex) and FDA, in which Nu-Pharm is seeking an injunction requiring FDA to grant final approval to its divalproex ANDA.
• Pharmalot posted a summary of a recent article in the Seattle Post-Intelligencer about a citizen petition that has stymied Nastech Pharmaceutical's bid to market a generic version of Miacalcin (calcitonin), a treatment for postmenopausal osteoporosis.
• Takeda announced earlier this month that on March 31, the Supreme Court denied Alphapharm's cert petition from the Federal Circuit's decision last year in the Actos (pioglitazone) litigation.

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.

Pharma News Briefs

• FDA recently posted numerous comments from industry regarding Ramipril 180-day exclusivity issues on its website.  The comments come in response to FDA's request last month.  A summary of the new comments is in the works.
• FDA also established a docket for comments on Granisetron HCl 180-day exclusivity issues.  This too follows an FDA request made last month.
• Yesterday, the WSJ Health Blog had two pessimistic reports on the pharmaceutical industry: "Drug Drought Deepens as FDA Approvals Lag" and "Pharma Woes Won't Let Up Soon."
• On a happier note, Wednesday, the U.S. District Court for the Eastern District of Virginia granted GSK's motion for a preliminary injunction against the USPTO, halting implementation of the PTO's new claims and continuation rules (see Patent Docs).
• Also on Halloween, the New York Time published a spooky article entitled "Chinese Chemicals Flow Unchecked Onto World Drug Market."  Reuters published a similar article the next day.  This can't be good publicity for pharmaceutical companies--both innovators and generics alike--who are increasingly outsourcing production of key ingredients to China.
• On Tuesday, the Federal Circuit denied rehearing of BIO and PhRMA v. District of Columbia, in which the court previously found Washington, D.C.'s drug price control law to be unconstitutional (see Patently-O).
• Last week, Sen. Bernie Sanders (D-VT) introduced a new bill that would scrap patent and market exclusivity for drugs and replace it with a "medical innovation prize fund" (see FDA Law Blog and Pharmalot).  I suspect that this bill is DOA, and therefore nothing to fear.
• Also last week, the WSJ Health Blog reported on Amgen's big win in its patent infringement suit against Roche's Mircera drug.
• A couple weeks ago, BioPharma Reporter published an interesting article, "U.S. Dragging its Heels on Biosimilars, Report Says."

BIO CEO Jim Greenwood Discusses Follow-On Biologics in Conference Call With Bloggers

Jim Greenwood, CEO of the Biotechnology Industry Organization (BIO), spent some quality time this afternoon answering questions from bloggers about follow-on biologics, patent reform, and FDARA/PDUFA legislation.

Mr. Greenwood said that follow-on biologics are a "critical, critical issue" for BIO.  From BIO's perspective, the ideal bill would reflect and parallel the Hatch-Waxman Act.  It would include 14 years of data exclusivity for innovators and would let physicians decide, on a case-by-case basis, whether to allow substitution of a brand-name biologic with a follow-on at the pharmacy.

Mr. Greenwood stated that 14 years of data exclusivity is needed in order to ensure a steady stream of new innovative drugs from the biotechnology industry.  He explained that patent protection is generally adequate to protect small molecule drugs, which have, on average, 13.5 years of market exclusivity prior to generic entry.  However, according to Mr. Greenwood, it is relatively easy for generic companies to design-around patents on biotech drugs and yet still take advantages of similarities for purposes of FDA approval.  Because patent protection is insufficient, data exclusivity is key.

With regard to interchangeability, Mr. Greenwood said that the decision to allow substitution of an innovator biotech drug with a follow-on should be left to physicians for safety reasons.  He said that such an arrangement would be preferable to giving the power to insurance companies.

In response to a question about reports that the generic drug industry is content to wait for passage of follow-on biologics legislation until the next Congress, when they might get a better deal, Mr. Greenwood emphasized that it is in the generic industry's interest as well for there to be a sufficient period of data exclusivity (without new drugs from the innovators, there will be no new drugs from the generics).  He stated that BIO is "not going to take a bad deal in this Congress for fear of the outcome of the next presidential election."  In the end, Mr. Greenwood predicted that the two sides would be able to come together before the next election, with a little prodding from Congress.

Patent Docs was on the call too.  They have this post about Mr. Greenwood's comments on patent reform.

RELATED READING:

• Good background info on follow-on biologics: Aug. 30 NEJM article
• Patent Baristas and Pharmalot also posted summaries of today's call

Pharma News Briefs

• The Federal Circuit reissued its July 11 opinion in Daiichi Sankyo v. Apotex as a precedential opinion, one day after denying Daiichi's petition for rehearing.  According to Hal Wegner, a major reason for making the decision precedential was Prof. Joseph Scott Miller's Rule 47.6(c) filing.
• Biosimilars legislation is "off the table" for now.  The FDA bill is moving forward without it.  (Bloomberg; Pharmalot).
• Novartis is set to launch its biosimilar Epoetin in Europe.  (msnbc.com).
• Cubist Pharmaceuticals has asked the FDA to delist a patent on its lead product, Cubicin, from the Orange Book.  (The Street.com).
• FDA issued final guidance on commercially distributed Analyte Specific Reagents, such as antibodies and nucleic acids.  (FDA Law Blog).
• Dr. Reddy's and Teva settled their patent dispute over generic Zoloft.  Teva had alleged that Dr. Reddy's infringed its sertraline HCl polymorph patents.  (Patent Docs; TMCnet.com).
• Imclone and Repligen/MIT settled their patent dispute over Erbitux.  (Patent Prospector).
• Ranbaxy vs. Pfizer worldwide Lipitor patent litigation scorecard: mixed results.  (MarketWatch.com).
• Feroz Ali Khader has written a new book on Indian patent law, particularly as it relates to pharmaceuticals.  (Generic Pharmaceuticals & IP blog).
• Mr. Kapil Sibal, Honorable Minister for Science and Technology in India, will be speaking tomorrow, September 17 at 4 pm at the George Washington University Law School.  (Flyer; Program).

Pharma News Briefs

• Novartis announced last week that European regulators have approved its follow-on biologic epoetin alfa, which is biosimilar to J&J's Eprex.  Pharmalot posted this story today about J&J's reaction.
• The WSJ Health Blog had this interesting post last week reporting that more clinical trials are now under way in China than in India.
• Adams Respiratory Therapeutics is facing a patent challenge by Perrigo over its Mucinex cough medicine.  Bloomberg recently published this report; MarketWatch.com had this one.
• The Wall St. Journal published this interesting article (subscription) a couple weeks ago about a drug development partnership between Eli Lilly and Chi-Med, a Chinese biotechnology company.
• FDA Law Blog had this post last month about impending FDA enforcement action on marketed unapproved drugs.
• Finally, a couple oldies but goodies from Pharma's Cutting Edge: Ariad v. Lilly patent litigation; response to Richard Epstein's Overdose.