Intellectual Property Law
Orange Book Blog: At the Intersection of Patent Law and FDA Law 
Reports on issues at the intersection of patent law and FDA law including all aspects of pharmaceutical patent law, judicial decisions and regulatory and legislative developments.
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ACI "Maximizing Pharmaceutical Patent Life Cycles" Conference, New York, October 7-8
Posted on September 12, 2009American Conference Institute is hosting a special 10th Anniversary Edition of its annual "Maximizing Pharmaceutical Patent Life Cycles" conference on October 7th and 8th in New York. According to ACI, this is "the one and only event that consistently allows...
Federal Circuit Affirms Invalidity of Bayer Patent on Yasmin
Posted on August 06, 2009Bayer Schering v. Barr Labs, No. 2008-1282 (Fed. Cir. 2009) A divided panel of the Federal Circuit today affirmed a district court decision holding Bayer's U.S. Patent No. 6,787,531 invalid due to obviousness. The '531 patent, which claims pharmaceutical compositions...
ACI's FDA Boot Camp Coming to Chicago and Boston
Posted on July 16, 2009American Conference Institute's popular "FDA Boot Camp" conference is coming to Chicago next week, July 21-22, and to Boston on September 15-16. The conference is billed as "basic training for products liability and patent lawyers." Presentations likely of most interest...
Supreme Court Denies Cert Petition in Lovenox Case
Posted on April 29, 2009Aventis Pharma v. Amphastar and Teva, S. Ct. Appeal No. 08-937 (2009) The Supreme Court on Monday denied Aventis Pharma's cert petition in a long-running dispute with generic biopharmaceutical manufacturer Amphastar. In its petition, Aventis had asked the Court to...
FDA: Under the QI Act, No 30-Month Stay Will Apply to ANDAs Referencing "Old Antiboiotics" and Containing a P.IV Certification to a Later-Listed Patent
Posted on March 18, 2009I'll have a post later today. For now, here is FDA's citizen petition response, released yesterday.
Federal Circuit Affirms Extension of 30-Month Stay Against Teva's Generic Evista
Posted on February 24, 2009Eli Lilly & Co. v. Teva Pharms. USA, Inc., No. 2009?1071 (Fed. Cir. 2009) Under the Hatch-Waxman Act, final FDA approval of an ANDA is automatically stayed for thirty months when a patent owner files suit for patent infringement within...
Sanofi Prevails Over Apotex in Plavix Appeal
Posted on December 12, 2008Sanofi-Synthelabo et al. v. Apotex, No. 2007-1438 (Fed. Cir. 2008) The Federal Circuit today affirmed the decision of the U.S. District Court for the Southern District of New York, following a 2007 bench trial, that Sanofi's U.S. Patent No. 4,847,265...
Federal Circuit Affirms $16.8 Million Award of Fees to Takeda in Pioglitazone Case
Posted on December 10, 2008Takeda v. Mylan and Alphapharm, Nos. 2007-1269, -1270 (Fed. Cir. 2008) In an opinion released Monday, the Federal Circuit affirmed a district court decision granting $16.8 million for attorney fees, expenses and expert fees to Takeda for baseless paragraph IV...
FTC Roundtable, "Competition Issues Involving Follow-On Biologic Drugs," Washington, November 21
Posted on November 16, 2008The Federal Trade Commission is hosting a roundtable entitled "Competition Issues Involving Follow-On Biologic Drugs," Friday, November 21, at its headquarters in Washington. Speakers include industry leaders, government officials, outside counsel and others...
ACI "Paragraph IV On Trial" Conference, New York, November 19-20
Posted on November 07, 2008American Conference Institute is presenting its first-ever "Paragraph IV On Trial" Conference, November 19-20 in New York. This is a unique conference, with the format of a mock trial in a Hatch-Waxman case. ACI states: "Structured as an actual trial...
BNA "Pharmaceutical Patent Laws" Conference, Arlington, VA, November 12
Posted on October 18, 2008BNA Legal & Business Edge is presenting a conference entitled "Pharmaceutical Patent Laws: A Prescription for Success in Challenging Times, November 12 in Arlington, VA. According to BNA, this will be a "fast-paced conference on the latest developments and changes...
C5 "EU Pharma Law and Regulation" Conference, Geneva, November 4-5
Posted on October 12, 2008C5 is presenting a conference next month entitled "EU Pharma Law and Regulation." It will take place November 4-5 in Geneva, Switzerland. According to C5, "From the EU Pharma Sector Inquiry to recent parallel trade cases, the continued growth of...
Federal Circuit Affirms Dismissal of Declaratory Judgment Counterclaims in Trusopt/Cosopt Case
Posted on October 09, 2008Merck & Co. v. Apotex, No. 2008-1133 (Fed. Cir. 2008) In 2005, Hi-Tech Pharmacal became the first company to file a paragraph IV certification relating to Merck's glaucoma drugs Trusopt and Cosopt. Hi-Tech filed paragraph IV certifications with respect to...
Federal Circuit Affirms Dismissal of Prasco's Declaratory Judgment Suit Against Medicis
Posted on October 07, 2008Prasco v. Medicis Pharm. Corp., No. 2007-1524 (Fed. Cir. 2008) Medicis markets a benzoyl peroxide cleansing product, Triaz. Prasco sells a competing benzoyl peroxide cleansing product, Oscion. Prasco filed a declaratory judgment complaint, requesting judgment that Oscion does not infringe...
Non-Patent Exclusivity and 180-Day Exclusivity Forfeiture Slides Posted
Posted on October 01, 2008Last week, I gave a talk about non-patent exclusivity at ACI's FDA Boot Camp conference in Boston. The talk covered new chemical entity (5-year) exclusivity; new clinical trial (3-year) exclusivity; orphan drug exclusivity; pediatric exclusivity; and generic drug (180-day) exclusivity...
CBI "Paragraph IV Disputes" Conference, Philadelphia, October 15-16
Posted on September 27, 2008On October 15-16 in Philadelphia, the Center for Business Intelligence will hold a conference entitled "Pharmaceutical Congress on Paragraph IV Disputes: Navigating Regulations and Enforcement Trends to Increase Preparedness and Optimize Paragraph IV Strategies...
ACI "Maximizing Pharmaceutical Patent Life Cycles" Conference, New York, October 15-16
Posted on September 21, 2008American Conference Institute is holding its ninth annual "Maximizing Pharmaceutical Patent Life Cycles" conference October 15-16 in New York. According to ACI, this "definitive Hatch-Waxman event provides the crucial information for pharmaceutical patent counsel to cultivate, modify, and enhance a...
ACI "FDA Boot Camp" Conference, Boston, September 22-23
Posted on September 05, 2008American Conference Institute will be holding another "FDA Boot Camp" in Boston, September 22-23. The conference is designed to give patent lawyers, product liability lawyers, and life sciences investment and securities experts a strong working knowledge of core FDA regulatory...
Federal Circuit Narrows the Scope of the Section 271(e)(1) Research Exemption
Posted on August 07, 2008Proveris Scientific Corp. v. Innovasystems, No. 2007-1428 (Fed. Cir. 2008) 35 U.S.C. § 271(e)(1) states: It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United...
District Court Denies Early Motion For Rule 11 Sanctions in Ritalin LA Case
Posted on August 04, 2008Celgene and Novartis v. KV Pharm., No. 07-4819 (D.N.J. 2008) KV Pharmaceutical filed an ANDA for a generic version of Ritalin LA (methylphenidate HCl extended-release capsules) with paragraph IV certifications to Celgene's U.S. Patent Nos. 5,837,284 and 6,635,284...
ACI "Biotech Patents" Conference, Boston, September 15-16
Posted on July 31, 2008ACI's "Biotech Patents" conference will be held at the Royal Sonesta Hotel in Boston, September 15-16. According to ACI, this is the "ONE place biotech patent practitioners come to learn and discuss the most recent and vital changes facing the...
Federal Circuit Affirms Validity and Enforceability of Eisai's Compound Patent on Aciphex
Posted on July 22, 2008Eisai v. Dr. Reddy's and Teva, Nos. 2007-1397, -1398 (Fed. Cir. 2008) Patents on chemical compounds are holding up well to obviousness arguments in the Federal Circuit, even after KSR. In an opinion released today, the Federal Circuit affirmed the...
OBB News Briefs
Posted on July 20, 2008Teva 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...
C5 "Biotech Patenting" Conference, London, September 23-24
Posted on July 18, 2008C5 will be bringing its popular "Biotech Patenting" conference to London on September 23-24. According to C5, the conference "provides updates on the latest developments in biotech patenting, including recent case law and regulatory developments." The conference is unique in...
Federal Circuit Vacates Dismissal of Delaratory Judgment Counterclaims in Fosamax Case as Moot
Posted on July 16, 2008Merck & Co. v. Apotex, No. 2007-1362 (Fed. Cir. 2008) Fosamax (alendronate sodium) is one of the all-time best-selling drugs for the treatment and prevention of osteoporosis, with over $3 billion in U.S. sales last year. Merck listed ten patents...
AstraZeneca Wins Seroquel Case on Summary Judgment; Teva and Sandoz to Appeal
Posted on July 13, 2008AstraZeneca v. Teva Pharms. USA and Sandoz, No. 05-5333 (D.N.J. 2008) On July 1st, the U.S. District Court for the District of New Jersey granted AstraZeneca's motion for summary judgment that its patent on quetiapine fumarate, the active ingredient in...
Federal Circuit Affirms Acular LS Decision in Favor of Roche and Allergan, and Against Apotex
Posted on July 09, 2008Roche Palo Alto and Allergan v. Apotex, No. 2008-1021 (Fed. Cir. 2008) In an opinion released today , the Federal Circuit affirmed a district court decision granting summary judgment that Roche's U.S. Patent No. 5,110,493 is valid and infringed by...
Book Review: Generic Pharmaceutical Patent and FDA Law
Posted on July 08, 2008Shashank Upadhye has written a new text, Generic Pharmaceutical Patent and FDA Law, that anyone reading Orange Book Blog will certainly find useful. Mr. Upadhye is Vice President & Global Head of Intellectual Property for Apotex. The book provides a....
OBB News Briefs
Posted on July 07, 2008On June 25, the Congressional Budget Office released a cost estimate for the Biologics Price Competition and Innovation Act of 2007 (S. 1695), concluding that the biosimilars bill would save American consumers $25 billion on prescription drug costs over the...
In a "Surprising" Victory, Barr and Mylan Invalidate Boehringer Ingelheim's Patent on Mirapex
Posted on July 03, 2008Boehringer Ingelheim v. Barr and Mylan, No. 05-700-JJF (D. Del. 2008) Last week, following a bench trial held in March, the U.S. District Court for the District of Delaware held that Boehringer Ingelheim's patent on Mirapex (pramipexole dihydrochloride) is invalid...
Mutual Pharmaceutical Jumps the Gun By Sending Paragraph IV Notice Letter Before Acceptance of ANDA
Posted on July 01, 2008GlaxoSmithKline v. Mutual Pharm., No. 08-549 (E.D. Pa. 2008) The U.S. District Court for the Eastern District of Pennsylvania recently granted a motion for judgment on the pleadings in a paragraph IV case because the ANDA filer sent its notice...
After Court Victory over FDA, Teva Receives Final Approval of Risperidone ANDA and Launches With 180-Day Exclusivity
Posted on July 01, 2008Teva announced yesterday that the FDA granted final approval to its ANDA for generic Risperdal (risperidone) tablets, that it was awarded 180-day exclusivity as the first paragraph IV filer for risperidone, and that it immediately commenced a commercial launch...
FDA Denies King Pharma's Citizen Petition Concerning Altace, Approves Ramipril ANDAs
Posted on June 25, 2008We reported last month that King Pharmaceuticals filed a citizen petition that could delay final approval of numerous ANDAs for generic versions of Altace (ramipril), which were set to earn final approval on June 7. King's citizen petition asked FDA....
Federal Circuit Refuses to Rehear Caraco v. Forest
Posted on June 24, 2008We previously reported that on April 1, in a 2-1 decision in Caraco v. Forest, the Federal Circuit held that an ANDA applicant may in some circumstances bring a declaratory judgment action for noninfringement even if the patentee has granted...
Mylan Prevails Over AstraZeneca in Appeal of Prilosec Case
Posted on June 11, 2008In re Omeprazole Patent Litigation, Nos. 2007-1476, -1477, -1478 (Fed. Cir. 2008) Yesterday, the Court of Appeals for the Federal Circuit affirmed a June 2007 district court decision finding that Mylan's generic version of Prilosec (omeprazole) does not infringe two...
OBB News Briefs
Posted on June 02, 2008The 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...
C5 "Pharma Patent Lifecycles" Conference, London, June 26-27
Posted on May 28, 2008C5 will be holding a "Pharma Patent Lifecycles" conference June 26-27 in London. According to C5, "since 2001, thousands of life sciences patent professionals have made C5's Pharma Patent Lifecycles conferences their source of information for the most up-to-date legal...
King Pharmaceuticals Files Citizen Petition Relating to New Patent on Altace (Ramipril)
Posted on May 27, 2008King Pharmaceuticals markets Altace (ramipril), which is indicated for the treatment of high blood pressure. Until last year, when the Federal Circuit invalidated King's compound patent on ramipril, King earned about $700 million annually from U.S. sales of Altace...
Patent Litigation Under a Future Biosimilars Act
Posted on May 21, 2008Biopharmaceuticals, such as Epogen® (epoetin) and Erbitux® (cetuximab), are becoming increasingly important for the treatment of disease. U.S. sales of such drugs were about $40 billion in 2006 and are expected to rise to over $90 billion in 2009. Accordingly,...
OBB News Briefs
Posted on May 18, 2008As 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...
IIR "Generic Drugs Summit," Washington, D.C., June 18-20
Posted on May 16, 2008The Institute for International Research will be holding its 9th annual "Generic Drugs Summit," June 18-20 in Washington, D.C. According to IIR, this is "the leading independent forum addressing business and legal concerns impacting the generics marketplace...
Federal Circuit Affirms Lovenox Decision
Posted on May 14, 2008Aventis Pharma v. Amphastar and Teva, No. 2007-1280 (Fed. Cir. 2008) Today's opinion Previous post More later...
GPhA Files Amicus Brief in Appeal of "Baseless Paragraph IV Certification" Case; Warns of Chilling Effect on Future Patent Challenges
Posted on May 12, 2008Takeda v. Mylan and Alphapharm, Nos. 2007-1269, -1270 (Fed. Cir.) In February 2006, the U.S. District Court for the Southern District of New York determined that Takeda's patent on pioglitazone, the active ingredient in ACTOS, is neither invalid for obviousness...
ACI "FDA Boot Camp" Conference, San Francisco, May 29-30
Posted on May 07, 2008American Conference Institute's very popular "FDA Boot Camp" returns to San Francisco later this month, May 29-30. The conference is designed to give patent lawyers, product liability lawyers, and life sciences investment and securities experts a strong working knowledge of...
OBB News Briefs
Posted on May 05, 2008Last 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. §...
ACI "In-House Counsel Forum on Pharmaceutical Antitrust," National Harbor, Maryland, May 20-21
Posted on May 03, 2008American Conference Institute is holding its fourth annual "Pharmaceutical Antitrust" conference on May 20-21, in National Harbor, Maryland. According to ACI, at the conference, "leading in-house pharmaceutical counsel, government regulators, and expert attorneys will provide practical advice on how to...
Barr and Caraco Win Summary Judgment that Ortho-McNeil's Formulation Patent on Ultracet is Invalid
Posted on April 29, 2008Ortho-McNeil Pharm. v. Kali Labs., No. 06-CV-3533 (DMC) by Robert S. Dailey In a decision released April 17th, the U.S. District Court for the District of New Jersey granted summary judgment that certain claims of U.S. Patent No. RE39,221 are...
Apotex Sues FDA to Recover 180-Day Exclusivity on Generic Plavix
Posted on April 28, 2008In November 2001, Apotex became the first company to file an ANDA for a generic version of Plavix (clopidogrel bisulfate) with a paragraph IV certification. In March 2002, Sanofi-Synthelabo and Bristol-Myers Squibb sued Apotex for infringing the Orange Book-listed patent,...
WBR "PharmaBiotech IP Summit," Philadelphia, May 28-30
Posted on April 28, 2008Worldwide Business Research will be holding a conference entitled "PharmaBiotech IP Summit," May 28-30 at the Ritz-Carlton in Philadelphia. According to WBR, "the event balances the challenges of IP protection, enforcement and management, providing both strategic and actionable insights through...
District Court Dismisses Impax's Declaratory Judgment Complaint in ANDA Case Against Medicis
Posted on April 25, 2008Impax Labs. v. Medicis Pharm., No. C-08-0253 MMC (N.D. Cal. 2008) Last Wednesday, the U.S. District Court for the Northern District of California dismissed a declaratory judgment complaint filed by Impax against Medicis, ruling that the court lacks jurisdiction because...
District Court Upholds Validity of Takeda's Patents on Prevacid, Rejecting Teva's Obviousness Arguments
Posted on April 22, 2008Takeda Pharma. v. Teva Pharms. USA, No. 06-033-SLR (D. Del. 2008) Following a week-long bench trial held last year, the U.S. District Court for the District of Delaware released an opinion on March 31st stating that Takeda's patents on Prevacid...
ACI "Paragraph IV Disputes" Conference, New York City, April 30-May 1
Posted on April 22, 2008American Conference Institute will be holding its 2nd annual "Paragraph IV Disputes" conference in New York City next week, April 30 to May 1. This should be an excellent meeting, with many great speakers on the agenda. Specific talks of...
Pharma News Briefs
Posted on April 18, 2008Last 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. On Tuesday, AstraZeneca and Ranbaxy announced a settlement of...
Informa Life Sciences "EU Pharmaceutical Law Forum," Brussels, Belgium, May 8-9
Posted on April 15, 2008Informa Life Sciences will be holding its 17th annual "EU Pharmaceutical Law Forum" in Brussels, Belgium, on May 8 and 9. This conference is billed as the "must attend" meeting for in-house counsel in pharmaceutical companies and lawyers in private...
Federal Circuit Finds Declaratory Judgment Jurisdiction Despite Covenant Not to Sue
Posted on April 01, 2008Caraco Pharm. Labs. v. Forest Labs. et al., No. 2007-1404 (Fed. Cir. 2008) Caraco filed an ANDA with paragraph IV certifications to Forest Labs' U.S. Patent Nos. RE 34,712 and 6,916,941. Forest sued Caraco on the '712 patent and granted...
Federal Circuit Affirms Topamax Decision in Favor of Ortho-McNeil and Against Mylan and Cobalt
Posted on April 01, 2008Ortho-McNeil v. Mylan, No. 2007-1223 (Fed. Cir. 2008); Ortho-McNeil v. Cobalt, Nos. 2007-1258, -1259 (Fed. Cir. 2008) U.S. Patent No. 4,513,006 is listed in the Orange Book as protecting Topamax (topiramate), Ortho-McNeil's blockbuster anticonvulsant for the treatment of migraines and...
Eisai Wins Preliminary Injunction Against Teva's Generic Aricept
Posted on March 31, 2008Eisai Co. et al. v. Teva Pharms. USA et al., No. 05-5727 (D.N.J. 2008) Eisai Co., Ltd., the Japanese manufacturer of Aricept (donepezil hydrochloride), has won a preliminary injunction against Teva Pharmaceuticals USA, Inc., keeping Teva's generic version of Aricept...
Pharma News Briefs
Posted on March 28, 2008Earlier 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...
IQPC "Optimising Pharmaceutical Patent Lifecycles" Conference, London, April 29-30
Posted on March 26, 2008Legal IQ, a division of IQPC, will be holding a highly interactive two-day conference, "Optimising Pharmaceutical Patent Lifecycles," in London, April 29-30. The conference will focus on how to maximize product revenues and yet avoid anti-competitive issues through strategic patent...
Federal Circuit Addresses Effect of 271(e)(1) "Safe Harbor" in ITC Actions
Posted on March 21, 2008Amgen v. Int'l Trade Comm'n and Roche, No. 2007-1014 (Fed. Cir. 2008) by Robert S. Dailey Amgen holds at least six US patents that relate to erythropoeitin and its derivatives (?EPO?) and processes for making EPO, protecting the Amgen drugs...
Pharma News Briefs
Posted on March 16, 2008Last 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...
District Court Upholds Validity of P&G's Actonel Patent, Rejecting Teva's Obviousness Arguments
Posted on March 12, 2008Proctor & Gamble v. Teva Pharms. USA, No. 04-940 (D. Del. 2008) Late last month, the U.S. District Court for the District of Delaware (J. Farnan) upheld the validity of Proctor & Gamble's U.S. Patent No. 5,583,122, which claims risedronate...
Federal Circuit Invalidates Pfizer's Latest-Expiring Patent on Celebrex, for Double Patenting
Posted on March 10, 2008Pfizer et al. v. Teva Pharms. USA, No. 2007-1271 (Fed. Cir. 2008) Pfizer owns three Orange Book-listed patents protecting its blockbuster arthritis drug Celebrex (celecoxib): U.S. Patent Nos. 5,466,823; 5,563,165; and 5,760,068. As we previously reported, last year a district...
Barr Labs Prevails Over Bayer in Yasmin Birth Control Pill Case; Bayer's Patent Held Invalid for Obviousness
Posted on March 07, 2008Bayer Schering Pharma AG et al. v. Barr Labs., No. 05-2308 (D.N.J. 2008) On Monday, the U.S. District Court for the District of New Jersey invalidated Bayer's U.S. Patent No. 6,787,531 on grounds of obviousness, relying heavily on KSR. The...
Pharma News Briefs
Posted on February 29, 2008The 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"...
Pharma News Briefs
Posted on February 16, 2008The 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...
Informa Life Sciences "Global Generics Strategy Summit" Conference, Barcelona, March 4-5
Posted on February 11, 2008Informa Life Sciences will hold its 7th annual "Global Generics Strategy Summit" conference in Barcelona, Spain, March 4-5, 2008. The conference "represents the largest gathering of Generics leaders from across the globe and will explore new and emerging strategies and...
Pharma News Briefs
Posted on February 08, 2008Fosamax, 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...
Federal Trade Commission Files Amicus Brief in Ciprofloxacin "Reverse Payment" Case
Posted on February 06, 2008The Federal Trade Commission announced last week that it recently filed an amicus brief in In re Ciprofloxacin Hydrochloride Antitrust Litigation, currently pending in the Federal Circuit. In the case, direct purchaser plaintiffs of Cipro (ciprofloxacin) alleged that settlements of...
FDA Answers Ramipril Letters, Explains Why Cobalt Has 180-Day Exclusivity
Posted on February 04, 2008As we reported last November, the Federal Circuit's decision invalidating U.S. Patent No. 5,061,722 on Altace (ramipril) was followed by a flood of letters to FDA concerning 180-day exclusivity for ramipril. FDA responded last week, shedding some light on how...
Pharma News Briefs
Posted on January 25, 2008Earlier 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...
IQPC "Pharmaceutical Patent Litigation Strategies 2008" Conference, London, March 31 - April 1
Posted on January 20, 2008IQPC will be holding its 3rd annual "Pharmaceutical Patent Litigation Strategies" conference in London, March 31 to April 1. The conference is split into two days--one focusing on European law, the other focusing on U.S. law--and includes an optional third...
Teva Seeks Relisting of J&J's Risperdal Patent and Asserts Right to 180-Day Exclusivity
Posted on January 17, 2008A reader recently e-mailed me about an interesting citizen petition that Teva filed last August. In the petition, Teva requests that FDA: (1) relist U.S. Patent No. 5,158,952 in the Orange Book for Risperdal (risperidone) tablets; (2) confirm Teva's right...
Pharma News Briefs
Posted on January 11, 2008Teva 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...
Pharma News Briefs
Posted on December 28, 2007Eisai 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...
ACI "Pharma/Biotech IP Due Diligence" Conference, New York, January 30-31
Posted on December 27, 2007American Conference Institute will hold its fifth annual "Pharma/Biotech IP Due Diligence" conference January 30-31 in New York. ACI describes this conference as the "complete guide for M&As, licensing and other collaborations." The agenda includes several talks that sound especially...
Pfizer Wins Dismissal of Ranbaxy's Counterclaims in Caduet Patent Litigation
Posted on December 12, 2007Pfizer v. Ranbaxy, No. 07-138 (D. Del. 2007) Pfizer sued Ranbaxy for infringement of U.S. Patent Nos. 4,681,893 and 6,455,574 after Ranbaxy filed paragraph IV certifications in its ANDA for a generic version of Caduet (atorvastatin calcium/amlodipine besylate)...
Pharma News Briefs
Posted on December 10, 2007Prof. 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...
District Court Upholds Validity of Pfizer's Accupril Patent, Rejecting Teva's Nonenablement Argument
Posted on December 05, 2007Warner-Lambert v. Teva Pharms. USA, No. 99-922 (D.N.J. 2007) Warner-Lambert (part of Pfizer) and Teva have been in patent litigation over Teva's ANDA for generic Accupril (quinapril hydrochloride) since 1999, when Warner-Lambert sued Teva for filing its ANDA with a...
Pharma News Briefs
Posted on December 01, 2007Apotex and an anonymous ANDA filer recently submitted new comments to FDA on ramipril 180-day exclusivity issues. Earlier this month, we summarized previous comments on the ramipril docket. Roxane Labs recently submitted new comments to FDA on acarbose 180-day exclusivity,...
Lovenox Patent Case Back at Federal Circuit; Generic Versions Still Not Yet Approved
Posted on November 30, 2007Guest post by Robert S. Dailey The Lovenox patent infringement litigation between Aventis and Teva/Amphastar is making its second trip to the Federal Circuit. In February, following remand from the Federal Circuit last year, a federal district court in California...
Dismissal of Invalidity Counterclaims Thwarts Apotex's Attempt to Trigger 180-Day Exclusivity on Cosopt
Posted on November 28, 2007Merck v. Apotex, No. 06-5789 (D.N.J. 2007) Merck has sold Cosopt (dorzolamide hydrochloride/timolol maleate), an opthalmic drug indicated for the treatment of ocular hypertension and open-angle glaucoma, since 1998. In October 2005, Hi-Tech Pharmacal filed the first ANDA for a...
Hatch-Waxman Tracker Update
Posted on November 14, 2007For the current version of the Hatch-Waxman Tracker, please click here. New cases added: Aricept: Eisai v. Teva Asacol: Medeva v. Roxane Astelin: Medpointe v. Cobalt (D.N.J.); MedPointe v. Cobalt (N.D. Ill.) Avinza: King v. Actavis Boniva: Hoffman-LaRoche v...
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On 08-12 at 12:59PM
Real Network's DVD copying software deemed to break DMCA's anti-circumvention provisions
On 08-12 at 12:57PM
Prepaid funeral operators indicted for $100 Million fraud
On 08-12 at 12:53PM
NY Jets join Cincinnati, Dallas, Green Bay, Houston & Seattle #NFL teams offering branded state lottery games
On 08-12 at 12:43PM
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My son and an acquaintence were leaving the store the guy had stolen video games in his book bag with his name in it. Teens says bag was not his, however they found his name and books with his name in the bag. My son sea
Many stores have undercover security guards, who are trained to spot potential s...
Can my principal expel me for signing myself out of school and leaving without the permission from a gardian when I'm eight-teen years of age?
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MY LAST NAME HAS BEEN USED IN TITLE OF A PUBLISHED BOOK. IS TH IS PERMISSABLE?
is your first name phone? I just recieved a
well mr recipe I enjoy...
can you patent the idea of letting, for a proper price, adults direct a porn scene for there own possesion over the internet or in person? A scene witch will be a one of a kind and owned by them without the ability for r
Probably not, as it's already been done....
Is it libel to write blog posts and/or online reviews about a local business that defames one's reputation?
Libel is the form of defamation expressed in fixed-- usually written form. Sland...
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