Source: https://www.patentdocs.org/2009/05/page/3/
Timestamp: 2020-07-06 00:16:15
Document Index: 174363492

Matched Legal Cases: ['§ 1337', '§ 271', '§ 271', '§ 271', '§ 271', '§ 271']

Patent Docs: May 2009
Posted at 10:04 AM in Court Report | Permalink | Comments (24) | TrackBack (0)
More on House Patent Reform Hearing
On April 30th, the House Committee on the Judiciary heard testimony from seven witnesses (and accepted written testimony from other interested parties) regarding the House patent reform bill (H.R. 1260) (see "House Judiciary Committee Holds Hearing on Patent Reform"). Part I of our coverage of the hearing examined written testimony submitted by hearing witnesses Dean Kamen of DEKA Research and Development Inc., the inventor of the Segway, and Jack Lasersohn, a Partner with the Vertical Group and representative of the National Venture Capital Association (NVCA), as well as testimony submitted by the Biotechnology Industry Organization (BIO). In the second part of our coverage, we examine the written testimony submitted by Bernard Cassidy, Senior Vice President and General Counsel for Tessera Inc., and John Thomas, Professor at Georgetown University Law School.
Mr. Cassidy's written testimony, which runs just over nineteen single-spaced pages in length, provides a detailed and well-supported attack on several provisions of H.R. 1260. Mr. Cassidy also suggests that in view of recent Supreme Court and Federal Circuit decisions, Congress would be better suited to redirect its patent reform focus from a post-grant perspective (i.e., patent litigation) to a pre-grant perspective (i.e., application examination). Given Tessera's position in semiconductor packaging, Mr. Cassidy's position on patent reform may come as a surprise to some (and are perhaps as surprising as the position that was taken by Tessera Vice President Taraneh Maghamé at the Senate Judiciary Committee's patent reform hearing in March; see "Senate Judiciary Committee Holds Hearing on Patent Reform"). However, the Tessera General Counsel noted that the company's success would not have been possible without "a strong patent system to protect our inventions and reward our innovators," and he contended that "[m]aintaining a strong patent system is essential to [Tessera's] continuing success."
Stating that "[i]t is troubling to many small technology companies that, at a time of such grave economic uncertainty, Congress would seek to fundamentally alter the economic structure of our nation's patent system," Mr. Cassidy argued that "the proposed changes to the law of damages, in particular, would cause a massive and irreversible transfer of wealth from the United States to foreign manufacturers." With respect to the damages and post-grant review provisions, Mr. Cassidy noted that "other industries share Tessera's concerns," listing venture capital, agriculture, biotech, universities, domestic manufacturers, nanotechnology, and green tech amongst opponents of these provisions of H.R. 1260.
On the subject of damages, Mr. Cassidy stated that "[g]iven the public statements of most stakeholders to date -- at least with respect to the Senate gatekeeper proposal -- the Senate's work has advanced the discussion [of damages] significantly," and he encouraged the House to "take advantage of the success achieved to date in the Senate on the damages provision of the bill." Mr. Cassidy offered this encouragement despite his skepticism that a patent damages problem exists -- a skepticism rooted, at least in part, in a PriceWaterhouseCoopers 2008 study showing that patent damages awards have remained largely consistent for more than a decade, and a survey by University of Houston Law School Professor Paul Janicke showing no pattern of runaway jury verdicts in patent cases in the past four years (the Janicke study indicates that for cases that go through trial, the median damages award is less than $2 million). For Mr. Cassidy, " Prof. Janicke's data illustrate that despite arguments made by proponents of damages reform, there is no pattern of runaway jury verdicts and that patent damages awards are modest."
Mr. Cassidy argues that "[d]ismantling the long-established framework for calculating reasonable royalties at trial will encourage infringers, and perhaps even existing licensees, to reject negotiated, market-based royalties," and "weaken the value of patents generally and unfairly advantage large companies looking to acquire a smaller innovator's property." He contends that:
[T]he tried and true principles that underlie Georgia Pacific and patent damages law generally are so firmly grounded in our legal system that it would be difficult to justify any significant departure without acknowledging an effort to transform patent rights into something far different, and far less valuable, than the nation's founders intended.
And he points to that which should be plainly obvious when stating that "[p]atent damages rules are based on the same principles that underlie compensatory damages generally; thus, the risks of inflated settlements are no greater in patent negotiations than in the context of any other commercial dispute."
As for post-grant review, Mr. Cassidy argues that:
The proposed hybrid [post-grant opposition]/inter partes system would (i) unleash a wave of administrative litigation with many of the costs and complexities of judicial litigation, (ii) invite serial and harassing validity challenges throughout the life of a patent, and (iii) effectively eliminate the statutory presumption of validity essential to a patent’s enforceability.
Instead of elaborating on these criticisms, however, Mr. Cassidy focuses the remainder of his testimony on a discussion of recent court decisions that "have unquestionably changed major areas of the law and shifted the balance of power between patent holders and users, tightening standards of patentability and narrowing patent rights and remedies." He "urges Congress and the Administration to allow these decisions to be implemented in the marketplace and consider carefully the impact of these decisions before enacting any legislation that will further decrease the value or enforceability of patents." Among the cases that he discusses are: eBay Inc. v. MercExchange, L.L.C., Medimmune, Inc. v. Genentech, Inc., KSR Int'l Co. v. Teleflex Inc., Microsoft Corp. v. AT&T Corp., Quanta Computer, Inc. v. LG Electronics, Inc., In re Seagate Technology, LLC, In re Bilski, and In re TS Tech USA Corp.
With respect to KSR, Mr. Cassidy states that:
In KSR International Co. v. Teleflex Inc. the Supreme Court altered the objective patentability test of obviousness which had been used by the USPTO and federal courts for two decades. The test was, and is still believed by many to be, necessary to avoid the inappropriate application of 20/20 hindsight to obviate non-obvious, and otherwise patentable inventions.
On the Quanta decision, he argues that:
Quanta is now being cited in some quarters as justification for amended damages rules that would value reasonable royalties according to a patent's "essential" or "inventive" features, comparable to the "prior art subtraction" test proposed in previous legislation. This argument has no merit and reflects a fundamental misunderstanding and misapplication of the Quanta decision. Neither Quanta nor the Court's discussion of a patent's essential features has any bearing on reasonable royalty valuation rules. Instead, Quanta addresses a completely different inquiry, namely the point at which downstream patent users should be free to engage in commercial transactions involving patented products without any liability to the patentee.
While the eight cases listed above "address[] virtually all of the substantive issues that originally prompted calls for patent legislation, including injunctions, willfulness, venue, and standards relevant to the patent-eligibility of claims and validity of issued patents," Mr. Cassidy notes that "the courts are obviously not institutionally positioned to address the USPTO's resource constraints and operational deficiencies, which have diminished the overall quality, predictability and efficiency of pre-grant patent examination processes," and concludes that "[t]hese problems merit urgent attention and should be the focus of current patent reform efforts."
In contrast with Mr. Cassidy's written testimony, Prof. John Thomas' (at right) testimony focuses on the issue of damages, and takes a decidedly different stance on that issue. Stating that "the perception is widely shared that the rules pertaining to damages are less certain than many other patent doctrines," Prof. Thomas argues for "greater precision in patent law's damages principles." He contends that "[p]revailing legal standards with respect to reasonable royalty determinations have been roundly criticized for their indeterminancy and logical shortcomings," adding that:
Experience suggests that the Georgia-Pacific factors are difficult to apply consistently. Although Georgia-Pacific provides a long list of ingredients, it offers no recipe–that is to say, no principles for deciding whether one of the seemingly randomly ordered elements should be weighed more heavily than another in a given determination. The laundry list of Georgia Pacific factors, many of which include several sub-components, cannot plausibly be considered to provide a "standard" for setting reasonable royalty rates at all.
And although Prof. Thomas suggests (without citation) that "[t]here seems to be widespread acceptance of th[e] basic position that damages should be based upon the incremental value of the invention" -- as called for in the House bill's damages provision, which proposes that reasonable royalties relate "only to the portion of the economic value of the infringing product or process properly attributable to the claimed invention’s specific contribution over the prior art" -- Prof. Thomas does not explain why the House provision would provide more precision or any greater certainty than the Georgia-Pacific factors, for which a body of case law already exists.
Prof. Thomas similarly fails to provide support for his statement that "damages rulings are widely viewed as unpredictable and difficult to review, but also as tending towards overcompensation to the patent proprietor." Absent any discussion of median damages awards (as provided in Mr. Cassidy's testimony), it is also difficult to gauge the types of awards that Prof. Thomas would consider as constituting "overcompensation."
Although the hearing was not made available for online viewing last month, a link to the hearing webcast is now available at the Committee's website. Written testimony for each witness can also be found at the Committee's website. Patent Docs will examine written testimony provided by the remaining witnesses, as well as reaction in the patent community to the hearing, in subsequent posts.
• "Senate Judiciary Committee Discusses S. 515 at Executive Business Meeting; Adopts 'Technical' Amendment GRA09350," March 26, 2009
Posted at 11:45 PM in Patent Legislation | Permalink | Comments (1) | TrackBack (0)
Patent Profile: Immunomedics Announces Patent for Dock-and-Lock Antibody Assemblies
By Mark Chael --
On May 5th, Immunomedics, Inc. announced that its majority-owned subsidiary, IBC Pharmaceuticals, Inc., was granted U.S. Patent No. 7,527,787, entitled "Multivalent Immunoglobulin-based Bioreactive Assemblies." Claim 1 from the patent reads:
1. A hexameric stably tethered structure comprising an IgG antibody attached to two AD2 moieties of SEQ ID NO: 4 and four antigen-binding antibody fragments of the same or different IgG with each fragment attached to a DDD2 moiety of SEQ ID NO: 2; the AD2 moieties bound to the DDD2 moieties.
The four antigen-binding antibody fragments can be Fab fragments. In particular, these Fab fragments can be the Fab fragments of humanized antibody hMN-14 that binds to CEA, humanized antibody hA20 that binds to CD20, humanized antibody hLL2 that binds to CD22, humanized antibody hL243 that binds to HLA class II, humanized antibody hCC49 that binds to TAG-72, humanized antibody hLL1 that binds to CD74, humanized antibody hPAM4 that binds to MUC 1, humanized antibody hRS7 that binds to EGP-1, humanized antibody hR1 that binds to IGF1R, anti-CD 14, anti-CD 111, adalimumab, infliximab, omalizumab, palivizumab, and humanized antibody hMN-15 that binds to CEA.
The abbreviation "AD" in claim 1 refers to the Anchoring Domain of A-kinase anchoring proteins (AKAPs), while "DDD" refers to the Dimerization and Docking Domain of cyclic-AMP-dependent protein kinase (PKA). These two domains cooperate in this Dock-and-Lock (DNL) technology.
According to a recent paper authored by the inventors of the '787 patent (and others), the Dock-and-Lock technology is:
[A] new approach to develop targeting molecules for improved cancer imaging and therapy. It involves the use of a pair of distinct protein domains involved in the natural association between cyclic adenosine monophosphate (cAMP)-dependent protein kinase A (PKA) and A-kinase anchoring proteins (AKAPs). The dimerization and docking domain found in the regulatory subunit of PKA and the anchoring domain (AD) of an interactive AKAP are each attached to a biologic entity, and the resulting derivatives, when combined, readily form a stably tethered complex of a defined composition that fully retains the functions of the individual constituents.
Another recent patent assigned to IBC Pharmaceuticals, U.S. Patent No. 7,521,056, relates to the same technology as the '787 patent. These two patents may be the first drawn to the PKA/AKAP Dock-and-Lock technology.
Other similar, so-called Dock-and-Lock systems are known. For example, scientists at SibTech, Inc. published a report in 2006 about such a system "based on mutated fragments of human RNase I that spontaneously bind to each other and form a conjugate with a disulfide bond between complimentary cysteine residues." Each of the mutated RNase I fragments may be independently linked to functionally heterogeneous compounds.
Posted at 11:30 PM in Patent Profiles | Permalink | Comments (0) | TrackBack (0)
BIO IP Policy Briefing
Last Friday, the Biotechnology Industry Organization (BIO) presented its members-only 2009 Spring IP Policy Briefing to member companies, particularly directed to member law firms. The presentation was moderated by Lila Feisee, BIO's Managing Director, Intellectual Property. The briefing included discussions on Membership Benefits, U.S. court cases, biosimilars and patent reform legislation, and the Department of Health and Human Service's draft report from the Committee on Genetics, Health and Society.
The Membership Benefits overview, presented by Jason Rupp, BIO's Membership Director, reminded participants of BIO's demographics: the organization has a staff of 160 and a membership of about 1,200 biotechnology and related companies. Two-thirds of these are R&D-focused organizations, with another 16% consisting of academic or other non-profit groups. The remainder are made up of service providers and state or international affiliates. Mr. Rupp mentioned several opportunities for participation on a number of committees, as well as other member benefits directed to practical business solutions (found at www.biobusinessolutions.com).
One of these committees, the amicus committee, files between 4 and 6 briefs a year; recent cases where BIO filed an amicus brief included eBay Inc. v. MercExchange, L.L.C.; KSR Int'l Co. v. Teleflex Inc.; Ferring B.V. v. Barr Labs., Inc.; In re Seagate Technology, LLC; Quanta Computer, Inc. v. LG Electronics, Inc.; Tafas v. Dudas; In re Bilski; In re Kubin; Amgen v. Hoffman-LaRoche; Aventis Pharma S.A. v. Amphastar Pharmaceuticals; and Prometheus v. Mayo (see BIO's Amicus Briefs page for links to the organization's filed briefs). The amicus committee considers cases that impact BIO members generally and does not typically take a position relating to specific commercial disputes or in cases between BIO members. Recent cases where BIO did not file an amicus brief include Laboratory Corp. v. Metabolite Labs., Inc.; Medimmune, Inc. v. Genentech, Inc.; Microsoft Corp. v. AT&T Corp.; Pharmastem Therapeutics, Inc. v. Viacell, Inc.; and In re Bilski's petition for certiorari. The committee is currently interested in petitions for rehearing en banc in the Kubin and Tafas cases, and in the patent term adjustment dispute in Wyeth v. Doll.
Sandra J.P. Dennis, BIO's Deputy General Counsel for Healthcare, then discussed the current state of biosimilars legislation. She reminded listeners that the last (110th) Congress saw five bills introduced, by Mr. Waxman (D-CA), Mr. Inslee (D-WA), and Ms. Eschoo(D-CA)/Mr. Barton (R-TX) in the House, and Senator Gregg (R-NH) and Senators Kennedy (D-MA), Clinton (D-NY), Hatch (R-UT), and Enzi (R-WY) in the Senate; the latter bill represented a compromise on the all-important data exclusivity period at 12 years. In this Congress, Mr. Waxman has introduced a bipartisan bill (H.R. 1427), joined by Mssrs. Deal (R-GA), and Pallone (D-NJ) and Ms. Emerson (R-MO) that provides only 5 years of data exclusivity and only if the "major substance" had not been previously approved (3 years otherwise) (see "Waxman Introduces Follow-on Biologics Bill"). There is a competing bill, H.R. 1548, introduced by Ms. Eschoo, Mr. Inslee, and Mr. Barton (that has more than 65 co-sponsors) that specifies 12 years of data exclusivity with provisions for an additional 2 years for a "medically-significant new indication" and 6 months for pediatric studies (see "Second Follow-on Biologics Bill Is Introduced in House"). In the Senate, a companion to the Waxman bills has been introduced (see "Third Follow-on Biologics Bill Introduced in 111th Congress"), and Senator Kennedy is expected to introduce a bill with a 12-year data exclusivity period.
Hans Sauer, BIO's Associate General Counsel for Intellectual Property, addressed patent reform legislation. Mr. Sauer characterized the Senate bill, S. 515, as a bill BIO could support, in contrast to the bills introduced (S. 1453) and passed (H.R. 1983) in the last Congress. Turning to specific provisions, Mr. Sauer said that BIO does not support the "trigger" provisions in the House bill on changing U.S. patent law to "first inventor to file" from "first inventor to invent." These provisions, not contained in the Senate bill, would forestall the legislated change until the President certified that the European Patent Office and the Japan Patent Office had instituted a "grace period," like ours, for an inventor's own prior disclosure. He said that BIO supports the Senate compromise on damages and post-grant review, and opposes provisions in the House bill that include public use or on-sale activity as prior art. BIO also opposes provisions in the House bill that specify a reasonable royalty determination would be based on "specific contribution[s] over prior art." BIO is also concerned, he said, about the absence of inequitable conduct reform in the pending bills, and noted that while some stakeholders have attempted to use reforming of inequitable conduct as a bargaining chip for damages apportionment, this was not acceptable to BIO -- inequitable conduct reform is not "tradable" for "harmful damages language." While BIO seeks repeal/elimination of the best mode requirement, the Senate compromise that retains the provision but strips it of any meaningful penalty for failing to disclose the best mode is acceptable to BIO. He also mentioned provisions on willfulness, interlocutory appeals, venue, mandatory publication, and ending fee diversion.
The last presentation, by Ms. Feisee, concerned the draft report from the HHS Secretary's Advisory Committee on Genetics, Health and Society. This draft report, dealing with recommendations on gene patenting and licensing practices, actually contains good news -- the purported anticompetitive effects of the mythical "tragedy of the anti-commons" do not exist, and the report concludes (somewhat begrudgingly) that patents are not "a cause of concern in relation to price and access." Rather than provide recommendations consistent with these empirical findings, however, the report presents "a range of potential policy options" for consideration, including policies that "promote 'broad licensing'" of genetic inventions, pursuing an Executive Order "clarifying authority under the Bayh-Dole Act" that would "impose a requirement for non-exclusive licensing" of materials produced using Federal funds, and "clarifying" Patent Office policies relating to genetic materials. Despite its express findings, somewhat incredibly the report also proposes statutory changes (to be promoted, no doubt, as "reform") to restrict patents on nucleic acid-based inventions. Comments on the report are due by May 15th; BIO will be providing comments.
BIO intends to have another policy briefing later this summer.
Posted at 11:47 PM in Biosimilars, Patent Legislation | Permalink | Comments (1) | TrackBack (0)
Yeda Research and Development Co., Ltd., v. Doll
1:09-cv-00820; filed May 4, 2009 in the District Court of the District of Columbia
Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,445,802 ("Site-Specific In Situ Generation of Allicin Using a Targeted Alliinase Delivery System for the Treatment of Cancers, Tumors, Infectious Diseases and Other Allicin-Sensitive Diseases," issued November 4, 2008). View the complaint here.
Monsanto Co. et al. v. E.I. Dupont De Nemours and Co. et al.
4:09-cv-00686; filed May 4, 2009 in the Eastern District of Missouri
Infringement of U.S. Patent No. RE39,247 ("Glyphosate-tolerant 5-enolpyruvylshikimate-3-phosphate Synthases," issued August 22, 2006) based on defendants' development of a stacked soybean product incorporating Monsanto's Roundup Ready® technology. View the complaint here.
Abbott Biotechnology Ltd. v. Centocor Ortho Biotech, Inc.
4:09-cv-40089; filed May 1, 2009 in the District Court of Massachusetts
Infringement of U.S. Patent No. 7,223,394 ("Human Antibodies that Bind Human TNF alpha," issued May 29, 2007) based on Centocor's imminent launch of it's Simponi product (golimumab, used to treat rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis). View the complaint here.
Warner Chilcott Laboratories Ireland Ltd. et al. v. Mylan Pharmaceuticals Inc. et al.
2:09-cv-02073; filed May 1, 2009 in the District Court of New Jersey
Infringement of U.S. Patent No. 6,958,161 ("Modified Release Coated Drug Preparation," issued October 25, 2005) following a Paragraph IV certification as part of Mylan's filing of an ANDA to manufacture a generic version of Warner Chilcott's Doryx® (modified release doxycycline hyclate, used for adjunctive treatment of severe acne). View the complaint here.
Alcon Research Ltd. v. Barr Laboratories Inc.
1:09-cv-00318; filed April 30, 2009 in the District Court of Delaware
Infringement of U.S. Patent Nos. 5,510,383 ("Use of Cloprostenol, Fluprostenol and Their Salts and Esters to Treat Glaucoma and Ocular Hypertension," issued April 23, 1996), 5,631,287 ("Storage-Stable Prostaglandin Compositions," issued May 20, 1997), 5,849,792 (same title, issued December 15, 1998), 5,889,052 ("Use of Cloprostenol and Fluprostenol Analogues to Treat Glaucoma and Ocular Hypertension," issued March 30, 1999) and 6,011,062 ("Storage-Stable Prostaglandin Compositions," issued January 4, 2000) following a Paragraph IV certification as part of Barr's filing of an ANDA to manufacture a generic version of Alcon's Travatan® (travoprost ophthalmic solution, used to reduce elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertention). View the complaint here.
Pfizer Inc. et al. v. Lupin Ltd. et al.
1:09-cv-01113; filed April 30, 2009 in the District Court of Maryland
3:09-cv-02052; filed April 30, 2009 in the District Court of New Jersey
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 6,001,876 ("Isobutylgaba and Its Derivatives for the Treatment of Pain," issued December 14, 1999), 6,197,819 ("Gamma Amino Butyric Acid Analogs and Optical Isomers," issued March 6, 2001), and 5,563,175 ("GABA and L-glutamic Acid Analogs for Antiseizure Treatment," issued October 8, 1996) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Pfizer's Lyrica® (pregabalin, used to treat fibromyalgia). View the Lupin complaint here.
Pfizer Inc. et al. v. Wockhardt Ltd. et al.
3:09-cv-02069; filed April 30, 2009 in the District Court of New Jersey
Pfizer Inc. et al. v. Sun Pharma Global Inc. et al.
3:09-cv-02070; filed April 30, 2009 in the District Court of New Jersey
The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 6,197,819 ("Gamma Amino Butyric Acid Analogs and Optical Isomers," issued March 6, 2001) following a Paragraph IV certification as part of defendants' filing of an ANDA to manufacture a generic version of Pfizer's Lyrica® (pregabalin, used to treat fibromyalgia). View the Wockhardt complaint here.
Novartis AG v. Doll
1:09-cv-00804; filed April 20, 2009 in the District Court of the District of Columbia
Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,446,175 ("Antibodies to human IL-1β," issued November 4, 2008). View the complaint here.
Posted at 10:58 PM in Court Report | Permalink | Comments (0) | TrackBack (0)
May 18-21, 2009 - BIO International Convention (Biotechnology Industry Organization) - Atlanta, GA
May 20, 2009 - Tafas v. Doll -- Dissecting the Decision and Preparing for Resurgence of USPTO Rules Limiting Patent Claims*** (American Conference Institute) - 1:00-2:30 PM (EST)
June 16-17, 2009 - Biotech Patenting (C5) - Munich, Germany
June 19, 2009 - Patent Enforcement & Early Stage Litigation (Law Seminars International) - San Francisco, CA
June 22-27, 2009 - Innovation Week 2009 (U.S. Patent and Trademark Office) - Arlington, VA
June 21-23, 2009 - IP Business Congress (Intellectual Asset Management magazine) - Chicago, IL
July 14-15, 2009 - Pharma/Biotech Collaborative Agreements (American Conference Institute) - San Francisco, CA
July 15, 2009 - Cost-Effective Patent Strategies (Law Seminars International) - Seattle, WA
July 21-22, 2009 - FDA Boot Camp*** (American Conference Institute) - Chicago, IL
Posted at 10:45 PM in Conferences & CLE's | Permalink | Comments (1) | TrackBack (0)
FDA Boot Camp Conference
American Conference Institute (ACI) will be holding the next session of its FDA Boot Camp conference on July 21-22, 2009 in Chicago, IL. The conference will allow attendees to:
• Master the basics of the approval processes for drugs, biologics, and devices, including in-depth discussion of the application, pre-approval, and post-approval requirements;
• Comprehend the structure of the FDA and the roles of the three major agency centers: CDER, CBER, and CDHR;
• Develop a practical working knowledge of clinical trials for drugs and biologics and the clearance process for devices;
• Learn how devices are classified, monitored, and regulated;
• Appreciate the complexities of pharmaceutical IP and the regulatory balance between brand name and generic products;
• Recognize the pivotal role of labeling in the drug and biologics approval process;
• Navigate the protocols of adverse events monitoring, signal detection, product withdrawals, and recalls; and
• Understand the implications of recent legislative and caselaw developments in the area of drug and biologic import/export guidelines.
• The basics: Understanding and working with the FDA and the New Administration -- Jurisdiction, functions, organizations & operations;
• The nature of the approval process;
• Essential requirements of the clinical trials processes;
• Patent & IP spotlight: Hatch-Waxman, the patenting process, and more -- to be presented by MBHB colleague and Orange Book Blog author Aaron Barkoff;
• Drugs, biological products: Labeling;
• Current good manufacturing practices (cGMPs) and quality system regulation (QSR);
• Import/export guidelines & emerging international regulatory concerns;
• Non-patent exclusivity (part of the conference's patent track);
• Bioequivalence: What patent lawyers need to know (patent track);
• Follow-on (comparable or biosimilar) biologics (patent track);
• Medical devices: Classification and the essentials of the device premarket review process;
• Post-market requirements and concerns for medical devices;
• Medical device labeling and advertising; and
• Recalls guidance for drugs, biologics, and medical devices.
An additional post-conference master class entitled: "Product Liability Master Class on Drug and Medical Device Preemption: Reconciling Wyeth, Riegel and the Medical Device Safety Act of 2009" will be offered on July 23, 2009. The master class will analyze the nuances of recent court decisions regarding preemption and provide insights into how to use these cases effectively in future litigation.
The agenda for the FDA Boot Camp conference can be found here. A complete brochure for this conference, including an agenda, list of speakers, and registration form can be downloaded here.
The registration fee ranges from $2,795 (conference) to $2,195 (conference plus workshop). Those registering on or before June 19, 2009 will receive a $200 discount, and those registering on or before May 15, 2009 will receive a $300 discount. Those interested in registering for the conference can do so here, by calling 1-888-224-2480, or by faxing a registration form to 1-877-927-1563.
Patent Docs is a media sponsor of ACI's FDA Boot Camp conference.
Posted at 11:58 PM in Conferences & CLE's | Permalink | Comments (0) | TrackBack (0)
USPTO Begins Pilot Program with the German Patent Office
As we previously reported by Patent Docs, the U.S. Patent and Trademark Office began a Patent Prosecution Highway (PPH) Pilot Program with the German Patent and Trademark Office (DPMA) on April 27, 2009 which will last for two years. The USPTO issued another press release on April 20, 2009, providing links for applicants interested in reviewing the requirements for participation in the pilot program via the USPTO or DPMA.
Posted at 11:24 PM in International IP, Patent Office Rules & Procedures | Permalink | Comments (0) | TrackBack (0)
Patent Profile: ImmunoCellular Therapeutics Announces Issuance of Patent for Method of Monitoring Myeloma or Ovarian Cancer Therapy
On April 29, 2009, ImmunoCellular Therapeutics, Ltd. announced that the U.S. Patent and Trademark Office issued Patent No. 7,498,129, which relates to the company's monoclonal antibody platform. The '129 patent is entitled "Myeloma Cell and Ovarian Cancer Cell Surface Glycoproteins, Antibodies Thereto, and Uses Thereof," and according to ImmunoCellular, is directed to the use of the company's antibodies to measure the effectiveness of proposed treatments for multiple myeloma and ovarian cancer.
Claim 1 of the '129 patent reads as follows:
1. A method for monitoring the effectiveness of therapy for a myeloma or ovarian cancer, comprising:
a) measuring changes in the level of the antigen recognizable by a monoclonal antibody or antigen binding fragment thereof in a bodily fluid sample from a patient undergoing therapy, wherein said monoclonal antibody is produced by the hybridoma cell line deposited at the American Type Culture Collection having accession No. PTA-450; and
b) correlating the change in the level with the effectiveness of said therapy, wherein a decrease in the level indicates a reduced tumor burden.
In 2007, ImmunoCellular acquired a portion of its monoclonal antibody-related technology from Molecular Discoveries. One such monoclonal antibody, ICT-109, targets small cell lung cancer (SCLC) and pancreatic cancer. ICT-109 is currently in pre-clinical development, and is useful as a diagnostic reagent to prescreen patients for the specific antigens to which it binds. According to ImmunoCellular, this antibody has shown encouraging preliminary data in pre-clinical studies and may be ready to enter clinical trials in the near future for SCLC and/or pancreatic cancer.
According to the assignment database at the USPTO, ImmunoCellular is the assignee of record on at least seven patents and one published patent application.
Posted at 11:13 PM in Patent Profiles | Permalink | Comments (6) | TrackBack (0)
New Administration, Same Result: U.S. Trade Representative's Section 301 Report
U.S. Trade Representative Ron Kirk issued a "Special 301 Report" on April 30. This report, on the state of intellectual property rights worldwide, identifies twelve countries on a "priority watch list" and another 33 on a "watch list," all relating to deficiencies in intellectual property protection in these countries. The Report "guides our efforts to protect American innovation and creativity around the world," according to a press release by the Representative's office, and in these times when "[o]ur creative and innovative products can hit the global marketplace . . . . with just a keystroke," the U.S. and its trading partners must be "vigilant" to protect and enforce intellectual property rights.
The Priority Watch List of the report lists China, Russia, Algeria, Argentina, Canada, Chile, India, Indonesia, Israel, Pakistan, Thailand, and Venezuela; this is an upgrade in priority for Algeria, Canada, and Indonesia, who last year were on the Watch List. Countries on this list "do not provide an adequate level of IPR [intellectual property rights] protection or enforcement, or market access to persons relying on intellectual property protection." This year, the Watch List names Belarus, Bolivia, Brazil, Brunei, Columbia, Costa Rica, Czech Republic, Dominican Republic, Ecuador, Egypt, Finland, Greece, Guatemala, Hungary, Italy, Jamaica, Kuwait, Lebanon, Malaysia, Mexico, Norway, Peru, Philippines, Poland, Romania, Saudi Arabia, Spain, Taiwan, Tajikistan, Turkey, Turkmenistan, Ukraine, Uzbekistan, and Vietnam; Brunei (software piracy), and Finland (lack of pharmaceutical product patent protection) are new to the Watch List this year. Korea and Taiwan were removed from the Watch List in this report; significantly, this is the first time that Korea has not been named on either the Priority Watch List or the Watch List.
As in prior years, the majority of the report focuses on software and entertainment piracy. Indeed, this is a major reason for Canada being named on the Priority Watch List, which includes the need for copyright reform as well as "weak border enforcement." The Report also notes that the Canadian government "has not delivered on [its] commitments" to improving IPR protection and enforcement. The Report emphasizes the problem of manufacturing and distributing counterfeit pharmaceuticals, singling out Brazil, China, India, Indonesia, and Russia as countries where such incidents have proliferated while noting that counterfeit pharmaceuticals are sold and distributed in several countries. The report calls "a significant contributing factor" of this problem production of counterfeit bulk active pharmaceutical ingredients (APIs); China is singled out for a "loophole" in its law that permits counterfeit APIs to avoid regulatory oversight merely by not declaring an intention to be used to produce pharmaceutical products. Algeria was added to the Priority Watch List for a law banning "numerous" imported pharmaceuticals and medical devices that prevents access by U.S. companies.
This year, the Report also has a section on "Intellectual Property and Health Policy," specifically relating to the 2001 Doha Declaration on the TRIPS Agreement. The Report states that the U.S. "respects a country's right to protect public health, in particular, to promote access to medicines for all." Accordingly, the Report states that the U.S. "respects our trading partners' rights to grant compulsory licenses" consistent with the provisions of the Doha Declaration, including provisions of the August 2003 agreement whereby countries are permitted to grant such compulsory licenses not only for producing pharmaceuticals for internal use but also for export to countries unable to produce drugs themselves. Interestingly, the Report notes that the U.S. was the first country to formally adopt the provisions incorporating these provisions into the TRIPS agreement, and that two-thirds of WTO members must ratify them by December 31, 2009 in order for them to come into effect.
Immediately following this discussion is a section highlighting efforts by the Representative to support pharmaceutical innovation by "eliminate[ing] market barriers" and to "support . . . innovation" in the pharmaceutical industry, pointing to concerns in the Report about market access barriers in Algeria and Indonesia. Also mentioned in the Report are "concerns" about pharmaceutical regulatory and other policies of Canada, France, Germany, Italy, Japan (specifically with regard to regulatory aspects), New Zealand, and Taiwan. Poland's adoption in 2006 of regulations establishing maximum wholesale and retail prices for imported drugs is also mentioned, as well as urging China to add new drugs to its national formulary (which controls which drugs are available in China).
The report notes positive developments in several countries, including Korea and Taiwan (taken off the Watch List as noted above), China (relating to rebroadcast of the Olympic Games), Russia (for acceding to the WIPO Internet Treaties, and combating software piracy), Chile, Egypt, India (for passing the Drugs and Cosmetics (Amendment) Act in 2008 relating to counterfeit pharmaceuticals), Indonesia, Lebanon, Saudi Arabia, Sweden (for the PirateBay website convictions), and Vietnam. The Report also contains a review of the status of patent and other intellectual property rights country by country for all the countries on these two Watch lists.
Section III of the Report is entitled "Notorious Markets," which sets forth a list of markets on the Internet (in China and Russia) as well as "physical" markets (in China, Russia, Mexico, India, Poland, the Philippines, the Czech Republic, Indonesia, Thailand, and the tri-border region between Paraguay, Brasil, and Argentina) where "[g]lobal piracy and counterfeiting continue to thrive."
Posted at 11:59 PM in International IP | Permalink | Comments (0) | TrackBack (0)
Patent Profile: Raptor Pharmaceuticals Secures Allowances for Brain Drug Delivery Methods
On April 29, 2009, Raptor Pharmaceuticals Corp. announced that the U.S. Patent and Trademark Office recently issued Notices of Allowance for two of its pending patent applications related to methods of delivering drugs to the brain. The Notices were issued for U.S. Patent Application Nos. 10/812,849 and 11/202,566. The published applications are entitled "Megalin-based Delivery of Therapeutic Compounds to the Brain and Other Tissues" and "Use of the Chaperone Receptor-associated Protein (RAP) for the Delivery of Therapeutic Compounds to the Brain and Other Tissues," respectively. These applications are directed to the company's NeuroTrans™ drug delivery platform.
An exemplary allowed claim from the '849 patent application reads as follows:
1. A method of delivering an active agent into the central nervous system of an animal comprising administering to said animal a conjugate comprising said agent conjugated to a Receptor Associated Protein (RAP) polypeptide consisting of an amino acid sequence at least 80% identical to amino acids 221-323 of RAP (SEQ ID NO:1), wherein said RAP polypeptide retains megalin-binding activity and wherein said agent is delivered into the central nervous system.
Similarly, one of the allowed claims from the '566 patent application reads as follows:
1. A method of delivering a therapeutic or diagnostic/investigational agent across the blood brain barrier (BBB) into the central nervous system in a subject in need thereof, said method comprising: administering to said subject a chimeric RAP fusion protein comprising said therapeutic or diagnostic/investigational agent, wherein the RAP portion of the chimeric RAP fusion protein consists of an amino acid sequence at least 80% identical to amino acids 221-323 of SEQ ID NO:1.
According to Raptor's website, the company was founded in 2005 by former executives and scientists from BioMarin Pharmaceutical, Inc. In January 2006, Raptor acquired the intellectual property for the NeuroTrans™ program from BioMarin. Since its incorporation in 2005, Raptor has completed five product and technology acquisitions, including Convivia™, which addresses the toxicity associated with ALDH2 deficiency, and DR Cysteamine, which may be useful for a variety of clinical applications.
The assignment databases at the USPTO list Raptor Pharmaceutical, Inc. as the assignee of four patent applications, and BioMarin Pharmaceutical as the assignor or assignee of a number of patents and applications.
Posted at 11:43 PM in Patent Profiles | Permalink | Comments (0) | TrackBack (0)
Novartis Denied Jury Trial in Famvir® Suit
Last week, the U.S. District Court for the District of New Jersey denied Novartis Pharmaceutical Corp.'s request for a jury trial in its suit against Roxane Laboratories Inc. In the lawsuit, filed in July 2008 (see "Court Report," May 18, 2008), Norvartis alleges that Roxane infringed Novartis patents covering Famvir®, a treatment for genital and oral herpes. The patent-in-suit, U.S. Patent No. 5,246,937, covers famciclovir, the active ingredient in Famvir®. Novartis' original filing followed Roxane's filing of an ANDA with the U.S. Food and Drug Administration seeking regulatory approval to manufacture and market a generic version of Famvir®.
In its arguments seeking a jury trial, Novartis argued that such a ruling would allow it to consolidate this trial with its action against Teva for infringement of the same patent. The District Court, however, denied the request, ruling that because the infringement action was based solely on Roxane's ANDA filing, relief was limited solely to injunctive relief, thereby negating Novartis' right to a jury trial. On the issue of consolidation, the Court ruled that Novartis' arguments were premature, as no consolidation of the cases had occurred.
The District Court also ruled on Roxane's motion to dismiss Novartis' claim that the case was exceptional, a claim that would set the stage for the awarding of attorneys fees. Roxane argued that the "mere filing of an ANDA cannot support a finding of willful infringement," but the Court disagreed and found it premature to dismiss claims for willful infringement. The Court concluded that during the course of litigation, Novartis could prove that the ANDA filing was unjustified, thereby making a ruling on this issue at this stage of litigation premature.
Par Drops GSK from Treximet® Suit
Par Pharmaceutical, the defendant in Pozen, Inc.'s infringement suit over its migraine treatment Treximet®, has agreed to drop GlaxoSmithKline PLC from the lawsuit due to GSK's cooperation with regard to discovery and abidance to the District Court's judgment. The suit (see "Court Report," November 23, 2008) is part of a consolidated patent suit in the U.S. District Court for the Eastern District of Texas in which Pozen sued Par, Alphapharm Pty. Ltd., and Mylan Inc. for infringement of U.S. Patent Nos. 6,060,499, 6,586,458, and 7,332,183, Pozen's patents covering the migraine treatment Treximet®. Pozen filed its original suit against Par in November on the heels of Par's ANDA filing with the FDA seeing regulatory approval to make and market a generic version of Treximet®. Pozen and GSK have an agreement allowing GSK to distribute Treximet® in the United States; based on this relationship, GSK was added to the current suit when Par filed amended counterclaims addressing the agreements between GSK and Pozen.
As part of its exit, GSK has promised to both give up any affirmative claims it might have had against Par and has agreed to be bound by "any and all judgments" in the current case or in any other related or consolidated actions. GSK has also stipulated to providing "full and complete discovery" to Par and to provide necessary witnesses for trial should the witnesses be required.
Galderma Drops Patent Suit over MetroGel®
The U.S. District Court for the District of Colorado has approved Galderma SA's voluntary dismissal of its patent infringement suit against Tolmar Inc. over the rosacea treatment Metrogel® (see "Court Report," March 8, 2009). The patents-in-suit, U.S. Patent Nos. 6,881,726 and 7,348,317, cover "aqueous compositions containing metronidazole," the active ingredient in Metrogel®. Galderma filed the suit on March 4 following Tolmar's submission of an ANDA to the FDA seeking regulatory approval to manufacture and market a generic version of Metrogel®. In a letter sent to Galderma, Tolmar claimed that its product would not infringe upon Galderma's patents, but Galderma initially disagreed. Galderma had been seeking an injunction preventing Tolmar from marketing or manufacturing the generic version of Metrogel®, and an order requiring Tolmar to destroy all infringing products. In addition to injunctive relief, Galderma had also been seeking damages and attorneys' fees.
Posted at 11:26 PM in Patent Litigation | Permalink | Comments (1) | TrackBack (0)
Amgen Inc. v. International Trade Commission (Fed. Cir. 2009)
Last year, a panel of the Federal Circuit affirmed the International Trade Commission's (ITC's) grant of summary judgment against Amgen in its attempts to block importation of Roche's Mircera® peglylated erythropoietin product. At the time, Patent Docs provided a detailed report of the decision and its implications. As a review, in an decision authored by Judge Newman, and joined by Judge Lourie, the Federal Circuit affirmed the ITC's interpretation of the interactions of 19 U.S.C. § 1337, 35 U.S.C. § 271(e)(1) and § 271 (g), finding that the safe harbor provision of § 271(e)(1), which protects activities that are "reasonably related" to producing information for submission in support of obtaining regulatory approval, is as applicable to actions under Section 337 of the Tariff Act as it is to patent infringement actions in district courts under § 271 (g). At issue was whether the Mircera® drug product produced by Roche offshore using a process covered by claims in the United States would fall under the safe harbor provision in an action brought before the ITC. Judge Linn dissented from this ruling as it applied to those process claims. Even though he believed that the Court's decision was consistent with the apparent intent of Congress, Judge Linn pointed out that the safe harbor provision provides that the activities covered by the provision "shall not be an act of infringement," but that the statute governing process claims before the ITC does not actually require an act of infringement. Therefore, based on the plain meaning of the statute, the fact that the safe harbor provision protects what otherwise would have been an act of infringement is irrelevant for the determination of whether the ITC can issue an exclusion order related to method claims. Judge Linn was, however, pleased to join the remainder of the opinion.
In its previous opinion, the Federal Circuit reversed and remanded on the question of whether any portion of the imported Mircera® drug product fell outside of the safe harbor because the ITC had not considered whether the imported Mircera® had been used for activities other than those related to obtaining FDA approval. Specifically, Amgen alleged that it did not bring the action until Roche has completed its submission to the FDA, and that Roche had shifted its attention in the United States to infringement analysis experiments, market-seeding trials, and litigation-related activity. Because the ITC had incorrectly held that all importation and uses of the Mircera® drug product are exempt while FDA approval is pending, the Federal Circuit remanded.
Finally, in Part II of its prior opinion, the panel held that the ITC had the power to use its authority prophylactically to ban importation, so as to prevent harm to American industry "in its incipiency." The ITC had determined that it lacked jurisdiction to "investigate and resolve" Amgen's charges of infringement because its jurisdiction was limited to acts of importation and the sale of infringing articles (or articles made by using an infringing process) and there was no evidence that any of Roche's Mircera® drug product had been sold or the subject of a contract for sale in the U.S. -- an observation that was true because Roche had not yet received FDA approval for Mircera®. The panel provided detailed reasoning for its decision, including pointing out that the purpose of an ITC action was to prevent infringing articles from getting into the stream of commerce, and that actions before the ITC unify actions against accused infringers before commercial activities require a profusion of individual suits to prevent infringement. The panel also noted that where the infringing acts are reasonably likely to occur, such as the present case where a party undertakes systematic efforts to meet regulatory requirements to market an imported drug product, the ITC has jurisdiction to consider infringement during the safe harbor period. Thus, the panel concluded that the ITC erred in holding that it lacked jurisdiction under the Tariff Act absent actual sale or contract for sale of the imported Mircera®.
At the urging of both the ITC and Roche, an en banc Federal Circuit "authorized" the panel in the earlier Amgen Inc. v. ITC case to revise Part II of its opinion related to the jurisdictional question, vacated the previous judgment and withdrew the accompanying opinion, and returned the appeal to the original panel. Correspondingly, on Thursday of last week, that panel issued a revised opinion to accompany that order from the en banc court. It appears from a comparison of the two opinions that the panels conclusions reached in Parts I.A and I.B were left unchanged, as well as Judge Linn's dissent from Part I.A. The only difference in the two opinions was that the panel revised its response to the jurisdictional question, which was apparently informed by further briefing from both parties. The panel noted that there was actually no dispute as to whether Roche had imported Mircera® -- even Roche had acknowledged this while at the same time arguing that the importation fell within the safe harbor provision of § 271(e)(1). Moreover, the panel pointed out that that this was a jurisdictional issue, and as such, it should not depend on the merits of Amgen's complaint. Simply put, Amgen alleged that Roche imported Mircera®, an article made by a process that is patented in the U.S. This was enough to overcome the jurisdictional hurdle. The question of whether such importation was entitled to the protection of the safe harbor provision, or whether there was actually any importation at all, goes to the merits of Amgen's complaint. The panel concluded that it did not need to address whether the ITC would have had jurisdiction based on "imminent importation," because Amgen had asserted actual importation. As a reader of the revised opinion will note, the outcome from Part II of the opinion remained unchanged -- the ITC had and has jurisdiction to decide this case. However, the reasoning behind the original decision (as well as the holding that it is possible for the ITC to have jurisdiction absent actual sale or a contract for sale) was replaced with the simple observation that jurisdiction is conferred by a simple allegation of importation. In the case of the importation of drug products, however, as long as the accused drug product is being imported prior to FDA approval, the patent holder should still be able to avail themselves of the ITC without worry. Whether the patent holder will be successful will obviously depend on the merits of the case.
Panel: Circuit Judges Newman, Lourie, and Linn
Per curiam, dissenting opinion as to Section I.A. by Circuit Judge Linn
Panel: Chief Judge Michel and Circuit Judges Newman, Mayer, Lourie, Rader, Schall, Bryson, Gajarsa, Linn, and Prost
Per curiam (order)
Posted at 10:10 PM in Federal Circuit | Permalink | Comments (0) | TrackBack (0)
Warner Chilcott Co. et al. v. Midlothian Laboratories L.L.C.
2:09-cv-02026; filed April 30, 2009 in the District Court of New Jersey
Warner Chilcott Co. et al. v. Mission Pharmacal Co.
2:09-cv-02025; filed April 30, 2009 in the District Court of New Jersey
The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 6,521,247 ("Dual Iron Containing Nutritional Supplement," issued February 18, 2003) based on Midlothian's manufacture and sale of its Foltabs and Foltabs DHA prenatal supplements and Misson's manufacture and sale of its CitraNatal DHA, CitraNatal90 DHA, and CitraNatal Rx prenatal supplements. View the Midlothian Laboratories complaint here.
Biogen Idec Ma Inc. v. Doll
1:09-cv-00792; filed April 30, 2009 in the District Court of the District of Columbia
Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,446,173 ("Polymer Conjugates of Interferon Beta-1A and Uses," issued November 4, 2008). View the complaint here.
Pfizer Inc. et al. v. Alphapharm Pty. Ltd. et al.
1:09-cv-00056; filed April 30, 2009 in the Northern District of West Virginia
Pfizer Inc. et al. v. Teva Pharmaceuticals USA Inc. et al.
1:09-cv-00307; filed April 29, 2009 in the District Court of Delaware
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 6,001,876 ("Isobutylgaba and Its Derivatives for the Treatment of Pain," issued December 14, 1999) and 6,197,819 ("Gamma Amino Butyric Acid Analogs and Optical Isomers," issued March 6, 2001) following a Paragraph IV certification as part of defendant's filing of an ANDA to manufacture a generic version of Pfizer's Lyrica® (pregabalin, used to treat fibromyalgia). View the Teva Pharmaceuticals complaint here.
1:09-cv-00309; filed April 29, 2009 in the District Court of Delaware
Pfizer Inc. et al. v. Actavis Elizabeth LLC et al.
1:09-cv-00311; filed April 29, 2009 in the District Court of Delaware
1:09-cv-00310; filed April 29, 2009 in the District Court of Delaware
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 6,001,876 ("Isobutylgaba and Its Derivatives for the Treatment of Pain," issued December 14, 1999), 6,197,819 ("Gamma Amino Butyric Acid Analogs and Optical Isomers," issued March 6, 2001), and 5,563,175 ("GABA and L-glutamic Acid Analogs for Antiseizure Treatment," issued October 8, 1996) following a Paragraph IV certification as part of defendant's filing of an ANDA to manufacture a generic version of Pfizer's Lyrica® (pregabalin, used to treat fibromyalgia). View the Lupin complaint here.
Pfizer Inc. et al. v. Cobalt Laboratories Inc. et al.
1:09-cv-00315; filed April 29, 2009 in the District Court of Delaware
Infringement of U.S. Patent Nos. 5,563,175 ("GABA and L-glutamic Acid Analogs for Antiseizure Treatment," issued October 8, 1996) and 6,197,819 ("Gamma Amino Butyric Acid Analogs and Optical Isomers," issued March 6, 2001) following a Paragraph IV certification as part of defendant's filing of an ANDA to manufacture a generic version of Pfizer's Lyrica® (pregabalin, used to treat fibromyalgia). View the complaint here.
1:09-cv-00313; filed April 29, 2009 in the District Court of Delaware
1:09-cv-00312; filed April 29, 2009 in the District Court of Delaware
The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 6,197,819 ("Gamma Amino Butyric Acid Analogs and Optical Isomers," issued March 6, 2001) following a Paragraph IV certification as part of defendant's filing of an ANDA to manufacture a generic version of Pfizer's Lyrica® (pregabalin, used to treat fibromyalgia). View the Sun Pharma complaint here.
Pfizer Inc. et al. v. Alphapharm Pty Ltd. et al.
1:09-cv-00308; filed April 29, 2009 in the District Court of Delaware
Infringement of U.S. Patent No. 6,001,876 ("Isobutylgaba and Its Derivatives for the Treatment of Pain," issued December 14, 1999) following a Paragraph IV certification as part of defendant's filing of an ANDA to manufacture a generic version of Pfizer's Lyrica® (pregabalin, used to treat fibromyalgia). View the complaint here.
Pronova BioPharma Norge AS v. Par Pharmaceutical Inc. et al.
1:09-cv-00305; filed April 29, 2009 in the District Court of Delaware
Pronova BioPharma Norge AS v. Apotex Corp. et al.
1:09-cv-00304; filed April 29, 2009 in the District Court of Delaware
The complaints in these cases are substantially identical. Infringement of U.S. Patent Nos. 5,502,077 ("Fatty Acid Composition," issued March 26, 1996) and 5,656,667 (same title, issued August 12, 1997) following a Paragraph IV certification as part of Eagle's filing of an ANDA to manufacture a generic version of Pronova's Lovaza® (omega-3-acid ethyl esters, used to reduce triglyceride levels in adult patients with very high triglyceride levels). View the Par Pharmaceutical complaint here.
Novartis Pharmaceuticals Corp. et al. v. Anchen Pharmaceuticals, Inc.
2:09-cv-02929; filed April 27, 2009 in the Central District of California
Novartis Pharmaceuticals Corp. et al. v. Anchen Pharmaceuticals Inc.
1:09-cv-00294; filed April 24, 2009 in the District Court of New Jersey
Novartis Pharmaceuticals Corp. et al. v. Watson Pharmaceuticals Inc. et al.
0:09-cv-60622; filed April 27, 2009 in the Southern District of Florida
1:09-cv-00292; filed April 24, 2009 in the District Court of New Jersey
The complaints in these cases are substantially identical. Infringement of U.S. Patent No. 6,106,864 ("Pharmaceutical Formulations Containing Darifenacin," issued August 22, 2000) following a Paragraph IV certification as part of defendant's filing of an ANDA to manufacture a generic version of Novartis' Enablex® (darifenacin, used to treat symptoms of overactive bladder). View the California Anchen Pharmaceuticals complaint here.
Novartis Pharmaceuticals Corp. et al. v. Teva Pharmaceuticals USA Inc.
1:09-cv-00291; filed April 24, 2009 in the District Court of New Jersey
Infringement of U.S. Patent Nos. 5,096,890 ("Pyrrolidine Derivatives," issued March 17, 1992) and 6,106,864 ("Pharmaceutical Formulations Containing Darifenacin," issued August 22, 2000) following a Paragraph IV certification as part of defendant's filing of an ANDA to manufacture a generic version of Novartis' Enablex® (darifenacin, used to treat symptoms of overactive bladder). View the complaint here.
Reckitt Benckiser Inc. v. Watson Laboratories, Inc. - Florida et al.
0:09-cv-60609; filed April 24, 2009 in the Southern District of Florida
Infringement of U.S. Patent Nos. 6,372,252 ("Guaifenesin Sustained Release Formulation and Tablets," issued April 16, 2002) and 6,955,821 ("Sustained Release Formulations of Guaifenesin and Additional Drug Ingredients," issued October 18, 2005) following a Paragraph IV certification as part of Watson's filing of an ANDA to manufacture a generic version of plaintiff's Mucinex® and Mucinex® DM (guaifenesin, and guaifenesin/dextromethorphan, respectively, used to treat chest congestion). View the complaint here.
Pozen Inc. v. Teva Pharmaceuticals USA Inc.
6:09-cv-00182; filed April 24, 2009 in the Eastern District of Texas
Infringement of U.S. Patent Nos. 6,060,499 ("Anti-migraine Methods and Compositions Using 5-HT Agonists with Long-Acting NSAIDS," issued May 9, 2000) and 6,586,458 ("Methods of Treating Headaches Using 5-HT Agonists in Combination with Long-Acting NSAIDS," issued July 1, 2003), licensed to GlaxoSmithKline, following a Paragraph IV certification as part of Teva's filing of an ANDA to manufacture a generic version of GSK's Treximet® (sumatriptan and naproxen sodium, used to treat migrane attacks). View the complaint here.
Hoffmann-La Roche Inc. v. Doll
1:09-cv-00760; filed April 24, 2009 in the District Court of the District of Columbia
Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,442,776 ("Cancerous Disease Modifying Antibodies," issued October 28, 2008). View the complaint here.
Biogen Idec Ma Inc v. Doll
1:09-cv-00754; filed April 23, 2009 in the District Court of the District of Columbia
Review and correction of the patent term adjustment calculation made by the U.S. Patent and Trademark Office for U.S. Patent No. 7,442,370 ("Polymer Conjugates of Mutated Neublastin," issued October 28, 2008). View the complaint here.