Tracy U. Palovich, PhD Colleen M. Schaller. Howson & Howson LLP Blue Bell, Pennsylvania
|
|
- Frank Clifford Simpson
- 6 years ago
- Views:
Transcription
1 Safe Harbor Exemption under 271(e)(1): What's not included after Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, 686 F.3d 1348, 103 USPQ2d 1800 (Fed. Cir 2012) Tracy U. Palovich, PhD Colleen M. Schaller Patent Agent Associate Howson & Howson LLP Blue Bell, Pennsylvania The protection of subject matter requiring review by the FDA plays an integral part in the fate of pharmaceutical and biotechnology companies. However, the FDA approval process is by no means a simple task. In fact, before 1984, FDA approval of a drug might not have occurred until long after the patent expired. Consequently, a generic competitor could immediately seek to enter the market, with no set period of exclusivity for the brand name drug. On the other hand, it was also impossible for generic companies to begin the necessary comparison of their generic counterpart drug with the reference drug until expiration of the reference patent. This loss of time equated to a de facto extension of the reference patent and the loss of millions of dollars by the generic company. In 1984, Congress, recognizing the issues, sought to address the competing interests of 1) FDA approval of new pharmaceuticals and 2) the use of patented technology by competitors to get FDA approval for generic counterpart drugs. Accordingly, Congress passed the Drug Price Competition and Patent Term Restoration Act ("Hatch-Waxman Act") and addressed both of these issues. Under Title II of the Hatch-Waxman Act, codified as 35 U.S.C. 156, pharmaceutical companies could obtain a five-year extension of their patent term beyond the standard patent term, for delays in regulatory review and approval. In exchange for the extension granted to the pharmaceutical companies, generic companies were permitted, under Title I of the Act, codified as 35 U.S.C. 271(e)(1), to utilize the patented technology in their efforts to submit information to the FDA in an Abbreviated New Drug Application (ANDA) FN1 without infringing the patent. 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 States a patented invention solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products 37 U.S.C. 271(e)(1) (emphasis added) 113
2 FN1. It is to be noted that the exemption is not applicable only to "the research relevant to filing an ANDA for approval of a generic drug." Merck KGaA v. Integra Lifesciences I, Ltd, 545 U.S. 193, 206 (2005). Rather, the use of patented inventions in activities that produce the types of information that are relevant to an Investigational New Drug Application (IND) or New Drug Application (NDA) is also eligible for protection. Id. at 208. Despite Congress' stated intentions, the language of the law is vague. This has led to a variety of lawsuits and resulting case law, with the courts interpreting the metes and bounds of the statutory language. Of significance, and in recent years, the courts addressed the hot ticket item of whether the infringing act was solely done in an effort to submit information which was required under a Federal law. This issue is addressed here. I. Merck KGaA v. Integra Lifesciences I, Ltd., 545 U.S. 193 (2005) In the Merck decision, the Supreme Court has taken an expansive view of activities related to submission of information under a Federal law which are covered by the 271(e)(1) exemption. The Court found that the "exemption from infringement extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the [Food, Drug and Cosmetic Act]." Id. at 202 (emphasis in original). According to the Court, under certain circumstances, this includes the use of patented inventions in "experimentation on drugs that are not ultimately the subject of an FDA submission" or "experiments that are not ultimately submitted to the FDA." Id. at 206. In Merck, the Supreme Court took an expansive view of what activities are protected in the preclinical setting, without discussion of post-fda approval activities. Since this decision, the Federal Circuit has struggled with what postapproval activities are also protected by the 271(e)(1) safe harbor provision. II. Classen Immunotherapies v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011), cert. denied, 133 S. Ct. 973 (2013) Classen owned 3 patents drawn to methods of optimizing vaccine immunization schedules related to possible associations with chronic immune-related illnesses. Classen alleged infringement by Biogen and GlaxoSmithKline (collectively "Biogen") for conducting studies after FDA approval "to evaluate suggested associations between childhood vaccinations, particularly against hepatitis B and Haemophilus influenza and risk of developing type 1 diabetes; and to determine 114
3 whether timing of vaccination influences risk". 659 F.Supp.3d 1057 at Biogen maintained that, although its work was performed after FDA approval of the subject vaccines, its activities were directed to actions conducted for purposes of complying with FDA regulations. Therefore Biogen asserted the activities fell within the 271(e)(1) exemption. Relying heavily on the legislative history of the Hatch-Waxman Act, the Federal Circuit refused to extend the 271(e)(1) exemption and found Biogen's acts infringing. In a 2-1 decision, Chief Judge Rader, writing for the Classen majority (with Judge Moore dissenting) held that: 271(e)(1) provides an exception to the law of infringement in order to expedite development of information for regulatory approval of generic counterparts of patented products. The statute does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained. Classen at 1070 (emphasis added). For most of the pharmaceutical community, this decision seemed to clarify the actions which could be safely undertaken relating to the FDA. Specifically, it appeared as though the Court was restricting 271(e)(1) to acts performed before FDA approval of a drug. III. Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. 882 F.Supp.2d 184 D.Mass., 2011 ("Momenta I") & Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc. 686 F.3d 1348, 103 U.S.P.Q.2d 1800, 2012 ("Momenta II") Almost one year later, the Federal Circuit faced a similar issue in Momenta II which involved enoxaparin, a drug that prevents blood clots. Enoxaparin is produced directly from heparin and, due to the composition of heparin, enoxaparin is made up of a range of different molecules. In such cases, where the identity of the drug is complex, an: ANDA Applicant must submit studies to establish that its drug is bio-equivalent to the reference drug [and] include sufficient information to establish that the generic drug has the same active ingredients as the reference drug. 686 F. 3d 1348 at Spurred by a request by Sanofi-Aventis, the marketer of the brand name drug, Lovenox, the FDA identified five criteria required to prove that generic 115
4 enoxaparin is the same as the active ingredient in Lovenox. One of the requirements was to show that the generic drug can be broken down into smaller blocks containing a 1,6-anhydro ring structure. Momenta is the assignee of U.S. Patent No. 7,575,886 which is drawn to methods for analyzing compounds such as heparin and enoxaparin, specifically for the aforementioned 1,6-anhydro ring. In the usual course of action, Momenta and Amphastar separately filed ANDAs for enoxaparin. Although Amphastar filed its ANDA first, Momenta was the first to receive FDA approval to market enoxaparin, more than one year before Amphastar was approved. To stem the potential loss in revenue estimated at about 1 billion dollars per year, Momenta asserted its patent two days after Amphastar's approval. Momenta claimed that Amphastar used Momenta's patented technology to analyze their samples of enoxaparin without Momenta's permission. Relying on Classen, Momenta alleged that Amphastar's activity was "post-approval" and outside of the safe-harbor exemption. Momenta II at Momenta further asserted that the records were never, in fact, submitted to the FDA, but instead were retained in case the FDA requested such data under Federal law. See, 21 C.F.R (a). In response, Amphastar argued that the use of Momenta's claimed method fell within the scope of 271(e)(1). In view of Classen, the patent community was not surprised that the District Court decision turned on the distinction between pre- and post-approval activity. In finding in favor of Momenta, the District Court noted: Although the safe harbor provision permits otherwise infringing activity that is conducted to obtain regulatory approval of a product, it does not permit a generic manufacturer to continue in that otherwise infringing activity after obtaining such approval... Momenta I at 197. Upon appeal to the Federal Circuit, Amphastar argued that the District Court was overly-restrictive, while Momenta argued that 271(e)(1) does not apply to activities which occur after FDA approval while referencing the Classen decision. In another 2-1 decision, the Court found the language of the statute to be unambiguous, eschewing the weight afforded to the legislative history by the majority in Classen. This time, with Judge Moore writing for the majority and Chief Judge Rader dissenting, the Court held that: 116
5 [T]he only coherent and consistent interpretation of "a Federal law which regulates the manufacture, use or sale of drugs" is that it must be broad enough to encompass submissions made pursuant to the Federal Food, Drug, and Cosmetic Act. Momenta II 686 F3d 1348, 1355, citing 35 USC 271(e)(1). The Court noted that, unlike the "closely related infringement provision" of 35 USC 271(e)(2), the safe harbor provision was not linked to an application submitted under the FDCA. Momenta II at Relying on Merck v. Integra, the Court found that its definition of submissions which fall within the safe harbor "extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the FDCA". Id. at 1356, citing Merck KGaA v. Integra Lifesciences I, Ltd, 545 U.S. 193, 202 (2005) (emphasis in original). While the Court acknowledged it was bound by the Classen decision, it stated that its view of the Momenta facts did not run afoul of the precedent. Rather than turning on the "artificial" pre-/post-approval distinction, the Court found that because the submissions were "required to maintain FDA approval", and were not "routine" or "generated voluntarily by the manufacturer", they were covered by the safe harbor provision. IV. After Momenta II At first glance, it appears as though the Momenta II decision contradicted the Classen decision by the same Court. In fact, in his dissent, Chief Judge Rader paints a very detailed picture of his view on the Momenta II decision and maintains that the Court ignored the precedent set by Classen. Chief Judge Rader aggressively notes that " this result will render worthless manufacturing test method patents." Momenta II at However, careful analysis leads to the conclusion that Momenta II actually parallels the Classen decision and provides clearer guidance for brand-name and generic companies to follow. The Momenta II Court noted that the information generated by Amphastar was "reasonably related to the development and submission of information under a Federal law", i.e., it was required by the FDA. Id. at 1353, citing 35 USC 271(e)(1). The Court noted that Amphastar was required to collect and retain the batch testing data, and have it available for inspection by the FDA. If such data was not available upon request of the FDA, suspension or revocation of the ANDA approval could result. Thus, the Court held, the "submissions" were not routine. Id. at
6 This is in contrast to Classen, where the data in question was not required by the FDA for approval or continued approval of the ANDA. Rather it was a "routine submission" to the FDA. The Court confirmed that the FDA required data need not physically be submitted to the FDA in any form. It only need be collected and stored for later inspection by the FDA. Id. at Finally, the Court noted that the safe harbor provision doesn't require the use of a non-infringing analysis method. The requirement is that the method is utilized to produce mandated information to the FDA. Id. at In eschewing the pre-/post-appeal distinction put forth by Classen, Momenta II provides a logical distinction between whether or not the submissions are required by the FDA. This test neatly integrates the Merck, Classen and Momenta II decisions. Thus, after Momenta II, it would appear that all testing done using patented inventions, whether done pre- or post-fda approval, will qualify for the safe harbor, provided that they are reasonably related to the development and submission of information which is required by the FDA. It follows that activities that are not covered by the safe harbor after Momenta II are those that are not mandatory, i.e., related to submissions that are not required by a specific mandate. V. Going Forward? Even though those in the patent community are split, these two decisions may better prepare those in NDA, ANDA, and biologic businesses. In gauging the wealth of discussions about this issue, the following "best practices" may be considered: Ensure that post-approval activity is required by the FDA in order to fall under the requirements of the safe harbor provision. Understand what is required to actually maintain FDA approval of the ANDA. For existing FDA submission, determine if there are any activities which may be required by FDA but are not expressly mandated. Ensure that there is a link between the data generated and the legal duty to submit it to the FDA. Educate personnel in record keeping (internal and patent prosecution based) and regulatory filings to ensure consistency with safe harbor restrictions. Consider keeping certain "methods of analyzing" a trade secret. 118
7 This article provides practical and useful information on the subject matter covered and expresses only the views of the authors. If legal advice or other expert assistance is required, the services of a competent professional should be sought. 119
The Weakening of Pharmaceutical Method Patents: The Federal Circuit Addresses the FDA Conundrum
Journal of Intellectual Property Rights Vol 19, March 2014, pp 89-96 The Weakening of Pharmaceutical Method Patents: The Federal Circuit Addresses the FDA Conundrum Brian Wm Higgins and Jay P Lessler Blank
More informationEXAMINING THE 271(E)(1) SAFE HARBOR OF THE HATCH-WAXMAN ACT: A LEGISLATIVE PROPOSAL GRANTING MANDATORY POST- MARKETING EXCEPTIONS
EXAMINING THE 271(E)(1) SAFE HARBOR OF THE HATCH-WAXMAN ACT: A LEGISLATIVE PROPOSAL GRANTING MANDATORY POST- MARKETING EXCEPTIONS INTRODUCTION... 652 I. HISTORY OF THE HATCH-WAXMAN ACT AND THE ENACTMENT
More informationKeywords: research tools, patents, Integra, research exemption, reach-through, royalties
Charles J. Raubicheck, Barry S. White, Thomas J. Kowalski and Daniel G. Brown are Partners in Frommer Lawrence & Haug LLP. Amy Leahy and Pamela Fekete are Law Clerks with Frommer Lawrence & Haug LLP. Keywords:
More informationMERCK v. INTEGRA LIFESCIENCES: THE SUPREME COURT PROTECTS THE USE OF PATENTED COMPOUNDS IN PRECLINICAL STUDIES TABLE OF CONTENTS
MERCK v. INTEGRA LIFESCIENCES: THE SUPREME COURT PROTECTS THE USE OF PATENTED COMPOUNDS IN PRECLINICAL STUDIES TABLE OF CONTENTS I. INTRODUCTION 54 II. DRUG PATENTS AND THE REGULATORY EXEMPTION SAFE HARBOR
More informationPatent Term Extension Not A 1-Trick Pony For Animal Drugs
Portfolio Media. Inc. 111 West 19 th Street, 5th Floor New York, NY 10011 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com Patent Term Extension Not A 1-Trick Pony
More informationHigh Court Interprets The Biosimilars Statute What Now?
Portfolio Media. Inc. 111 West 19 th Street, 5th Floor New York, NY 10011 www.law360.com Phone: +1 646 783 7100 Fax: +1 646 783 7161 customerservice@law360.com High Court Interprets The Biosimilars Statute
More informationIntegra v. Merck: Limiting the Scope of the 271(e)(1) Exception to Patent Infringement
Berkeley Technology Law Journal Volume 19 Issue 1 Article 11 January 2004 Integra v. Merck: Limiting the Scope of the 271(e)(1) Exception to Patent Infringement George Fox Follow this and additional works
More informationIn Sierra Club v. Environmental Protection Agency, 2013 U.S. App. LEXIS 1408
Skadden Skadden, Arps, Slate, Meagher & Flom LLP & Affiliates If you have any questions regarding the matters discussed in this memorandum, please contact the following attorneys or call your regular Skadden
More informationPharmaceutical Intellectual Property Summit Biosimilars Panel. Janis Fraser, moderator October 28, 2010 Princeton, NJ
Pharmaceutical Intellectual Property Summit Biosimilars Panel Janis Fraser, moderator October 28, 2010 Princeton, NJ Pharmaceutical Intellectual Property Summit Biosimilars Panel Terry G. Mahn October
More informationGuidance for Industry New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products
Guidance for Industry New Chemical Entity Exclusivity Determinations for Certain Fixed-Combination Drug Products DRAFT GUIDANCE This guidance document is being distributed for comment purposes only. Comments
More informationI. THE HATCH-WAXMAN ACT S EXEMPTION FROM PATENT INFRINGEMENT AND THE CONCERNS OF RESEARCH TOOL PATENT OWNERS
407 ARE PATENTED RESEARCH TOOLS STILL VALUABLE? USE, INTENT, AND A REBUTTABLE PRESUMPTION: A PROPOSED MODIFICATION FOR ANALYZING THE EXEMPTION FROM PATENT INFRINGEMENT UNDER 35 U.S.C. 271(e)(1) VIHAR R.
More informationPersonalized Medicine Patents at Risk: Tips for Battling Prometheus and Myriad to Obtain Claims to Diagnostics CIPA Journal March 1, 2013
Personalized Medicine Patents at Risk: Tips for Battling Prometheus and Myriad to Obtain Claims to Diagnostics CIPA Journal March 1, 2013 AMELIA FEULNER BAUR, PHD 610.667.2014 amelia.baur@mcneillbaur.com
More informationIntegra Lifesciences I, Ltd. v. Merck KGAA: Re- Examinig the Broad Scope of the 271(E)(1) Safe Harbor
Berkeley Technology Law Journal Volume 23 Issue 1 Article 6 January 2008 Integra Lifesciences I, Ltd. v. Merck KGAA: Re- Examinig the Broad Scope of the 271(E)(1) Safe Harbor Daniel Wobbekind Follow this
More informationUnited States Court of Appeals for the Federal Circuit
United States Court of Appeals for the Federal Circuit CLASSEN IMMUNOTHERAPIES, INC., Plaintiff-Appellant, v. BIOGEN IDEC, Defendant-Appellee, and GLAXOSMITHKLINE, Defendant-Appellee, and MERCK & CO.,
More informationI. FDA s Proposed Revocation of Unexpired Regulatory Exclusivity Cannot Stand
May 13, 2016 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Draft Guidance for Industry: Implementation of the Deemed To Be a
More informationIN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE ) ) ) ) ) ) ) ) ) ) C.A. No. COMPLAINT
Case 1:99-mc-09999 Document 732 Filed 12/15/11 Page 1 of 10 PageID #: 67711 IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF DELAWARE PFIZER INC., WYETH LLC. and WYETH PHARMACEUTICALS INC., v. SANDOZ
More informationEU and FDA GMP Regulations: Overview and Comparison
THE QUALITY ASSURANCE JOURNAL, VOL. 2, 55 60 (1997) EU and FDA GMP Regulations: Overview and Comparison The increasing emphasis on global supply of drug products, as well as starting materials and investigational
More informationPharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act
Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act Guidance U.S. Department of Health and Human Services Food and Drug Administration Center for
More informationANDA ANDA APPROVAL
DEPARTMENT OF HEALTH & HUMAN SERVICES ANDA 206726 Food and Drug Administration Silver Spring, MD 20993 ANDA APPROVAL Mylan Pharmaceuticals, Inc. 781 Chestnut Ridge Road P.O. Box 4310 Morgantown, WV 26504
More informationKey Regulatory Issues in Biosimilars
Key Regulatory Issues in Biosimilars May 4, 2017 John Manthei, Esq. Moderator Latham & Watkins LLP Latham & Watkins operates worldwide as a limited liability partnership organized under the laws of the
More informationPHARMACEUTICAL ANTITRUST: Delayed Generic Entry Cases. December 7, 2011 Linda Nussbaum John Radice
PHARMACEUTICAL ANTITRUST: Delayed Generic Entry Cases December 7, 2011 Linda Nussbaum John Radice What is Pharma Antitrust? General antitrust principles applied to the pharmaceutical industry, generally
More informationIn The Supreme Court of the United States
No. 11-1366 ================================================================ In The Supreme Court of the United States --------------------------------- --------------------------------- AVIDAIR HELICOPTER
More informationWashington and Lee Journal of Energy, Climate, and the Environment
Washington and Lee Journal of Energy, Climate, and the Environment Volume 1 Issue 1 Article 9 3-1-2010 Case Summaries Follow this and additional works at: http://scholarlycommons.law.wlu.edu/jece Recommended
More information13 Abbreviated Approval Pathway for Biosimilars and Patent Policy: Balancing the Incentives of Innovation and Price Competition (*)
13 Abbreviated Approval Pathway for Biosimilars and Patent Policy: Balancing the Incentives of Innovation and Price Competition (*) Invited Researcher: Dong Tao (**) Recently, there is a rallying cry for
More informationAbout a year ago, President
FOCUS ON... The regs The New US Biosimilar Legislation, One Year Later by Jacqueline Wright Bonilla and Nathan Beaver About a year ago, President Obama signed into law the highly publicized health care
More informationSeptember 12, Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852
September 12, 2013 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: : Draft Guidance for Industry on Pediatric Study Plans: Content
More informationCMC Considerations for 505(b)(2) Applications. Monica Cooper, Ph.D. FDA/CDER/OPS/ONDQA AAPS Annual Meeting Washington, D.C.
CMC Considerations for 505(b)(2) Applications Monica Cooper, Ph.D. FDA/CDER/OPS/ONDQA AAPS Annual Meeting Washington, D.C. October 2011 1 Introduction Outline Brief overview of FDA drug approval pathways
More informationA New Patent Dance: The Biologics Price Competition and Innovation Act
A New Patent Dance: The Biologics Price Competition and Innovation Act J. Eric Thies David M. Conca Jeffrey A. Wolfson Jeffrey L. Kopacz Michael K. Kirschner J. Eric Thies Assistant Counsel, Intellectual
More informationFood Fight: FSMA and the FDA s New Era of Enforcement. July By Sandra J. Wunderlich
Food Fight: FSMA and the FDA s New Era of Enforcement July 2017 By Sandra J. Wunderlich Panelists: Michael Landa, Retired Director, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration
More informationNo IN THE Supreme Court of the United States. ASSOCIATION FOR MOLECULAR PATHOLOGY, et al., MYRIAD GENETICS, INC., et al.,
No. 12-398 IN THE Supreme Court of the United States ASSOCIATION FOR MOLECULAR PATHOLOGY, et al., v. MYRIAD GENETICS, INC., et al., Petitioners, Respondents. ON WRIT OF CERTIORARI TO THE UNITED STATES
More informationCase 0:15-cv JIC Document 119 Entered on FLSD Docket 04/07/2016 Page 1 of 12 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF FLORIDA
Case 0:15-cv-61631-JIC Document 119 Entered on FLSD Docket 04/07/2016 Page 1 of 12 UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF FLORIDA CASE NO. 15-61631-CIV-COHN/SELTZER AMGEN, INC., and AMGEN MANUFACTURING
More informationUpdated trends in US brand-name and generic drug competition
Journal of Medical Economics ISSN: 1369-6998 (Print) 1941-837X (Online) Journal homepage: http://www.tandfonline.com/loi/ijme20 Updated trends in US brand-name and generic drug competition Henry Grabowski,
More informationDetermining Patient Access to Investigational Drugs in the US
Determining Patient Access to Investigational Drugs in the US Philip Katz examines the reasons for and against treating terminally ill patients with investigational drugs, focusing on efforts to change
More informationDEFINING LIMITS TO THE APPLICATION OF THE STATUTORY EXPERIMENTAL USE EXCEPTION WITHIN THE AGRICULTURAL BIOTECHNOLOGY INDUSTRY
DEFINING LIMITS TO THE APPLICATION OF THE STATUTORY EXPERIMENTAL USE EXCEPTION WITHIN THE AGRICULTURAL BIOTECHNOLOGY INDUSTRY Jennifer Carter-Johnson 2015 MICH. ST. L. REV. 509 ABSTRACT The Hatch Waxman
More informationMisclassification of Independent Contractors By Stacey Mark Chair, Sustainable Development Advisory Group and Labor and Employment Group November 2005
Misclassification of Independent Contractors By Stacey Mark Chair, Sustainable Development Advisory Group and Labor and Employment Group November 2005 A common and potentially costly mistake made by employers
More informationGENERAL ASSEMBLY OF NORTH CAROLINA SESSION 2017 H 1 HOUSE BILL 366. Short Title: Retail Workers' Bill of Rights. (Public)
GENERAL ASSEMBLY OF NORTH CAROLINA SESSION 0 H 1 HOUSE BILL Short Title: Retail Workers' Bill of Rights. (Public) Sponsors: Referred to: Representatives Brockman, Fisher, Harrison, and Holley (Primary
More informationUS FDA: CMC Issues for INDs
ISBTC Global Regulatory Summit October 29, 2008 US FDA: CMC Issues for INDs Keith Wonnacott, Ph.D. keith.wonnacott@fda.hhs.gov US Food and Drug Administration Center for Biologics Evaluation and Research
More informationNatural Resources Journal
Natural Resources Journal 19 Nat Resources J. 3 (Summer 1979) Summer 1979 New Mexico Water Pollution Regulations and Standards Upheld David N. Whitham Recommended Citation David N. Whitham, New Mexico
More informationAnalysis. Domestic Supplier Verification FDA Position in Proposed FDA Position in Supplemental
To: Stephanie Barnes, Food Marketing Institute From: Erik R. Lieberman Date: Re: FSMA Final Preventive Control for Human Food -Comparison with s and Proposed and Proposed s You asked us to draft a memorandum
More informationRegulatory Considerations and Trends Europe and the U.S.
Regulatory Considerations and Trends Europe and the U.S. Professor Kjell Strandberg MD PhD Chairman NDA Advisory Board, NDA Regulatory Science Ltd UK Former CPMP Member and Director General Medical Products
More informationCopyright. Jeremiah J. Kelly (2015). All rights reserved. Further dissemination without express written consent strictly prohibited.
Statutory Framework for Biologics Drugs Investigational Use Application IND Pre-Market Approval Applications 505(b)(1) NDA 505(b)(2) NDA 505(j) ANDA Over-the-Counter (OTC) Non- Rx Drugs Monograph Biologics
More informationBrief. IP Strategies in the Emerging Biosimilar Market. U.S. Patent Strategies in the Biosimilars Space. Biosimilar Litigation Landscape
Brief IP Strategies in the Emerging Biosimilar Market U.S. Patent Strategies in the Biosimilars Space Biosimilar Litigation Landscape Decision Points and Strategies for the Patent Dance U.S. Patent Strategies
More informationPatent Challenges Post-MMA Third Annual FDA Regulatory and Compliance Symposium
Third Annual FDA Regulatory and Compliance Symposium Presented by Richard J. Berman, Partner Arent Fox LLP Washington, DC August 23, 2007 Topics To Be Discussed Hatch-Waxman Summary Pre-MMA Law On Generic
More informationSTATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS PUBLIC UTILITIES COMMISSION
STATE OF RHODE ISLAND AND PROVIDENCE PLANTATIONS PUBLIC UTILITIES COMMISSION In re: REVIEW OF BELL ATLANTIC RHODE ISLAND TELRIC STUDIES: DOCKET NO. 2681 UNBUNDLED NETWORK ELEMENTS ORDER I. INTRODUCTION.
More informationA New Pathway for Follow-on Biologics. Steven A. Nash 1 Rebecca Workman 2 Connolly Bove Lodge & Hutz LLP 3
Steven A. Nash 1 Rebecca Workman 2 Connolly Bove Lodge & Hutz LLP 3 I. Introduction The recent passage of the Patient Protection and Affordable Care Act establishes an abbreviated pathway by which the
More informationGuidance for Industry
Guidance for Industry Comparability Protocols - Protein Drug Products and Biological Products - Chemistry, Manufacturing, and Controls Information DRAFT GUIDANCE This guidance document is being distributed
More informationThe Role of Chemists in the FDA Drug Approval Process
The Role of Chemists in the FDA Drug Approval Process 231 st ACS National Meeting Atlanta, GA M. Scott Furness, Ph.D. March 26, 2006 Introduction Presentation Outline FDA Organization CDER Organization
More informationCHAPTER V COUNCIL ON ENVIRONMENTAL QUALITY
CHAPTER V COUNCIL ON ENVIRONMENTAL QUALITY Part Page 1500 Purpose, policy, and mandate... 745 1501 NEPA and agency planning... 747 1502 Environmental impact statement... 751 1503 Commenting... 758 1504
More informationSeptember 16, Via Electronic Submission
Via Electronic Submission Division of Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm. 1061 Rockville, MD 20852 Re: Draft Guidance for Industry: Internet/Social Media Platforms: Correcting
More informationASIAN PATENT ATTORNEYS ASSOCIATION Recognized Group of Korea. Report to Emerging IP Rights Committee 2012, Chiang Mai
ASIAN PATENT ATTORNEYS ASSOCIATION Recognized Group of Korea Report to Emerging IP Rights Committee 2012, Chiang Mai SPECIAL TOPIC REPORT ON Business Methods and the Laws of Nature, As Discussed by the
More informationHOW WILL EBAY V. MERCEXCHANGE AFFECT PHARMACEUTICAL AND BIOTECHNOLOGY PATENT OWNERS?
LOWENSTEIN SANDLER PC HOW WILL EBAY V. MERCEXCHANGE AFFECT PHARMACEUTICAL AND BIOTECHNOLOGY PATENT OWNERS? By Mark P. Kesslen, Esq., Maureen A. Ruane, Esq., and Margaret M. Buck, Esq. According to a recent
More informationSupreme Court Decision on Gene Patents
Supreme Court Holds Naturally Occurring, Isolated DNA Is Not Patentable, While Synthetic DNA Is Patentable SUMMARY In a decision having implications for the healthcare, biotechnology, and pharmaceutical
More informationA Bill Regular Session, 2017 HOUSE BILL 1778
Stricken language would be deleted from and underlined language would be added to present law. Act of the Regular Session 0 State of Arkansas st General Assembly As Engrossed: H// A Bill Regular Session,
More informationChapter. The Implications of Patent-Term Extension for Pharmaceuticals
Chapter The Implications of Patent-Term Extension for Pharmaceuticals Chapter 4 The Implications of Patent-Term Extension for Pharmaceuticals This chapter examines the possible impact of pharmaceutical
More informationPatricia Van Arnum Issue Date: February 2012 Editor Contact: Patricia Van Arnum, (732)
Pharmaceutical Technology Patricia Van Arnum Issue Date: February 2012 Editor Contact: Patricia Van Arnum, pvanarnum@advanstar.com, (732) 346-3072 Biopharmaceutical Industry in 2012: Optimism on the Rise
More informationCOMPOUNDING PHARMACIES: STEPS TO AVOID ISSUES WITH THE FDA, DEA, PHARMACY BOARDS, AND PATENT HOLDERS. Denise Leard, Esq Brown & Fortunato, P.C.
COMPOUNDING PHARMACIES: STEPS TO AVOID ISSUES WITH THE FDA, DEA, PHARMACY BOARDS, AND PATENT HOLDERS Denise Leard, Esq. 2017 Brown & Fortunato, P.C. INTRODUCTION 2 INTRODUCTION In the fall of 2012, a meningitis
More informationHCT/P Regulation vs 361 Products
HCT/P Regulation - 351 vs 361 Products Presented by: Paul Gadiock February 15, 2017 Arent Fox LLP Washington, DC New York, NY Los Angeles, CA San Francisco, CA 1 Presentation Overview Introduction Public
More informationMomenta Pharmaceuticals Reports First Quarter 2017 Financial Results
May 2, 2017 Momenta Pharmaceuticals Reports First Quarter 2017 Financial Results --Company reports Glatopa 20 mg product revenues of $23 million, a 58% increase over the same period in 2016-- --Ended the
More informationCalifornia s New Fair Pay Law: What It Means for Your Business
California s New Fair Pay Law: What It Means for Your Business by Christopher Olmsted, Esq. Ogeltree Deakins The California Fair Pay Act (FPA), a state law that codifies the principle that an employee
More informationAntibody Decisions and the Written Description Requirement. Workgroup
Antibody Decisions and the Written Description Requirement Workgroup 1640 2016 Overview 1. The Written Description Requirement 2. Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341 (Fed. Cir.
More informationPatient Protection and Affordable Care Act (H.R. 3590) Approval Pathway for Biosimilar Biological Products
Approval Pathway for Biosimilar Biological Products On December 24, 2009, the U.S. Senate passed the, its version of comprehensive healthcare reform legislation. On March 21, 2010, the U.S. House of Representatives
More informationLabor Board Slugs Grand Slam, Smashing Obama-Era Rulings
Labor & Employment December 19, 2017 Labor Board Slugs Grand Slam, Smashing Obama-Era Rulings In a remarkable two days, the National Labor Relations Board firmly in Republican control slugged a grand slam,
More informationAmerican Postal Workers Union, AFL-CIO
American Postal Workers Union, AFLCIO 1300 L Street, NW, Washington, DC 20005 To: Local and State Presidents National Business Agents National Advocates Regional Coordinators Resident Officers From: Greg
More informationPharmaceutical Pricing and Patent Law
91-748 E Revised November 22, 1991 Pharmaceutical Pricing and Patent Law Sylvia Morrison Specialist in Industry Economics Economics Division SUMMARY Rapid increases in the prices of pharmaceuticals over
More informationGeorgia House Bill 173: Leveling the Playing Field to Make Georgia Businesses More Competitive. February 9, 2010
Georgia House Bill 173: Leveling the Playing Field to Make Georgia Businesses More Competitive February 9, 2010 Henry M. Perlowski Andrew B. Flake Arnall Golden Gregory LLP 171 17 th Street, NW, Suite
More informationPediatric Exclusivity and Drug Development Requirements in the Overall Pediatric Population. Prepared by Beckloff Associates, Inc.
and Drug Development Requirements in the Overall Pediatric Population 1 INTRODUCTION AND OVERVIEW Prepared by Beckloff Associates, Inc. Although children suffer from many of the same diseases as adults
More informationBoard of Alien Labor Certification Appeals 800 K Street, NW, Suite 400-N Washington, DC (202) (202) (FAX)
U.S. Department of Labor Board of Alien Labor Certification Appeals 800 K Street, NW, Suite 400-N Washington, DC 20001-8002 (202) 693-7300 (202) 693-7365 (FAX) Issue Date: 12 May 2016 BALCA Case No.: ETA
More informationFollow-On Biologics: Intellectual Property and Innovation Issues
Follow-On Biologics: Intellectual Property and Innovation Issues Wendy H. Schacht Specialist in Science and Technology Policy John R. Thomas August 3, 2009 Congressional Research Service CRS Report for
More informationSeptember 13, 2000 FIRST QUESTION PRESENTED
September 13, 2000 No. 8273 This opinion is issued in response to questions from Greg McMurdo, Executive Legal Officer, Oregon Department of Education, about public charter schools. FIRST QUESTION PRESENTED
More informationSupreme Court of the United States ASSOCIATION FOR MOLECULAR PATHOLOGY et al., Petitioners v. MYRIAD GENETICS, INC., et al. Decided June 13, 2013.
Supreme Court of the United States ASSOCIATION FOR MOLECULAR PATHOLOGY et al., Petitioners v. MYRIAD GENETICS, INC., et al. Decided June 13, 2013. Justice THOMAS delivered the opinion of the Court. Respondent
More informationJohn F. Myers, Attorney at Law
John F. Myers, Attorney at Law Title VII of the Civil Rights Act of 1964 makes it illegal for an employer to discriminate in the workplace on basis of race, sex, national origin, religion, or national
More informationChapter 1. Pharmaceutical Industry Overview
Chapter 1 Pharmaceutical Industry Overview 1.1 Introduction 2 1.2 Regulations 2 1.2.1 Health Insurance Portability and Accountability Act 2 1.2.2 The Code of Federal Regulations 3 1.2.3 Guidance for Industry
More informationCOMMENTS JULIE DOHM INTRODUCTION
COMMENTS EXPANDING THE SCOPE OF THE HATCH-WAXMAN ACT S PATENT CARVE-OUT EXCEPTION TO THE IDENTICAL DRUG LABELING REQUIREMENT: CLOSING THE PATENT LITIGATION LOOPHOLE JULIE DOHM INTRODUCTION The Food and
More informationNovember 15, Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20852
November 15, 2013 Division of Dockets Management (HFA-305) Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20852 RE: Proposed Rule - Current Good Manufacturing Practice and Hazard
More informationAn Economic Analysis of Generic Drug Usage in the U.S.
September 2011 $931 Billion SAVINGS An Economic Analysis of Generic Drug Usage in the U.S. EXECUTIVE SUMMARY As government leaders in Washington and across the country look for ways to cut health care
More informationRadioactive Tank Waste from the Past Production of Nuclear Weapons: Background and Issues for Congress
Order Code RS21988 Updated January 3, 2007 Summary Radioactive Tank Waste from the Past Production of Nuclear Weapons: Background and Issues for Congress David M. Bearden and Anthony Andrews Resources,
More informationFLSA Rule Proposal Could Make Millions Eligible for Overtime
A new federal wage regulation proposed by the Department of Labor raises salary thresholds in a way that significantly expands the number of employees who must be paid time and a half for overtime. Here
More informationEnergy Auction for the CPV Sentinel Generating Facility
Energy Auction for the CPV Sentinel Generating Facility Energy Auction Instructions and Terms and Conditions of Participation Updated June 11, 2013 A. GENERAL A.1. Company ( SCE ) seeks to sell, by this
More informationCase 2:18-cv Document 1 Filed 01/16/18 Page 1 of 110 PageID #: 1 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF TEXAS MARSHALL DIVISION
Case 2:18-cv-00012 Document 1 Filed 01/16/18 Page 1 of 110 PageID #: 1 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF TEXAS MARSHALL DIVISION AHOLD USA, INC., on behalf of itself and all those similarly
More informationThe Benefit of Japanese Patent Law System Over that of the US in the Pharmaceutical Area
The Benefit of Japanese Patent Law System Over that of the US in the Pharmaceutical Area William Han (GlaxoSmithKline) Japan Patent Attorneys Association International Activities Center 1 Japan undeniably
More informationSTATEMENTS OF POLICY Title 52 PUBLIC UTILITIES
2852 STATEMENTS OF POLICY Title 52 PUBLIC UTILITIES PENNSYLVANIA PUBLIC UTILITY COMMISSION [ 52 PA. CODE CH. 41 ] [ M-2011-2188361 ] Scope of Commission Jurisdiction Over Passenger Transportation Services
More informationOctober 29, Comments on CPSIA Section 102: Requirements for Certificates for Conformity Testing and Third Party Testing
Mr. Todd A. Stevenson Secretary Consumer Product Safety Commission 4330 East-West Highway Room 502 Bethesda, MD 20814 Re: Comments on CPSIA Section 102: Requirements for Certificates for Conformity Testing
More informationCase 2:00-mc DPH Document 673 Filed 06/10/2009 Page 1 of 12 UNITED STATES DISTRICT COURT EASTERN DISTRICT OF MICHIGAN SOUTHERN DIVISION
Case 2:00-mc-00005-DPH Document 673 Filed 06/10/2009 Page 1 of 12 In Re: UNITED STATES DISTRICT COURT EASTERN DISTRICT OF MICHIGAN SOUTHERN DIVISION Settlement Facility Dow Corning Trust. / Case No. 00-00005
More informationKurniawan v. Atty Gen USA
2006 Decisions Opinions of the United States Court of Appeals for the Third Circuit 12-18-2006 Kurniawan v. Atty Gen USA Precedential or Non-Precedential: Non-Precedential Docket No. 05-4593 Follow this
More informationFollow-On Biologics: Intellectual Property and Innovation Issues
Order Code RL33901 Follow-On Biologics: Intellectual Property and Innovation Issues Updated January 17, 2008 Wendy H. Schacht Specialist in Science and Technology Resources, Science, and Industry Division
More informationUNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD
UNITED STATES PATENT AND TRADEMARK OFFICE ------------------------------------- BEFORE THE PATENT TRIAL AND APPEAL BOARD ------------------------------------- FRESENIUS KABI USA, LLC, Petitioner, v. HOSPIRA,
More informationGuidance for Industry
Guidance for Industry Notification to FDA of Issues that May Result in a Prescription Drug or Biological Product Shortage DRAFT GUIDANCE This guidance document is being distributed for comment purposes
More informationPublic Inquiry on Commission Jurisdiction over Postal Service. Determinations to Close or Consolidate Post Offices
This document is scheduled to be published in the Federal Register on 12/16/2015 and available online at http://federalregister.gov/a/2015-31572, and on FDsys.gov Page 1 of 14 BAC 7710-FW-P POSTAL REGULATORY
More informationUNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS
Amgen Inc. v. F. Hoffmann-LaRoche LTD et al Doc. 976 Case 1:05-cv-12237-WGY Document 976 Filed 09/03/2007 Page 1 of 5 UNITED STATES DISTRICT COURT DISTRICT OF MASSACHUSETTS AMGEN INC., Plaintiff, v. CIVIL
More informationCONTRACT WITH THE TEMPORARY WORKERS (TERMS OF ENGAGEMENT/CONTRACT FOR SERVICES) 1.1. In these Terms of Engagement the following definitions apply:
Page 1 CONTRACT WITH THE TEMPORARY WORKERS (TERMS OF ENGAGEMENT/CONTRACT FOR SERVICES) 1. DEFINITIONS 1.1. In these Terms of Engagement the following definitions apply: Assignment Client means the period
More informationThe Future of Generic Pharmaceuticals
The Future of Generic Pharmaceuticals David R. Gaugh, R.Ph. Senior Vice President, Sciences and Regulatory Affairs Generic Pharmaceutical Association A Look Ahead Aging Demographics 1 YEARS OF AGE A Look
More informationDiving Deeper into PSD Applicability: The RMRR Exemption and the Demand Growth Exclusion
Diving Deeper into PSD Applicability: The RMRR Exemption and the Demand Growth Exclusion Chicago, Illinois Midwest Environmental Compliance Conference November 3, 2016 John P. Iwanski, Trinity Consultants
More informationREGULATIONS FOR PRODUCT/SERVICE CERTIFICATION
CONTENTS 1. PURPOSE AND SCOPE 2. REQUIREMENTS FOR CERTIFICATION 3. GENERAL PRINCIPLES AND GUARANTEES FOR THE CLIENT 4. STATUTORY AND REGULATORY REQUIREMENTS AND LEGALITY CONTROL LIMITS 5. CERTIFICATION
More information2004 rulemaking by which the defendants, who are officers and an agency of the Agriculture
1 0 rulemaking by which the defendants, who are officers and an agency of the Agriculture Department, sought to eliminate numerous environmental protection requirements that implement the National Forest
More informationUnited States Court of Appeals for the Federal Circuit
NOTE: This disposition is nonprecedential. United States Court of Appeals for the Federal Circuit LAWRENCE J. PALMATIER, Claimant-Appellant v. ROBERT A. MCDONALD, SECRETARY OF VETERANS AFFAIRS, Respondent-Appellee
More informationGuidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff
Guidance for Sponsors, Institutional Review Boards, Clinical Investigators and FDA Staff Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not
More informationGlossary of Abbreviations
Glossary of Abbreviations ANDA APhA Abbreviated New Drug Application American Pharmaceutical Association API Active Pharmaceutical Ingredient BA/BE Bioavailability/Bioequivalence BE Bioequivalence Bio
More informationConducted Under an IND to Support a
Using Foreign Clinical Trial Data not Conducted Under an IND to Support a US Application PDA Midwest Chapter Meeting March 15, 2018 2013 2017 Regulatory Compliance Associates Inc. All Rights Reserved.
More informationSTIMULI TO THE REVISION PROCESS
Page 1 of 6 STIMULI TO THE REVISION PROCESS Stimuli articles do not necessarily reflect the policies of the USPC or the USP Council of Experts USP's Nomenclature Initiatives Angela G. Long, M.S.; Andrzej
More information