Regulatory Focus™ > News Articles > Regulatory Recon: WTO to Announce 17-Year Extension to Drug Patent Exemption for LDCs (3 November 20

Regulatory Recon: WTO to Announce 17-Year Extension to Drug Patent Exemption for LDCs (3 November 2015)

Posted 03 November 2015 | By Michael Mezher 

Regulatory Recon: WTO to Announce 17-Year Extension to Drug Patent Exemption for LDCs (3 November 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher, @Zachary Brennan and @RAPSorg on Twitter.

In Focus: US

  • Shuren: We're Not In Competition With Europe (Gray Sheet-$)
  • FDA Letter Raises Questions About Biomarin Handling of Muscular Dystrophy Drug (The Street)
  • House Energy and Commerce Committee Markup of Seven Bills (E&C)
  • FDA to Hold A Public Hearing for a Quartet of Draft HCT/P Guidances: A Scorecard (FDA Law Blog)

In Focus: International

  • Overworked Notified Bodies Turn Clients Away And Demand Own 5-Yr Transition (Clinica-$)
  • Pfizer partners with South Africa to produce pneumococcal vaccine (Reuters)
  • WTO Decision on Least Developed Country (LDC) Drug Patent Waiver (KEI) (IPWatch)
  • Russian biotech wins case against Genentech in patent dispute (PharmaLetter-$)
  • Health Canada issues safety alert on Abilify (PharmaLetter-$) (Health Canada)

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US: Pharmaceuticals and Biotechnology

  • Traveling to the Heartland to Discuss Antimicrobial Resistance (FDA)
  • FDA Presses Pause on Novel Testosterone Product (MedpageToday)
  • 3 Key Questions As Biosimilar Naming Fight Rages On (Law360-$) (Focus)
  • Physicians Lack Incentives For FDA Postmarket Study Participation, But Progress ‘Adequate,’ GAO Finds (Gray Sheet-$) (Focus)
  • Health Canada and United States Food and Drug Administration Joint Public Consultation on International Conference on Harmonisation (FDA)
  • Saving Endangered Drugs (DD&D)
  • Hilleman CEO On Tackling Regulatory Challenges For Vaccines (SCRIP-$)
  • Parkinson's Needs FDA Flexibility, NIH Funding Certainty (SCRIP-$)
  • Will a compounded version of Martin Shkreli’s drug really make a difference? (Pharmalot)
  • Valeant sends letter to doctors, seeks to reassure over pharmacy ties (Reuters)
  • Philidor to Wind Down Operations (WSJ-$)
  • Trends in global clinical trial registration (AllTrials)
  • For Statins, Cholesterol Care May Be Just the Start (NYTimes)
  • GSK aims to file up to 20 new drugs for approval by 2020 (Reuters)
  • Placebo response may be making pain trials tougher (Outsourcing-Pharma)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Boehringer Ingelheim initiates pivotal programme for novel third-generation EGFR targeting lung cancer compound (Press)
  • AADi Launches Its Phase 2 Registration Trial for ABI-009, a Targeted mTOR Inhibitor, for Patients with Advanced PEComa, a Rare Form of Sarcoma (Press)
  • Alnylam Reports Positive Results from Ongoing Phase 2 Open-Label Extension (OLE) Studies for Patisiran and Revusiran, in Development for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis (ATTR Amyloidosis) (Press)
  • BRIEF-Corline Biomedical applies for Orphan Drug status for Renaparin at FDA (Reuters)

US: Medical Devices

  • 9 Things to Submit to the US FDA to Prove Your Device’s Electromagnetic Compatibility (Emergo) (Gray Sheet-$)
  • 2 Companies Seek FDA Approval for Brain Games to Treat ADHD (Scientific American)
  • How Long Does It Take to Bring Innovative Devices to Market? (MDDI)
  • New Imaging Technique Measures Chemical Composition of Cells in Living Tissue (medGadget) (MNT)
  • Medtronic Unveils New Aortic and Peripheral Data from Two Late-Breaking Clinical Trials at VIVA 2015 (Press) (MassDevice)
  • REALITY Study to Evaluate Use of Directional Atherectomy and Drug Coated Balloon in Patients with Peripheral Arterial Disease (Press)

US: Assorted and Government

  • Congress Asks Generic Makers to Pay Rebates Under New Budget (FDANews-$) (Focus)
  • No False Claims Act Case Where There is No False Claim – DNJ Throws Out Qui Tam Action Against Genentech (FDA Law Blog)
  • Supplier to ANDA Filer Is Not Liable for Induced Infringement Until After ANDA Approval - Shire LLC v. Amneal Pharms., LLC (National Law Review)
  • Massachusetts Physician Arrested and Indicted for Kickbacks from Warner Chilcott (Policy and Medicine)
  • Exemptions enable hacking of med devices for safety (FierceHealthIT) (Library of Congress)
  • Mylan Receives SEC Subpoena Related to Real Estate Deals (WSJ-$)
  • USP launches dietary supplement GMP audit program (DSN)
  • FDA Clarifies When Dietary Supplements Are Considered Drugs (FDANews-$)

Upcoming Meetings and Events              


  • The CJEU Calls Extra Time For SPCs - But There May Be Further Battles Ahead For Companies (SCRIP-$)
  • MHRA Touts the Benefits of Being a Medical Assessor (MHRA)
  • EU’s New Telematics Strategy for the Regulation of Medicines (PharmTech)
  • The Brexit Effect: A Blow To UK Life Science Leadership (SCRIP-$)
  • Pharmaceutical industry faces huge pressure to invest for traceability (PharmaLetter-$)
  • Mainstay Medical sails toward CE mark for neuromodulation implant (FierceMedicalDevices)
  • Janssen Submits Application to the EMA to Expand Use of IMBRUVICA (ibrutinib) in Previously Untreated Chronic Lymphocytic Leukaemia Patients (Press)


  • Iclusig now available under Australian PBS for chronic myeloid leukemia (PharmaLetter-$)
  • Paracetamol, aspirin and other 'common medicines' will come off PBS (The Guardian)
  • Australian Therapeutic Goods Advisory Council meeting statement, Meeting 7, 4 August 2015 (TGA)
  • Australian Therapeutic Goods Advisory Council meeting statement, Meeting 6, 17 February 2015 (TGA)



  • Gilead, WuXi to test NCEs in Shanghai (BioCentury)
  • China mulls drug approval reforms to incentivize researchers (Xinhua) (FiercePharmaAsia)
  • China Food and Drug Administration (CFDA) Grants Approval for Avedro’s KXL® System (Press)

Other International

  • WHO Mobilizes 510,000 Doses of Oral Cholera Vaccine to Help Control Outbreak in Iraq (ICT)
  • US and Mexico must jointly combat Chagas disease (Rice University)

General Health and Other Interesting Articles

  • Penn Scientists Reveal 90 Percent of Skin-Based Viruses Represent Viral 'Dark Matter' (ICT)
  • UNAIDS Announces New Strategy To End AIDS Epidemic By 2030 (Kaiser) (UNAIDS)
  • Researchers identify E. coli strain that protects against ‘collateral damage’ of infections (Pharmaceutical Journal-$)
  • Self-Disseminating Vaccines: An Infectious Disease Treatment? (PharmPro)
  • Death Rates Rising for Middle-Aged White Americans, Study Finds (NYTimes)
  • Vaccines aren’t just for kids (Washington Post)
  • Be on the Lookout for This Early Sign of Lyme Disease, Says Study (MPR)

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @Michael_Mezher or send him an email at

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.

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