Christopher David PE'ITY, Catrin Helen ROGAN, Jack William RUSSELL, Tim SAYER, Robert David TAOR, Simon Edward William THORNILEY, Peter WAIASKI, Jan Filip WHITING, Gary all of Vennel' Shipley LLP, 200 Aldersgate, London EC1A 4HD, United Kingdom and DUNLEAVY, Christopher Squire BLEND, Almut Susanne GILANI, Anwar JOHNSON, Stephen William MeNAMARA, Kathryn PIOTROWICZ, Pawel Jan Andrzej SHELTON, Ruth Emily all of Venner Shipley LLP, Byron House, Cambridge Business Park, Cowley Road, Cam bridge CB4 OWZ, United Kingdom 0779 0779 Ex. 1011 (Part 3 of3) West Pharma V. Sanofi US.

s h revels Eulop hisshes Palentarnt European mm mm [mice européen Representative: Alexander Brown Venner Shipley LLP 200 Aldersgate London EC1A 4H0 United Kingdom Phone: +44(0) 20 7600 4212 Fax: +44(0) 20 7600 4133 E—mail: mail@vennershipley.oo.uk Letter accompanying subsequently filed items 30298 Munich Germany Tel.

A safety device ( l ) according to one of the previous claims, characterized in that the guide track (1.2.5) comprises an inclined section (1.2.5.1 ) oriented at an angle with respect to the central axis (A).

A safety device (_ l ) according to one of the previous claims, characterized in that the guide track (_ l .15) comprises an inclined section (1.2.5.1 ) oriented at an angle with respect to the central axis (A).

A safety device (_ l ) according to one of the previous claims, characterized in that the guide track (1.2.5) comprises an inclined section (1.2.5.1 ) oriented at an angle with respect to the central axis (A).

The separating wall 1.2.6 is integral to the support body 1.2 and acts as a no-return feature preventing the guide pin 1.1.3 from returningto its start position Pl after an injection stroke has been carried out.

The biased guide pin 1.1.3 passes the separating wall 1.2.6 in the lateral direction L, as indicated in figure 9D, whereby the deflected and energized flexible arm 1.1.4 at least partially relaxes.

According to a possible embodimentof the invention, an audible feedback is generated whenthe needle shield is retracted with respect to the support body by a distancethat matches or exceeds the minimal axial distance.

The separating wall 1.2.6 is integral to the support body 1.2 and acts as a no-return feature preventing the guide pin 1.1.3 from returningto its start position Pl after an injection stroke has been carried out.

The biased guide pin 1.1.3 passes the separating wall 1.2.6 in the lateral direction L, as indicated in figure 9D, wherebythe deflected and energized flexible arm 1.1.4 at least partially relaxes.

Mylan's Upgraded EpiPen Torn Apart By Experts Dr. Julie C. Brown, a University of Washington School of Medicine pediatric emergency physician, holding two EpiPens, the new design at left and the old at right.James Cheng / for NBC News So, as Congress has been trying to figure out the company's business model, a medical technologies expert and a doctor have been physically taking apart Mylan's famed auto-injectors to find out exactly how — and where — that money was spent.

After a Seattle doctor cut open EpiPens from before and after Mylan's upgrades, NBC News sent versions of the epinephrine auto-injectors to a medical technology consulting firm.

In her sworn testimony before the House Committee on Oversight and Government Reform last week, Mylan's CEO said most of the money the company had spent on EpiPens went towards marketing and lobbying.

Senator Chuck Grassley, an Iowa Republican, sent a letter in August to Bresch requesting more information about how changes to the EpiPen had caused Mylan to increase the price.

In response to a request for comment on this story, Grassley said in an emailed statement to NBC News: "The company cited product improvements as reason for justifying the cost increases.

EpiPen inventor helped millions and died in obscurity - Tampa Bay Times 15 captures 26 Sep 2009 - 16 Jun 2017

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Top shares Clearwater woman is oldest living American After paralyzing injury, Samantha Slusak never stopped believing Spring Hill mom vows to fight bullying in son's name Jurors say Bubba the Love Sponge Clem did not defame Todd 'MJ' Schnitt Pasco deputies say woman, 37, seduced teen Most commented Jurors say Bubba the Love Sponge Clem did not defame Todd 'MJ' Schnitt Bubba the Love Sponge Clem, 'MJ' Schnitt recap trial on air Suncoast Seabird Sanctuary no longer taking in injured birds Sweetbay will not keep Midtown store open On guns, do something worthy of Daniel Human Interest_News Eckerd College celebrates opening of new $25 million science building Beauty in bloom Palm Harbor couple create art with a twist Safety Harbor Dalmatian statue honors 9/11 first responders Suncoast Seabird Sanctuary no longer taking in injured EpiPen inventor helped millions and died in obscurity By Kevin Smetana, Times Staff Writer In Print: Thursday, September 24, 2009 Danielle Davis, a Charleston, W.Va., high schooler with severe nut allergies, holds an EpiPen, an autoinjector containing epinephrine, that could save her life.

EpiPen inventor helped millions and died in obscurity - Tampa Bay Times birds The possibility of inadvertently coming into contact with an allergen is a dangerous reality for those at risk.

Carrying an EpiPen makes some feel at ease, said Dr. Richard Lockey, an allergist and professor of medicine at the University of South Florida.

Inventors: Gareth Roberts, Wrexhan (GB); Chris Ward, Prestatyn (GB); Matthew Ekman, Macclesfield (GB) (73) Assignee: Sanofi-Aventis Deutschland GMBH, Frankfurt am Main (DE) ( *) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 U.S.C. 154(b) by 596 days.

It is a further object of the invention to provide an improved injection device comprising a pre-filled syringe that is safe to handle and in particular prevents accidental needle stick inju nes.

FIG. 8 shows a perspective view of a support body accord ing to the second embodiment that is cut open parallel a central axis for illustrative purposes.

FIG. 1 shows the safety device 1 that comprises an essen tially cylindrical and hollow outer body 1.3 with an open distal and a closed proximal end.

The second longitudinal tongues 1.2.2 are located adjacent to each guide track 1.2.5 and extend over an axial length of the support body 1.2 and parallel to the central axis A. Each second longitudinal tongue 1.2.2 is received in a correspond ingly shaped groove (not illustrated) formed into an inner surface of the needle shield 1.1 when the needle shield 1.1 is moved with respect to the support body 1.2 from the initial 35 position I to the retracted position II.

• Elayne Kornblatt Phillips, Clinical Associate Professor University of Virginia School of Nursing, Charlottesville, VA, USA • Judith Landau, ARISE Founder, CEO & President, Boulder, CO, USA • Rashad Massoud, Director USAID Health Care Improvement Project, Director USAID Applying Science to Strengthen and Improve Systems Project, Senior Vice President Quality & Performance Institute, University Research Co LLC Center for Human Services, Bethesda, MD, USA • Shaheen Mehtar, FRC Path (UK), FC-Path (Micro) (SA), MD (Eng) Chair Infection Control Africa Network (ICAN), Extraordinary Professor Div Community Health Faculty of Health Sciences, Stellenbosch University, Cape Town, South Africa WHO guideline on the use of safety-engineered syringes in health care settings Acknowledgements • Nancy Muller, Programme Officer at PATH, Seattle, WA, USA • Babacar Ndoye, Expert Consultant, Formateur, Hygiène hospitalière/Contrôle des infections/Sécurité des patients, Dakar, Senegal • Joseph Perz, Team Leader, Quality Standards & Safety (Proposed), Prevention and Response Branch, Division of Healthcare Quality Promotion Centers for Disease Control and Prevention, Atlanta, GA, USA • Glenn Post, Senior Medical Advisor USAID Office of HIV/AIDS, Washington DC,

• Cristiane Rapparini, Riscobiologico.org, Rio de Janeiro, RJ, Brazil • Abimbola O. Sowande, Consultant/Expert, Injection Safety/HCWM in the context of IPC (Infection Prevention and Control), Regional Coordinator, Board of Trustees, International Federation Infection Control (IFIC), Surulere, Lagos, Nigeria • Ruth Stringer, Research Scientist, International Science and Policy Coordinator Health Care Without Harm, Exeter, UK • Darin Zehrung, Portfolio Leader, Vaccine Delivery Technologies PATH, Seattle,

auto-disable syringe adverse events following injections acquired immunodeficiency syndrome Centers for Disease Control and Prevention European Public Service Union European Union European Medical Technology Industry Association Food and Drug Administration full-time equivalent employee Global Alliance for Vaccines and Immunization global burden of disease Guideline Development Group hepatitis B virus hepatitis C virus human immunodeficiency virus health care worker European Hospital and Healthcare Employers’ Association intradermal International Labour Office intramuscular International Organization for Standardization intravenous low- and middle-income countries Member State CDC National Institute for Occupational Safety and Health needle-stick injury The US President’s Emergency Plan for AIDS Relief post-exposure prophylaxis population, intervention, comparison, outcomes syringe with re-use prevention feature Safe Injection Global Network syringe with sharps injury protection feature subcutaneous United Nations Children's Fund United Nations Population Fund United States Agency for International Development World Health Organization WHO guideline on the use of safety-engineered syringes in health care settings

The ETD Framework is structured around the following criteria, listed in rows: • extent of the problem; • values and preferences; • quality of evidence; • balance of benefits and harms; • resource use; • equity; • feasibility; • acceptability.

• It is essential that ADs, RUPs and SIPs and any other type of injection equipment be provided to health care facilities with the necessary quantity of safety boxes for the safe collection of used devices (bundling principle).

the-art Hudson humidifiers and Siemens ventilators • Directed Engineering design efforts for an Insulin Pump start-up company - Bionica, Inc. • Optimized a patented venting method for sterilized laryngeal mask products.

Traveled to 20+ major cities & 50+ Hospitals in the US and Europe to interface directly to Doctors, Clinicians, Nurses, as well as Regulatory Agencies to gather critical drug delivery knowledge to be used in a Quality Function Deployment effort.

CHARLES E. CLEMENS resume • Initiated & directed a competitive technical benchmarking effort of US & European drug delivery systems which provided the foundation for the marketing strategy as well as the fundamental measuring parameters for the design team.

Helped train the technical team with new skills in the area of Quality Function Deployment (QFD), DFMA, Design of Experiments (DOE), and the Performance Excellence (PE) process.

Lead the development of a new mono-leaflet implantable heart valve • Invented and directed the proprietary design of an accurate rotary dry chemical delivery system to feed zirconium oxide granules to a fluidized bed coating process.

[0006] There therefore remains a need for a device for protecting a needle, without additional manual intervention onthe part of the user and which doesnotgive rise to aneffect of friction against the patient's skin.

[0034] Advantageously, the said second section ofthe said running passageway comprises at least one step forming a stop catch for the said peg whenthesaid sleeve is in the said protection position and at least partially defining the said second safety means.

The user thus con- ofthe support 3 with respect to the sleeve 4: in FIG. 1, these nects the syringe body 17 to the protection device 1 of the guide meansare inthe form ofdiametrically opposed longi- invention.

3, these longitudinal bulges 29 collaborating with diametri- [0062] Once the syringe body 17 is connected to the pro- cally opposed slideways 30 situated ontheinternal wall of the tection device 1, the user begins to cause the needle 2 to sleeve 4, facing the said bulges 29. penetrate the injection site, until the distal radial wall 15 ofthe [0053] In FIG. 1, the support 3 comprisesa flexible tab 5 sleeve 4 comes into contact with the surface of the injection which runs longitudinally from the proximalpart of the sup- site and then be continues,via the syringe 17, to press on the port 3 in the distal direction.

The comes into abutment against the distal end 20 ofthis first support 3 comprises a stop wall 8 partially closing off the longitudinal section 11. window 7, the function of which will be explained later on.

Samson & Partner More specifically, the cylindrical portion of one component is formed with a guide mechanism that includes a locking cutout, an axially aligned linear track and a deflectable arm.

However, even assuming arguendo that the above argumentis dismissed, the person skilled in the art, if faced with the above stated problem and the requirement ofreduced number of individual parts, would without any inventive step arrive at the same solution as presented in claim | of the Patent, .

Since the idea oflocking via a flexible arm is already suggested in D2, to arrive at the feature di, all the person skilled in the art would haveto do,Is to incorporate the individual pieces of Figure 6 into the needle guard.

The Patent states that the audible feedback can be generated bythe flexible separating wall snapping back into its rest position substantially parallel to the central axis A whenthe needle shield is moveddistally with respect to the support body by an axial length that exceeds the minimalaxial distance.

If oral proceedings are to take place, parties are advised to check the electronic file via the European Patent Register at www.epo.org/register in advance of the hearing to ensure that they are in possession of all relevant documents.