L14 Introduction to Intellectual Property Rights PDF

L14 Introduction to Intellectual Property Rights Introduction to Intellectual Property Rights - How it works Clive Page, Sackler Institute of Pulmonary Pharmacology  Types of IPR...

L14 Introduction to Intellectual Property Rights Introduction to Intellectual Property Rights - How it works Clive Page, Sackler Institute of Pulmonary Pharmacology  Types of IPR Patents – novel, inventive, industrially applicable Confidential Information/Know How – ideas, information Copyright – text, graphics,software,data compilations,databases,art,music Patent – has to be INVENTIVE. Patent is a public document. 2  Learning outcomes By the end of this lecture, students should be able to Describe the various ways in which intellectual property rights are protected, with particular reference to those of relevance to drug discovery and development. Describe the patenting process for a new drug. Describe some of the reasons that patents might be challenged. Possible types IPR associated with an Asthma drug Confidential information Patents – drug itself (composition) – use of drug – ways to make it – ways to deliver it (formulation) IPR is a new chemical entity not used before. 3  Composition of matter patent – protects a new chemical entity You have to own the molecule – if someone else uses it for another purpose you have to get a secondary use patent. Secondary medical use patent – you can claim something for a second use. You would share royalties with original inventor. You can file a patent to cover route of synthesis. Possible types of IPR associated with an Asthma drug Copyright – patient leaflet Trademark Design rights/registered design – inhaler design – testing kit/equipment Patient leaflets can also be protected as intellectual property. Companion aids can also be copyrighted. Trademark – associated with your brand or product. Delivery device can be a registered design. 4  Why do companies need patents? What rights given? A patent stops others using your technology without your agreement Territorial basis Term – 20 years from date of application (priority date) Other people can use your technology, but you must agree and ensure they are not going to put your work at risk. Fees in every country you file the patent in. Patents run out after 20 years, so delay filing it until the drug is in development. 5  Typical Drug Development and Approval Process: Timeline Research (candidate) 2-3 years Preclinical 1 year Clinical (PhaseI,II,&III) 6 years Average 10 years Review & Approval 1-2 years Short remaining patent protection Pharmaceutical companies want at least 7 years patent life left. Patents Formal application process Requirements for obtaining patent protection – Novel – Inventive – Industrially applicable 6  File in any country in patent convention treaty. Show that the invention is novel, inventive Patent Process Term is 20 years from date of application 0 years UK patent application 1 year International application (PCT) 18 mths Application published ( + Search Report) 2- 4 yrs Examination Report received , negotiation on Patent Claims 4-5 yrs Patent granted You can add to patent in the first year. Published 18 months later with the search report. This is public. 7  Novelty Judged at Priority Date – ie date of first filing must not form part of the state of the art – including any product,process,information in any form which could be oral,written or by use or in any way whatsoever which was made available to the public anywhere in the world before Priority Date In the UK, this is first to file. In US, it is first to invent. 8  Confidential information Key information should be kept confidential and not disclosed anywhere in the world (including on the net) until patent protection in place This can be done using Confidentiality Agreement – Non Disclosure Agreement – Controls use that can be made of the Information NDA – can sue someone if they try and use your invention. Inventive step Must not be obvious a person skilled in the art would NOT have found it an obvious invention to make at the Priority date 9  Capable of Industrial Application Covers all industries Patent application requires full technical disclosure Eventual publication of the information to allow the patent to be worked Include every detail e.g., temperature, incubation times etc. Patent for COMPLETE exposure of your work. 10  Anatomy of patent application Inventors, Applicant(s) Title Methods (enabling) Results (exemplification) Patent claims Definition of the new technology and the scope of the legal protection requested Claim every route of administration e.g. all inflammatory diseases. Value of IPR Combination of Know How, patent protection, Trademarks Patent/Trademark enforceable Know How generally less valuable 11  Know how is less valuable. Key points on patents A patent stops others from using your technology without your agreement BUT a patent does not give you the right to use your technology – May depend on others’ prior rights – Dominated by a prior broader patent Key points on patents Effective patent coverage on drug must extend beyond life of patent on drug itself Patent portfolio – Compound, analogues, chiral (composition) – Methods of manufacture – Medical Use of the compound, combinations – Second Medical Use of the compound – Product (formulation and reformulation) 12  Sildenafil had second medical use patent for sildenafil as an ED drug. Today, in England, a patentable invention must “involve an inventive step” which is defined as something that is “ not obvious to a person skilled in the art”. English courts have developed various prescriptive and detailed “tests” which a judge must apply. The main ones are the so-called “Windsurfing questions”, restated by Lord Justice Jacob in 2007 as: 1a) Identify the notional “person skilled in the art”. 1b) Identify the relevant common general knowledge of that person 2) Identify the inventive concept of the claim in question or, if that cannot readily be done, construe it; 3) Identify what, if any, differences exist between the matter cited as forming part of the “state of the art” and the inventive concept of the claim or the claim as construed 4) Viewed without any knowledge of the alleged invention as claimed, do those differences constitute steps which would have been obvious to the person skilled in the art or do they require any degree of invention? 13  WHY DO PATENTS GET CHALLENGED? Infringement of composition of matter Use of others technology Dubious Claims Accurate Speculation is not enough Get it down in writing You must prove that the claims are supported. DUBIOUS CLAIMS “Many claims do not stand up to scrutiny” Often initial patent applications make very broad claims and nearly all biotechnology patents have to be amended after examination by Patent office 14  You can get a patent without data but it is much more likely to be challenged. DUBIOUS CLAIMS Initial claim: A claim for a machine that washed round widgets described in general terms as “an electrical appliance that washes things” Amended claim:”widget washer is not meant to wash dishes and that it can’t wash square widgets, only round widgets” 15  RESOURCES Nature Drug Discovery – monthly Patent Watch United States patent database http://www.uspto.gov/ European patent database http://gb.espacenet.com/ 16