INTELLECTUAL PROPERTY RIGHTS: INNOVATION, ECONOMICS AND ACCESS OF PHARMACEUTICALS BY SANJAY JAIN VP, QUALITY MANAGEMENT AMNEAL PHARMACEUTICALS

DISCLAIMER The opinions expressed herein are personal and not those of my employer. Information contained herein does not provides any kind of legal or other opinion. Please consult appropriate expert for business advice.

INTELLECTUAL PROPERTY  Patents  Right to exclude other from making, using, import or selling an invention.  Trademarks  To protect a logo or name that is used for the purpose of trading goods. E.g. Crocin or Coca-cola  Copyrights  Original works of authorship that fall under the categories of literature, drama, musical, painting, sculptures, software etc. which can be either in published or unpublished form. E.g. Music album, Microsoft licence, Novel etc. Copyright protects the form of expression of idea whereas patent protects the idea itself. Eg Article on tablet manufacturing technologies vs process of preparing tablet.

INTELLECTUAL PROPERTY  Intangible asset  Considered while valuation of the company  Can be sold Alembic to get milestone payments MUMBAI: Alembic has entered into a licensing agreement with the Brussels-based UCB for its novel drug delivery platform for Keppra XR (Levetiracetam Extended Release tablets). Under the terms of the agreement, Alembic will receive milestone payments of $11 million and royalty on future worldwide net sales of Keppra XR, subject to necessary legal and regulatory approvals. Phase III clinical trials on Keppra XR, the once daily formulation of Keppra, are in progress and results are expected in the fourth quarter of Keppra is UCB's leading anti-epileptic drug. The development of Levetiracetam XR is a milestone for the Alembic's novel drug delivery system (NDDS) programme. Source : The Hindu

PATENTS - FRAMEWORK  No World patent.  Right are territorial.  Governed by respective national laws.  PCT (Patent co-operation treaty) is international framework for recognizing priorities of every applicants within member states. Generally 30 months timeline.  Term - 20 years from the date of filing.  Regulatory extensions available in US, EU, RU, AU, JP etc.  Monopoly against complete disclosure of invention.

PATENTS – WHAT DOES IT CONTAINS?  Title  Abstract  Background  Description  Examples  Diagrams  Claims – Heart of the patent. Decides the boundaries of the property. Infringement (Trespassing) is decided based on this boundaries Vadodara-based Alembic Pharmaceuticals Ltd is eyeing to capitalise on the recent approval from the US drug regulator for extended release Desvenlafaxine base tablets, which is bio-equivalent of Pfizer's popular drug Pristiq (Desvenlafaxine Succinate) which went off patent recently. "We have recently received approval from US Food and Drug Administration (USFDA) for extended release Desvenlafaxine base tablets. This will add significant revenues to the company in coming months. Presently we are the only player in this segment to have received approval from the regulator," said Pranav Amin, executive director, Alembic Phrama.US drug regulator Analysts, however, pointed out that the benefit to Alembic and Ranbaxy for the product will be limited as several other players have filed Para IV ANDAs of the same product. "However, including Alembic Pharma, five to six other players (like, Lupin, Cadila, Watson) has filed for Para IV ANDAs of the same, which are under litigation with the innovator. If these players get approval by the end of 2015, then Pristiq will not remain big opportunity for Ranbaxy and Alembic Pharma," analyst report by IndiaNivesh Securities Private Limited stated. 'Keeping view the genericisation of Pristiq by the end of 2015, we anticipate only two years of opportunity for Ranbaxy and Alembic. We assessed this product to contribute around Rs 90 crore of profit (post tax) in fiscal 2014 and Rs 110 crore in fiscal 2015 for Alembic and Ranbaxy each,' the analyst report claimed. Source : Business Standard

PATENTING PROCESS  Provisional application (PA).  Complete application/PCT within 12 months of PA.  Publication of patent application at 18 months from PA.  Pre-grants opposition.  Examination starts.  Examiner issues first examination report (FER) in view of know prior arts.  Applicant responds on rejections.  Allowed – Patent granted; Rejected – No rights.  Post- grant opposition within 1yrs of grant.  Appellate bodies – Intellectual property appellate board (IPAB); High Court; Supreme court  Infringement – DC; High Court; Supreme court

HISTORY OF INDIAN PATENT LAW VS % SHARE Pre Product Patent Regime 1970 Act amended (Indira Gandhi) - Process Patent Regime 1995 India signs WTO agreement on TRIPS Product Patent regime

INDIAN PATENT ACT - POST – 2005  Law amended - Product patent regime takes effect.  India also introduced Section 3(d).  Section 3 - What are not inventions?  Section 3(d)  (d) the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.  Explanation.—For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance, unless they differ significantly in properties with regard to efficacy; Novartis Loses Glivec Patent Battle in India NEW DELHI—India's Supreme Court rejected Novartis AG's attempt to win patent protection for a major cancer drug, a landmark judgment roundly criticized by pharmaceutical companies but praised by public-health activists, who said it would protect India's ability to make inexpensive generics for the developing world. (Source : The Wall street Journal)Novartis  Beta crystalline form of Imatinib mesylate – Patent denied. Novartis challenged it till Supreme court and lost. No enhancement of known efficacy.

ACCESS - COMPULSORY LICENSING (CL)  Section 84 - Compulsory licences (1) At any time after the expiration of three years from the date of the grant of a patent, any person interested may make an application to the Controller for grant of compulsory licence on patent on any of the following grounds, namely:— (a) that the reasonable requirements of the public with respect to the patented invention have not been satisfied, or (b) that the patented invention is not available to the public at a reasonably affordable price, or (c) that the patented invention is not worked in the territory of India.

ACCESS - COMPULSORY LICENSING (CL)  Sorafenib – Carcinoma.  Bayer’s Nexavar for Rs. 2,84,000 per patient per month.  Natco’s therapy - Rs. 8, 800 per patient per year.  Question – Return on investment for research vs Access to medicine for life saving drugs.  Patent office granted CL to Natco.  Later on decision upheld by IPAB, Bombay high court and Supreme court. Natco Pharma wins cancer drug case Bayer's plea dismissed by the Intellectual Property Appellate Board The Intellectual Property Appellate Board (IPAB) on Monday upheld the grant of compulsory licence (CL) to the Hyderabad-based Natco Pharma Limited, a generic drug maker, to produce and market Nexavar, a patented cancer drug of multinational pharma major Bayer Corporation. The order will pave the way for reduction in the prices of costly life saving drugs. Disposing an appeal filed by Bayer Corporation, the Board held that various international conventions and Indian laws allowed the member countries to grant such compulsory licence in order to make medicine cheaply available to the public. Declining to interfere with the order of compulsory licence, the Board said, “We are not inclined to interfere with the order of Controller General in the interest of the public. The invention must be available to the public at reasonable and affordable price if not compulsory licence is given.” “We must bear in the mind of public interest but neither the investor nor the compulsory licence applicant. Patents are granted to benefit the inventions to the public.” Source : The Hindu  BDR’s CL for Dasatinib and Lee Pharma’s – Saxagliptin denied  US anthrax attacks through the US Postal Service, the US Government threatened to issue a compulsory license for the antibiotic drug ciprofloxacin, if the patent owner, Bayer, didn't lower the price to the government. Bayer lowered the price and the government backed down on the threat.

ACCESS AND INNOVATION – WAY FORWARD  Innovation  India pharmaceutical Industry – Mainly generic  Blockbuster drugs are going off patent in coming years.  Generic Competition across the globe within Indian players and from companies in other countries  Positives – High Quality  (Sofosbuvir, Gilead signed agreement with 7 Indian generic manufacturer to sale the product in 91 countries)  To manage economics well innovation is inevitable. Many Indian companies are already onto this path.  Access – Possible options  CL applications in appropriate case for life saving drugs.  By third party under Section 84.  By government under Section 92.

ACCESS AND INNOVATION – WAY FORWARD  Strategy  New Chemical Entity  Innovative formulations  New Dosage form of existing DP  Changes in release pattern  Drug repurposing, (new Indication)  New strength  Digital Medicine (e.g. Aripiprazole ANDA by Otsuka ) Digital Medicine

Let’s INNOVATE Thank you