Freedom To Operate A Prerequisite From the Commercialization

Freedom To Operate: A Prerequisite From the Commercialization Perspective Dr. Nidhi Sandal Scientist DRDO Bhawan nidhisandal@hqr. drdo. in

WHAT IS FREEDOM TO OPERATE? "Freedom to operate", abbreviated "FTO", is the ability to proceed with research, development and commercialization of a product, without infringing valid intellectual property rights of others. FTO ensures that a product can be made, used, sold, offered for sale, or exported, with a minimal risk of infringing the unlicensed intellectual property rights (IPR) or tangible property rights (TPR) of others. Freedom to Operate Search

WHAT IS THE NEED FOR FTO? • If a company/individual is interested to know whether his conceptualized work would infringe an already existing patent (patent application) • If a company wants to commercialize its product in a country A company/individual must do the FTO analysis well before launch to avoid the risk of litigation. Freedom to Operate Search

EXCEPTIONS FOR FTO ANALYSIS Bolar Provision: Performing research and tests for preparing regulatory approval, does not constitute infringement before the end of patent term. (Roche Products v. Bolar Pharmaceutical Fed. Cir. 1984) ▫ Experimental Use trying to make an improvement to the invention testing Freedom to Operate Search

WHO SHOULD CARRY OUT FTO SEARCH • In-house IP Counsel of Companies before starting work for a Product • Attorney Freedom to Operate Search

WHAT TYPE OF PRIOR ART TO BE SEARCHED FOR FTO? 1. Granted & Active Patents 2. Under Prosecution Patent Applications 3. WIPO application which may enter national phase For FTO Non-Patent Literature search is not required. Freedom to Operate Search

IMPORTANT FEATURES OF PATENTS • Patent protection is territorial i. e. country specific so is Freedom To Operate • Patents have a limited duration. • Patents have limits of scope. Freedom to Operate Search

METHODOLOGY FOR FTO OPINION Step 1: Identify the Country where you intend to launch your product or use your invention. Step 2: Identify the keywords/classification/s that properly define your invention/product. Step 3: Identify the search engines. Step 4: Know the Law, Doctrines and Case laws of the country w. r. t. infringement Step 5: Collate relevant patent documents Step 6: Prepare FTO opinion. Freedom to Operate Search

Step 1: Identify the Country where you intend to launch your product or use your invention. • Patents are territorial therefore FTO analysis is country specific. • For same product in two different countries; two FTO analysis of their respective patents is must. Freedom to Operate Search

Step 2: Identify the keywords that properly define your invention/product. 1. Include all the features of the invention in Keywords and classifications. 2. The keywords list must include broad and specific terms to identify the invention. 3. Keywords must also include synonyms e. g for Bio-digester, bioreactor should also be searched; for car, four wheelers; Freedom to Operate Search

Step 3: Identify the search engines. • Official site search of the Countries Patent Office ▫ www. uspto. gov www-european-patent-office. org www. wipo. int www. brevets-patents. ic. gc. ca www. ilpatsearch. justice. gov. il www. ipo. gov. uk www. patentoffice. nic. in • Commercially available data bases like ▫ Scifinder ▫ STN ▫ Derwent ▫ Dialogue ▫ Delhpion Freedom to Operate Search

Step 4: Know the Law, Doctrines and Case laws of the country w. r. t. infringement • Statute: What constitutes infringement in a country is well defined in several sections of Patent laws eg, in US, section 271, In India section 104 -115 dictates the rule. • Doctrines: Doctrine is a body of inter-related rules (usually of common law and built over a long period of time) associated with a legal concept or principle. E. g. In US Doctrine of Double Patenting; Doctrine of equivalents • Case laws: ▫ Case law incorporates courts' decisions from individual cases and encompasses courts' interpretations of statutes, constitutional provisions, administrative regulations ▫ Both presidential and non- presidential case laws of that country wherein invalidation grounds have been discussed must be referred and known Freedom to Operate Search

Step 5: Collate relevant patents 1. Granted & Active Patents 2. Under Prosecution Patent Applications 3. WIPO application which may enter national phase Freedom to Operate Search

Step 6: Prepare FTO opinion. • Product Name • Product/process details for which FTO is being prepared • Closest competitor/s Product details Freedom to Operate Search

Step 6: Prepare FTO opinion. S. No. Patent/ Patent Application Number Priority Date Expiry Date Independe nt Claims 1 US 7, 343, 209 Jan 2, 2004 Jan 2, 2024 Claim 1. Analysis Remarks Claim 5 2 3 Freedom to Operate Search

Step 6: Prepare FTO opinion. • Analyze your invention with each independent claim for ▫ Literal infringement ▫ Infringement under Doctrine of equivalence ▫ Indirect Infringement i. e inducement of infringement Freedom to Operate Search

Claim analysis • Bifurcate the claim in maximum possible elements. Each element defines the scope of the claim. • Read the description of each element from the specification to understand the scope of element. • Now read your invention over the claim wherein you broaden the claim to its maximum scope. • One must read prosecution history of the patent as well to analyze infringement Freedom to Operate Search

Claim analysis • Our invention: a tablet dosage form of Paracetamol containing HPMC as a rate controlling polymer and other pharmaceutical excipeints wherein the tablet controls the release of Paracetamol for 8 hrs. • Claim 1 of IN 261234 patent is : ▫ “A pharmaceutical composition of paracetamol comprising rate controlling polymer along with other pharmaceutical excipieints wherein the said dosage form is capable of controlling the release of Paracetamol for at least 12 hr. ” Freedom to Operate Search

Claim analysis Claimed invention Description in specification Our Invention pharmaceutical composition of Paracetamol pharmaceutical composition comprises tablet, capsule, sachet, powder, suppository and the like Tablet composition of Paracetamol comprising rate controlling polymer HPMC, HPC, ethyl cellulose, cetostearyl alcohol, alginate, methyl cellulose, waxes, methacrylates ant the like HPMC other pharmaceutical excipeints Diluent, filler, lubricant, glidant, binder and the like. other pharmaceutical excipeints controlling the release of Paracetamol for at least 12 hr. Delailed description: the pharmaceutical composition of the present invention controls the release of paracetamol for 10 -12 hrs. Background: pharmaceutical composition of paracetamol with 8 hr control release are described in several prior art 8 hr control release Freedom to Operate Search

Step 6: FTO Opinion: No infringement issue Go Ahead Freedom to Operate Search

Step 6: FTO Opinion : Infringement issues • Option 1: ▫ Design around strategy; if this option is not feasible then • Option 2: ▫ Purchase the patent or in-licensing. ▫ Cross-licensing. ▫ Compulsory licence regime Freedom to Operate Search

Step 6: FTO Opinion : Infringement issues • Option 3 ▫ Search Invalidation Grounds of the hindering Patent: Validity Search ▫ In case of a patent application, search the prior art to analyze whether it would be granted of not. Freedom to Operate Search

Step 6: FTO Opinion : Infringement issues • Option 4: Forget the Product for time being and wait till the hindering patent expires. Freedom to Operate Search

• Thanks…………. . Freedom to Operate Search