General Principles of Intellectual Property.pptx

samkhan166 654 views 43 slides Mar 06, 2025
Slide 1
Slide 1 of 43
Slide 1
1
Slide 2
2
Slide 3
3
Slide 4
4
Slide 5
5
Slide 6
6
Slide 7
7
Slide 8
8
Slide 9
9
Slide 10
10
Slide 11
11
Slide 12
12
Slide 13
13
Slide 14
14
Slide 15
15
Slide 16
16
Slide 17
17
Slide 18
18
Slide 19
19
Slide 20
20
Slide 21
21
Slide 22
22
Slide 23
23
Slide 24
24
Slide 25
25
Slide 26
26
Slide 27
27
Slide 28
28
Slide 29
29
Slide 30
30
Slide 31
31
Slide 32
32
Slide 33
33
Slide 34
34
Slide 35
35
Slide 36
36
Slide 37
37
Slide 38
38
Slide 39
39
Slide 40
40
Slide 41
41
Slide 42
42
Slide 43
43

About This Presentation

*Intellectual Property *Rights (IPR) – Overview**

Intellectual Property Rights (IPR) refer to the legal protections granted to creators for their inventions, literary and artistic works, symbols, names, and designs. These rights ensure that individuals and businesses can control and benefit fro...


Slide Content

General Principles of Intellectual Property Presented By :- Mohd Sameer Presented To :- Dr Rabea Parveen Subject:- Pharmaceutical Validation (MQA202T) Class :- M. Pharm. Quality Assurance 2 nd Sem

Intellectual Property Intellectual property (IP) refers to creations of the mind, such as inventions; literary and artistic works; designs; and symbols, names, and images used in commerce. You own intellectual property if you: Created it (and it meets the requirements for copyright, a patent, or a design) Bought intellectual property rights from the creator or a previous owner Have a brand that could be a trademark, for example, a well-known product name Intellectual property can: Have more than one owner Belong to people or businesses Be sold or transferred If you're self-employed, you usually own the intellectual property even if your work was commissioned by someone else—unless your contract with them gives them the rights. You usually will not own the intellectual property for something you created as part of your work while you were employed by someone else.

INTELLECTUAL PROPERTY PROTECTION (IPP) Having the right type of intellectual property protection helps you to stop people from stealing or copying the names of your products or brands, your inventions, the design or look of your products, and things you write, make, or produce.

TYPES OF PROTECTION The type of protection you can get depends on what you've created. You get some types of protection automatically, while others you have to apply for. Type of Protection Examples of Intellectual Property Copyright Writing and literary works, art, photography, films, TV, music, web content, sound recordings Design Right Shapes of objects Type of Protection Examples of Intellectual Property Time to Allow for Application Trademarks Product names, logos, jingles 4 months Registered Designs Appearance of a product including shape, packaging, patterns, colors, decoration 1 month Patents Inventions and products, e.g., machines and machine parts, tools, medicines Around 5 Years Protection You Have to Apply For Automatic Protection

Intellectual Property (IP) Organizations Organization Headquarters Established Key Functions World Intellectual Property Organization (WIPO) Geneva, Switzerland April 26, 1970 Administers global IP treaties, Patent Cooperation Treaty (PCT), Madrid System for Trademarks, and provides IP dispute resolution. World Trade Organization (WTO) Geneva, Switzerland January 1, 1995 Enforces TRIPS Agreement (Trade-Related Aspects of Intellectual Property Rights) and resolves IP-related trade disputes. European Patent Office (EPO) Munich, Germany October 7, 1977 Grants European patents under the European Patent Convention (EPC). Eurasian Patent Organization (EAPO) Moscow, Russia August 12, 1995 Grants Eurasian patents valid in Russia and neighboring countries under the Eurasian Patent Convention. Intellectual Property India (IPI) New Delhi, India 1856 (Modern system established in 1970) Administers patents, trademarks, copyrights, geographical indications, and industrial designs in India. United States Patent and Trademark Office (USPTO) Alexandria, Virginia, USA July 31, 1790 Grants US patents and trademarks, provides IP legal assistance and dispute resolution. European Union Intellectual Property Office (EUIPO) Alicante, Spain March 23, 1994 Manages trademarks and industrial designs across the European Union.

Economic Importance of Intellectual Property (IP) Intellectual Property (IP) plays a crucial role in economic growth and innovation by: Encouraging Innovation: Provides incentives for research and development. Boosting Economy: Strengthens industries like pharmaceuticals, IT, and entertainment. Enhancing Competitiveness: Helps businesses differentiate their products/services. Attracting Investments: Investors prefer businesses with strong IP protection. Creating Jobs: Generates employment in IP-related industries. Facilitating International Trade: Strengthens exports and global business expansion.

Types of Intellectual Property Rights

Type of IPR What it Protects Validity Period Example Patent Protects new inventions , including processes and products. 20 years New pharmaceutical drugs (e.g., COVID-19 vaccine). Trademark Protects brand names, logos, symbols, or slogans . 10 years (renewable) Nike’s "Swoosh" logo, McDonald's “I'm Lovin' It” slogan. Copyright Protects original literary, artistic, and digital works . Life of the author + 60 years (India) Books, music, movies (e.g., Harry Potter novels, Marvel movies). Trade Secret Protects confidential business information . No expiry (as long as secrecy is maintained) Coca-Cola’s secret formula, Google’s search algorithm. Industrial Design Protects product shapes, appearances, or designs . 10-15 years iPhone design, car models. Geographical Indication (GI) Protects products linked to a specific region . 10 years (renewable) Darjeeling Tea, Swiss Watches.

Copyright Copyright (or author’s right) is a legal term used to describe the rights that creators have over their literary and artistic works. Works covered by copyright range from books, music, paintings, sculpture, and films to computer programs, databases, advertisements, maps, and technical drawings. There are two types of rights under copyright: Economic rights, which allow the rights owner to derive financial reward from the use of their works by others. Moral Rights Moral rights protect the non-economic interests of the author. The Elements of the Copyright Notice For published works, there are three elements: The word “Copyright” or the abbreviation "©". The year of first publication. The name of the owner of the copyright.

Additionally, the phrase “All Rights Reserved” can be added for protection in Latin American countries. For unpublished works, it is recommended that a copyright notice be combined with a trade secret notice since most unpublished software works are also maintained as trade secrets. Duration of Copyright For works created on or after January 1, 1978 (or works created earlier but not published/registered), the duration of copyright is the life of the author plus 70 years. For a joint work by multiple authors who did not work for hire, copyright lasts for the life of the last surviving author plus 70 years. In the case of a work for hire, copyright endures for the shorter of 95 years from first publication or 120 years from creation. Copyright in such works may not be renewed, and terms run to the end of the calendar year in which they would otherwise expire.

Trademark Category Famous Examples Words or Slogans "Just Do It" (Nike), "I'm Lovin' It" (McDonald's), "Think Different" (Apple) Logos, Symbols, or Pictorial Representations Nike "Swoosh", McDonald's Golden Arches, Apple logo, Mercedes-Benz Three-Pointed Star Numerals, Letters, or Combinations 501 (Levi’s jeans), IBM (International Business Machines), V8 (Vegetable juice) Unique Packaging Shapes Coca-Cola’s curved bottle, Toblerone’s triangular chocolate bar, Hershey’s Kisses Colors Tiffany Blue (Tiffany & Co.), UPS Brown, Cadbury Purple, Home Depot Orange Sounds Intel's 5-note jingle, MGM lion’s roar, NBC chimes, Nokia ringtone Scents Play-Doh’s sweet vanilla scent, Verizon’s "Flowery Musk" scent for stores Trademarks serve two purposes: To distinguish goods from those sold by another. To indicate the source of the identified goods. A trademark is a sign capable of distinguishing the goods or services of one enterprise from others. Trademarks are protected by intellectual property rights.

Category Definition Examples Trademark A symbol, word, or phrase legally registered to represent a company or product. Nike (Swoosh logo), Apple (bitten apple logo), Coca-Cola (script logo) Service Mark Identifies and distinguishes services rather than physical products. McDonald's (fast food services), FedEx (courier services), Netflix (streaming services) Trade Name The official name under which a company does business, but not necessarily registered as a trademark. The Coca-Cola Company , Microsoft Corporation , Tesla, Inc. Trademark Registration Legal process to secure exclusive rights by filing an application at the national or international level. Apple® , Adidas® , Google® (registered with USPTO, WIPO) International Trademark Protection Trademark protection in multiple countries via national filings or the WIPO Madrid System . Samsung (protected globally under Madrid System), Louis Vuitton , Toyota Trade Name Protection A trade name cannot be registered unless used as a trademark; infringement is legally actionable. Amazon Inc. , Facebook Inc. , PepsiCo Ltd.

Federal trademark/service mark registrations last for 10 years and are renewable indefinitely if the mark remains in use. Between the 5th and 6th year of registration, the registrant must file a declaration of use . An Affidavit of Use must also be filed before each renewal term, or the registration will be canceled . Trademark Registration Term

1. Always use a trademark as a proper adjective modifying a noun ✅ LEGO® bricks (not just " legos ") TESLA® electric cars 2. Distinguish the trademark from surrounding text Use bold, italics, capital letters, or quotation marks ✅ Apple® iPhone® 3. Use appropriate trademark symbols ™ (Trademark) → For unregistered marks SM (Service Mark) → For unregistered service marks ® (Registered Trademark) → Only for trademarks officially registered with the U.S. Patent and Trademark Office (USPTO) Examples: ✅ Nike® sneakers ✅ McDonald's® restaurants Trademark Usage Guidelines

Patent A patent is an exclusive right granted for an invention—a product or process that provides a new way of doing something or offers a technical solution to a problem. To get a patent, technical information about the invention must be disclosed to the public in a patent application. Inventions Patentable For an invention to qualify for a patent, it must meet three basic criteria: Novelty : The invention must be new and unique , with no prior existence. Uniqueness : It must not be an obvious improvement over existing technology. Usefulness : It should add value to society and must not be illegal or immoral . Certain scientific discoveries (e.g., Newton’s law of gravity, Einstein’s relativity ) cannot be patented , as they are fundamental laws of nature. Inventions Non-Patentable Certain things are not patentable under Section 3 and 5 of the Indian Patents Act (1970) : Agricultural or horticultural methods . Medical, surgical, curative, or treatment processes for humans, animals, or plants. Discoveries or upgrades in atomic energy . Discoveries of new machines, apparatus, or processes .

Types of Patent Applications The five types of patent applications are: Provisional Application Ordinary or Non-Provisional Application Convention Application PCT International Application PCT National Phase Application Patent of Addition Divisional Application

Provisional Application A temporary application filed when an invention is still in development . Helps establish an early priority date . The complete specification must be filed within 12 months , or the application is abandoned. Ordinary or Non-Provisional Application A complete patent application filed without any previous provisional application. Requires a detailed specification of the invention. No claim for priority from an earlier filing. Convention Application Filed when an applicant wants to claim priority from a patent application filed in a foreign country under the Paris Convention . Must be filed within 12 months from the first application in another country. PCT International Application Filed under the Patent Cooperation Treaty (PCT) , which allows the applicant to seek patent protection in multiple countries with a single application. It does not result in a direct patent grant but simplifies the process for international patents.

PCT National Phase Application After the PCT International Application , the applicant enters the national phase by filing separate applications in individual countries where they seek patent protection. Must be filed within 30/31 months from the priority date. Patent of Addition Filed when an inventor makes an improvement or modification to an existing patented invention. No need to pay a separate renewal fee as long as the main patent remains valid. Divisional Application Filed when an original patent application contains more than one invention and the applicant wants to separate them into distinct applications. Ensures each invention gets individual patent protection .

Process of Filing a Patent Application Step No. Process Details Timeframe Approximate Cost (INR) Step 01 Invention Disclosure Disclose the invention to a professional or patent attorney under a Non-Disclosure Agreement (NDA). Provide all known details. Immediate Free (NDA signing) Step 02 Patentability Search A professional conducts a prior art search to determine if similar patents exist. A detailed report is generated. 2-4 weeks 10,000 - 20,000 Step 03 Decision to File a Patent Application Based on the patentability search, decide whether to proceed with filing. Ensure your invention has an "inventive step" (technical advancement/economic significance). 1-2 weeks Free (Decision making) Step 04 Patent Drafting Prepare a detailed description of the invention, including claims, technical specifications, and drawings. Can be done by the inventor or a professional. 2-6 weeks 20,000 - 30,000 Step 05 Filing the Patent Application File the patent with the Indian Patent Office (IPO). Filing fee varies depending on the type of applicant (individual, startup, or company). If no early publication is requested, the patent is published after 18 months. 1-2 weeks 1,600 (Individual), 4,000 (Startup), 8,000 (Company)

Step 06 Publication of Patent Application By default, the patent application is published in the official journal after 18 months unless early publication is requested (which speeds up the process). 18 months (or 1 month for early publication) 2,500 - 12,500 (for early publication) Step 07 Request for Examination (RFE) The applicant must request an examination within 48 months of filing. The patent office examines the application for novelty, inventive step, and industrial applicability. Within 48 months of filing 4,000 (Individual), 10,000 (Startup), 20,000 (Company) Step 08 Examination and First Examination Report (FER) The patent examiner issues an examination report (FER), which may contain objections regarding novelty or clarity. 12-24 months from RFE Included in RFE cost Step 09 Responding to Objections The inventor has a chance to respond to objections raised in the FER by providing clarifications, technical arguments, and modifications. 6-12 months Varies (Legal/professional fees if needed) Step 10 Patent Grant If all objections are resolved and the invention meets all requirements, the patent is granted and published in the official journal. 3-6 months after approval No additional cost Step 11 Renewal of Patent A patent is valid for 20 years. To keep it active, the patent must be renewed every year from the 3rd year onward by paying a renewal fee. Annually (starting from 3rd year) Varies (Starts from INR 800 per year)

Benefits of Getting a Patent Prevents theft of your invention. Exclusive rights and control over your idea. Easy commercialization and branding. Higher market value as your idea becomes a brand. More profit margins. Even though the patent filing process is complex and long, digital advancements have made it simpler. Having a patent in place ensures no one can claim rights over your invention. In case of infringement, legal actions can be taken.

Patent Application Forms & Guidelines Form No. Purpose Form 1 Application for grant of a patent (mandatory). Form 2 Submission of Provisional or Complete Specification . Form 3 Statement regarding foreign applications filed for the same invention. Form 5 Declaration of inventorship . Form 9 Request for early publication . Form 18 Request for examination of the patent . Form 26 Authorization of Patent Agent (if applicable). Form 27 Statement of working of patent (mandatory for granted patents in India). Guidelines for Filing a Patent Application: ✅ The invention must be novel, non-obvious, and industrially applicable . ✅ The application must be clear, complete, and supported with drawings (if needed) . ✅ Fees vary based on individuals, startups, and corporate applicants . ✅ In India, patents are filed with the Indian Patent Office (IPO) . ✅ International applications can be filed via the Patent Cooperation Treaty (PCT) for multi-country protection.

Patent Application Form

Patent Infringement : The Indian Patent Act, 1970 (IPA), does not explicitly define infringement, but any act violating or encroaching on the rights of the patentee, including unauthorized use, making, selling, or importing a patented product/process, is considered infringement. Sections 104-115 of the IPA deal with patent infringement suits. Types of Patent Infringement Direct Infringement: Occurs when a patented product/process is copied exactly. The alleged product/process performs the same function as the patented one. Claims of the patent define the scope of protection. If prior art elements are fully adopted in the alleged product/process, it is direct infringement. Indirect Infringement: Occurs when infringement is done through a third party or an indirect source. Even if the elements appear different, they are fundamentally the same. Includes encouraging or inducing another person to infringe a patent. Infringement may be intentional or unintentional. Often, the infringer becomes aware of the infringement only when sued.

Factors affecting choice of IP protection Nature of the Innovation Patents: Suitable for inventions, processes, and technological advancements. Copyright: Best for literary, artistic, and creative works. Trademarks: Ideal for branding elements like logos and slogans. Duration of Protection Needed Patents last 20 years , copyrights can last 50–70 years , while trademarks can be renewed indefinitely . Cost of Protection Patents involve high filing and maintenance costs. Copyrights are usually inexpensive and automatic upon creation. Trademarks require periodic renewals but are cost-effective in the long run.

Geographical Scope Protection is territorial (country-specific), but international protection can be sought through treaties like the Patent Cooperation Treaty (PCT) or Madrid System for trademarks . Competitor Landscape If competition is high, securing strong IP rights can prevent copying and ensure market exclusivity. Ease of Enforcement Some forms, like patents, require legal enforcement through lawsuits, whereas trademarks and copyrights are easier to monitor and enforce. Monetization Potential Licensing & commercial use : Patents, trademarks, and copyrights can generate revenue through licensing agreements. Level of Innovation or Creativity If the work is unique and technical , a patent is best; if it's creative , copyright is sufficient; for branding , trademarks are preferable.

Trade Secret A trade secret is any confidential business information that provides a company with a competitive advantage. Unlike patents, trade secrets are not publicly disclosed but are protected through secrecy measures Key Features of Trade Secrets: Confidentiality: Must be kept secret and not be generally known. Competitive Advantage: Provides an edge over competitors. No Registration Required: Unlike patents, trade secrets do not need to be registered. Unlimited Protection: Remains protected as long as secrecy is maintained. Legal Protection: Can be protected through Non-Disclosure Agreements (NDAs), employment contracts, and legal actions for misappropriation. Examples of Trade Secrets: Formula: Coca-Cola's secret recipe. Process: Google's search algorithm. Customer Lists: Confidential client databases. Manufacturing Methods: Special production techniques.

Industrial Design An Industrial Design (ID) refers to the aesthetic or ornamental aspects of a product, including its shape, pattern, color, or combination of these elements. It enhances the visual appeal and marketability of a product. Key Features of Industrial Design: Aesthetic Value: Focuses on the external appearance rather than functionality. Unique and Original: Must be novel and distinctive to qualify for protection. Product-Specific: Applies to manufactured products like electronics, furniture, packaging, etc. Fixed Duration of Protection: Typically, 10-25 years , depending on the country. Exclusivity Rights: Prevents others from copying or imitating the design. Examples of Industrial Designs: Apple's iPhone design (sleek appearance). Coca-Cola bottle shape (distinctive contour). Car body designs (unique aesthetics). Fashion accessories (branded handbags, watches).

Geographical Indication (GI) A Geographical Indication (GI) is a type of intellectual property that identifies a product as originating from a specific geographical location (town, region, or country), where its quality, reputation, or characteristics are essentially linked to that location. Key Features of GI: Origin-Based Identity: The product must have a specific geographic origin and possess qualities or reputation linked to that place. Collective Right: Unlike patents or trademarks, GI is owned collectively by producers from that region. Quality and Reputation: The product’s unique features must be due to natural factors (climate, soil, water) or human factors (traditional techniques, local expertise). Legal Protection: Prevents unauthorized use by producers outside the designated region. No Expiry: GI rights do not expire as long as the product maintains its geographical significance. Examples of GI Products: India: Darjeeling Tea (West Bengal) Basmati Rice (Punjab, Haryana, UP) Alphonso Mango (Maharashtra) Kanjeevaram Silk Saree (Tamil Nadu)

Penalties for Violation in India Type of IPR Civil Penalties Criminal Penalties Patent Infringement (Indian Patent Act, 1970) - Injunction (court order to stop infringement) - Compensation/damages to the patent owner - Seizure or destruction of infringing products - No direct criminal penalties, but courts can impose heavy fines and compensation Copyright Infringement (Copyright Act, 1957) - Injunction to stop unauthorized use - Compensation for financial losses - First offense : 6 months to 3 years imprisonment , fine ₹50,000 to ₹2 lakhs - Subsequent offenses : Up to 5 years imprisonment , fine up to ₹5 lakhs Trademark Infringement (Trademarks Act, 1999) - Injunction against unauthorized use - Compensation/damages to the trademark owner - 6 months to 3 years imprisonment - Fine ₹50,000 to ₹2 lakhs - Seizure of counterfeit goods Trade Secret Violation (Under Contract Law, Copyright Act, or IT Act) - Compensation for financial losses - Court orders to stop misuse - If linked to data theft/cybercrime : Up to 3 years imprisonment , fine up to ₹5 lakhs (under IT Act, 2000) Industrial Design Infringement (Designs Act, 2000) - Injunction to stop production/sale - Compensation up to ₹50,000 per breach - No specific criminal penalties, but repeated offenses may lead to higher fines and seizure of goods

Penalties for Violation in different countries IPR Type United States (US) European Union (EU) India China World Trade Organization (WTO) TRIPS Agreement Patent Infringement - Injunctions - Triple damages (willful infringement) - Legal costs - Injunctions - Compensation for damages - Seizure of infringing goods - Injunction - Compensation - Seizure of goods - Fines - Injunctions - Seizure of goods - TRIPS mandates civil remedies & injunctions, but enforcement varies by country Copyright Infringement - 5 years imprisonment - Fines up to $250,000 - Damages for losses - 3 years imprisonment - Fines based on damage - 3 years imprisonment - Fine ₹50,000 to ₹5 lakh - Up to 7 years imprisonment - Heavy fines - TRIPS mandates criminal penalties for willful piracy on a commercial scale Trademark Infringement - 10 years imprisonment - Fines & seizure of goods - Up to 5 years imprisonment - Heavy fines - 3 years imprisonment - Fine up to ₹2 lakh - Up to 7 years imprisonment - Heavy fines & seizure - TRIPS requires penalties for counterfeiting Trade Secret Violation - Up to 10 years imprisonment (Economic Espionage Act) - Heavy fines - Civil suits for damages - Trade secret laws vary by country - Up to 3 years imprisonment - Fine up to ₹5 lakh (IT Act) - Severe fines & imprisonment - Seizure of assets - TRIPS encourages trade secret protection, but enforcement varies Industrial Design Infringement - Injunctions - Damages for losses - Fines & seizure of infringing designs - Fine up to ₹50,000 per breach - Fines & business license revocation - TRIPS mandates design protection, but penalties differ

Role of Intellectual Property (IP) in the Pharmaceutical IP Type Role in Pharmaceutical Industry Patents - Provide 20 years of exclusivity, allowing recovery of R&D costs. - Encourage investment in drug discovery and development. - Prevent unauthorized production of patented drugs. Trademarks - Protect brand identity and prevent counterfeit medicines. - Help in differentiating original drugs from generics. Copyright - Protects medical literature, drug manuals, and research papers. - Ensures exclusive rights over clinical trial data. Trade Secrets - Safeguard formulas, manufacturing processes, and clinical trial data. - Prevent competitors from replicating proprietary methods. Industrial Designs - Protects the unique shape, color , and packaging of drugs. - Helps in distinguishing products in the market. Why IP is Important in Pharma? ✅ Encourages Innovation – Ensures companies invest in new drug discovery. ✅ Boosts Revenue – Helps pharmaceutical firms recover huge R&D expenses. ✅ Ensures Patient Safety – Prevents counterfeit drugs and ensures quality. ✅ Drives Economic Growth – Strengthens the pharmaceutical sector globally.

Global Ramifications and Financial Implications of Intellectual Property (IP) Intellectual Property (IP) plays a crucial role in the global economy, influencing innovation, trade, and financial stability. The enforcement and protection of IP rights (IPR) impact industries, governments, and consumers worldwide.

Global Ramifications of IP Aspect Impact Economic Growth Strong IP protection drives innovation, foreign investments, and industrial growth in developed countries. Developing nations struggle to balance IP enforcement with economic development. International Trade IP-intensive industries contribute significantly to global trade . Disputes over patents, trademarks, and copyrights lead to trade wars (e.g., US-China IP conflict). Access to Technology & Medicine Strict IP laws limit access to essential medicines and technology in low-income countries. Compulsory licensing allows governments to override patents for public health crises (e.g., HIV/AIDS drugs in Africa). Counterfeit Goods & Piracy Weak IP enforcement results in $500 billion+ in global losses annually from counterfeit products, affecting brands and consumer safety (e.g., fake medicines, luxury goods). World Trade Organization (WTO) & TRIPS Agreement The TRIPS ( Trade-Related Aspects of Intellectual Property Rights) Agreement mandates global minimum standards for IP protection, balancing innovation with public interest. Developing nations seek waivers for essential goods. Cultural & Creative Industries Strong IP laws protect films, music, and literature , but piracy remains a major issue, especially in digital markets (e.g., Hollywood vs. online piracy).

Financial Implications of IP Factor Financial Impact R&D and Innovation Costs Companies invest billions in research. For example, developing a new pharmaceutical drug costs $1-2 billion over 10-15 years . Market Monopoly & Exclusivity IP rights grant exclusivity (patents: 20 years, copyrights: 70+ years), allowing companies to charge premium prices. Global IP Licensing & Royalties Tech and pharma giants generate billions from licensing IP (e.g., Microsoft, Apple, Pfizer). Global royalty payments exceed $400 billion annually .

Thank you