Fundamental Requirements for Patent Protection in the United States Chapter 3

Why have Patents? Stimulates R&D. Protect the rights of the inventers. Encourage rapid disclosures. Create product improvements. Allow time to recover cost to create the product.

Protection requirements: Novel: Knowledge of the invention was not previously available to the public. Non-Obvious: Not obvious at the time of the invention to one skilled in the art. Proper Subject: Utility Patents: Useful: credible, specific, real-world use. Anything under the sun made by human ingenuity Design Patents: Primarily ornamental

Novelty

Non-obvious

Requirements for Patent Application at the Patent and Trademark office (PTO) 1.A description of the invention. 2.An illustration of best mode of carrying out the invention. 3.All known information relating to patentability of the invention. 4.The precise aspects of the invention claimed for patent protection.

Was the patent application filed in time? Date of invention = date of concept. – Drawings Models Working prototype are carried out with due diligence. – In practice or patent application is filed. 1 year grace period. – Inventor discloses information. – Public use or sale. Experimental use: controlled private studies.

Patent Duration It takes 1½ - 3 years for the PTO to issue a patent. Utility Patents: 20 years from date of filing. – Biotech Industry: 5-10 years before patent. Adjusted duration so it equals or exceeds 17 years. Design Patents: 14 years from date of patent issuance.

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Pharmaceutical Patents Require approval from: PTO and FDA; Clinical trials approximately 5-10 years New Drug Application (NDA) 2-7 years Hatch-Waxman Act (1984) – Extended patents for pioneered drugs up to 5 years. – Made generics more quickly available after the patent ended. Abbreviated New Drug Application (ANDA) 180-day hold for other generics.

Enforcement Issues Protecting your patent: Lawsuit – Requires lots of time, energy, and resources Forum-shopping: best location for the lawsuit. Anywhere they made, used, or sold the invention. Defenses – Invention does not infringe on the patent. – The patent was invalidly granted. Newegg and Overstock. Lose the patent. other manufacturers know how to make your invention. Take to the Federal Circuit Court of Appeals – Prior use rights. Only covers for methods of doing business

First-to-Invent Priority

Why the United States is Adopting a First-to-File System Easier to determine priority. To decrease litigation expenses and time. Global consistency. 95% first to file = first to invent. Advantageous for inventor internationally. – Simultaneously file international application with the WIPO specifying protection in desired countries.

Obtaining and Defending patents rights in the United States and Globally Chapter 4

Patent applicaton process Who may file the Patent Application – Inventor Assignee to the patent * Employer might file if invention assignment agreement is filed. ( patent reform act) Procedural Requirements – Comprehensive, detailed,wittnessed and dated record keeping – Perform Prior Art search ( not mandatory but extremely helpful) – File as soon as possible (with in a year of certain events like sales or pubications)

Important components of the Patent Application Summary of the Invention (exhibit 4.2) Enablement Applicant must provide enough information about the invention to enable one skilled in art to practice it – Objectivity – Withholding Information – Breadth of Claim Case 4.1 White Consolidated Industries v. Vega Servo-Control, Inc.

Best mode Disclosure of best mode of carrying out the invention contemplated by the inventor at the time of the paten application. Information Disclosure Statement All information that bears upon patentability of an invention needs to be disclosed. must steer clear of the inequitable conduct. The Claims It defines the boundary of legal monopoly of the patent. Could be a mean- for or a means-plus-function claim.

PTO Procedures and Appeals Secrecy order Secrecy of information submitted to PTO Publication of patent file after 18 months of application with exception for inventor filing in US only Patent Examination Process Appeals Reexamination Oppositions (pre-grant v. post grant) Litigation

Infringement and Remedies Infringement Making, using or selling of any patented invention without authority within US during the term of patent Literal Infringement 1. Rule of exactness 2. Rule of Addition 3. Rule of Omission Doctrine of Equivalents item performs substantially the same function in substantially the same way to obtain same result Prosecution history Estoppel

Infringement of Process Patents Whoever without authority imports, sells or uses within the US a product which is made by a process patented in the US shall be liable as an infringer (Process Patent Amendments Act) Remedies for Patent Infringement – Damages Lost profits – Sales to customers not reached by patentee – Insufficient production capacity of Patentee – Sales due to features other than the patented technology

Reasonable Royalty – Established rates in Industry – Whether parties are competitors – The advantages of invention over prior techniques – Importance of invention to Infringer’s product

Penalty for Willful Infringement – The Infringer acted despite high likelihood that its actions constitute infringement – The infringer knew or obviously should have know of that objectively high risk of infringement – Injunctions Four factor test – The plaintiff has suffered irreparable damage – Traditional remedies are inadequate to compensate for injury – Public interest would not be disserved. – Hardships to plaintiff outweigh those to defendant from continued infringement

International Patent protection Issues Patent Law Treaty – The requirement for obtaining a filing date – Procedures for recording a change of address or patent ownership – Issues regarding reviews of patent Invalidation decisions. More Issues under consideration – Patent Term Measure term from date of filing At least a 20 year term from date of filing. – Patentable Subject Matter – First to File Priority – Grace Periods – Secrecy of Patent Application

Prior user Rights – Oppositions and Delays – Issues Regarding National Emergencies and Public health (compulsory license) The Paris Convention – Filing date of an Application filed in a signatory company will be considered the effective filing date of an application filed in an other country The European patent convention ( one application for Europe) Patent Cooperation Treaty – Search Report – International Preliminary Examination Authority

CASE FIRACT MONSANTO COMPANY AND MONSANTO TECHNOLOGY LLC, v. VERNON HUGH BOWMAN MICROSOFT CORP. v. AT&T CORP.