INTRODUCTION TO PATENT RIGHTS The Business of Intellectual Property Presented by Dawn C. Russell Arent Fox LLP Washington, DC | New York, NY | Los Angeles

Types of patents and applications Criteria for patentability Topics to be covered What is a patent? Why obtain a patent? Types of patents and applications Criteria for patentability Pitfalls: U.S. vs. the rest of the world 2

What is a Patent? A patent is an agreement between the granting government and an inventor wherein, in exchange for the inventor fully disclosing his invention to the public, the government grants the inventor the right to exclude others from making, using, or selling the patented invention for the term of the patent. Patents are only enforceable within the borders of the granting countries. The patent system promotes the progress of the sciences and the useful arts, as set forth in the U.S. Constitution.

Why Do Companies Obtain Patents? Offensive use of patents: Preventing others from making, using, and selling your product, thereby providing the patent holder with a type of “legal monopoly.” Defensive use of patents: Companies with large patent portfolios do not always actively assert their patent rights. If accused of infringing a competitor's patent, the accused infringer could then assert patent rights in a “defensive counterattack,” in an effort to force a settlement or cross-license. Revenue Generation: Patents can be licensed to generate significant amounts of income for the patent owner, even if the patent owner never builds or sells the patented invention.

Types of U.S. Patents Utility Patents (for “any new and useful” invention): Term is 20 years from filing date. Design Patents (for “any new, original and ornamental design”): Term is 14 years from date of issuance. Plant Patents (for “any distinct and new variety of plant”): Term is same as Utility Patent.

Types of Patent Applications Non-provisional: Examined by a patent office examiner. More formal requirements: requires at least one claim. Provisional: Not examined by a patent office examiner (good for 1 year). Less formal: does not require claims or other formalities. Can be anything from a scientific paper to a hand- written disclosure. PCT: International filing and “preliminary prosecution” with international examiner.

Criteria for Patentability The process, machine, manufacture, or composition of matter must be: USEFUL (as required by 35 USC § 101) NOVEL (as required by 35 USC § 102) NON-OBVIOUS (as required by 35 USC § 103)

Criteria for Patentability: Utility Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent problems in biotechnology and software inventions

Criteria for Patentability: Novelty The invention must be newly invented by the inventors. Any public use, offer for sale, publication or commercialization of the product, by anyone including the inventors, more than one year prior to the filing of a U.S. patent application, may bar patentability. Prior invention by another party will bar patentability. Invention can be proven with engineering/laboratory notebooks.

Criteria for Patentability: Non-Obviousness U.S. PTO looks at the differences between the “invention” and the prior art and determines: Would the subject matter, as a whole, have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains

Criteria for Patentability: Three Additional Requirements Written Description: invention must be “described” in the specification. problems in biotechnology inventions Enablement: a person of ordinary skill in the art must be able to make and use the invention given what is provided in the specification. Best Mode: cannot keep the best way of practicing the invention a secret.

Pitfall #1: Novelty “Grace Period” (USA) vs. “Absolute Novelty” USA: 1 year “grace period” for novelty: gives an inventor 1 year from first disclosure to file a patent application. Most of the World: “absolute novelty” needed – first disclosure must be patent application. Solution: keep options open by filing in U.S. before any public disclosure.

Pitfall #2: “First to Invent” (USA) v. “First to File” USA: In a dispute over who invented the invention first, the inventor who can prove a first date of invention (e.g., using lab notebooks) wins. Most of the World: In a dispute over who invented the invention first, the inventor who filed his application first wins. Solution: File early and maintain records.

Pitfall #2 (cont): Proving “Invention” (USA) U.S. patent system awards patents to the first to “invent”; most other countries award patents to the first to file patent applications. (Conception) + (Reduction to Practice) + (Diligence) = INVENTION Careful documentation in engineering/laboratory notebooks can prove all of these elements.

Pitfall #3: Duty of Disclosure (USA) USA: Inventors and each other individual associated with the filing and prosecution of the patent application has a duty to disclose “all information known to that individual to be material to [the] patentability” of the invention. This includes: Prior art cited in search reports of a foreign patent office in a counterpart application. The closest information over which the individual believes the invention defines. All information that refutes an argument made to the USPTO in favor of patentability (e.g., negative test results). Most of the World: No such duty exists. FAILURE TO COMPLY WITH THE DUTY OF DISCLOSURE CAN RESULT IN THE INVALIDATION OF THE PATENT.

Obtain patents to exclude others from practicing your inventions. Summary Obtain patents to exclude others from practicing your inventions. File (at least) a provisional before any public disclosure to maintain option for foreign rights. Carefully document work done by employees and consultants. Understand and comply with the “duty of disclosure” obligations.

Contact Information: Dawn C. Russell PH: 202.775.5771 russell.dawn@arentfox.com Arent Fox LLP 1050 Connecticut Ave., N.W. Washington, DC 20036