March 30, 2012 “Patenting 101” Workshop Sponsored by Commercial Ventures & Intellectual Property (CVIP) and Research Development (RD) University of Massachusetts Amherst To Contact CVIP: Phone (413) Web:

Patenting 101 Patent Law for Researchers and Innovators

Overview Patents Contrasted with Other Types of Intellectual Property Obtaining a Patent –Invention –Requirements to Obtain a Patent –Changes resulting from the 2011 America Invents Act (AIA) Asserting Your Own Patent and Defending Against the Patents of Others

Why should you care about patents? Patents demonstrate that your work is innovative UMass shares patent licensing revenue with inventors Patents can support the formation of start-up companies

Types of Intellectual Property Trade Secret –any information that provides a commercial advantage –lost if publicly known –risk of others independently discovering and patenting the secret Patent –plant: new variety of asexually reproduced plant (20 years) –design: ornamental designs for manufactured articles (14 years) –utility: process, machine, manufacture, or composition of matter (20 years) Trademark –word, symbol, design used to identify goods and distinguish them from goods of others Copyright –works of authorship embodied in a tangible medium (life of author +70 years; or, for corporate works, lesser of 95 years from publication or 120 years from creation)

Patents are Rooted in the Constitution U.S. Constitution, Article 1, Section 8, Clause 8: “To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.” society benefits from disclosure of inventions –encourages innovation –improvements can begin immediately

Patent Quid Pro Quo Requires Disclosure disclose your invention in exchange for the possibility of a time-limited right to exclude others from using your invention –disclosure in general, a patent application is published 18 months after filing, whether or not it leads to a patent –exception: if filing patent application in US only and request nonpublication, can keep invention secret unless and until a patent is granted –possibility of a right to exclude (not a right to practice) currently about 50-60% of US patent applications become patents

Patent Process Overview invention and documentation search of prior art draft application file application (U.S. and optionally non-U.S.) examination (“prosecution”) appeal (optional) issue or abandonment

Patent-Related Costs approximate cost of obtaining and maintaining a US patent –preparation and filing: $5,000-$25,000 –prosecution: $2,000-$20,000 –issue and maintenance fees: $5,000-$10,000 under AIA, universities will pay ¼ government fees –total: $12,000-$55,000 patent litigation cost: $1,000,000-$5,000,000 other patent-related costs –product clearance: $2,000-$20,000 –noninfringement and invalidity opinions $5,000-$25,000

Patent-Related Benefits time-limited right to exclude others from practicing your invention –“time-limited” = 20 years from filing –scope of right defined by patent claims –right to exclude, not right to use for practicing patentee, time in the market without competition for non-practicing patentee, right to licensing fees stronger negotiating position for an accused infringer competitor uncertainty during application pendency

Patent Claims claims are listed at the end of the patent and define the invention a patent can contain one claim, a few claims, or many claims –about 20 claims is typical a patent can contain more that one type of claims –e.g., claims to a new drug, a method of making the drug, and a method of using the drug to treat a disease each claim is a single sentence

Example of a Patent Claim US claim 1: A method of swinging on a swing, the method comprising the steps of: a) suspending a seat for supporting a user between only two chains that are hung from a tree branch; b) positioning a user on the seat so that the user is facing a direction perpendicular to the tree branch; c) having the user pull alternately on one chain to induce movement of the user and the swing toward one side, and then on the other chain to induce movement of the user and the swing toward the other side; and d) repeating step c) to create side-to-side swinging motion, relative to the user, that is parallel to the tree branch.

Invention conception: when the inventor perceives a specific result and a particular means of accomplishing the result, so that no more than ordinary skill in the art is needed to build or carry out the invention –if more than ordinary skill is required to build or carry out the invention, then building or carrying out the invention is required before conception is complete AIA: signed, dated, witnessed documentation of conception and implementation remains important even as the US moves from a first-to-invent to a first-to-file patent system –inventorship –unexpected results

Inventorship determined claim-by-claim only those who contributed to the inventive concept can legally be considered an inventor –not those carrying out routine work pursuant to instructions –not those merely posing the problem to be solved –not those with only managerial responsibility –decisions as to who should be listed as an inventor must be made in “good faith”

Inventorship joint invention does not require physically working together working at the same time making the same amount or type of contribution working on all aspects of the invention

Inventorship inventorship is not the same as ownership –most universities and companies have explicit assignment agreements with their inventors –a corporation can have rights under common law (“shop rights”) –an inventor’s obligation to aid (e.g., provide signatures) continues after employment ceases

Search of the Prior Art (Optional) “optional”, but omitted at applicant’s peril –critical to defining a patentable, valuable invention prior art includes –publications: books, articles, patents, published patent applications –previously sold products –public use of the invention by applicant or others –AIA: “otherwise available to the public” patentability search analysis seeks to answer the questions –Is the invention new? –If the invention is new, what is the closest prior art, and why is the invention not obvious in view of that art?

Parts of a Patent Application background summary of the invention –mirrors claims description of any figures detailed description of the invention claims

Drafting and Prosecution requirements to obtain a US patent include –statutory subject matter –utility –novelty –nonobviousness –enablement and written description –best mode –disclosure of material art relevant during patent examination and litigation

Statutory Subject Matter is the invention the kind of thing that can be patented? U.S. Federal Law (35 U.S.C. 101): “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 therefor, subject to the conditions and requirements of this title.” Excluded: abstract ideas, laws of nature, tax-avoidance strategies –AIA: human organisms Included but controversial (and excluded in some non-US countries): software, business methods, life forms, methods of medical treatment

Is this claim directed to statutory subject matter? A method of optimizing therapeutic efficacy for treatment of a disease, comprising: –(a) administering a drug to a subject and –(b) determining the level of a metabolite in the subject, –wherein a metabolite level less than X indicates a need to increase the amount of drug and a metabolite level greater than Y indicates a need to decrease the amount of drug subsequently administered to the subject Mayo v. Prometheus (2012)

Utility is the invention useful? a very low hurdle for patent applicants examples of inventions from actual patents include –method of exercising a cat –method of swinging on a swing –“beerbrella” to keep sun off beer can

Novelty is the invention new? new as of what date? –Until 3/15/2013, new as of the date of invention –AIA: after 3/16/2013, new as of the date of patent application filing with the change from first-to-invent to first-to-file, it is more important than ever to contact CVIP as soon as possible after an invention has been made

Bars to Novelty public disclosure public (non-secret) use sales and offers for sale AIA: “otherwise available to the public” U.S. has one year grace period U.S.: applicant’s own disclosure, public use, offer for sale or sale cannot occur more than one year before filing most non-U.S. countries: disclosure, public use, offer for sale or sale cannot occur any time before filing

Nonobviousness at the time applicants made their invention, would the invention have been obvious to a skilled person? a very high hurdle for applicants –the single most important reason that many US applications do not lead to a patent the hypothetical “skilled person” has perfect knowledge of the prior art and ordinary creativity a 2007 Supreme Court case (KSR) made it easier for the USPTO and courts to find inventions obvious

Enablement and Written Description written description: a skilled person should be able to tell from the application that applicant made the invention claimed enablement: a person skilled the art should be able to practice the invention without undue experimentation separate requirements, often confused by courts

Best Mode the application must set forth the “best mode contemplated by the inventor of carrying out the invention” AIA: as of 9/16/2011, a patent cannot be invalidated for failure to comply with the best mode requirement, but the requirement continues often conflicts with applicant’s desire to maintain trade secrets two-step inquiry: –did the inventor contemplate a best way to practice the invention when the application was filed? –if yes, did the inventor disclose the best way to practice the invention?

Duty of Disclosure of Material Art applicants have no requirement to search the prior art, but... the USPTO REQUIRES that all inventors and attorneys disclose “material” art to the USPTO failure to disclose such art can invalidate that patent as well as any related patents duty to disclose continues from date of filing to date of issue

Material Art would be considered important to an examiner in deciding patentability or is inconsistent with, or refutes, a position that the applicant has taken examples: published patent applications, patents, articles, dissertations, books, web sites, publicly available product descriptions, publicly available presentations, offers for sale, sales

Examination by the USPTO almost all patent applications are initially rejected responses to rejection –argue –amend claims (narrow definition of invention) claim amendments must be supported by application as filed –appeal –abandon filing application entitles applicant to two office actions and two responses, with more available with payment of fee

Overview of the Filing Process US provisional application –establishes priority, not examined –allows one year for further experimentation and to better determine value of application US nonprovisional application –examined, can become US patent Patent Cooperation Treaty (PCT) application –International, preserves right to file applications in most countries 30 months after initial filing “foreign” (non-US country) applications

Commercialization frame of reference: you have a US patent and want to commercialize your invention licensing –an existing company commercializes the invention –licensing revenues are shared between the inventors and the University start-up –a new company is created to commercialize the invention –venture capital is required

Patent Assertion frame of reference: you have a US patent and sue someone else for infringing it once issued, a patent grants its owner the exclusive right to prevent others from –making, –using, –offering for sale, –selling the claimed invention in the United States, or –importing the claimed invention into the United States right to exclude is defined by the patent claims a federal law suit is filed against the accused infringer a losing defendant can be forced to stop infringing activity and/or pay monetary damages for infringing activity

Defense frame of reference: someone else sues you for infringing their patent responses include –defense of noninfringement (e.g., design around) –defense of invalidity (the patent should not have been granted) –settlement (e.g., agree to pay royalties) –AIA: non-profit use for public good >1 year before patent filing date is not infringement, unless patentee is institute of higher education

Summary our patent system is rooted in the constitution and intended to encourage innovation and benefit society patents are expensive to obtain and enforce but can be extremely valuable researchers can help themselves and the University by –documenting their invention at the time it is made –contacting CVIP well before any planned disclosure –disclosing to CVIP and their patent attorney any public references relevant to the patentability of their invention –helping to respond to patent office rejections

Questions? Mike Buchanan Cantor Colburn LLP