Intellectual Property/Patents

Q. What is "intellectual property"?

A. Intellectual property means slightly different things to different people, but generally in the legal sense it is thought of as material that may be protected under the patent, trademark and/or copyright laws.

Q. What is UM's policy on ownership of inventions?

A. The basic policy is stated in Regents' Bylaw 3.10. A copy of that Bylaw can be found at the following website: www.techtransfer.umich.edu/inventors/reglaws.html.

Q. What is the UM policy concerning technology transfer and the out-licensing of inventions made at UM?

A. The policy can be found at www.techtransfer.umich.edu/inventors/policies.html. Other resources can be found that the website of the Office of Technology Transfer, www.techtransfer.umich.edu.

Q. What type of subject matter can be patented?

A. Under United States law, at least one aspect of an invention may be patentable. Patentable subject matter includes processes, machines, compositions of matter, articles, some computer programs, and methods (including methods of making compositions or methods of making articles and even methods of performing business). For more information, see www.techtransfer.umich.edu/inventors/patents.html and http://www.uspto.gov/web/offices/pac/doc/general/what.htm.

Q. May someone patent a naturally occurring substance?

A. No, though a natural substance that has never been isolated or known may be patentable, but only in its isolated form (since the isolated form has never been known before). Even a slight variation of naturally occurring substances may be patentable if an inventor is able to demonstrate advantages of using the variant.

Q. What is a patent?

A. The idea of a modern patent system dates back to at least 15th Century England. The United States Constitution provides for the U.S. patent system, and the U.S. Congress defines the patent laws in Title 35 of the United States Code. In the U.S., a patent provides the holder the right to exclude others from making, using, selling, offering to sell, and importing any patented invention. Thus, a patent does not necessarily provide the holder any affirmative right to practice a technology - it provides the right to exclude others from practicing it. See http://www.uspto.gov/web/offices/pac/doc/general/index.html#patent and http://www.uspto.gov/web/offices/pac/doc/general/whatis.htm.

     The legal definition of an invention is found in the "claims" of a patent -- the numbered paragraphs at the end of an issued patent. The claims define the scope of an invention just as a property deed defines the scope of land ownership of real estate. Thus, the term patent claim differs from the term "claim" as it is used in the context of advertising and FDA. Other sections typically found in a U.S. patent include: Abstract, Summary, Detailed Description, Examples, and Figures, all of which must together describe the invention in sufficient detail so that other people skilled in the field to which the invention pertains are able to understand what the invention is and practice the invention in a general sense. A patent need not provide mundane production details or information that would relate only to commercialization of the invention, but the patent must describe the inventor or inventors' preferred manner (if there is a preference) of practicing the invention.

A. The PTO is the federal agency, organized under the Department of Commerce, that administers patents on the part of the government. (A part of the PTO also issues federal trademark registrations.) A description of the PTO may be found at http://www.uspto.gov/web/offices/pac/doc/general/index.html#uspto. Although the PTO issues patents, patents must be enforced in the federal court system of the United States.

Q. How does the patenting process generally work?

A. Patent applications are generally drafted by a patent attorney (or patent agent, a non-attorney with a science education licensed to practice at the PTO) and filed by mail with the PTO in Arlington, Virginia. Generally, the patent attorney will need the inventor(s) to sign an Inventor's Declaration (which states, among other things that the inventor made the invention claimed in the application) and an Assignment (which evidences the inventor's duty to assign the patent to the inventor's employer (such as the University)). Patent applications are required to be held confidential by the PTO during the time of their pendency.

    Usually within a few months, a patent applicant will receive written notice back from the PTO as to whether the application and its claims have been accepted in the form in which they were filed. More often than not, however, the PTO, represented by a Patent Examiner, rejects the application because either certain formalities need to be cleared up, or on the basis that the claims are not patentable over the "prior art" (see the definition below). The letter sent by the patent examiner is referred to as an Office Action or Official Action.

    If the application is rejected, the patent attorney will then need to file a written response (generally within three to six months) to any rejections. In such cases, generally the attorney will amend the claims and/or point out why the PTO's position is incorrect. This procedure is referred to as patent prosecution. Often it will take two PTO Official Actions and two responses by the patent attorney (and sometimes more) before the application is resolved. The resolution is hopefully in the form of a PTO notice that the application is allowable (meaning that the PTO agrees to issue a patent). During this process, the patent attorney will often need the input of the inventor(s) in order to confirm the attorney's understanding of the technical aspects of the invention and/or the prior art cited against the application.

    Currently, the average patent application is pending for just over two years, though inventors in the biotech and computer fields should plan on their applications taking longer. Once a patent is issued, it is enforceable until the date 20 years from the initial filing of the application that resulted in the patent, assuming that PTO-mandated maintenance fees are timely paid.

    Pursuant to an international treaty, the Paris Convention, foreign patent applications must be filed within a year of the filing of the U.S. application in order to receive the filing date of the U.S. application.

A. Prior art is defined by statute (35. U.S.C. 102), but it may generally be thought of as anything that prior workers in the field have made or disclosed in the past. Prior art may include printed publications, conference handouts (and sometimes even presentations within a university), books, newspaper articles - often regardless of where the material was published, where it was published, and in what language it was published. Prior art may also include orally presented material, such as discussions at conferences, disclosures to competitors, certain disclosures to colleagues in a field, and other public statements.

    Thus, an inventor may under certain circumstances create prior art against herself (thereby jeopardizing patent rights) by publicly disclosing an invention prior to the filing of a patent application.

Q. Who is an inventor of a U.S. patent application?

A. An inventor is a person that takes part in the conception of the patent claims (discussed above) of a patent application. Thus, inventorship of a patent application may change as the patent claims are changed during prosecution of the application. An employer or person that furnishes money to build or practice an invention is not an inventor. Inventorship is a sometimes intricate legal determination that is made by the patent attorney prosecuting the application. See, for example, http://www.uspto.gov/web/offices/pac/doc/general/faq.htm#a5.

Q. Is there such a thing as a provisional patent?

A. No. However, there is a provisional patent application, which is described below.

Q. What is the difference between a provisional patent application and a regular (or "utility") patent application?

A. U.S. provisional patent applications provide a tool in the right circumstances for preserving patent rights while keeping costs to a minimum. Provisional applications must name an inventor, but do not require an inventor's declaration or claims. Governmental filing fees for a provisional application are now $80 for a small entity (such as a university), compared to $375 for a regular (utility) application. In order to claim the priority date of a provisional application, a regular U.S. application (and foreign, e.g. PCT, applications) must be filed within 1 year of the provisional. However, an applicant only receives the benefit of the earlier filing date for material that is described in the provisional application. A provisional application is not examined during the one year in which it is pending, while a regular application typically will receive its first examination within the first year it is pending.

Q. How may I review patent literature?

A. Patents may be searched at no cost on the website of the United States Patent and Trademark Office (www.uspto.gov, more particularly www.uspto.gov/patft/index.html - and see http://www.uspto.gov/main/profiles/acadres.htm and http://www.uspto.gov/web/menu/helpfaq.htm#a20). On that web page, searching "Issued Patents" will uncover patents issued (i.e., approved) in the United States since 1976. "Patent applications" are unissued (i.e., unapproved) patents, which are generally published 18 months after they are filed. Since applications have only been published since 2001, searching "Patent Applications" will uncover a different (and limited number) of documents. Searching may also be performed at http://www.wipo.int/ipdl/en/search/pct/search-adv.jsp.

A. More than 300,000 U.S. patent applications are filed each year by people and companies from all over the world. The U.S. government has issued more than 6,500,000 patents. (The current patent numbering system began in 1836.) Roughly 170,000 patents are issued each year in the United States.

Q. Is there such a thing as an international patent?

A. No, there is no such thing as an "international patent."

    An important international treaty called the Paris Convention permits a patent application filed in a second country (or a PCT application, as discussed above) to claim the benefit of the filing date of an application filed in a first country. However, pursuant to this treaty, these so-called "convention applications" must be filed in foreign countries (or as a PCT, as described below) within one year of the first filing date of the U.S. application.

    Although an international patent does not exist, another international treaty called the Patent Cooperation Treaty ("PCT") provides a streamlined filing procedure for most of the industrialized nations of the world. (See http://www.uspto.gov/web/offices/pac/dapps/pct/index.html. Lists of member countries are found at http://www.wipo.org/pct/en/texts/pdf/time_limits.pdf and http://www.uspto.gov/web/offices/pac/dapp/pctstate.html.) For U.S. residents, a PCT application is generally filed one year after the corresponding U.S. application (either provisional or regular ) is filed (since U.S. residents generally file in the U.S. first). The PCT application must later be filed in the national patent office of any country in which the applicant wishes to seek patent protection, generally within 30 months of the earliest claimed filing date. (Patent attorneys refer to this as "nationalization" of a PCT application.) Each national patent office thereafter handles the application according to its own laws and procedures.

    For example, if an applicant files an application in the U.S. on January 1, 2003, she must file any corresponding PCT application by January 1, 2004 (under the Paris Convention). This PCT application "designates" any PCT-member country in which the applicant wishes to preserve the right to file a corresponding national application. National applications generally must then be filed in the desired countries by 30 months from January 1, 2003, i.e. by July 1, 2005.

    An applicant may request examination ("international preliminary examination") of the PCT application by a PCT examiner (physically located at either the U.S. Patent Office or the European Patent Office), and this examination will result in the examiner issuing an International Preliminary Examination Report ("IPER"), which is the examiner's opinion on the patentability of the PCT application. This IPER is later shared with national patent offices where the application is later filed, and although the IPER is not binding upon those patent offices, many patent offices may view a positive IPER as persuasive evidence that an application/invention is patentable.

    Thus, PCT provides two main advantages. First, PCT provides the opportunity to delay the need to file (generally very expensive) foreign applications until the 30-month date, often after an applicant has the opportunity to further develop, evaluate and/or market her invention. Second, the international preliminary examination procedure often allows an applicant to simplify the patent prosecution process by having a single examiner speak to the patentability of the claims, which can save significant costs in prosecuting foreign patent applications.

Q. What do the terms "patent pending," "patent pend." and "patent applied for" mean?

A. These are terms placed on products or product packaging to inform the public that the manufacturer or seller has applied for patent protection in the U.S. Once a patent has issued, a patent holder is supposed to place the patent number on its products covered by the patent (and remove the "patent pending" markings). This is referred to as patent marking. A manufacturer or seller is not permitted to falsely mark its products.

Q. How are patent rights treated in my sponsored research?

A. UM retains ownership of the patent rights resulting from sponsored research. Sponsored research projects are handled by OVPR's (Office of the Vice-President for Research) Division of Research Development and Administration (DRDA) (www.research.umich.edu/contacts/drda/drda_contact.html). Often, sponsored research contracts provide the sponsor an option of limited time to negotiate a license to any patent rights developed as the result of the research. If you have questions about sponsored research, please see the website above or contact the DRDA Project Representative responsible for the sponsor (described at www.research.umich.edu/contacts/drda/sponsor.html) For more information, you may call 734-764-5500.

Q. Where can I find more information concerning conflict of interest management as it concerns research and intellectual property?

A. Information concerning conflict of interest relating to UM research may be found at the following webtsite: www.research.umich.edu/policies/um/conflict_procedures.html.

Q. Is UM liable for patent infringement of third-party patents by virtue of work by UM researchers?

A. UM researchers have at time been accused of patent infringement. If you are accused of infringement, you should immediately contact the Office of the General Counsel (see the contact information in this website). The United States Constitution may provide that state universities have immunity from lawsuits for these types of actions. However, patent holders often are not likely to accuse universities of patent infringement due to the non-commercial nature of the research and the public benefits that the research provides.

Q. How does patent law affect the generic drug industry?

A. The so-called "Waxman-Hatch Act of 1984" (also known as the "Drug Price Competition and Patent Term Restoration Act of 1984") provided a compromise between pioneering drug companies and generic drug manufacturers (and their customers). The act provides a series of checks and balances for both the first marketer of a new drug and manufacturers that wish to produce a generic version of a drug. This is a complicated issue, but for a summary of the act, see http://library.lp.findlaw.com/articles/file/00553/007032/title/subject/topic/administrative%20law_federal%20agencies/filename/administrativelaw_2_13.

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