Medical Technology Patents

A patent is an exclusive right granted for an invention, which is a product or process that provides a new way of doing something, or offers a new technical solution to a problem. A patent gives the owner of the patent protection for the invention, usually for 20 years.

Anyone applying for a patent at the national or international level is required to determine whether their creation is new or is already owned or claimed. To determine this, huge amounts of information must be searched. The U.S. Patent and Trademark Office (USPTO) and the World Intellectual Property Organization's (WIPO) International Patent Cooperation Treaty (PCT) have created classification systems which organize information concerning inventions into indexed, manageable categories for easy retrieval.

The patent literature is a key source of information on medical devices. Device industry professionals use the results of a patent search in different ways—to determine whether an invention, or part of the invention, is already patented; to find all of the patents of a particular inventor; or to monitor a competitor's recent patent applications. Also, before a patent application is submitted, patent attorneys conduct an extensive review of all prior art, including patents, in order not to infringe on an existing patent.

Patent-issuing bodies include the USPTO, WIPO, and the European Patent Office (EPO). Most individual countries also grant patents. However, the WIPO-administered PCT provides for the filing of a single international patent application, which has the same effect as national applications filed in each of the 180 WIPO member countries. A similar situation exists with patents issued by the EPO.

Searching the Patent Literature

Compared to pharmaceutical patent searching, the process for finding device patents is less well defined and more subjective. The highly organized detail of compound and chemical structures and nomenclature important to pharmaceutical patent searching is not a factor in medical devices.

Patent classes and the images included in a patent are key elements in the device patent search. The images are critical in evaluating a patent, as they illustrate, along with the written description, the mechanics involved in the device. The image alone may determine the significance of the patent in question.

Patent classifications divide the entire set of U.S. and international patents into searchable collections based on the technology claimed in that patent. The primary U.S. patent groupings, called Classes, are divided into more specific Subclasses, which in some cases are further subdivided in Sub-subclasses. On the other hand, the International Patent Classes (IPC) specifies the Class, Subclass, Group, and Subgroup. The EPO's European Patent Classification (ECLA) is assuming greater importance, since it further subdivides the IPC.

Patent classifications are important search tools. Ideally, the product, process, or technology to be researched will fall neatly into an existing classification. This is frequently not the case in device and combination product searching, especially given the rapid changes in technology. As with the indexing of the clinical literature, it is not easy for the classifying bodies to keep current with scientific advances.

In addition, patents are often written in a way to disguise the technology, process, or device. Realizing this, the good patent searcher will consider various types of spellings, synonyms, and phrasing, which fall outside the common language of the device industry.

It is often appropriate to look at all the patents assigned to a specific class/subclass. However, it is important to use keywords to search the titles, abtracts, and claims, and sometimes even the full text of patents within a broader range of patent classes in order to capture all patents of interest.

Because of all these factors, a good approach to conducting a typical patent search is:

1. Decide the body of patents you want to search—U.S. only? WO? Others?

2. Determine the key function, effect, mechanism of action, structural characteristics, and other relevant factors of the techology, process, or product your are researching. This information will be used to narrow your search as necessary to find the most relevant patents.

3. Identify appropriate classes and subclasses to search. Remember that U.S. and WO patents have different classifications.

4. If you can't find an appropriate class or classes to search, scan patent titles in some of the subject subclasses, noting those which appear relevant to the invention in question. Of which potentially relevant patents, look at the more specific subclasses assigned to the patents, and review the patents in these areas.

5. Use this method to identify the most relevant subclasses to search, incorporating into your search keywords, phrases, spelling variants, etc., which you have already formulated, to retrieve the most relevant patents.

Searching for patent inventors or assignees is fairly straightforward. The patent databases described below provide information on how to perform these types of searches.

Key Device Classes US Patent Classes:

• Class 128: Surgery—includes Respiratory Method or Device and Liquid Medicament Atomizer or Sprayer.

• Class 600: Surgery—includes Diagnostic Testing; Radioactive Substance Applied to Body for Therapy; and Body Inserted Urinary or Colonic Incontinent Device or Treatment.

• Class 601: Surgery: Kinesitherapy.

• Class 602: Surgery: Splint, Brace, or Bandage.

• Class 604: Surgery—includes Controlled Release Therapeutic Device or System and Means for Introducing or Removing Material from Body for Therapeutic Purposes (e.g., Medicating, Irrigating, Aspirating, etc.).

• Class 606: Surgery—comprised of Instruments.

• Class 607: Surgery: Light, Thermal, and Electrical Applications.

• Class 623: Prosthesis (i.e., Artificial Body Members), Parts Thereof, or Aids and Accessories Therefor.

A complete list of U.S. Classes is available on the USPTO web site.

International Patent Classifications (IPC):

• A61: Medical or Veterinary Science, Hygiene.

• A61B: Diagnosis, Surgery, Identification.

• A61M: Devices for Introducing Media into, or onto, the Body.

• A61N: Electrotherapy, Magnetotherapy, Radiation Therapy, Ultrasound Therapy.

A complete list of IPC Classes is available on the WIPO website.

Databases [email protected]®. espacenet.com Munich: European Patent Office. Database of the European Patent Office (EPO), part of the European Patent Organization founded in 1973 to establish a uniform patent system in Europe. About 28 European countries are members of the organization, with several others anticipated to join. The EPO grants European patents for the contracting states. [email protected] is a robust site with a newly designed user-friendly interface. Provides four separate patent databases:

• EP—patents applications published by EPO in last 24 months.

• WIPO—WO patent applications published in last 24 months.

• Worldwide—published patents of over 70 countries, including the U.S. Coverage for each country varies, but goes back to at least to the 1970s for most major European countries, and back to the 1800s for the U.S. and Germany.

• Patent Abstracts of Japan—search English-language abstracts from 1976 forward.

Quick and Advanced Search features. Can also search by patent number or EP Classification. Available online.

Patent Abstracts of Japan. 1976- . Tokyo: Japanese Patent Office. URL: http://www.ipdl.go.jp/homepg_e.ipdl. English abstracts plus drawings of Japanese patent applications. Includes legal status data. Computerized translations are available at the site, but usually several months behind. Available online.

U.S. Patent and Trademark Office (USPTO). Washington DC: United States Patent and Trademark Office. URL: http:// www.uspto.gov/. Provides information on the patenting process, U.S. and International patent law and regulations, resources for independent inventors, search aids, and fee-based online delivery of patents. Includes U.S. patent applications and issued patents back to 1790. The full-text of patents is available since 1976. Includes help on viewing the images and searching by U.S. classifications. Classifications and related information, including a U.S. to International Patent Classifications concordance and an overview of the classification system, are available from the USPTO's Office of Patent Classification. Available online.

World Intellectual Property Organization (WIPO). Geneva. URL: http:// www.wipo.org. WIPO's objective is to promote the effective protection and use of intellectual property (IP) throughout the world through cooperation with and among its over 160 Member States and other stakeholders. WIPO is one of the 16 specialized agencies of the United Nations, administering 23 international treaties dealing with different aspects of intellectual property protection. The WIPO site includes extensive information about all aspects of IP. A broad introduction to intellectual property is available free in the WIPO publication Wipo Intellectual Property Handbook: Policy, Law And Use, as is a summary of intellectual property legislation in member States, in the WIPO Guide to Intellectual Property Worldwide. WIPO's database, the PCT Electronic Gazette, is not especially user-friendly. Available online at http://www.wipo.int/ipdl/en/ search/pct/search-adv.jsp.

Nonetheless, search options include:

• Structured search—a menu of various searchable fields.

• Simple search—keyword or phrase.

• Advanced search—options for searching front page or fulltext, limiting the date range, and sorting results chronologically or by relevance.

Patent Aggregators

Aggregators offer searchable access to different types of patents. Each service offers different subscription options.

Derwent World Patents Index® (DWPI). Philadelphia: Thomson Scientific. Derwent, owned by Thomson Scientific, is an important resource for its added-value features. Derwent covers more major and minor countries, including 40 patent issuing authorities, with coverage of technology going back to 1963; provides auxiliary indexing using descriptive, industry-specific terms; and provides English titles and abstracts of non-English language patents. Derwent's "World Patents Index First View,'' contains details of new patent documents in advance oftheir inclusion in DWPI. DWPI can be searched from Thomson Scientific's Delphion service. An intiative of IBM

started in 1997, Delphion is intended as a site to research, manage, and analyze IP information to generate new levels of insight and extract the full value of their IP. Search options include keyword, accession or patent number, Boolean text, and multiple text fields. Derwent records on Delphion are enhanced with INPADOC Legal Status information as well as the original claims. Search help and other Delphion features are available on their Web site. Delphion offers different subscription options on a pay-per-use cost basis. Derwent is also available from Dialog and STN.

Dialog. Cary, North Carolina: Thomson Dialog. Dialog, part of the Thomson Corporation, offers a number of online patent databases, including: U.S. Patents Fulltext; CLAIMS®/Cita-tion; CLAIMS®/Comprehensive; CLAIMS®/Current Legal Patent Status; CLAIMS®/U.S. Patents; Derwent World Patents Index; Derwent Patents Citation Index; INPADOC/ Family and Legal Status; European Patents Fulltext; WIPO/ PCT Patents Fulltext; JAPIO—Patent Abstracts of Japan.

Micropatent. East Haven, CT: Micropatent. URL: http:// www.micropat.com/. Micropatent provides several databases. The PatSearch® integrated database searches the fulltext of US, EP, PCT, Great Britain, and German patent records and the front page of JP documents. US, EP, and DE are covered at first publication and when granted. Drawings are included when available. (US data is from 1836, EP from 1978, PCT from 1978, Great Britain from 1979, and Germany from 1989). Use "Front Page Searching—Worldwide Pat-Search'' to search the front page only of US, EP, PCT and JP patents and applications published from 1976 to the present. Drawings are included when available. Search patent family and legal status using Micropatent's Patent Index (MPA) Database. Many corporate information centers subscribe to Micropatent to take advantage of specialized features, including search and display options, Aureka® online patent analysis and collaboration tools, file histories, and patent alerts. Available online.

Books

Gibbs A, DeMatteis B. Essentials of Patents. Hoboken, NJ: John Wiley Publishers, December 2002. E-book, March 2003. This book presents invention and the U.S. patent system in a real-world context. Practical content includes chapters on Patent Strategy, Patent Tactics, Managing Patents in the Engineering Department, and Managing Patents in Manufacturing and Operations. E-book option ensures greatest currency. Publisher states that all updates will be provided free with purchase of the main volume (in either format).

Gordon TT, Cookfair AS. Patent Fundamentals for Scientists and Engineers. 2nd ed. Boca Raton, FL: CRC Press, 2000. Provides a clear explanation of the patent system and patent principles. Designed for nonlawyers. Includes information on the patenting process, obtaining patent protection, and how to recognize patentable inventions and avoid legal problems of infringement. International scope. Includes techniques for searching the Internet.

Other Resources

Patent Information Users Group Inc. The International Society for Patent Information. URL: http://www.piug.org/

''... a not-for-profit organization for individuals having a professional, scientific or technical interest in patent information. With the ever increasing volume of patents and related technical documents, the effective retrieval and analysis of patent information has become an essential skill in business.''

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