Medical Device Link.

Originally Published MX May/June 2004

GOVERNMENTAL & LEGAL AFFAIRS

Executives can strategize to save time and money when searching for relevant technological references.

Mark D. Barrish and Scott M. Smith

In light of recent court decisions regarding the patent infringement case Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. Ltd. and SMC Pneumatics Inc., commonly referred to as Festo, medical device company leaders would be prudent to protect their core technologies by learning as much as they can about prior art.¹ Indeed, device companies must understand the patent landscape so that they can intelligently assess patentability and freedom-to-operate issues and explain them to potential investors.²

Unfortunately, gaining and maintaining a comprehensive knowledge of intellectual property in a particular medical field can be a daunting task, especially for start-up or small device companies with budgetary constraints. Even established companies with in-house counsel and significant funds devoted to intellectual property may find it challenging to monitor patent publications if they practice in a "crowded" or "hot" technology area, such as stent-related devices, minimally invasive cardiology devices, and certain orthopedic surgery specialties.

Faced with an array of search options, ranging widely in cost and thoroughness, device company executives should consider the following.

• Conduct a search that is broad enough to ensure that no significant information is missing, without spending an inordinate amount of time and money.
• Discover what sources are needed for a search to be complete, including U.S. patents and published applications; nonpatent publications; and foreign publications.
• Upon performing an initial search, update search results efficiently and effectively to stay current with new intellectual property.
• Keep track of patent applications that have been filed but not yet published.

No search is perfect—and searches that approach perfection are often too costly and time-consuming to be practical for start-up device companies and even more-established companies. Even where significant funds are available, spending too much money and effort on the wrong search and at the wrong time can waste resources and be an unnecessary distraction. This article, therefore, does not provide cut-and-dried solutions but suggests strategies for searching relevant technological references (often called "prior art") and monitoring intellectual property developments to relieve at least some of the frustration felt by medical device company executives.

Before Starting the Search

To address completeness versus practicality, there are a number of steps a medical device executive and device company patent counsel can take before starting a prior-art search. First, the medical device executive should consider consulting a patent lawyer who specializes in medical devices. Lawyers with an in-depth knowledge of medical devices may already have a general (or even specific) understanding of prior art in several medical device fields.

Once patent counsel is chosen, the medical device executive should ensure that the attorney gains a detailed knowledge of the company and the technology it plans to sell (or is already selling) or develop. The attorney should then be given a thorough explanation of the technology that is being pursued, and what the purpose of the search will be. Finally, any other information the device executive can share, such as a list of actual or potential competitors and known innovators and inventors in the field, should be shared with the attorney.

Exclusivity versus Freedom to Operate

To help guide patent counsel, executives should first identify the primary goal of the search and then specify the type of search they want performed.

Prior-art searches (and intellectual property in general) have two overarching aspects: exclusivity and freedom to operate. Exclusivity deals with executives' own patents, trade secrets, and trademarks, and protecting their markets and ideas from competitors. Freedom-to-operate issues originate from patents and intellectual properties that belong to others. While it may seem as though companies will always want to address both exclusivity and freedom to operate in all searches, the emphasis will often be on one side or the other, and will typically change over time. When executives initiate a patent search because their company's technical staff has just developed a new catheter that can safely and permanently treat pancreatic cancer, their primary concern should be to seek exclusivity for the new technology. If executives are about to commercially launch a new coronary stent product in the United States after years of successful sales in Europe, they had better concentrate on whether they will be free to sell the product without infringing other patents.

Once executives have identified whether they are primarily interested in obtaining exclusivity or in finding out if they will be free of other patents, they can work with patent counsel to identify a specific search type to perform. For exclusivity, different search types typically occur at different stages of a product's life. The costs for these searches can and should vary; depending on an assessment of the overall value of the exclusive market one is seeking.

Three types of exclusivity searches might include the following.

• "State of the Art" searches are appropriate when an executive first considers entering a field but does not know what specific technology to pursue. This type of search features a relatively low cost, and may be performed in-house or with the help of patent counsel. It typically identifies examples of recent patents, published patent applications, or journal articles.
• "Patentability" searches are often used as a filter to determine whether to proceed with the patent process. For this type of search, the costs remain significantly less than what one would incur when drafting a patent application. Even if executives know that an application will be drafted, this search can significantly improve the quality of any patent they eventually obtain. Issued patents and published patent applications will often be identified.
• "Validity" searches are useful before executives acquire another patent or assert a patent of their own against a competitor who is infringing their claim.

When another party's patent is the primary concern, executives may want to consider one or more of the following searches.

• "Blocking Patent" searches seek to identify any broad pioneering patents with claims that cover an entire field.
• "Invalidity" searches seek references that may invalidate a patent that currently exists or that a competitor is threatening to assert.
• "Clearance" searches are performed when a product design is being finalized and a commercial launch is planned.

While having some familiarity with these different search types can be helpful in communicating with a patent attorney, executives should not hesitate to pick and choose from the search aspects that pertain to them. Also, executives should ask their attorneys to inform them if any potentially problematic claims arise involving issued patents.

The Hunt Begins

Once a medical device executive and patent attorney know what they are looking for, the simplest way to start a prior-art search is via the U.S. Patent and Trademark Office (PTO). The PTO Web site is free to the public and provides a database with the full texts of all U.S. patents issued since 1976 and all U.S.-published patent applications published since March 15, 2001. A number of different search strategies may be used, such as typing keywords in titles, abstracts, or entire patents, or searching by patent or application number, assignee, inventor, classification, issue date or other categories. Unfortunately, patent drawings cannot be viewed on the site, and if a searcher is not experienced in performing keyword searches, many prior-art references may be overlooked.

A similar Web service, Esp@cenet, is also free to the public, and available for searching European patents. This site offers a network of patent databases, including databases for searching patents in Japan and other international locations.

Once various patents and published applications are found through free searches, these initial references may then be used to broaden the search. For example, a patent often cites other relevant patents in the field, either on the cover page or in the background section of the patent, or a particular inventor or assignee may be searched in further detail.

Sometimes a prior-art searcher may wish to conduct further investigations into a particular patent to determine, for example, whether it has been assigned or licensed, or whether the inventor has a university affiliation.

In some cases, a university office of technology transfer will be willing to share additional information about a patent or inventor, such as whether certain researchers are being funded by a medical device company. Information about a particular patent application may be found on the PTO patent application information retrieval Web page. Other sources of information may include press releases, company Web sites, Securities Exchange Commission documents (such as licensing agreements) of publicly traded companies, and even Web-based search engines such as Google.

For some medical device companies, an initial search may be sufficient. In many cases, however, it is only a beginning.

Detailed Search Techniques

Searching prior art can be similar to peeling an onion, with the removal of one layer revealing additional layers. Device company executives should realize at the outset that no search is perfect. Even with thorough searches, new intellectual property or references can be missed and may appear at any time.

Despite the impossibility of searching everything, some steps can be taken to perform a more thorough prior-art search. For example, several services are available via the Internet for prior-art searching on a fee-for-service basis, including Dialog, Nerac Inc., and Delphion. All three require subscriptions and charge for each search; the cost is typically based on the number of results retrieved and the format in which the results are presented. Many intellectual property law firms have subscriptions to these services and some have paralegals, patent agents, and attorneys who are skilled at using them.

All three services provide access to U.S. and foreign patents and published applications, but one service may be preferable for certain tasks. Dialog, for example, often works well for finding complete patent families and the legal status of published applications and patents. Nerac, on the other hand, may provide less-expensive, ongoing patent-monitoring services.

Other fee-based Internet services include LexisNexis and a site from the Patent and Trademark Library at the Sunnyvale Center for Innovation, Invention, and Ideas that is directly affiliated with the PTO.

Even more thorough prior-art searching can be performed by patent search firms, many of which are located in Virginia for easy access to the PTO. Such firms can be found through the Internet or other directory services, but it is probably best to get a referral from a patent attorney to find a qualified and appropriate searcher. Some professional searchers, for example, are former PTO patent examiners—and some even specialize in medical device patents.

The advantage of hiring professional searchers is that they will actually go to the patent office and search the on-site PTO database (which includes full-text copies of patents, including drawing figures) and will also manually search through the "shoes" (i.e., boxes) of patents that are stored there. Such manual searching may be beneficial because relevant intellectual property is often shown in figures—and Internet searching is typically limited to word-based search techniques. Additionally, the searcher may have a particular expertise and will know which patent classifications to search. The searcher may also be already familiar with technology, inventors, and competitors in the field.

In some cases, such as in preparation for litigation, a medical device company needs to perform a "scorched earth" search of prior art that leaves no stone unturned. When such a detailed search is required, professional search firms are available, including Global Prior Art Inc. These types of firms have experts in various areas such as medical devices and biotechnology. Depending on the needs of the client, searches may range from sources specifically related to U.S. patents and published applications to all U.S. sources (including all publications, dissertations, etc.), as well as sources in Europe, Japan, Russia, or any other country of interest. References found by the search firm are also initially reviewed by the firm for relevance, and detailed charts and analyses may be prepared in some cases. Such searches are not inexpensive; costs range from $5000 to $50,000 or more.

Foreign Prior-Art Searching

Foreign prior art may be one of the more frustrating "black holes" for medical device company executives. It may not be necessary to search foreign prior art if, for example, a particular technology area has historically been completely developed and dominated by U.S. companies and researchers. Also, there is often tremendous overlap between foreign and U.S. patents, in which case a domestic prior-art search will find all relevant art. Oftentimes, however, a device company executive will want to perform at least a cursory search for prior art from Europe and perhaps other regions, such as Asia.

Many of the resources discussed above, such as Dialog and Nerac, may be used to search foreign patents and published applications. Other publications may also be available through services such as Dialog's dissertation abstracts database, which contains dissertations accepted at accredited U.S. institutions from 1861 to the present, as well as some master's theses, Canadian dissertations, and British and other European dissertations.

The Center for Research Libraries offers a foreign doctoral dissertations database that includes more than 750,000 noncatalogued foreign doctoral dissertations. Dissertation Abstracts International provides bibliographic citations for dissertations written in the United States between 1938 and 1984, as well as some Canadian and foreign dissertations. (Dissertations written for professional degrees are not included in the collection.) If appropriate, a medical device company might ask its patent attorney to contact foreign associates to broaden the search to additional countries.

One factor to consider in foreign prior-art searching is that the United States is a first-to-invent country, while most of the rest of the world is first-to-file. In other words, in the United States, whoever invents something first has precedence. In other countries, the first person to file a patent application has precedence. This contrast may have complex consequences from a prior-art perspective, which are outside the scope of this article.

Prior-Art Monitoring

Staying abreast of new intellec-tual property developments in a particular field can be another difficult challenge. This is often especially frustrating for a start-up company in a crowded technological field that does not have an in-house patent lawyer or patent agent who can devote significant time to watching for and evaluating newly issued patents, published patent applications, and other nonpatent publications.

One simple way to conduct continuous monitoring is to set up an ongoing Nerac ("Tech Track") or Dialog ("Alert") search. For a fee, these sites will send weekly, monthly, or quarterly updates of newly issued patents and patent applications found under certain search criteria. Results can be sent in a number of different formats, such as a list of titles and abstracts.

Ideally, a medical device company should designate someone within the company to initially review ongoing prior-art updates. If the designated in-house reviewer finds a potentially troublesome reference, the company's patent attorney can then be consulted. By keeping the initial review process in-house, the company can save attorney's fees. For easy access, the in-house reviewer may wish to organize incoming intellectual property in separate binders for each of the company's competitors.

What to Do with the Information

Once a company completes a prior-art search and continues to monitor new intellectual property, executives should consult qualified patent counsel about how best to evaluate the intellectual property in the company's field. A good patent attorney can interpret the references from both patentability and freedom-to-operate perspectives.

No matter how potentially damning a piece of prior art may first appear, executives should not panic. For example, a U.S. patent application published under 35 USC 122 may have extremely broad claims that appear to exclude any device company from practicing in a given area, but this is only an application and not an issued patent. The PTO will likely force the applicant to narrow the claims extensively before issuing the patent. Additionally, device company executives may be able to force an interference under 35 USC 135(b) if the company invented the technology before the inventors of the published application.

Finally, it is important to remember that no prior-art search or intellectual property–monitoring program is perfect. Patents, applications, journal articles, or other pieces of intellectual property will inevitably be missed. The most a medical device company can do is to perform appropriate searches and stay current.

While having knowledge of the patent landscape is tremendously valuable, it is important that executives work in conjunction with engineers and avoid obsessing over patent issues at the wrong time. Ignorance in this area is not bliss, but it is possible to become so centered on other patents, for example, that time and money that should be used to perfect one's own invention is wasted.

Executives should instead concentrate on developing the best possible product (and their own patents) as their first priority, and only ratchet up their freedom-to-operate concerns as the product design is finalized. It is amazing how often patents that were thought to be major problems during initial development end up being completely irrelevant to a final new medical device product.

References

1. Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. Ltd., 344 F3d 1359 (Fed Cir 2003).

2. MD Barrish and SM Smith, "Patent Defense in Uncertain Times," MX 4, no. 1 (2004): 50–53.

Mark D. Barrish is a partner and practice group leader and Scott M. Smith, MD, is an associate in the medical and mechanical devices group of Townsend and Townsend and Crew LLP (Palo Alto, CA).

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