Biotechnology Patent Boom Offers Career Opportunities For Scientists

Opportunities For Scientists The number of biotechnology patent applications filed in the United States has grown about 10 percent per year since 1990, reaching 15,600 for fiscal 1995. In contrast, the total number of patent applications has risen only about 2 percent annually. As the U.S. Patent and Trademark Office (USPTO) scrambles to find qualified examiners to analyze and rule on the patentability of these biotech inventions, scientists in genetics, immunology, molecular biology, and related fields are finding a lucrative niche. CLEARER GUIDELINES: Tom DesRosier notes the "utility" rejections are less common since USPTO commissioner met with industry representatives in 1994. USPTO, headquartered in Arlington, Va., has hired a growing number of scientists as patent examiners in Group 1800, the unit that handles biotechnology patent applications. Since last fall, USPTO has employed 50 scientists in examiner positions, according to John Doll, director of Group 1800. He hopes to hire another 25 before the fiscal year ends, and then 50 to 75 more next year. Candidates are found through USPTO-sponsored job fairs in the Washington, D.C., area, as well as on recruiting trips to selected universities around the country. In many cases, scientists at other federal agencies learn about patent examining by word of mouth. "Our new hires are mostly Ph.D. [scientists]," says Doll. At last count, Group 1800 had 175 examiners, he reports. Of these, 120 hold Ph.D. degrees, and many have postdoctoral experience. Another 36 biotechnology examiners have master's degrees, 17 have law degrees, and 14 have bachelor's degrees. Examining biotechnology patents requires sophisticated scientific knowledge. However, that expertise is applied differently from the way it is in other scientific endeavors, says Doll. The scientific skepticism proper in the peer review of a journal article or grant proposal is replaced by a law-based review. The biotech patent examiner joins scientific understanding and the appropriate legal standards to determine whether the technology described in an application is new, unobvious, useful, and "enabled," meaning that someone should be able to reproduce the invention from the description published when the patent is issued. James Martinell recalls that working as an examiner was "a little scary at first. It is very different from lab work." A senior-level patent examiner in Group 1800, Martinell joined the office in 1981. Before that, he earned a Ph.D. in biology from Wesleyan University in Middletown, Conn., and did postdoctoral research at the National Institutes of Health. An examiner decides whether an invention deserves a patent primarily by reading and analyzing the inventor's claims as stated in the application and by comparing the invention with "prior art," or similar existing technology, says Martinell. Examiners spend from a few hours to several days digging into commercial database records, the USPTO patent database, and foreign patent records. If the invention includes DNA or proteins, the examiner must do a search of online sequence data for previous reports of molecules like those in the invention. "The main scientific qualification [examiners] need is to be able to read the scientific literature," Martinell offers. He adds that much of the job is like being a perpetual student: "That's why it helps to have [examiners] with an advanced degree or with direct laboratory experience. It helps if you can see in your mind the steps someone goes through in the lab to create the invention described in the application." Resources for Patent Examiners American Intellectual Property Law Association (AIPLA) 2001 Jefferson Davis Highway, Suite 203 Arlington, Va. 22202 (703) 415-0780 Fax: (703) 415-0786 World Wide Web: http://www.aipla.org President: Don Martens 10,000 members AIPLA is a professional association of attorneys specializing in the practice of intellectual property law. Patent examiners with law degrees are eligible for membership in this organization. Patent and Trademark Office Society (PTOS) P.O. Box 2089 Arlington, Va. 22202 (Contact by mail only.) World Wide Web: Site in preparation President: Elizabeth Dougherty 2,000 members Journal: Journal of the Patent and Trademark Society PTOS sponsors professional programs and social events for members. The society also supports a liaison to the United States Congress and a committee that follows legislative issues and prepares testimony. Patent Office Professional Association (POPA) P.O. Box 2745 Arlington, Va. 22202 Phone and fax: (703) 305-3000 President: Ronald Stern 2,200 members POPA is the labor union that represents patent office professionals, not including management and those working in the trademarks area. In addition to negotiating on behalf of these employees, POPA lobbies Congress on issues important to members. The examiner decides whether the inventor's claims meet the new, unobvious, useful, and enabled tests and produces a "first action"-the written evaluation of an invention stating where it falls short in patentability. The applicant then can modify or drop claims to the examiner's satisfaction, or file a response that outlines why the examiner's rejections should be overturned, Martinell explains. The applicant's responses often follow face-to-face consultations with the examiner, notes Martinell. "They [attorneys] will frequently bring in the inventors, and you get your own little seminar. I've had Nobel Prize winners come to talk to me." The examiner's work on any single case is completed in short bursts of activity stretching over 18 months to several years, he explains. Consequently, several patent cases at various stages of completion may be active at once. One examiner is likely to take actions on several hundred cases in a year. "If you're curious, [patent examining] can be a lot of fun," he comments. "But like any real job, it has its moments when there is some tedium." Examiners face deadline and productivity pressure. Good writing skills are also important, since an examiner must produce a document making a clear, reasonable case for or against patentability. "It can be hard for perfectionists," Martinell continues. "You want to do a good job, but it also has to be completed at some point." Working with the applicant to hammer out the exact wording of what the patent will cover is as important as making the initial scientific determination about an invention's uniqueness. "The best examiners have the combination of scientific ability and negotiation skill," states Richard Schwartz, a biotechnology practice specialist in Group 1800. However, according to Schwartz, "there's room for a lot of different styles" in how examiners go about their work and interact with applicants and their attorneys. Some examiners favor face-to-face encounters, while others "clam up" during interviews and rely on written communication, he says. Each case concludes in one of three ways: a patent is issued; the inventor abandons the application; or the examiner rejects the invention as unpatentable, a decision the applicant can dispute before the USPTO Board of Appeals or federal court. The examiner's power to make or break an invention has at times been a sore point in the biotechnology industry, although things are changing for the better, according to Charles Ludlam, vice president for government relations for the Washington, D.C.-based Biotechnology Industry Organization. For example, a few years ago some examiners were rejecting inventions for failing a usefulness test. In such cases, inventors might want to patent a new biotech process that can synthesize a protein with therapeutic potential. Some examiners wanted proof of the protein's value before allowing a patent on the synthesis process, although evaluating therapeutic efficacy falls to the U.S. Food and Drug Administration. USPTO Commissioner Bruce Lehman met with biotechnology industry representatives in 1994 and agreed that the examiner corps needed clearer guidelines to distinguish legal standards of patentability and drug approval issues. Today, these so-called utility rejections are much less common, says Tom DesRosier, vice president and chief patent counsel for Genetics Institute Inc. of Cambridge, Mass. "Since Commissioner Lehman took over the patent office [in 1993], he has instilled in the corps-particularly in the biotechnology area-that their job is to issue patents. They [USPTO] have done a good job educating patent examiners in the law." Doll explains that he has tried to instill a "positive attitude" among Group 1800 examiners toward patent applicants. He likes to remind examiners that many biotechnology companies don't have products to sell, so the potential embedded in a patented technology often becomes the basis of a firm's value in the eyes of investors. Training emphasizes that the examiner should focus on telling the applicant all that is "allowable," or eligible for a patent, rather than on finding fault in the application. Doll has gone so far as to post a "motto" for Group 1800: "It's your job to help [the] applicant to get a patent." 'A MONUMENTAL TASK': Intellectual-property lawyer Cathryn Campbell sympathizes with patent examiners. Cathryn Campbell, partner in the San Diego-based intellectual property law firm Campbell and Flores, says the biotechnology examiners of today have much greater understanding of science than the examiners from the early 1980s. "The good thing about this is that we [attorneys] don't have to educate the examiners about the technology. The bad thing is that they often don't know the law well enough and may take positions that are not consistent with patent law," such as the inappropriate utility rejections issued by some biotech examiners. Doll acknowledges that USPTO works hard to make sure the biotech examiners learn and apply patent law and procedure properly. New hires begin their jobs with several weeks at the Patent Academy run by USPTO. Then it's back to the unit to analyze applications under the guidance of experienced examiners. More training sessions are scheduled throughout the first year. "It takes a good year [for an examiner] to be semi-functional on a consistent basis," says Schwartz. For new examiners who stick with the job, the pay and promotion schedules are attractive. Examiners in Group 1800 are assigned to "complex" or "classical" pay schedules, depending on the technical knowledge required to handle assignments. In the complex area, examiners typically hold Ph.D.'s and work on inventions that involve recombinant DNA technology. The classical examiners may have bachelor's and master's degrees; the technology they review relies on nonrecombinant microbiological techniques such as standard fermentation methods. A Ph.D. scientist who joins the examiner corps in a complex area starts at $45,000. Promotions can boost pay to nearly $67,000 in about four years. "The vast majority of examiners do progress at that rate," says Doll. "In fact, it's management's job to see that they do." The top rate for biotech examiners on the complex scale is $95,000. To reach this level, a good 10 years of experience is usually required. On the classical examiner pay scale, an entering Ph.D. starts at $37,000, and earns about $62,500 after four years. With a bachelor's degree, an examiner starts at $25,000; with a master's, starting pay is $30,700. Advancement is explicitly linked to the number of cases an examiner ushers through the examination process each quarter. The goals put a premium on efficiency, USPTO officials acknowledge, although work quality is also evaluated. "I'm very sympathetic to the examiner," comments attorney Campbell. "To read an application and understand it, and then write a response [within the quota's allotted time for a case], that's just a monumental task." Productivity goals vary by subject area and are based on the average time required to complete cases. Examiners receive biweekly reports on progress toward their goals. Examiners who fall short get help from management, says Doll, but will be fired if improvement doesn't come. Those who surpass their goals while doing outstanding-quality work receive cash bonuses that can go as high as 10.5 percent of salary. Career advancement opportunities are plentiful for patent examiners. For those who want to remain close to examining, there are supervisory and administrative positions in USPTO as well as positions on the Board of Appeals, which decides patent disputes. Other examiners become "registered" patent agents, nonlawyers who represent inventors in dealing with USPTO. CAREER CHANGE: Biophysics Ph.D. Greg Hook, formerly a patent examiner, is now a patent attorney. Some examiners take advantage of USPTO's 60-percent tuition-reimbursement policy and attend law school at night. A law degree combined with experience at USPTO can be the ticket to a whole new career. Examiners who hold Ph.D.'s often find positions at law firms and companies that need scientists who understand patent law and the workings of the patent office. Greg Hook, an attorney for Campbell and Flores, applied to become a USPTO examiner to take advantage of the agency's law school program. He has a Ph.D. in biophysics and did research at the National Institutes of Health and Johns Hopkins University before joining the patent office. Although Hook always intended to leave patent examining for private practice, he has positive feelings about the profession. "I think that people who like to learn about technology will enjoy the job. And you get to learn about the law, and that can be stimulating, too," he says. Lee Katterman, a writer based in Ann Arbor, Mich., is editor of Research News, a publication of the University of Michigan.

Biotechnology Patent Boom Offers Career Opportunities For Scientists

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