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ne made an improvement that prove to be more practicable to purchase your patented invention and uses hybridomas from ATCC for research or commercial purposes whether purposes. We suggest that you promote e in a university or not-that is your own sale of hybridomas by publigement of your patent."

cizing their availability to the NIH ree've had correspondence with search community." put have not resolved the issue.' Dellenbaugh replied that each case VIH patent attorney Thomas Fer- should be considered individually, and We don't consider it infringement that a determination should not rest searchers to use cell lines) as long "simply on whether the use is 'experis experimental." In letters to Del- mental.' . . . Since there is) clear ecoigh, NIH patent attorneys have nomic harm to Ortho, the rationale "{We will cooperate in your al- sometimes used for excepting experito enforce your patent nights while mental use from infringement should not : same time recognizing that the sts of the research programs of the NIH recently convened a meeting of I must be paramount, if it should its internal patent board, a group that


Judge Curbs Use of Toxic Shock Data The Push to Protect Patents on Drugs

In a legal victory for the Procter & Gamble Company, a deral judge in St. Louis last month ruled that the deposi. yn of a researcher at the University of Wisconsin cannot : used in a suit against the company because his research as "preliminary." The researcher's findings are said to ok Procter & Gamble's Rely tampon with the production toxin assoriated with toxic shock syndrome. The ruling is the latest development in a continuing legal le over the tata of microbiologist Merlin S. Bergdoll nd its use in court. The controversy has raised questions out access to sensitive research findings during litigation icience, 13 April. p. 132).

The court decision is contrary to an earlier decision by nother federal judge, who allowed the data to be discussed ia trial. A Procter & Gamble spokeswoman characterized ie St. Louis ruling as a strong precedent," while the laintiff's lead attorney, Tom Riley, remarked that the vo decisions "send conflicting signals." The lawsuit as filed by Michael W. Rogers, whose wife allegedly ied of toxic shock syndrome after using Rely tampons in 980.

Bergdoll, with support from Procter & Gamble and other ompanies, has studied the production of toxic shock toxin i tampons since 1980. He has not released or published his ata because he believes his findings are preliminary and conclusive. But lawyers for toxic shock victims point out nat Bergdoll has discussed his findings with the company nd that the company has replicated his findings,

Although Bergdoll and Procter & Gamble have successully fended off many attempts by lawyers to use the data in ourt, a U.S. District judge in Fort Worth ruled in 1983 that he data are admissible as evidence. During that trial, leredoll's data were revealed for the first time in detail by n expert witness for the plaintiffs, who reported that in aboratory tests Bergdoll fount Rely tampons produced nore toxic shock toxin than any other brand of tampon.

Bergdoll still contends that his research is incomplete ind reiterated this point in a deposition in the Rogers case. J.S. District judge James Meredith agreed with Bergdoll ind emphasized the need to protect preliminary research indings in general.

includes patent attorneys and representatives from the various institutes, to consider the policy implications of the letters and has considered making recommendations on these issues to the Department of Health and Human Serv. ices. Currently, NIH is telling researchers to go along the way they are."

Though Johnson & Johnson is not planning legal action to enforce its patent rights, according to Dellenbaugh, "If we decided an example needs to be made of an egregious infringement, we might do it." Hence, Ferris says, no matter what policy is laid down, such issues "ultimately can only be resolved in the courts."-JEFFREY L. Fox

He wrote. “Dr. Bergdoll's research is preliminary in nature; ... it would be misleading to the jury given the inconclusiveness of its nature. [Tju use (Bergdoll's] deposition in this trial would hinder his research efforts as well as other research efforts at universities throughout the coun. try." Furthermore, "(A) release of incomplete data will harm Dr. Bergdoll's professional reputation and impair his ability to complete and publish the final results of his research, efforts. Premature public disclosure of research is not harmful in this case alone, but will have an adverse affect (sic) on research into controversial areas conducted throughout the nation." Meredith ruled that Bergdoll's deposition and documents introduced at the deposition be placed under seal. The case was settled before trial.

Procter & Gamble spokeswoman. Sydney McHugh, said that the ruling was signiñcant because, for the first time, a judge heard Bergdoll himself describe what conclusions could be drawn from his research.

Meredith said that Bergdoll "is not associated with defendants. . . . He denies that his research will assist the jury in this lawsuit. Under the circumstances, his testimony and data will be excluded." Riley, the plaintiff's attor. ney, contends, however, that because Bergdoll receives substantial support from Procter & Gamble, he is not an impartial witness,

Michael Liethen, legal counsel for the University of Wisconsin, who along with Procter & Gamble represented Bergdoll, rejects any suggestion that Bergdoll has been improperly influenced by Procter & Gamble. Liethen says that company money is paid to the university and the university then allots the money to Bergdoll. The company “ought to be congratulated for funding toxic shock research. The federal government doesn't support it. If not for P&G funding, the research wouldn't be done."

Liethen says he is not sure what meaning the St. Louis ruling will have in other cases. “As a practical matter, each case has to be weighed on its own merits. In this case, there was extensive balancing of public and private interests." Given the hundreds of toxic shock lawsuits still pending, the issue of Bergdoll's data and its use in court is far from settled. - MARJORIE SUN

The drug industry nearly won last year, but then the

political winds changed

For nearly 3 years, the pharmaceutical notes that it is taking longer and longer to at only a selected number of drugs and industry has been campaigning for a develop a drug and obtain approval by want a complete list. Although the data change in patent law that would extend the Food and Drug Administration were requested 2 years ago, PMA did not patent protection for drugs and pesti- (FDA). For example, according to PMA submit the information until just last cides. The industry contends that the figures, drugs approved in 1981 lost an week. Waxman and Gore plan to ask the change is needed to redress an injustice: average of 10.2 years of the statutory 17- Office of Technology Assessment to anawhereas patents convey 17 years of ex- year patent lives before their first sale. lyze the data. clusive use on most products, the patent The number of drugs that come on the Opponents call attention to other inlife of drugs is shortened by the time market and are new compounds has re- formation to undercut the PMA's arguconsumed by regulatory review. The in- mained stable. The PMA paper says, "It ments. They point out that industry as a dustry argues that this reform will en- should be a matter of concern that an whole received a 25 percent tax credit on courage innovation and help stave off industry which has quadrupled in size in R & D in 1981. In contrast to industry's increasing foreign competition, by mak- two decades has not been able to afford contention, top selling drugs in 1980 had ing available billions of dollars in new to increase innovation at a comparable a marketing life nearly equal to a 17-year revenues that the industry can spend on rate."

patent term. Opponents also find it diffiriscarch. But the bill's principal effect

cult to believe PMA's statement that an the enrichment of one of the country's

extension of patent terms would do no most profitable industries is also its

economic harm to generic firms." Gemain political liability.

neric firms have been fighting an uphill Just a year ago, legislation that would

battle in the marketplace because the have achieved industry's objectives was

large, established drug companies even on the brink of victory. A bill had passed

dominate generic drug sales. The estabunanimously in the Senate and a similar

lished companies market branded drugs measure was moving easily through the

under the trade name or generic name House. But the political situation has

accompanied by the imprimatur of the changed dramatically in the past few

firm's name, making it difficult for genermonths and now the legislation's future

ic firms to compete. is at best cloudy.

Much of the information that oppoThe chief roadblock is in the House.

nents cite is based on findings in a 1981 Two key legislators, Representatives Al

report by the congressional Office of bert Gore, Jr. (D-Tenn.), and Henry

Technology Assessment (OTA). While Waxman (D-Calif.) strongly oppose the

OTA officials testified before Congress legislation and have been instrumental in

that the report "neither supports nor blocking its passage. However, Waxman

refutes the position that innovation will has introduced a bill designed to aid

increase significantly because of (patent manufacturers of so-called generic

term) extensions," the report played an drugs. He badly wants the legislation Representative Henry Waxman

important role in the downfall of the passed and there is speculation that he

House bill last year. Perhaps most signifmay work out a compromise with sup

A possible wedding of his generic drug bill icantly, it argued that innovation could porters of patent extension to push his with industry's pateni term legislation.

be measured several ways and concludown bill through.

Opponents speculate that the profited that it is not clear whether innovation The industry's case is being pushed by windfall created by patent law reform in the drug industry had indeed declined. the Pharmaceutical Manufacturers Asso- will primarily benefit corporate stock- The report also pointed out various ways ciation (PMA). A PMA briefing paper holders, not researchers or the public. in which a con.pany can protect its prodstates that "lost patent life reduces in- Government figures show that the drug uct. For example, according to Donna centives to invest in drug research, re- industry has consistently spent the same Valtri, assistant project director of the tards the rate of medical innovation, percentage of sales on research and de- report, drug companies, in some inerodes the U.S. competitive position in velopment for several years despite an stances, can secure additional patents on an important high technology, and raises alleged decline in innovation. Critics also a product. She testified at a House hearthe cost of medical care at a time when question the reliability of the industry's ing that in some instances, process palmedical expenditures are a critical na- conclusions. Waxman and Gore, for ex- ents can be n effective means for tional problem."

ample, note that the raw data on which ensuring exclusive market positions." The PMA paper says that the legisla- the industry's argument is based have the report also said it was unclear tion now before Congress is a “simple not been reviewed by independent ana- whether patent extension would give and direct antidote." The measure lysts. The two legislators have repeated companies an incentive to increase rewould give companies an incentive to ly asked PMA for data that may resolve a search in the United States. Valtri points put more money into research and devel- dispute about the real patent lives of out that domestic companies are increasop new and better drugs. The industry drugs. They charge that PMA has looked ingly licensing drugs invented by foreign


Ken Heren

firms and also testing the drugs abroad For the time being, there is a lull in the vehicle that will achieve his goal and that where the cost of labor and rescarch is action. Congressional aides from the of the drug industry. cheaper.

Senate and the House say there is not For several years, Waxman has chamIn August 1982 the PMA was almost likely to be much movement on the issue pioned the need for generic drugs and, in sure that patent extension legislation until the new year and even then, it is July, introduced legislation that is dewould pass Congress. The House Judi- hard to say what will happen. The OTA signed to encourage their production and ciary Committee had already approved a analysis of the industry data, which were reduce the cost of drugs for the consumbill. The measure went before the Rules recently submitted to Waxman and er. In essence the bill would make it Committee where, according to a count Gore, could also delay legislative action. much easier for generic companies to by PMA, a majority of committee mem- But PMA is still hopeful and has contin- copy drugs whose patents have expired. bers favored the proposal. Furthermore, ued to push the issue hard. Association The bill, however, has not gone far in the the bill had the backing of the Reagan staff members have blirzed 140 newspa- House. To ease the bill's passage, WaxAdministration and a battalion of other pers around the country with packets of man is now talking with PMA to see if groups, including the American Bar As- information about the bills and have there is a way to combine his wish list sociation, the Chemical Manufacturers criss-crossed the nation to meet with with theirs. Association, the U.S. Chamber of Com- editors of 75 of the newspapers.

Waxman's bill addresses a gap in FDA merce, the American Heart Association, Identical bills, similar to last year's policy that has constrained the producnumerous professional medical socie- legislation, have been reintroduced in tion of a wider variety of generic drugs. ties, and several universities such as both chambers. They would extend pal- The agency imposes few restrictions on Massachusetts Institute of Technology. ent protection to drugs and pesticides for generic drugs that were approved before

But Richard Bolling, former Democrat a period equivalent to the time the prod- 1962. (In 1962, FDA reformed its drug from Missouri, who was then chairman ucts are filed or registered with the feder. regulations and required drugs to be not of the Rules Committee, opposed the bill al government and undergo agency re- only safe but effective.) In effect. generic and refused to bring it up for a vote. The view before approval. The legislation companies do not need to conduct PMA, confident that it had overwhelm

lengthy clinical trials to again prove the ing support, circumvented the Rules

safety and effectiveness of an old drug. Committee by having the bill brought to Patent term legislation

But FDA treats off-patent drugs apthe floor under the suspension rule. The

has become a particularly

proved after 1962 much differently. The rule is designed to assure the passage of

agency says that to duplicate post-1962 noncontroversial bills and requires the

sensitive issue in an

drugs, a generic company must either approval of a two-thirds inajomny. But election year because conduct clinical trials or submit data shortly before the floor vote, the political

opponents now include from scientific journals that show the environment changed.

duplicate drug is safe and effective. GeThe New York Times reversed its posi

organizations such as the

neric companies have problems meeting tion on the bill and, in an editorial that


either requirement because the firms, relied heavily on the OTA report, de

which frequently are small, cannot afford nounced the measure as “unjustified,

the research and because studies on patunsuited to the stated purpose of increas- limits the extension to 7 years beyond ented drugs are usually considered proing research, and offensive to the basic the patent expiration date.

prietary information and are not reported principle of a free economy." Gore and Fowlkes predicts that the bill will in the scientific literature. Waxman circulated the editorial to all again pass easily in the Senate. Accord- Waxman's bill would eliminate the disHouse members. Shortly thereafter, ing to a staff aide to the Senate judiciary tinction between the pre- and post-1962 Congress Watch, a Ralph Nader group, subcommittee on patents, copyrights, drugs. Fowlkes says that PMA has no released a report, "Sugar Coating a Mo- and trademarks, the bill may be marked problem with the concept provided that nopoly, A Study of the Drug Patent up by the subcommittee some time in the drugs have adequate patent protecRestoration Act." The manufacturers of November. Again, the biggest hurdle tion before they are duplicated by the generic drugs lobbied legislators that a will be in the House where the situation generic companies. PMA in fact submitvote for the bill was a vote against the has become very complex.

led a draft bill to Waxman in September consumer. The legislation lost by four Although the House bill was intro which sandwiched together proposals for votes.

duced in June, a judiciary subcommittee generic drug production and parent resFrank Fowlkes, PMA vice president has not yet held hearings on it. Subcom. toration. But Waxman rejected the entire of communications, said in a recent in- mittee chairman Robert Kastenmeier proposal because it was so lopsided in terview, "The Times editorial hurt a (D Wis.), who sponsored patent exten- favor of PMA members. That Waxman whole lot." The combination of the edi- sion legislation last year, is opposed to even entertained a draft proposal from torial and the Nader report "scared this year's version of the bill which PMA has led some observers of the fray enough fence-sitters who were up for would allow a greater number of drugs to to venture that some sort of compromise reelection that the bill was anti-consum- qualify for the extension. Gore is still might eventually be struck. er." fighting the legislation.

Waxman's bill may be complicated by Now the drug industry. so close to Al present, attention is focused mainly an FDA proposal that is now before victory last year, finds itself on the de- on Waxman. He has been a formidable Margaret Heckler. Secretary of Health fensive and trying to win back support. foe of patent extension. Fowlkes said, and Human Services. Like PMA's bill, ers. The issue has become particularly "We didn't anticipate that Waxman the FDA proposal contains provisions on sensitive in an election year because would make the legislation a do-or-die generic drug production and patent ex. opponents of current legislation now in- issue like he did." But it may be Wax. tension. clude the American Association of Re- man, a master of compromise and politi- The plan would provide more encour tired Persons and the AFL-CIO.

cal tactic, who will provide a legislative agement than PMA's draft bill for the Although it appears that all the parties applies to FDA for permission to begin involved are at loggerheads, there may marketing the drug. The consumer group be room for compromise. Some oppo- argues that this is actually the period nents of patent extension, such as Public when a drug undergoes federal review. Citizen Litigation Group, have suggested This period would add perhaps 2 years, a modest form of patent extension that far fewer than the time allotted by the even PMA says would be better than draft legislation. A House aide involved nothing. PMA's best hope is that the in the issue said that the shorter way of period of patent extension would be measuring the patent extension is a measured from the date when a company major improvement" over the current applies to FDA 10 begin clinical trials to legislation. Nevertheless, according to the date when the drug is approved. this aide and others, Gore and Waxman Public Citizen has proposed that the still believe that the drug industry has yet clock start running when a company to prove its case.-MARJORIE SUN

production of generic drugs, but not as much as Waxman's legislation. The main potential problem with the proposal is that it attempts to extend the patent life of drugs by an administrative ruling rather than through legislative change in patent law. The plan would guarantee that drugs could not be duplicated generically for up to 15 years after FDA approval. Al a hearing in August, Waxman challenged FDA's authority to carry out the proposal and the measure would almost certainly be challenged in court if approved by Heckler

World Model for the Joint Chiefs

The Joint Chiefs of Staff (JCS) are getting a new toy that should make other government agencies green with envy: a computerized global model of political, resource, and social data that represents a step toward catching up with private sector capacities.

The system, called FORECASTS, is in its second year of development, at a cost of $1.2 million. It will be tested for 6 months by the Army Corps of Engineers before the Joint Chiefs get it next year. The primary reason for the acquisition is to help the JCS make their 4-year Joint Long Range Strategic Appraisai, a new exercise, started in 1980, to evaluate global and national trends up to 30 years hence. The services, which do their own appraisals, will also be using the model.

For several years the JCS has had the use of the World Integrated Model (WIM), FORECASTS' predecessor. But the new one goes far beyond WIM, according to Patricia G. Strauch, president of Prospective Decision Models, Inc., the contractor WIM, which is in use in several other government agencies, has a much smaller data base, it divides the world by multination regions, and contains little information on such critical areas as the environment,

Unlike WIM, which is designed for long-range projections, FORECASTS has three modes of operation: a data base covering the years 1960 to 1980, short-range statistical procedures for extrapolations up to 5 years, and a longrange program which contains complex feedback and interactive capacities for projections up to 30 years in the future.

While most global models divide the world into regions or sectors (such as agriculture), FORECASTS can present data on a national as well as a regional basis. The vastly expanded data base contains information on vital characteristics ranging from land use to international political agreements. There is a new "political stability" module capable of being decoupled if security demands it. The model contains extensive detail on population, including sex, fertility, employment, urban-rural distribution, and migration, as well as social, religious, and linguistic subdivisions

In recognition of the discontinuities that mark the present and probable future, says Strauch, a fundamental premise of the model is that 'the past won't repeat itself." In facilitating economic analysis, for example, designers of

the model place reliance on detailed data about humanresource interactions rather than building in traditional and now.dubious assumptions about the causes and effects of inflation or unemployment.

Knowing the capacities of the new system does not answer questions about how it will be used. What sort of questions, for example, is it uniquely equipped to address? Colonel James Edgar of the JCS submits that it would be interesting to know if 20 years ago FORECASTS could have cued analysts in to the emergence of the Middle East as the world's energy fulcrum. It might also be asked whether the model will be used by the military to reinforce prior assumptions, or whether it will result in the introduction of a greater variety of nonmilitary, nonpolitical factors and a keener awareness of global interdependencies into defense analyses. Says Mihajlo Mesarovic of Case Western Reserve University, who developed WIM: "Using strategic planning models is absolutely essential in analysis of long-term policies, but in the hands of people without insight into future options it would be grossly misleading and dangerous to use-like a gun."

It would be interesting to speculate how this capability might alter the relation of the defense establishment to the Central Intelligence Agency and the State Department when it comes to assessing long-range political trends. State, in particular, is deeply attached to traditional ways and, says an official, tends to think of long-range planning as "anything over 6 months." Gerald O. Barney, who headed President Carter's Global 2000 effort, says the department has “very little expertise in the use of models" and little interest in them. Yet, he asserts, they are “ultimately going to have a big impact on the way foreign policy is formulated."

Comprehensive attempts at global modeling, starting with Limits to Growth in 1972, are often associated with "gloom and doom" visions of the world's future (Science, 22. July, p. 341). The White House, for example, has criticized calls for a centralized "foresight" capability as being motivated by an anti-free market, progovernment intervention ideology. Perhaps, then, the most significant contribution of FORECASTS will be to decouple global modeling from ideology and present it as a valuable tool in a world where some mistakes have become too costly to make.-CONSTANCE HOLDEN

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In a patent infringement suit, the patentee who considers preliminary injunctive relief has traditionally not pursued such relief. Rather, the patentee customarily seeks the final remedies at trial of a permanent injunction and the recovery of money damages. This bas been true even though the actual injury to the patentee cannot be adequately compensated for in money damages.

The authors are of the opinion that seeking preliminary relief may well be an “overlooked” remedy that is ill-known, clouded with uncertainties and, therefore, seldom employed, or, on the other hand, improperly pursued. In Teledyne Industries, Inc., v. Windmere Prod ucts, Inc., the authors' firm successfully pursued an award of preliminary relief to enjoin the infringement of three young patents. The entire prosecution lasted only seven months and resulted in a settlement of the case after the award. Had traditional litigation to the merits ensued, there is no doubt that many years of expensive litigation would have transpired.

The favorable comments received after the Teledyne case prompted the authors to further investigate the award of preliminary injunctions in patent infringement cases. It was readily apparent that little had been written on this topic. The purpose of this paper, there.

1 433 F. Supp. 710, 195 U.S.P.Q. 354 (S.D. Fla. 1977). Teledyne manufactures and markets a wall mounted adjustable showerhead known as the “Water Pik SHOWER MASSAGE". Teledyne was awarded a preliminary injunction which prohibited Windmere from importing and marketing a device similar in appearance which contained virtually identical parts. 2 At the date of the decision the patents stood as follows:

1. Patent 3,762,648: age 4 years (issued 10/2/73).
2. Patent 3,801,019: age 3 years (issued 4/2/74).

3. Patent 3,958,756: age 1 year (issued 3/25/76). 83 Robinson, The Law of Patents for Useful Inventions (1890); P.D. Rosenberg, Patent Law Fundamentals (1975); R.A. White, Patent Litigation: Procedure and Tactics (1977); Latman, Preliminary Injunctions in Patent, Trademark and copyright Cases, 60 Trademark Rptr. 506 (1970); Pravel and Hewitt, Preliminary Injunctions in Patent, Trademark, Copyright and Unfair Competition Ca868, Patent Law Annual (1973); Schwartz, Injunctive Relief in Patent Infringment Suits, 112 U. Penn. L. Rev. 1025 (1964).

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