Patti M Tereskerz

Infected Physicians and Invasive Procedures: National Policy and Legal Reality

Recent reports of the transmission of hepatitis B, hepatitis C, and HIV from physicians to patients during invasive procedures have again raised the question of whether physicians infected with bloodborne pathogens should perform invasive procedures that place patients at risk, and if so, under what conditions. Attempts to formulate a national policy on this subject must consider the competing interests of the patients welfare versus the physicians livelihood. A review of the legal aspects of this topic is provided to assist policy makers and to serve as a foundation for the recommended establishment of a multidisciplinary committee to develop a uniform national policy. Both legal and medical realities call for the formulation of a clear policy to guide those who must make the decisions on this issue.

RISK OF HIV-1 INFECTION AFTER HUMAN BITES

THE FIRST DOCUMENTED SEROCONVERSION OF HIV-1 FOLLOWing a human bite1 raises an important concern regarding occupational transmission of HIV from patient to health care worker. The HIV seroconversion described [in The Lancet article “Transmission of HIV-1 by human bite”] suggests that for HIV-1 transmission to occur, there must be blood in the mouth of the source patient and a break in the integrity of the skin of the health care worker. Seventy-four hospitals in the U.S. participating in the Exposure Prevention Information Network (EPINet) report their employees’ occupational percutaneous injuries and exposures to blood or body fluids to researchers at the University of Virginia. A review of EPINet data from 1993 to 1995 was conducted to determine the rate of bite exposures in health care workers and the frequency of associated risk factors that might increase occupational infection risk. There were no occupational HIV-1 seroconversions in participating hospitals, and 50/70 (71%) hospitals reported that overall 1.7% of exposures involved an HIV-1-positive source patient. Fifty (.5%) of 10,125 total incidents involved a health care worker who was bitten by a patient, an annual rate of 0.12 reported bites per 100 occupied hospital beds. Based on 518,400 occupied U.S. hospital beds, this yields an estimated annual total of 622 reported bite exposures in U.S. hospitals. The job categories and locations of bites are shown in the table below. Nineteen of the 50 bites (38%) involved non-intact skin or a percutaneous injury to the health care worker. Information concerning presence of blood in the source patient’s mouth was available for 36 of the 50 cases. Of these, blood was noted in three cases of exposure to intact skin and in none of the cases in which there was a break in the integrity of the skin. In contrast to the case reported [in The Lancet1], of the 28 incidents in which descriptions of the bites were available, none involved an involuntary bite as might occur during a seizure. In the 28 cases, 14 source patients were combative, ten were children, three were psychiatric patients, and one involved the removal of an orthodontic appliance. These data show that occupational bites are fairly infrequent. Nevertheless, because 86% of bites were to the hands and arms of health care workers, the frequency of these exposures can be minimized by consistent glove use and arm protection when health care workers are in close contact with pediatric, psychiatric, or combative patients.

Changing patent strategies: what will they mean for the industry?

Could the decline in DNA-based patent applications actually increase the potential for an anticommons effect?

Empirical analysis of major stem cell patent cases: the role of universities

325 inquiry. On appeal, the US Court of Appeals for the Federal Circuit reversed the decision and remanded the case. Duke’s petition to the Supreme Court seeking review of the Federal Circuit’s decision was denied11. The Federal Circuit held that the experimental-use exemption for patent infringement does not apply to research that furthers universities’ “business objectives,” including research and educating and enlightening students and faculty. The court held that “so long as the act is in furtherance of the alleged infringer’s legitimate business and is not solely for amusement, to satisfy idle curiosity or for strictly philosophical inquiry, the act does not qualify for the very narrow and strictly limited experimental-use defense”9. Moreover, the profit or nonprofit status of the user is not relevant. Thus, the court found that the experimental-use exception should not insulate commercial research from claims of patent infringement. This applied to Duke University, which, as Judge Gajarsa noted, was “not shy in pursuing an aggressive patent licensing program from which it derives a not insubstantial revenue stream”9. The FTC and NRC reports question whether the absence of an observed anticommons is associated with researchers’ lack of knowledge about the Madey decision6–8. As more researchers and their institutions become more knowledgeable about the potential for patent violations following Madey, they, as well as private industry, may become more litigious in protecting their intellectual property rights, allowing an anticommons to emerge. We studied stem cell patents to determine the rate of litigation of such patents, to describe that litigation and to determine if it has, in fact, been increasing since Madey. We chose to study stem cell patent litigation industry is unable to innovate and successfully commercialize new products. Moreover, the risk of being sued for patent violation has now become a major concern to universities since Madey v. Duke University9. John Madey was a laboratory director at Duke University who received two patents related to free electron laser technology. After internal disagreements, Duke removed him as a director but continued to use his patents. Madey sued, claiming patent infringement. The district court dismissed his claim based on the common law experimental-use doctrine10 or the idea that infringement is acceptable when done to satisfy “philosophical” or scientific inquiry. The experimental-use exemption was articulated in 1813 by Judge Story10, who used the term “philosophical” instead of “scientific” to describe the experimentaluse exemption from patent infringement. The essential component of the court’s reasoning was that those skilled in such “useful arts” are free to use the knowledge imparted by a patent disclosure for amusement, to satisfy idle curiosity or for strictly philosophical It has been theorized1,2 that litigation is an important contributor to the concept of the anti-commons, which occurs when multiple owners hold the right to exclude each other from a scarce resource, so that no one holds an effective right of entry and underuse of the resource results3. This may occur with royalty stacking, where an inventor must obtain multiple licenses to commercialize a product. If this activity is leading to an anti-commons, then, is the multitude of patents that has been granted actually inhibiting, rather than facilitating, the transfer of technology3? Patent litigation and the strategies firms follow to protect themselves from the risk of litigation (e.g., defensive patenting by enlarging a firm’s portfolio of patents to influence settlement terms or foregoing otherwise valuable research because of the risk of litigation)4 generate costs that may divert resources away from innovative activities, or make subsequent commercialization no longer feasible or more costly. Thus, litigation and strategies to avoid litigation can be seen as contributing to an anti-commons. The perception that a large amount of litigation is occurring is one point advocates use to justify patent reform. For example, the 110th Senate Judiciary Committee’s Report on the Patent Reform Act of 2007 warns that excessive litigation creates costs for industry participants5. This notion derives from reports by the Federal Trade Commission (FTC) and the National Research Council (NRC)6–8 that warn of dire consequences if Empirical analysis of major stem cell patent cases: the role of universities

DNA-based patents: an empirical analysis

The perception of rising litigation rates is driving the push for patent reform.

Human DNA patent renewals on the decline

The universe of human DNA patents may not be as large as previously anticipated if patent holders are not renewing their patents.

Patent reform in the United States.

Abstract The recent financial meltdown has muted the patent reform debate in the United States. But given that President Obama, as well as many members of Congress, support patent reform, we expect the debate to resurface. In this essay, we look carefully at reports from three prestigious organizations which have been enormously influential in the debate. We examine the empirical basis contained in these reports upon which proposed legislative changes are based. We conclude that the empirical data being used to justify the need for reform either has serious methodological limitations or is non-existent. Moreover, we review recent court decisions which have already altered the patent environment calling into further question whether the limited data that exists is still applicable. The effect of these recent decisions has not been adequately evaluated or assessed. Thus, we recommend other empirical studies are needed to inform public policy as to whether patent reform is necessary.

Projecting human DNA patent numbers.

In the News Focus story “The human genome (patent) project” (4 February, p. [530][1]), S. Kean focuses on the concern that large numbers of human gene patents and assignees holding these patents can block or have a chilling effect on commercialization. We believe that Kean may have overstated