The big patent news in October 2001 was CIPRO. Perhaps it started when NBC Nightly News anchor Tom Brokaw held a bottle of the antibiotic to the camera and said, "In Cipro we trust." Patent things got interesting when Senator Charles Schumer, (D-NY) proposed on October 16 that the government buy generic versions of CIPRO, (ciprofloxican), for its emergency stockpile. He said this would both reduce reliance on a sole supplier and could significantly reduce costs. The next day, on Oct. 17, Health and Human Services Secretary Tommy Thompson (formerly the Republican governor of Wisconsin), stated that the United States was talking to German drugmaker Bayer AG about relaxing its patent on CIPRO, which has become the drug of choice for those worried about anthrax. n2 On October 17, the AP ran a story which touched on the somewhat contradictory position of the United States as to the patent issue. n3 Although the U.S. was taking a potentially "anti-patent" stance as to CIPRO, the U.S. previously had made a formal complaint to the WTO over clauses in Brazil's patent laws which it believed hurt American companies. The complaint had been dropped earlier in 2001. In the AP article, Bradley Tusk (spokesman for Senator Schumer) said the FDA's plans to approve labeling of other antibiotics for treating exposure to anthrax is a step in the right direction, but "when you have a crisis you need to have access to every source of medicine available." Also in the article, James Love, director of the Consumer Project on Technology, stated that U.S. law allows for patent infringement as long as the patent holder is compensated. Love noted the World Trade Organization also allows governments to ignore patents if there is a public health emergency, which was of course the position of Brazil and certain African countries. On October 19, Canada decided to override the Bayer patent on CIPRO and ordered one million generic tablets. On October 23, after Bayer provided 200,000 free Cipro tablets for front-line workers and had promised to deliver more for $ 1.30 per pill within two days of an attack, Canada reversed its position. If the German-based company can't deliver, then Health Canada would be free to use its stockpiled generic drug. n4 Also on October 23, Health and Human Services Secretary Tommy Thompson said that he was prepared to go to Congress to seek a generic version of an antibiotic used to treat anthrax infection if the manufacturer did not lower its price. "The price is the question, not the supply," he told a congressional hearing. Also on October 23, ABC news reported: "But as health officials scramble for supplies of antibiotics to treat anthrax, the maker of the now-infamous Ciprofloxacin has had its ethics questioned over whether or not it's appropriate to protect its drug-making recipes in a potential crisis." John C. Rother, director of legislation and public policy of AARP was quoted: "This is a situation where the national interest is so clear that I think it will outweigh the normal business process. There is a public interest in having more public suppliers and more of the product readily available." Rother was further quoted: "Have they abused their patent situation and has the price tag been inappropriately high? People haven't asked that yet because they've been so concerned with getting the drug, but I think in the long run it will become clear that they have." n5 On October 24, Bayer stated that an announcement of a deal with the U.S. would be forthcoming, which was later noted to be that Bayer would sell the government 100 million pills at 95 cents each, a cost of $ 95 million. This reflects a drop of $ 82 million from Bayer's original price of $1.77 a pill.
On October 25, AP ran an analytical story n6 which included the text: "While these are extraordinary times, analysts see a potential backlash in future matters such as a prescription drug benefit for the elderly now that a branded firm has been forced to make a deal with the government. Ira Loss of independent research firm Washington Analysis was quoted: "This illustrates why the drug companies are apoplectic about a prescription drug benefit for the elderly where the government is a key buyer. The government has a lot of power to bring price down. And if they were doing that on drugs for Medicare through direct purchasing, it would not be a good thing for the the drug industry." An extreme anti-patent position was expressed by Tom Sobol, a partner at San Francisco-based law firm Lieff Cabraser Heimann & Bernstein: "Why shouldn't the government get the pills for the pennies and nickels it costs to make them?" Sobol is part of a coalition that on Oct. 25 joined an existing lawsuit against Bayer over deals keeping cheaper generic versions of Cipro from the market.
On October 26, the Washington Post n7 highlighted the contradictory position of the U.S.: "Amid its own efforts to obtain cheap supplies of CIPRO to fight the anthrax threat, the Bush administration is battling to keep Brazil and other developing countries from securing broad rights to override patents and lower the prices of drugs for treating AIDS and other illnesses. The dispute is raging at the World Trade Organization and poses a serious threat to reaching agreement on the launch of new global trade negotiations at a major WTO meeting scheduled for Nov. 9 to 13 in Doha, Qatar." Also on October 26, the AP carried a story which touched on potential antitrust issues: "The Boston-based Prescription Access Litigation represents 14 advocacy groups that filed the lawsuit in the Eastern District of New York in Brooklyn to declare illegal Bayer's agreements with Barr Laboratories; Rugby, a division of Watson Laboratories; and Hoeschst-Marion-Roussel, part of Aventis. Bayer has paid $200 million to the companies who had been seeking to bring generic versions of Cipro to the market. Barr and Bayer were set to go to trial over the Cipro patent in 1997, but reached an out-of-court settlement in which Barr receives $30 million a year from Bayer." On October 29, Bayer AG said it expected the United States to honour its agreement with the German company to recommend use of its CIPRO antibiotic in the early stages of anthrax treatment. Oddly, on October 29, doxycycline was made available to the U.S. Supreme Court and staff. n8 On November 2, AP writer Theresa Agovino noted: "Poor countries are accusing the United States of applying a double standard to the already contentious issue of pharmaceutical patents in a clash that will likely dominate international trade talks next week."
IN PASSING
One year has elapsed since the writing of "Patents at the Millennium: A Christmas Carol or Bleak House?" (IPT, pp. 42-43, Dec. 2000). Therein, we discussed, among other things, the prophetic book "The Coming Internet Depression," by Michael J. Mandel, buckyballs, and diamond films. Richard K. Lyon's invention on laser isotope separation, related to earlier work by Jean Robieux, was developed at Exxon's Corporate Research Labs and led to an interaction of Richard E. Smalley with Exxon, that led to Exxon buying a certain machine from Professor Smalley, that led to Exxon's identification of C60, that led to Smalley's recognition of the buckyball. Of diamond films, we note that on June 29, 1989 at the Biennial Carbon Conference held at Penn State, B. Spitsyn presented a plenary talk "Chemical Crystallization of Diamond from the Activated Gas Phase," which described the early Russian work on synthetic diamond that was ignored by American workers. Hamilton Township, New Jersey received publicity as the location of the postal distribution center for some of the earliest anthrax-tainted letters, including those sent to Tom Brokaw and Senate Majority Leader Tom Daschle. By November 6, there were plans to sanitize about a half-million pieces of unsorted, potentially-contaminated mail from the Hamilton center by means of electron beams. The saga of the cars of Hamilton Township continues. The earlier position that the cars had been there "for four years" (for example, see the New York Times, Section 14NJ, p. 5, March 4, 2001) has now diminished to "at least two years". Separately, the New Jersey Tort Claims Act appears to offer greater complexity than patent law, such that a convolution of the notice provision is offered as a defense to the taking, in spite of text from DeBlasio v. Zoning Bd. of Adjustment, 53 F.3d 592 (CA3 1995) ["Because DeBlasio has asserted intentional tort claims, the notice provisions of the NJTCA do not apply and it was error for the district court to apply them."] and from text in Greenway Development v. Borough of Paramus, 750 A.2d 764, 769 (N.J. 2000).
ENDNOTES
n1 The views expressed are solely those of the author. The text herein is designed to foster academic discussion, and should not be imputed to the employers of the author, past, present, or future. As was the case with Joe DiMaggio in 1968 at the time Paul Simon wrote Mrs. Robinson for the movie The Graduate, Dr. Richard K. Lyon has not "gone" anywhere. Dr. Lyon is the inventor of US 3,900,554 (thermal de-NOx) and of several patents on laser isotope separation. It is suggested that a study of the innovation of Dr. Lyon, Dr. Robieux, Dr. Jefferts (the truthful witness in the Finnigan case) and similar workers may offer more valuable guidance for patent policy than may be found in a number of the Festo briefs.
n2 Jim Wolf, Reuters, Oct. 17, 2001
n3 Theresa Agovino, AP, Oct. 17, 2001
n4 Tom Cohen, AP, Oct. 23, 2001
n5 This text could be related to an earlier FTC investigation. In August 2001, the Federal Trade Commission was studying whether drug companies are trying to block the launch of generic drugs but is also exploring if the generic firms are colluding with the big players to benefit. The FTC had investigated Barr for an arrangement with Bayer AG over a deal the two reached to end a patent dispute over antibiotic Cipro, which resulted in Bayer paying Barr $ 25 million a year. Theresa Agovino, "Barr Labs Ships Version of Prozac," AP (Aug. 2, 2001).
n6 Jonathan Landreth, Cipro deal masks concerns over patent breaches, AP, Oct. 25, 2001.
n7 Paul Blustein, Drug Patent Dispute Poses Trade Threat Generics Fight Could Derail WTO Accord, Washington Post, Oct. 26, 2001.
n8 ANNE GEARAN, Anthrax Scare Moves Justices, AP, Oct. 29, 2001.