Glickman's data about the state of the condom industry proved difficult to confirm. One condom consultant, John Gerofi, who runs a condom-testing company in Australia, was skeptical of the numbers. Even if the percentage figures were correct, notes Gerofi, the total market for specialty condoms was likely quite small compared to the overall market.
Still, the very existence of the multiple lawsuits, along with the ITC complaint (which itself can be a very expensive undertaking), indicates that there is serious money at stake. So before evaluating what is most likely the most morally significant aspect of the case, that is, the question of how best to fight STDs, it might be worth delving into the arcane world of patent litigation to figure out who, if anyone, actually has the law on their side.
There is little question that the three condoms in question have some clear visual similarities. To wit: All of them get kind of bumpy near the end part. But at the moment, the litigators in New Jersey are sparring over the hotly contested question of whether the Twisted Pleasure has a "generally constant diameter."
Condom measurement, it should be noted, is more complex than one might imagine. As one condom industry veteran serving as an expert witness for the defense noted, condoms are difficult to measure in their limp state. In the case of the Twisted Pleasure, even if one adheres to the relevant international condom standards, which require that a condom be "laid flat over the edge of a ruler, perpendicular to the condom's axis, allowing it to hang freely," a vexing problem still remains: How do you deal with the twisted part?
In point of fact, declared the expert, the bulging double helix that spirals around the latter portion of the Twisted Pleasure creates a constantly varying diameter.
Predictably, the lawyers for the plaintiff disagreed, furnishing the court with their own declarations from two more expert witnesses, an engineering professor conversant with all things latex and a Florida doctor with "expertise regarding male and female genitalia and the interaction thereof." These experts argued that the Twisted Pleasure has "valleys" between the spirals which remain in permanent contact with the penis, thus giving the condom a constant diameter.
Why does condom size matter? Because in a patent-infringement suit, perhaps more so than with most litigation, little details count. Lawyers for Church and Dwight (the Trojan company) are asking that the case be summarily dismissed, based on their contention that one of the patent claims at issue, which describes the condom as having a "generally constant diameter," does not apply to the twisty, unevenly bumped Twisted Pleasure. Should the judge agree with C&D, that fact alone might be enough to get the lawsuit thrown out.
Similarly, in 1999, PTI's attempt to get an injunction preventing distribution of the Inspiral was denied by Judge Greenaway after his own investigation (not his personal experience, mind you) of the two condoms determined that they were sufficiently dissimilar that PTI had little likelihood of winning a full trial. His reasoning followed lines that are reminiscent, in their exquisite attention to detail, to the reasoning employed by C&D's lawyers.
Greenaway noted, for example, that in his opinion the language in the patent appeared "to limit the protected stimulation to the area of the glans penis." The spiral-shaped pouch on the Inspiral went beyond just that region, he observed, and extended further down the shaft of the penis. He also pointed out that the patent described the condom's second pouch as "having its inner surface spaced radially outwardly" from the tubular portion of the condom, thus providing "looseness" between the tubular portion and the outer surface of the glans penis. But, concluded the judge, "the second pouch of the Inspiral condom is not spaced radially outwardly from the condom. Instead, the second pouch of the Inspiral condom is spaced spirally extending from the closed end of the condom longitudinally down the shaft."
The spiral shape of the second pouch, decided the judge, "actually results in no looseness."
Now, even a cursory examination would appear to the layman to indicate that if anything, Trojan's Twisted Pleasure is even more unlike the Pleasure Plus than the Inspiral. And given that the same judge is presiding over the case, an outsider might be excused for thinking that PTI's prospects of winning, the second time around, are rather bleak.
Not necessarily, says Paul J. Kozacky, a lawyer working on the case for PTI. First of all, wrote Kozacky in an e-mail, even though an appellate court upheld Greenaway's denial of the preliminary injunction, it did not fully agree with his decision. In fact, the three-paragraph affirmation of the decision states that "this court does not endorse the district court's claim interpretation." The judge writing the opinion took particular pains to dispute Greenaway's contention about the limits on the area of protected stimulation expressed in the patent.
As far as Kozacky is concerned "their opinion is a strong indication that the Inspiral product does indeed infringe on PTI's patent."
Lawyers for C&D did not respond to inquiries, and C&D's director of marketing did not return a phone message. And so the litigation continues, while the condom world waits.
But let's step back a second. If Reddy's primary motivation was to fight disease -- and if, as is manifestly true, health professionals consider condoms to be an essential weapon in the war on AIDS, then why are we wasting time wrestling over obscure patents? Shouldn't the goal just be to forge ahead and get condoms with the latest bells and whistles into the hands of everyone who needs them? Isn't there a point where the public good transcends the profit motive? Let a hundred Pleasure Plus condom imitators bloom! Alas, despite the noble dream that enhancing male pleasure will help save the world from the scourge of STDs, there are some cold, hard reasons why Reddy's pouch-on-pouch breakthrough (admittedly, a bad word to use when discussing condoms) may not be the answer to global sexual disasters.
For one thing, as outlined in "The Male Latex Condom: Specification and Guidelines for Condom Procurement," published by the World Health Organization, condoms with unusual shapes are specifically not recommended for distribution by reproductive health and family planning programs.
"Anecdotal information from testing laboratories suggests that they are more likely than smooth condoms to fail critical test requirements and have therefore not been recommended in this specification."
In other words, they are supposedly more likely to break, an assertion vigorously denied by Condomania's Glickman, who says he has seen no studies proving such a claim.
But perhaps more important, "specialty" condoms, also called "novelty" condoms, are more expensive. And in a world where family-planning agencies are calling for donors to provide them with billions and billions of condoms, price counts.
But perhaps most telling was a study, recently concluded in Jamaica, that tracked condom usage among men who were given a choice of four condoms, including the Inspiral. Dr. Markus Steiner, the researcher in charge of the study, determined that not only did the men quickly abandon the novelty condoms and return to their regular old familiar condoms, but those men who did use the novelty condoms demonstrated a slightly higher incidence of sexually transmitted infection.
"In fact, we had a hard time giving away the Inspiral condoms after the study," notes Steiner, who concluded that "providing 'Cadillac condoms' does not appear to be justified if resources are scarce."
"I think the participants in Jamaica just did not like the feel of the loose-fitting condoms," Steiner says. "We conducted a very similar set of studies in Ghana, Kenya and South Africa."
Does that mean that the dream is dead?
"Never say never!" Steiner says. "We are disappointed by the current findings. But for the time being, we think money is definitely best spent on ensuring access to condoms and appropriate counseling. But we remain optimistic that design improvements in the future could lead to increased condom use."
If that indeed proves true, then somewhere down the line, future researchers and family-planning specialists may want to give a shout-out to Dr. A.V.K. Reddy. No matter how the patent case in New Jersey plays out, his contribution can't be ignored. "Dr. Reddy," says Glickman, "was just way ahead of the curve in recognizing that the condom could be so much more than just a medical device to provide protection."