Innovation Patent

Sex, Side Effects and a Vague Viagra Patent: IP Juris-prurience?


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A friend once asked me: if you were to do a series on IP with a view to inspiring interest in this esoteric subject, what would it be? I thought long and hard and realized that if there is one subject that excites and enthuses like no other, it is “sex”!

Well, sex may be taboo in India, where despite a cultural legacy dating back to the Khajuraho carvings and the Kamasutra calisthenics, we still wince at the mere mention of this word. And rush to “ban” it in places where friars fear to tread.

Sorry folks! We’re Indian and we’re prudish. Raunchiness is not for us! Speaking of raunchy, the parent of a law school aspirant once asked me: “What do you think of the raunchy law school? And I said: “Huh? Almost all law schools that I know are raunchy (ps: we even had a spot at the National Law School (Bangalore) during my student days called Fornica park…).”

It was only later I realized he meant the National University of Study and Research in Law (NUSRL) in Ranchi, Jharkand. Mind you, some of us from the south of the Vindhyas have a tendency to add a “u” after an “a” (so “Ranchi” becomes “Raunchi”), much like the Bengalis will convert an “a” to an “o” (I was incessantly called Shomnad during my tenure at NUJS) or change a “v“ to a “b” (bery bet this bed is!) .

Sex Sells: The Viagra Vagaries

Anyway, I digress. Short point is this: Sex sells like no other! And what better way to teach IP than through the prism of prurience. Trust me, I’ve had some first hand experience with this. I tried very hard to get students to appreciate the nuances of “inventive step” or “non-obviousness” in patent law. They tired of the discussions quite quickly and had to be bribed through pizzas and the like to stay engaged.

But when I chanced upon the “non-obviousness” analysis in the famed Viagra case and exposed them to it, they were all ears. From a flaccid feel for the subject, we finally saw some patent pizzazz! With many of them actually reading the case in its entirety (a rarity for law student these days)!

So, will this strategy work for our blog? Spicy we are; but can we salacious as well? Ruminating on risqué IP cases to spark up some interest in the subject? Offering a bold and bawdy account, with a view to helping readers appreciate the finer nuances of IP nuggets?

Let’s start with the Viagra case itself. As many of you may have heard, Viagra (Sildefanil Citrate) was allegedly a “surprise” side effect! Pfizer scientist were testing Sildenafil for use as a heart medication (to lower blood pressure etc), and found that patients refused to return left over samples; since the pills aroused them in other ways! A history that finds more eloquent expression in this piece here:

“In the early 1990s, Pfizer began clinical trials in Britain for the drug, which by then it had named Viagra. At first, the experiments seemed like business as usual. Then something strange and unexpected started happening. The test subjects began reporting some very peculiar — and titillating — side effects.

While Viagra wasn’t as effective in treating cardiovascular diseases as researchers had hoped, it was exceptionally potent at doing something else: opening up the arteries in the penis and flooding erectile tissue with blood. In other words, it got men hard — sometimes for up to four consecutive hours.”

Indeed, Viagra rates as one of the innovation classics, with the blue pill spawning not just copy-cats (Cialis and Levitra), but many a lewd line as well. Here goes one:

Ode to Viagra

Some say it is super

Some say it is silly.

We hear it works great

for a limp-acting Willie.

It’s side effects aren’t charted

It may be too iffy.

But what some men won’t do

For a good old-fashioned stiffy!

Viagra Patents: Obvious and Vague?

With such a histrionic history behind the blue pill, could IP have been far behind? Indeed, the Viagra patent was a veritable gold mine, enabling Pfizer to bring in more than 2 billion a year. But the patent was always suspect. The English courts struck it down. And so did the Canadians (on another ground though). And the Chinese too…along with the Columbians, Venezuelans and South Koreans! But the Japanese upheld it. And some others too. As for India, there was no patent issued at all! (as many of you know, the Indian regime prohibits second medical use patents and methods of medical treatment).

Leading us to wonder as to how one could naively assume that the present patent system is doing just fine from an investment protection standpoint. Put another way, with this level of uncertainty in global patent protection, one needs to really ask if the patent system serves as an inducement to pump in more money into R&D (and hopefully get more innovation out).

For those interested, see this piece of mine where I highlight the Viagra patent case and make the larger point that the present patent system is not really “investor” friendly. And that we must move towards a more direct investment protection regime.

UK Patent Position: Obvious to Try?

Back to the Viagra patent. While the UK courts invalidated on the grounds of obviousness, the Canadians and the Chinese relied on more on lack of sufficient disclosure. To appreciate these differential rulings, one must have some sense of the invention and the prior art that came before.

Put very simply, the Viagra patent centred around Silderanfil citrate, a chemical substance that works by inhibiting an enzyme (PDE enzyme) that retards the relaxation of the penile muscle. In other words, inhibiting the enzyme effectively relaxes the penile muscle, paving the way for an erection. As an Australian judge rightly noted:

“An erection occurs when the smooth muscles relax. The arteries open up, blood flows in…and the penis stiffens. When the smooth muscle is contracted the influx of blood is restricted and the penis returns to its normal flaccid state. So, paradoxical as it might seem to the layman, it is relaxation in the penis which causes stiffness and erection.”

The trouble was that Sildenafil Citrate was already known in the art; though as a potential cure for cardiovascular ailments (in fact it was disclosed in two prior patent documents of Pfizer itself!). The court essentially had to wrestle with this basic issue: was there anything in the prior art that made it obvious for a skilled person to turn to Sildenafil as a cure for male erectile dysfunction (MED)? The British courts held in the affirmative, with a hard hitting decision by Justice Laddie (god bless his soul) at the first instance. What swung the court against Pfizer’s claim to a serendipitous/accidental discovery was a renowned science publication (by a bunch of authors including a Nobel laureate). This in conjunction with two other prior art pieces (by Dr Murray and Dr Bush) strongly “suggested” the specific route that Pfizer finally took i.e. experimenting with Sildenafil Citrate as a potential PDEv inhibitor with the strong expectation that it would pave the way for an erection.

Canadian Position: Hide and Seek?

The Canadians however disagreed, noting that something that was merely “worth a try” was not good enough to knock down a patent! Rather, the claimed invention would be obvious, only when the “try” was “more or less self evident” and required no significant thinking or effort.

However, in a subsequent challenge, the Canadian apex court struck the patent ground on another ground; that Sildenafil was too well hidden in the patent specification (one amongst a potential 260 quintillian compounds) to merit a patent! The judge held that the use of “Sildenafil Citrate” as an enabler of erections was not sufficiently disclosed in the patent, castigating Pfizer’s patent strategy as below:

“Pfizer gained a benefit from the Act — exclusive monopoly rights — while withholding disclosure in spite of its disclosure obligations under the Act. As a matter of policy and sound statutory interpretation, patentees cannot be allowed to “game” the system in this way.”

The lower court was even more caustic in its criticism (albeit in “obiter” mode): “Why did the disclosure not simply state that [the] compound in Claim 7 was sildenafil? The patent plays “hide and seek” with the reader. The reader is expected to look for the “needle in the haystack”, or “the tree in the forest”. Remember, Claim 1 is for a range of compounds which includes 260 quintillion compounds.”

Incidentally for those struggling with “quintillion”, that’s a whooping 18 zeros!

Chinese Position: Mud-slinging Much?

China too invalidated the patent; though unlike the UK and Canadian decisions which were seen as plausible applications of problematic patent precepts, the Chinese ruling was extensively maligned by US corporations and others. Almost similar to the way India faced much mud-slinging in the aftermath of Novartis and Nexavar decisions. Here is an excellent piece from Professor Yinliang Liu documenting this unsavoury history:

“A US patent attorney, after reading only summary of the PRB’s decision on invalidation of the Viagra patent, expressed his fury towards the PRB and China…… Was the PRB’s invalidation of the Viagra patent so substantially different from those rulings of the courts or patent offices in other countries that China alone deserved such ferocious criticism?”

Prof Liu then ends his piece (published in the JIPR, one of India’s leading IP journals) with a cautionary note on Pfizer’s “risky” patenting strategy:

“…Pfizer hid information necessary for the person skilled in the art to carry out the invention….For anyone who would take advantage of the patent system, the lesson to be learned could be, among others, a party should not play games with the patent law… At any time when one party would challenge the patent law, it could be challenged back as seriously as the challenging itself.”

You gotta love that last sentence!

Conclusion

So in the end, what does the Viagra patent saga teach us? That hard cases make bad law? Or good law? Or no law at all? Well, the jury is out there, depending on which side of the juris-pruriential fence we find ourselves in!

Ps: Speaking of Viagra, did you know that the brand was allegedly coined by combining “vigour” with “Niagara”? Per a naughty note in Harpers’ Bazaar: the brand is meant to “invoke the pounding power of the Niagara falls”.

Shamnad Basheer

Shamnad Basheer

Prof (Dr) Shamnad Basheer founded SpicyIP in 2005. He is currently the Honorary Research Chair of IP Law at Nirma University and a visiting professor of law at the National Law School (NLS), Bangalore. He is also the Founder of IDIA, a project to train underprivileged students for admissions to the leading law schools. He served for two years as an expert on the IP global advisory council (GAC) of the World Economic Forum (WEF). In 2015, he received the Infosys Prize in Humanities in 2015 for his work on legal education and on democratising the discourse around intellectual property law and policy. The jury was headed by Nobel laureate, Prof Amartya Sen. Professional History: After graduating from the NLS, Bangalore Professor Basheer joinedAnand and Anand, one of India’s leading IP firms. He went on to head their telecommunication and technology practice and was rated by the IFLR as a leading technology lawyer. He left for the University of Oxford to pursue post-graduate studies, completing the BCL, MPhil and DPhil as a Wellcome Trust scholar. His first academic appointment was at the George Washington University Law School, where he served as the Frank H Marks Visiting Associate Professor of IP Law. He then relocated to India in 2008 to take up the MHRD Chaired Professorship in IP Law at WB NUJS, a leading Indian law school. Prof Basheer has published widely and his articles have won awards, including those instituted by ATRIP and the Stanford Technology Law Review. He is consulted widely by the government, industry, international organisations and civil society on a variety of IP issues. He also serves on several government committees.

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