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Supreme Court Voids Viagra Patent as Insufficient Disclosure Means It Fails the "Patent Bargain"

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Thursday November 08, 2012
The Supreme Court of Canada this morning shocked the pharmaceutical industry by voiding Pfizer's patent in Canada for Viagra. The unanimous decision provides a strong reaffirmation of the policy behind patent law, namely that patents represent a quid pro quo bargain of public disclosure of inventions in return for a time limited monopoly in the invention. The Supreme Court describes it in this way:

The patent system is based on a "bargain", or quid pro quo: the inventor is granted exclusive rights in a new and useful invention for a limited period in exchange for disclosure of the invention so that society can benefit from this knowledge. This is the basic policy rationale underlying the Act. The patent bargain encourages innovation and advances science and technology.

Disclosure is therefore a crucial part of the patent bargain.

The court clarifies that this involves not only a description of the invention and how it works, but rather a much more practical level of disclosure "to enable a person skilled in the art or the field of the invention to produce it using only the instructions contained in the disclosure." In this case, the court finds that Pfizer failed to provide sufficient disclosure, concluding:

the public's right to proper disclosure was denied in this case, since the claims ended with two individually claimed compounds, thereby obscuring the true invention. The disclosure failed to state in clear terms what the invention was. 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.

Pfizer argued strenuously that this should not result in invalidating the patent, but Justice Lebel, writing for the court, found no other alternative. The Viagra patent is therefore voided in Canada (which will allow for generic substitutes) and the importance of the basic foundation of patent policy for the broader benefit of society reaffirmed.
Comments (35)add comment

Dorkmaster Flek said:

Excellent!
This is the exact opposite of how the US seems to see patents. Somebody tell the federal government this when they're negotiating CETA with those damn pharmaceutical patent reforms.
November 08, 2012

rtms said:

...
Agreed, the US tech industry would welcome a ruling like this given all the headaches that are going on right now. Apple,Samsung etc would be put in their place properly if they had a ruling like this.
November 08, 2012

Devil's Advocate said:

SCC pulls a boner on Pfizer!
Great News!
The price of good, artificial wood is about to drop dramatically.
November 08, 2012

Crockett said:

...
Are there some lessons here in regards to copyright and the ever lengthening terms, where is the balance of benefit to society?
November 08, 2012

Shawn H Corey said:

YAY!!!
☺☺☺☺☺☺☺☺☺☺
November 08, 2012

Bill Stewart said:

Now the Canadian Pharmacies will be able to sell the real thing
Just in case we weren't getting enough spam :-)
November 08, 2012

Ray Saintonge said:

Full disclosure and copyright
There is one place in copyrights where disclosure could be a factor. In later editions what constitutes new material, and are the changes substantial enough to generate a new copyright? It would seem valid to require disclosure of these changes in case of a dispute.

Also with web pages, is it legitimate to change the copyright date every time the calendar advances by one year? The effect of this may be more theoretical than practical since no website is yet 50 years old.
November 09, 2012

Chris C. said:

This is Great News!
Finally, some reason and common sense in a field where criminally distorted argumentation by morally corrupt lawyers usually wins...

This is great news for Canada, following the prior containment of the copyright hawks in parliament earlier in the summer and the 'University Revolt' against the outrageous dictatorial control on content by Access Copyright, that otherwise would have rung the bell for the long term destruction of our society.

I can only hope this level-headed decision, along with other victories for fundamental citizen rights on the same lines in Europe (the ACTA revolt comes to mind), will sound a strong warning bell to the mega corporations, especially those of our neighbors to the south, who have been dictating their agendas to our western governments for the past 15 years, to BACK OFF, lest they face a global revolt, as people finally realize this is no less than an attempt to revive fascism, with an even more dreadful stranglehold on society than it had almost one hundred years ago.

Kudos to Justice Lebel for his wisdom and clarity, stating and putting down the gavel on something informed, ordinary people have been saying now for several years: that copyright and patents are not meant to give absolute monopoly power and that innovation is a vital, fundamental right of our society and is not meant to give unlimited power of exclusion to creators (remember the outrageous Sony Bono Bill?), but is meant to balance the rights of inventors while benefiting society as a whole.

This is landmark decision, I tip my hat to Justice Lebel. Let us hope to see more sanity on those lines in the future, we sorely need it.
November 09, 2012

Rohan Jayasekera said:

Is this truly the "patent bargain"?
Without patent protection, there is nothing to stop an invention from being copied as soon as it hits the market, and I'd always been under the impression that this is why patents exist: to ensure that inventors get sufficient return on their investment that they have incentive to spend the required effort and expense.

This decision states a very different rationale. I don't know the history of patent protection, in Canada nor anywhere else, but I don't find this supposed bargain convincing. The disclosure of the method doesn't seem terribly beneficial to society given that it can't be used by anyone else until the patent expires, by which time the invention (if it's at all useful) will have been out on the market for a long time and subject to examination by anyone. Even if this is indeed the bargain that was struck centuries ago, I doubt that it makes sense today.
November 09, 2012

Kim said:

@Rohan
Yes, that truly is the patent bargain.
November 09, 2012

Ted said:

Great News, Now India is Not so Far
I think this is great! Now we only have to cross our Northern border to reach a country that doesn't respect IP rights. How cool is that. Maybe they'll open a fake Apple store like in China. Maybe this weekend I'll drive up and buy some cheap pirated software and a few DVD's. It's great to know that our friends who provide us with a nearly limitless supply of beaver and moose meat are leeching even further of America's research based pharmaceutical industry. Hey, who wants to do some curling???
November 09, 2012

Steve said:

...
I would like to do some curling, Ted.
November 09, 2012

Betty McKinnon said:

Great News for PH Patients
I just learned that a year's worth of Viagra (Sildenafil) to treat Pulmonary Hypertension (a rare and incurable disease) is more than $20,000 a year. It is such a relief to know that the price will come down now that generics may soon be available. I agree with a limited monopoly for the inventor of a drug or product, but it should, indeed, be limited to allow for repayment of research and production expenses and a fair profit. Pharma companies are often holding patients hostage for huge and unaffordable costs for life-saving drugs. Supporting health care needs for all citizens must be paramount in a civil and humane society, without impoverishing anyone and forcing people into charity status.
November 09, 2012

Carlos said:

fool me once and fool me always
@Ted, if you don't mind being a serf to companies that abuse the patent system, such as Apple and Pfizer, you can continue to pay for their overpriced goods. Over here we have laws that apply to both companies and citizens. Too bad Pfizer thought it could get away with gaming the patent system.
November 09, 2012

DB Cooper said:

...
Canadas patent laws are the reason drugs are so much more expensive in the US. Expect drug prices to rise even more now so companies can recoup lost profits from this idiotic ruling. Governments produce nothing and only take. In this cas I suspect ample bribs were taken.
November 09, 2012

Hutz said:

Big hole in the logic
It seems to me that if they obscured the invention then invalidating the patent would not lead to generic drugs. The fact that there are so many generic Viagra's out there already would imply that the patent filings gave a clear path to duplicating the invention.
November 09, 2012

Richard Westgate said:

Just look it up!
For those complaining about this decision, just go look it up in Wikipedia. First paragraph is exactly what the SCC said.
November 09, 2012

Ted said:

Where should those $$$$ go????
@Carlos: a few thoughts

Ask the multitudes of people here with fungal meningitis and fungal abscesses about what kind of value they think they're getting from their low cost generic pharmaceuticals. Or ask the chronic pain patients who a while back received generic oxicodone from China with no oxicodone it. Or you could ask why the US government went to pharma hat in hand basically begging them to work on next gen AI drugs. Why? Because we are all screwed without them. MDRTB and XDRTB are taking off. Dengue is taking off like a rocket. And on and on. I want big pharma to make money more than any other class of company except new energy.
November 09, 2012

Chris C. said:

Invasion of the Trolls...
I can't believe some of the negative comments I'm reading here. You'd think Big Pharma had sent their minions to tweet their 'poor us' trumpets, while in reality they average double digit yearly profits while people are dying because they can't afford life-saving but overpriced medication...

I'd like to see how DB Cooper, Ted and other self-righteous, brainwashed reactionaries would feel if they had to pay $2,000 a month for medication, like a relative of mine in the US had to pay for several years to get back to health. If he hadn't been well to do, he'd be dead by now, like regular folks out there.

Aren't Excess Copyright and Patent Prison great? No wonder average lifespan is lower in the US than in Canada... Pitiful!
November 10, 2012

Hephaestus said:

hep@hast.us
@DB Cooper
The damnable thing is that I can't tell whether you're joking or dead serious. What you said is just so utterly ridiculous, yet sounds so much like Republican talking points.

"Canadas patent laws are the reason drugs are so much more expensive in the US."
A market one tenth of America's drives up prices really high? This ruling only applies to Canada after all.

"Governments produce nothing and only take."
What do you think patent laws are? Something created by the private sector, rather than the Canadian parliament? And how would the private sector fare without patent laws?

"In this cas I suspect ample bribs were taken."
Unanimous decision of the Canadian Supreme Court. They must have all been bribed, eh?

Think about that again - unanimous ruling. Can't imagine a clearer sign that Pfizer did something wrong.
November 10, 2012

Gregg said:

Can We Eventually Hope For....
A female Viagra?
November 10, 2012

Ted said:

Progressive Liberal, Not a Reactionary
Yes that's right. Voted for Obama. Support Obamacare even though it will cost me. I am not a troll. I promise. I have worked in healthcare for a long time. The thing is I am not brainwashed. I just understand the realities of the drug business. Guess what, the Gates foundation was going to solve diseases of poverty. How many drugs have they come up with? Zero. That not being a troll. That's just a fact. Drug discover is a high risk business and that is what no one wants to hear. Pfizer paid a billion dollars for a compound called torcetrapib and at the end of some of the early trials they had to pull the plug because there were some signals that there might be excessive risk. Now the conventional wisdom would have you believe that a drug company would suppress the trial. Sweep it under the rug. Launch the drug and make billions while innocents died. But that didn't happen. Pfizer pulled the plug and flushed a billion dollars down the toilet. How many lives have statins saved. Remember it is a scientific FACT that they save lives. How many lives have antibiotics saved. Remember it is a fact they save lives. When was the last time you did anything that contributed to actually saving a life. Great work on that new chat client!
November 10, 2012

Adam said:

...
@Ted:
In Canada, kneejerk ad hominem attacks do not inform the bulk of our public discourse.
Pfizer has its share of skewed clinical studies and unethical releases: Chantix, Lipitor, Geodon, Trovan, Bextra, Celebrex, Lyrica, and Zoloft are examples. Oversight and scrutiny by government are absolutely necessary especially in the case of pharmaceuticals to represent the interests and safety of the public. The invisible hand doesn't work to regulate industries, we have seen very clearly. Bravo to our supreme court for standing up and defending the public interest!
November 11, 2012

Ray Saintonge said:

re Ted
Bringing up the "generic oxicodone from China with no oxicodone it" shows a clear failure of understanding generics, and willfully conflating them with fraudulent products.
November 11, 2012

Ted said:

Not ad hominen just a bit snarky
1. Actually both the generics cases I brought up and many others demonstrate that when you cut cost to the bone you have to cut expenses somewhere. Sadly it is often quality. As the medical director of a large VA hospital recently told me, "you can't provide a months worth of medication for 10.99 and expect much".

2. Pfizer pulled Trovan off the market immediately after there was any hint of problems.

3. Pfizer pulled Bextra proactively off the market after there was a statistically insignificant signal in the data about cardiac issues. Many physicians and patients asked that it be kept on the market even knowing the risks.

4. The issues around data and SSRI's in general have more to do with a general lack of understanding of the role of serotonin in depression by the general public and appropriate patient selection by primary care physicians.

5. I agree that government oversight of pharma is crucial. I wish that supplements and vitamins had the same oversight here in the US. I cringe whenever an ad says help your vision with XXX once a day.

6. Indisputably, when IP is not protected innovation founders. Say anything you want but that is a stone cold fact.
November 11, 2012

Napalm said:

Software patents
I'm patiently waiting until this gets to software patents. It would mean that either you open source it or your patent is invalid.

November 11, 2012

NotAnAstroTurfer said:

Didn't Pfizer use this logic for a USA extension?
Nice work, Pfizer astroturfers! By the way, I believe that in the USA, Pfizer used the lack of disclosure in the initial application, coupled with later disclosure, to argue for an EXTENSION of the Viagra monopoly in the USA! I have read articles claiming that they have been successful in obtaining an extension in the USA on the basis that they may have changed the formulation since initial introduction, claiming that the clock should be reset to the time of the "improved" formulation.
November 12, 2012

joeMoma said:

hahah drugs are more expensive in the USA due to this ruling
LOL @ DB Cooper


The reason drugs are so expensive in the US is because people in the US are too dumb to do anything about the gauging.

Medical procedures and the cost of doctors is also most expensive in the US, but wait, if it was a free market, that would mean more doctors right? They all would be flooding to the US. Guess what, no such luck, the US is very restrictive to new doctors, the numbers are the lowest in the western world per capita, hence there is no free market even though the pay is the best in the world.

Soooo little buddy the system is rigged.
November 14, 2012

Ted said:

Actually....
In reality according to the AMA International Medical Graduates(IMG) represent 25% of the physicians in the USA. In some major cities that number is as high as 45%. AS far as Docs per capita, sure North Korea has more but they only have a life expectancy of 68 years so it doesn't buy them much.

Here is the real reason that drugs are cheap in other countries. Mostly the government is the sole or nearly the sole buyer of drugs. The negotiation on price goes like this. The drug company comes in and the governments, "We are cutting your price 20% as of now. Take it or leave it."

Don't even get me started on parallel trade.
November 14, 2012

gurjeet said:

...
Over here we have laws that apply to both companies and citizens. Too bad Pfizer thought it could get away with gaming the patent system.

gurjeet
November 19, 2012

Crockett said:

What do Bell and Pfizer have in common? Incredulous denial.
Apparently Pfizer is not happy with this ruling and has asked for reconsideration. The SCC response is essentially ... while the penalty is indeed stiff, take it like a man.
November 28, 2012

Fayre Playe said:

Mr.
"In man, certain especially preferred compounds have been tested orally in both single dose and multiple dose volunteer studies. Moreover, patient studies conducted thus far have confirmed that one of the especially preferred compounds induces penile erection in impotent males. [Emphasis added; A.R., vol. X, at p. 173.]".

This is Pfizer's statement about their invention. As the Supreme Court Judge ruled this is NOT proper disclosure. The bargain made is that any reasonable person should be able to understand and reproduce the candidate for a Patent for wich Pfizer is granted exclusive access to the invention for a certain period of time.
Pfizer, the Supreme Court ruled, obscured the compounds to two leaving any reasonable person unable to duplicate the compound.
February 17, 2013

john said:

...
What is significant about this case is the SCC went farther than ever before in a PMNOC case. typically you only invalidate in a full blown action involving a counter claim or an impeachment suit. In PMNOC cases the inquiry is limited to whethere the generic's allegation was or was not justified. Very good day for generics in Canada and consumers down the road....
March 10, 2013

Pinsky Law said:

...
This kind of conduct on the part of Pfizer has always been an ingredient of a "good" chemical/medicine patent application. Whereas mechanical and electrical patent applications are trying to disclose an invention to a fullest extent, chemical/medicine applications are trying to hide the ball and make the application as confusing as possible.

Pinsky Law

April 06, 2013

Pinsky Law said:

...
...also, not a "Patent Bargain", but insufficient disclosure which in itself is a ground for refusing to grant a patent.
April 06, 2013

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