Canada's Supreme Court Tosses Viagra Patent For Vagueness

Freshly Exhumed writes "In a 7-to-0 decision, the Supreme Court Of Canada has ruled that Pfizer Canada Inc.'s patent on well-known erectile dysfunction remedy Viagra is now invalid due to insufficient information in Pfizer's patent application. The upshot is that competitors can now manufacture cheaper, generic versions of Viagra for sale in Canada."

Comments

Insufficient information

[mattack2]

So the Supreme Court Of Canada found the patent hard to understand.

Re:Insufficient information

[Maow]

So the Supreme Court Of Canada found the patent hard to understand.

You can believe that if it makes you feel good, but reality says otherwise, that the patent was purposefully obfuscated:

"Pfizer gained a benefit from the act -- exclusive monopoly rights -- while withholding disclosure in spite of its disclosure obligations under the act," Justice Louis LeBel wrote on behalf of the court.

"As a matter of policy and sound statutory interpretation, patentees cannot be allowed to 'game' the system in this way. This, in my view, is the key issue in this appeal.

"Pfizer had the information needed to disclose the useful compound and chose not to release it."

So, no one could "understand" it because they didn't disclose proper information - enough for someone skilled in the profession to create a copy of the drug.

It's a remarkably sensible decision and one that should be applied in US courts - particularly in the current mobile patent war (the part about not being allowed to "game the system").

Generic name

[Anonymous Coward]

Now that there will be generic Viagra, there will be the issue of selecting a generic name. The leading candidate based on Internet searches is "Mycoxaphalin."

Re:Generic name

[JustOK]

Penisfillin

Re:Generic name

[symbolset]

V!gara. They can sell it by email.

Fantastic

[Tragek]

My favourite part of the whole thing:

Writing for a unanimous court, Mr. Justice Louis LeBel said that the quid pro quo of patent legislation dictates that inventors can have an exclusive monopoly on a product provided they forthrightly disclose how it operates.

"If there is no quid – proper disclosure - then there can be no quo – exclusive property rights," he said.

Damn straight.

Software next

[EmperorOfCanada]

Now if the US supreme court could apply the same level of common sense and justice to the software patent problem it would be a real turn on (I couldn't help myself).

It looks like this decision is that a greedy company tried bending the rules and were punished. Normally the sense that I get from situations like these that such judgements don't happen because of the whole corporations are the backbone of the country crap so the punishments are usually a tiny portion of the profits from the misbehavior. To lose the viagra patent ought to deflate their profits in Canada (still can't stop).

This is the magical aspect of modern corporations they think that it is somehow good to work every angle, to twist every law, and bend every regulation. It is almost as if they feel bad about themselves if they aren't screwing someone somehow. This is a perfect case in point. Viagra is the wet dream of any big Pharma (on a roll now) a normal patent would have been solid and made them bazillions of dollars; but no they had to squeeze another nickle or dime out of the patent so they risked it all. Viagra also fell into their lap as it was a crappy heart drug that had an interesting side effect. If I were a major shareholder I would demand that the company reevaluate itself to see if a more ethical approach would result in less overall risk.

Generics and Legal Challenges

[reverseengineer]

This particular patent fight is also occurring in other places. In the US, there was a decision last year between Pfizer and Teva that was ruled the opposite way, and if no other challenge is successful, I believe Viagra will continue to exist under patent for Pfizer until 2019. At issue is that Viagra really has two patents- one for sildenafil and its formulation into a drug and one for the use of sildenafil to treat erectile dysfunction. Sildenafil was originally developed for blood pressure and cardiovascular disease, so the application for the ED indication patent trailed the formulation patent by several years. The formulation patent expired this year, but the indication patent lasts until 2019. In the US, a regulatory framework known as a Paragraph IV challenge exists for generic drug manufacturers to either argue that their proposed generic does not violate the existing patents, or that the patents themselves are invalid. This potentially allows them to open up the generic market years before the patent was originally set to expire, so this sort of legal action is not uncommon, particularly for blockbuster drugs.

Re:Generics and Legal Challenges

[reverseengineer]

Just to follow on, the Canadian Supreme Court decision is here and the invalidated patent is here. What caused the patent to be invalidated was that the patent is basically written to cover a wide array of similar molecules, all derivatives of a central molecular skeleton. Often, minor alterations to a molecule can be made that do not change the behavior of the molecule as a drug. What it appears Pfizer was looking to do here was prevent competitors from developing ED drugs that were simple derivatives of sildenafil (Viagra) (like adding a methyl group or a fluorine atom somewhere it would have no significant effect). That's considered acceptable strategy, and as a result, other ED drugs like vardenafil (Levitra) and tadalafil (Cialis) have differences in their core structures that keep them from infringing.

However, the Canadian court found that Pfizer had failed to essentially zero in on sildenafil with their claims. When it came down to actually stating that this molecule is the one that lab studies have found treats ED, Pfizer only ever mentions the core skeleton (known as "formula I") and never uniquely identifies sildenafil. It mentions sildenafil (not even by name, only by its R groups) in one claim, but never connects it and only it to ED. The court judgement notes that "formula I" represents 260 quintillion possible compounds, and therefore rejected the patent for vagueness.

Re:A surprising post.

[Greyfox]

If you stay surprised for more than 4 hours, you should contact a doctor.

Re:Maybe they require photos?

[Samantha Wright]

No, a chemical patent has to be very specific about the range of structures that are patented. A good chemical patent may contain sentences that are over a hundred words in length, just listing out alternative functional groups that could be at a given spot on the backbone. They're very technical and extremely detailed; you can't just patent a cause-and-effect relationship like that. In software, maybe, but not in pharmacology.