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Pfizer Can't Keep Its Viagra Patent Up In Canada

from the no-quid,-no-quo dept

Today, in a ruling from the Supreme Court of Canada, Pfizer lost its Canadian patent on Viagra as the result of a long-fought battle with rival pharmaceutical manufacturer Teva, which sought to make a generic version of the popular drug. Though the patent was not set to expire until 2014, Teva argued (and the Supreme Court agreed, though lower courts had rejected the argument) that it was in fact never valid in the first place, because it was written in such a way as to obscure the information that is required disclosure in a patent:

P holds Patent 2,163,446 for the use of a “compound of formula (I)” or a “salt thereof” as a medicament for the treatment of erectile dysfunction (“ED”). The patent’s specification ends with seven cascading claims for successively smaller ranges of compounds, with Claims 6 and 7 relating to a single compound each. Only sildenafil, the subject of Claim 7 and the active compound in Viagra, had been shown to be effective in treating ED at the time of the patent application. Although the patent includes the statement that “one of the especially preferred compounds induces penile erection in impotent males”, the patent application does not disclose that the compound that works is sildenafil, that it is found in Claim 7, or that the remaining compounds had not been found to be effective in treating ED.

...

The patent application did not satisfy the disclosure requirements set out in the Patent Act, R.S.C. 1985, c. P‑4 (“Act”). The patent system is based on a “bargain”: 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. Sufficiency of disclosure lies at the very heart of the patent system, so adequate disclosure in the specification is a precondition for the granting of a patent.

The ruling goes back to this all-important concept a few times: without disclosure, there can be no patent. It's good to see the court making this a central point, because pharma companies are notorious for attempting to twist the patent system so they get virtually perpetual monopolies on their drugs, while still shrouding their research and manufacturing methods in as much secrecy as possible. In the US, Pfizer had a similar showdown with Teva over generic Viagra starting in 2010, in which Pfizer won using a second patent that didn't cover the active compound in Viagra itself, but rather the marketing of it as an erectile dysfunction drug. Thus, even though the core patent on the drug expired this year, Pfizer will likely retain a monopoly on it until 2019. This is in stark contrast to the UK, where the patent on using the drug to treat ED was invalidated for obviousness way back in 2000—but Pfizer still dominates the market there thanks to related patents on manufacturing methods.

Basically, Pfizer uses any method it can think of to prevent its patents from ever expiring and benefiting the public the way patents are supposed to, including writing disclosures that obscure the necessary facts. The Supreme Court was having none of it—rather than letting Pfizer retroactively fix the disclosure, or coming up with any kind of partial remedy that allowed them to retain the patent, the ruling correctly states that patents must be a deal between two sides to function, and thus the patent is (and always has been) invalid:

Although s. 27 does not specify a remedy for insufficient disclosure, the quid pro quo underpinning the Act leads to the conclusion that deeming the patent invalid is the logical consequence of a failure to properly disclose the invention and how it works. If there is no quid — proper disclosure — then there can be no quo — exclusive monopoly rights.

...

There is no question that sildenafil’s utility had been demonstrated as of the time of filing of the patent application. This takes the invention out of the realm of sound prediction. As to the delay of 13 years between the filing of the patent and the challenge, the relevant question is whether the disclosure was sufficient as of the date of filing, so the delay is inconsequential.

This is a big victory for Teva and a major blow to Pfizer's Viagra empire, which is slowly crumbling around the globe. It's also likely to lead to even more illegal cross-border pharma sales, and even more of everyone's favorite email spam advertising online Canadian pharmacies—but that's another story.



Reader Comments (rss)

(Flattened / Threaded)

  1.  
    icon
    Dark Helmet (profile), Nov 8th, 2012 @ 12:05pm

    Kudos

    This is one of the best post titles I've seen on this site in quite a while....

     

    reply to this | link to this | view in thread ]

  2.  
    icon
    Leigh Beadon (profile), Nov 8th, 2012 @ 12:09pm

    Re: Kudos

    Credit goes to Mike for coming up with that one

     

    reply to this | link to this | view in thread ]

  3.  
    identicon
    Michael, Nov 8th, 2012 @ 12:10pm

    Re: Kudos

    It's full of great lines:

    "big victory for Teva and a major blow to Pfizer's Viagra empire"

     

    reply to this | link to this | view in thread ]

  4.  
    identicon
    Anonymous Coward, Nov 8th, 2012 @ 12:17pm

     

    reply to this | link to this | view in thread ]

  5.  
    identicon
    Michael, Nov 8th, 2012 @ 12:19pm

    Re:

    I was bit by a spider once and it did cause swelling.

     

    reply to this | link to this | view in thread ]

  6.  
    icon
    Dark Helmet (profile), Nov 8th, 2012 @ 12:22pm

    Suggestion for additional line

    "Cases like this are why some experts recommend that if you experience a patent for more than 4 years, you should see a physician."

     

    reply to this | link to this | view in thread ]

  7.  
    identicon
    Anonymous Coward, Nov 8th, 2012 @ 12:28pm

    Re: Re:

    LoL

    Well, on the funny side of things I just saw this comments elsewhere about the spider venom.

    Quote:
    "commento
    01:26 AM on 09/08/2012
    Wow, it's Dirty Hairy !!! Let's see if it can make my day. "

    Source: http://www.huffingtonpost.com/2012/08/29/spider-venom-viagra-brazilian-wandering_n_1840381.html

    Q uote:"Cured in 20 minutes but you only get 40 minutes to use it before your dead. She had better be worth it.

    - George , NY,NY, 30/8/2012 02:07"
    Source:http://www.dailymail.co.uk/health/article-2195208/Venom-worlds-deadliest-spider-cure- erectile-dysfunction-20-minutes.html?ITO=1490

    Quote:"It's amazing what you can find out on the web,,

    - Silky , England, 29/8/2012 23:45"
    Source: http://www.dailymail.co.uk/health/article-2195208/Venom-worlds-deadliest-spider-cure-erectile-dysfun ction-20-minutes.html?ITO=1490

    Quote:"Oh the irony! A lifetime of erectile dysfunction which can only be cured by a spider which kills you in an hour! Suppose at least it would be the best hour of your life.

    - Nikki , Bucks, 29/8/2012 22:35"
    Source: http://www.dailymail.co.uk/health/article-2195208/Venom-worlds-deadliest-spider-cure-erectile-dysfun ction-20-minutes.html?ITO=1490

     

    reply to this | link to this | view in thread ]

  8.  
    identicon
    Lord Binky, Nov 8th, 2012 @ 12:29pm

    "patent system is based on a “bargain”: 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."

    And that is EXACTLY why design patents should not exist. Microsoft should not have a design patent on the shape of an xbox and more than Apple should have a design patent on the shape of a tablet.

    There is not any knowledge being offered, it is merely for product differentiation which would be a under trademarks where it should be and is applicable.

     

    reply to this | link to this | view in thread ]

  9.  
    identicon
    Anonymous Coward, Nov 8th, 2012 @ 12:34pm

    One might say that Pfizer got stiffed.

     

    reply to this | link to this | view in thread ]

  10.  
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    weneedhelp (profile), Nov 8th, 2012 @ 12:41pm

    Must resist innuendo

    LOL so many Beavis and Butthead comments come to.. damn I tried not to.

     

    reply to this | link to this | view in thread ]

  11.  
    icon
    weneedhelp (profile), Nov 8th, 2012 @ 12:41pm

    Re: Must resist innuendo

    mind.

     

    reply to this | link to this | view in thread ]

  12.  
    identicon
    Anonymous Coward, Nov 8th, 2012 @ 12:53pm

    Re: Re: Must resist innuendo

    I don't mind at all. Go right a head.

     

    reply to this | link to this | view in thread ]

  13.  
    identicon
    Anonymous Coward, Nov 8th, 2012 @ 12:56pm

    marketing patent?

    You can have a patent on how something is marketed?

     

    reply to this | link to this | view in thread ]

  14.  
    identicon
    Crisis Management, Nov 8th, 2012 @ 1:00pm

    heaaaah

    This article is really too much.

     

    reply to this | link to this | view in thread ]

  15.  
    icon
    Leigh Beadon (profile), Nov 8th, 2012 @ 1:07pm

    Re: marketing patent?

    i guess "marketed" isn't really the right wort -- that's partially just me being facetious. It's called a "method of treatment" patent, covering using a particular compound to treat a particular condition, and sadly yes it does exist.

     

    reply to this | link to this | view in thread ]

  16.  
    identicon
    Anonymous Coward, Nov 8th, 2012 @ 1:40pm

    Looks like they'll have to do things the hard way.

     

    reply to this | link to this | view in thread ]

  17.  
    identicon
    Anonymous Coward, Nov 8th, 2012 @ 1:41pm

    If Pfizer can't keep its viagra patent up, what can they keep uo?

     

    reply to this | link to this | view in thread ]

  18.  
    icon
    DannyB (profile), Nov 8th, 2012 @ 2:21pm

    Re:

    One might say that the public got stiffed by the lack of disclosure in the patent.

     

    reply to this | link to this | view in thread ]

  19.  
    identicon
    Anonymous Coward, Nov 8th, 2012 @ 2:22pm

    Pun Dysfunction?

     

    reply to this | link to this | view in thread ]

  20.  
    icon
    DannyB (profile), Nov 8th, 2012 @ 2:24pm

    More patents need to be examined for disclosure

    Maybe more patents need to be examined to ensure they include the proper full disclosure of the purported "invention".

    Does a patent on 1-click purchasing (Amazon), or Slide To Unlock (Apple), for example, disclose all of the technology involved?

     

    reply to this | link to this | view in thread ]

  21.  
    icon
    gorehound (profile), Nov 8th, 2012 @ 2:24pm

    Re: Kudos

    True it is a really funny Title.

     

    reply to this | link to this | view in thread ]

  22.  
    identicon
    Michael, Nov 8th, 2012 @ 2:53pm

    Re: More patents need to be examined for disclosure

    "1-click purchasing"

    1) click
    2) THERE IS NO #2!!!

    Patent, please.

     

    reply to this | link to this | view in thread ]

  23.  
    identicon
    Anonymous Coward, Nov 8th, 2012 @ 3:30pm

    Re: Re: marketing patent?

    Be careful how you use your worts... :-)

     

    reply to this | link to this | view in thread ]

  24.  
    identicon
    Anonymous Coward, Nov 8th, 2012 @ 4:04pm

    The US has one of the stupidest patent offices in the world! A method of treatment is to prescribe a certain medicine. How in the world can doctor's hands be tied like this? In line with the findings: "a process is patent-eligible if the process (1) is tied to a particular machine or apparatus, or (2) transforms a particular article into a different state or thing", how can they justify that the medicine that they patented for ED is transformed by the method of prescribing that same exact medicine? It boggles the mind.

     

    reply to this | link to this | view in thread ]

  25.  
    identicon
    Anonymous Coward, Nov 8th, 2012 @ 4:11pm

    Re: Re: marketing patent?

    It's really surprising to me that they didn't run into a double patenting problem with the method of treatment patent in light of the patent on the compound.

     

    reply to this | link to this | view in thread ]

  26.  
    icon
    G Thompson (profile), Nov 8th, 2012 @ 8:57pm

    Re: Re: Kudos

    Kudos to Mike since it's sometimes quite Hard to come up with Viagra puns

     

    reply to this | link to this | view in thread ]

  27.  
    icon
    Hephaestus (profile), Nov 8th, 2012 @ 10:35pm

    Re: Re: Kudos

    Yeah that title was the money shot. >:}

     

    reply to this | link to this | view in thread ]

  28.  
    identicon
    Lizzardborn, Nov 9th, 2012 @ 1:18am

    On a serious note - can this be used to invalidate overly broad software patents, because there is rarely full disclosure, and they seem to think they can patent the end result, not the way to get there.

     

    reply to this | link to this | view in thread ]

  29.  
    identicon
    MHab, Nov 10th, 2012 @ 11:42am

    ER Embarassment

    Pfizer's 4+ hour patent erection has finally been taken care of....

     

    reply to this | link to this | view in thread ]

  30.  
    identicon
    John Meistro, Apr 4th, 2014 @ 1:40pm

    Re: Kudos

    I take it daily - It helps me especially being a male stripper.

    -------------------
    http://www.nymalestripclub.org/male-strippers/black-male-strippers-nyc

     

    reply to this | link to this | view in thread ]


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