Patents are only for the old machine by Alexandre Dulaunoy (CC BY-SA 2.0) https://flic.kr/p/zw2KV

Patents are only for the old machine by Alexandre Dulaunoy (CC BY-SA 2.0) https://flic.kr/p/zw2KV

Columns

How a 20 Year Old Patent Application Could Up-End Canada’s Biggest Trade Deal

In the early 1990s, pharmaceutical giant Eli Lilly applied for patent protection in Canada for two chemical compounds, olanzapine and atomoxetine. The company had already obtained patents over the compounds, but asserted that it had evidence to support new uses for the compounds that merited further protection. The Canadian patent office granted the patents based on the content in the applications, but they remained subject to challenge.

Both patents ultimately were challenged on the grounds that there was insufficient evidence at the time of the applications to support the company’s claims. The Federal Court of Canada agreed, invalidating both patents. Eli Lilly proceeded to appeal the decision to the Federal Court of Appeal and later to the Supreme Court of Canada. The company lost the appeals, as the courts upheld the decision to invalidate the patents.

My weekly technology law column (Toronto Star version, homepage version) notes that under most circumstances, that would conclude the legal story as nine Canadian judges reviewed Eli Lilly’s patent applications and ruled that they failed to meet the standards for patentability. Yet in June 2013, the company served notice that it planned to file a complaint under the North American Free Trade Agreement claiming that in light of the decisions, Canada is not compliant with its patent law obligations under the treaty. As compensation, Eli Lilly is now seeking $500 million in damages.

The Eli Lilly claim is winding its way through the legal process – the Canadian government filed its defence several weeks ago – but the implications are being felt far beyond the specifics of the case.

If the pharmaceutical giant succeeds, it will have effectively found a mechanism to override the Supreme Court of Canada and hold Canadian taxpayers liable for hundreds of millions in damages in the process. The cost to the health care system could be enormous as the two Eli Lilly patents may be the proverbial tip of the iceberg and claims from other pharmaceutical companies could soon follow.

Indeed, it appears that the Canadian government has awoken to the danger associated with dispute resolution systems that risk trumping domestic regulations and place billions of dollars at risk.

Last week, reports out of Germany indicated that the German government might not support the Canada – European Union Trade Agreement (CETA) if it includes such a system (referred to as an investor-state dispute settlement or ISDS). ISDS has attracted considerable attention there, due to concerns over a multi-billion dollar claim involving Germany’s decision to phase-out nuclear power.

While the ISDS concerns have centered on Germany, the reality is that the Canadian government has been holding up finalizing the agreement due to related fears stemming from fears of more Eli Lilly-style cases. The pharmaceutical industry is a powerful lobby group in Europe and some may be willing to pursue similar litigation over Canadian patent law.

According to leaked versions of CETA texts, Canada is requesting that court decisions and administrative tribunal rulings involving the creation or limitation of intellectual property rights be carved out of the treaty’s ISDS provisions.

The European Union has thus far rejected the Canadian proposal.  However, given the mounting opposition to ISDS in Europe, it may be willing to shift its position.  From a Canadian perspective, the Eli Lilly case has provided a powerful reminder that the risks associated with ISDS may outweigh the benefits with legal cases that can take decades to resolve.

17 Comments

  1. ISDS is effectively dead in EU trade deals. Germany said it would block CETA adoption in the Council when ISDS is included, a strong measure. However, ISDS just relates to the enforcement of CETA. In other words, both sides could agree on CETA substance without the ISDS in no time.

    The reason is that ISDS was envisaged for uneven treaties with unreliable nations, not advanced economies with proper legal redress. The EU competence to conduct trade deals on their own is new and they put high emphasis on ISDS enforcement. Now member states and public call them back. De Gucht is leaving office and probably German Oettinger would take over.

    With ISDS out of CETA it also won’t happen for T-TIP.

  2. Pingback: Did Canada Cave on the Pharmaceutical Patent ISDS Issue in CETA?: Still No Text, But Official Comments Suggests It Did - Michael Geist

  3. The United States has a long-established principle that constitutional considerations override treaties. If Lilly is successful with its current process, perhaps the next step could be for someone to seek a restraining order to prevent payment by the federal government on the grounds that it is in contempt of a Supreme Court decision.

  4. relevant does these concepts hold good in indian context and some details about the prefab construction.
    alçıpan

  5. Hi friends, good piece of writing and fastidious urging
    commented here, I am genuinely enjoying by these.

    My homepage; Auf dem PKV Tarifportal

  6. Hi! Quick question that’s completely off topic. Do you know how to make your
    site mobile friendly? My website looks weird when browsing from my iphone.

    I’m trying to find a theme or plugin that might be able to resolve this issue.

    If you have any suggestions, please share.
    Appreciate it!

    Feel free to surf to my blog :: http://pkv-tarifportal.de/die-wichtigsten-versicherungen-im-ueberblick/die-haftpflichtversicherung/

  7. This design is wicked! You definitely know how to keep a reader entertained.
    Between your wit and your videos, I was almost moved to start my own blog (well, almost…HaHa!) Excellent job.
    I really enjoyed what you had to say, and more than that,
    how you presented it. Too cool!

    Feel free to visit my website – Vergleichen Sie auf dem PKV-Tarifportal

  8. I always spent my half an hour to read this web site’s articles
    or reviews everyday along with a cup of coffee.

    Have a look at my web-site – shopping (code.smartoff.net)

  9. Hello! This is kind of off topic but I need some advice from an established blog.
    Is it very difficult to set up your own blog?
    I’m not very techincal but I can figure things out pretty
    quick. I’m thinking about setting up my own but I’m not
    sure where to start. Do you have any tips or suggestions?
    Cheers

    my site :: ranking checker

  10. Hey great blog! Does running a blog similar to this take a lot
    of work? I have virtually no understanding of coding however I was hoping to start my own blog in the near
    future. Anyways, if you have any recommendations or techniques for new blog owners
    please share. I know this is off topic but I simply wanted to ask.
    Appreciate it!

  11. Hey there would you mind letting me know which hosting company you’re
    working with? I’ve loaded your blog in 3 different web browsers and I must say this blog loads
    a lot quicker then most. Can you recommend a good hosting provider at a fair price?
    Thank you, I appreciate it!

  12. This piece of writing will help the internet visitors for building up new webpage or even a weblog
    from start to end.

  13. I loved as much as you will receive carried out right here.
    The sketch is tasteful, your authored material stylish.

    nonetheless, you command get bought an impatience over that you
    wish be delivering the following. unwell unquestionably come
    more formerly again since exactly the same nearly very often inside case you shield
    this hike.

  14. Hi! I just wanted to ask if you ever have any trouble with hackers?

    My last blog (wordpress) was hacked and I ended up losing many
    months of hard work due to no backup. Do you
    have any methods to prevent hackers?

  15. Howdy are using WordPress for your site platform? I’m new to the blog world but I’m trying to get started and set up my own. Do you require any coding
    expertise to make your own blog? Any help would be really appreciated!

  16. It’s awesome to pay a visit thiks web sitte andd reading the views of all colleagues regarding this puece of writing, while
    I amm also eager of getting experience.

  17. Definitely believe that which you stated. Your favorite reason seemed to be on the internet the easiest thing
    to be aware of. I say to you, I definitely get annoyed while people consider worries that they
    plainly don’t know about. You managed to hit
    the nail upon the top as well as defined out the whole thing without having side effect , people could take a signal.
    Will likely be back to get more. Thanks

    my website Margeret V. Ikner