EN | ES | DE | FR | IT | 日本語 | 한국어 | 中文

CAFC Affirms IPR Dismissal for Lack of Standing and Mootness

CAFC Upholds Unpatentability of Diagnostic Method Claims
March 3, 2019
Lessons Learned on the Eve of the 10,000th Post Grant Petition Filed at the PTAB
March 24, 2019
Show all

CAFC Affirms IPR Dismissal for Lack of Standing and Mootness

 

By: Katie Rubino

 


On February 7th, 2019 the Court of Appeals for the Federal Circuit (CAFC) affirmed a decision by the Patent Trial and Appeal Board (PTAB) dismissing an inter-partes review (IPR) due to a lack of standing and mootness. This decision centers around IPR 2015-01537, Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co.

Bristol-Myers Squibb Co. (BMS) is owner of ‘239 patent which is directed at formulations for cytotoxic T-lymphocyte associated protein 4 immunoglobulin (CTLA4Ig), commonly known as abatacept and sold by BMS under the brand name Orencia. Orencia is commonly used for conditions associated with immune system over-stimulation such as rheumatoid arthritis and psoriatic arthritis. Orencia works by blocking antigen-presenting cells from delivering stimulatory signals, thus leading to down regulation of T cells, and as such blocking an inflammatory response.

In July of 2015, Momenta filed a petition for IPR review of BMS’s ‘239 patent, as Momenta was developing a biosimilar drug product containing CTLA4Ig in partnership with Mylan. The PTAB initiated the IPR and upheld patentability of BMS’s ‘239 patent. Momenta then appealed the PATB’s decision to the CAFC.

Upon appeal to the CAFC, BMS moved to dismiss the appeal, claiming that Momenta did not have standing to bring the appeal, after Momenta’s phase I trials of its biosimilar product failed testing. In November of 2018, Momenta had terminated its partnership with Mylan to develop the biosimilar drug product containing CTLA4Ig.

In view of these findings, the CAFC dismissed Momenta’s appeal for lack of standing and mootness. Generally, a party cannot bring suit unless he or she can demonstrate that he or she will be imminently harmed. The CAFC reasoned that because Momenta had stopped its development of a biosimilar product it “is not engaged in any activity that would give rise to a possible infringement suit.” Momenta then argued that it may at some future time receive a royalty from Mylan, if Mylan were to ever produce a biosimilar containing CTLA4Ig. The CAFC also dismissed this argument, citing that unknown future events were speculative at most.

During the appeal at the CAFC, BMS brought up a mootness argument, pointing out that Momenta’s decision to abandon pursuit of the biosimilar placed Momenta beyond the reach of the law. Cases that are considered moot are dismissed under Article Three of the Constitution which limits the jurisdiction of the federal courts to actual cases and controversies. The CAFC affirmed BMS’s mootness argument, explaining that “Momenta has not shown an invasion of a legally protected interest that is actual or imminent, not conjectural or hypothetical.” The CAFC concluded by claiming “there is no real need to exercise the power of judicial review.”

The CAFC further explained that even though Momenta may have been working in a potentially infringing space, jurisdiction must exist throughout the entire review. Because Momenta abandoned its plans to pursue the biosimilar partway through the review, the intervening abandonment of the controversy leads to a loss of review. In E.I. DuPont de Nemours & Co. v. Synvina C.v., the CAFC held that an appeal was available, because an actual controversy existed. In that case, both parties were actively engaged in activities that were likely to pose a significant risk of patent infringement.

After reviewing all evidence, the CAFC affirmed the PTAB’s dismissal. Looking ahead, this case demonstrates that activities that occur throughout the appeal process can have a direct impact on a pending appeal. Cases that are brought before the CAFC must be ripe and have an actual concurrently engaged controversy. Proposed and speculative future events will not account for ripeness and may even lead to dismissal as moot.

19 Comments

  1. Excellent post. I absolutely appreciate this website.
    Thanks!

  2. Hello! This is kind of off topic but I need some help from an established blog.
    Is it very hard to set up your own blog? I’m not very techincal but I can figure things out pretty fast.
    I’m thinking about creating my own but I’m not sure where to start.
    Do you have any points or suggestions? With thanks

  3. Do you have a spam problem on this site; I also am a blogger,
    and I was wondering your situation; many of us have
    developed some nice practices and we are looking to trade techniques
    with other folks, why not shoot me an email if interested.

  4. Nice weblog here! Also your web site lots up fast! What web
    host are you the usage of? Can I am getting your associate link to your host?
    I want my site loaded up as fast as yours lol

  5. Hmm it looks like your website ate my first comment
    (it was extremely long) so I guess I’ll just sum it up what I wrote and say, I’m thoroughly enjoying
    your blog. I as well am an aspiring blog blogger but I’m still new to everything.

    Do you have any helpful hints for beginner blog writers?
    I’d really appreciate it.

  6. Incredible points. Outstanding arguments. Keep up the good spirit.

  7. Excellent blog right here! Additionally your website quite a bit
    up very fast! What host are you using? Can I get your associate link for your host?
    I desire my web site loaded up as quickly as yours lol

  8. Heya i’m for the first time here. I came across this board and I to
    find It really helpful & it helped me out much. I hope to present something back and help others like you aided
    me.

  9. At this time it seems like Expression Engine is the best blogging
    platform available right now. (from what I’ve read) Is
    that what you’re using on your blog?

  10. Hi there colleagues, pleasant paragraph and fastidious urging commented at this place, I am actually enjoying by these.

  11. It’s really a nice and helpful piece of info. I am glad that
    you just shared this helpful information with us.
    Please stay us up to date like this. Thanks for sharing.

  12. Does your blog have a contact page? I’m having a tough time locating it but, I’d like to send
    you an e-mail. I’ve got some creative ideas for your blog you might be interested
    in hearing. Either way, great website and I look forward to seeing it grow
    over time.

  13. ps 4 games says:

    Yes! Finally someone writes about playstation 4 games.

  14. tinyurl.com says:

    Having read this I thought it was rather informative.
    I appreciate you taking the time and effort to put this informative article together.
    I once again find myself spending a significant amount
    of time both reading and leaving comments. But so what, it was still worthwhile!

  15. Write more, thats all I have to say. Literally, it seems as though you relied on the video to
    make your point. You definitely know what youre talking about,
    why waste your intelligence on just posting videos to your site when you could be giving
    us something informative to read?

  16. I used to be suggested this website by my cousin. I’m now not positive whether or
    not this put up is written by way of him as no one else know such exact about my problem.
    You are wonderful! Thank you!

  17. Pretty nice post. I just stumbled upon your weblog and wished to say that I have really enjoyed surfing around your blog posts.
    In any case I will be subscribing to your feed and I hope you
    write again soon!

  18. Hello would you mind sharing which blog platform
    you’re using? I’m looking to start my own blog in the near future but
    I’m having a difficult time choosing between BlogEngine/Wordpress/B2evolution and Drupal.
    The reason I ask is because your layout seems different then most blogs and I’m looking
    for something completely unique. P.S Apologies
    for getting off-topic but I had to ask!

  19. quest bars says:

    That is very interesting, You are an excessively skilled blogger.

    I have joined your feed and stay up for in search of extra
    of your excellent post. Additionally, I’ve shared your site in my social networks

Leave a Reply

Your email address will not be published. Required fields are marked *