[E-trademarks] FDA Approval

Tue Dec 5 15:28:40 EST 2023

Far more products "that affect the function or function of the human body" do not require FDA approval than those that do. 

But for the purpose of this question, let's assume that Client's "medical device" does require FDA approval. I do not suggest that you try to figure this out yourself.  21 CFR is best left to those specialists who handle that type of law.

It is not the role of either you or the trademark examining attorney to determine whether a product does or does not require regulatory approval. You may advise Client that it should be investigated, but if Client needs further advice, that determination should be made by a Certified Regulatory Affairs Professional (see RAC/RAPS). It is not your role to research and determine whether commercialization of the product is lawful, just as it is not your role to research and determine whether Client is laundering money, nicking office supplies, running a backyard still, or dodging tax payments. You assume that after receipt of your advice, Client does the right thing - unless you have proof otherwise.

The question of WHETHER a product requires marketing approval is a different issue altogether from whether products are deemed by law to be illicit and CANNOT (currently) achieve marketing approval at all.  That is the reason that trademark examining attorneys reject applications relating to federally illicit products - those are specifically called out as unlawful by an Act of Congress (37 CFR 2.69). In the case of something that may or may not be lawful (no applicable statute exists deeming it unlawful), or that may otherwise be lawful but for having entered the stream of commerce unlawfully, that is of no concern to the trademark examining attorney, whose job is to review applications for registration of marks, and to so register them if the marks meet the requirements for being registered.

I have filed MANY applications for registration of marks that are used on products obviously requiring FDA approval, and not once did an examining attorney ask whether we actually were seeking such regulatory approval.  Examining attorneys treat an identification of "pharmaceuticals for use in the treatment of autoimmune diseases" the same way the treat an identification of "t-shirts." Just meet the requirements for registration, and job well done.  

And now:

The first hypothetical is easy.  Client begins commercialization of the product without having the required FDA approval and obtains registration for the mark in an application filed under either 1(a) or 1(b).  The examining attorney, seeing nothing amiss, accepts the Allegation/Statement/Declaration of (lawful commercial) Use on its face.  

It's not that the product itself is unlawful, it's that its commercialization was commenced unlawfully.   If authorities later force removal of the product from the market for not having proper regulatory approval, then no post-registration commercial use Affidavits can be filed, and the registration will be canceled automatically.  Well, I suppose unless FDA approval can be sought and obtained, or a persuasive Declaration of Excusable Non-Use can be submitted by the next post-registration filing deadline.

The next hypothetical is a little more complicated. For parties undergoing FDA review, typically more than one mark is ITU-filed, in case any are refused. It is important to have at least one mark through examination/publication and "ready to go" near the end of regulatory review. Part of the regulatory review process includes strict labeling requirements that are scrutinized prior to final marketing approval, and which include the intended branding.  Moreover, the FDA has some of their own "extra" special requirements for trademarks of regulated products.  So, it is a best practice to have more than one mark already in allowed status and available for the FDA to approve.

Note that interstate shipments of branded samples prior to marketing approval, for example, for the purpose of clinical studies, do in fact qualify as "commercial use" for the purpose of filing a Statement of Use.  And Client can use as many of the allowed marks as it wants in those shipments so that there are multiple allowed marks from which to make a final choice. It sometimes happens that one of the other allowed marks can be maintained in allowed status with extension requests and used for another product coming down the pipeline.

But even if Client had no such pre-FDA-approval interstate shipments, an application in allowed status, combined with eventual FDA approval, paves the way for filing a Statement of Use. And note, nowhere in that Statement of Use will there be any reference made to FDA approval.  The only place that is specifically addressed is in extension requests, where you must give justification for extensions 2-5. But again, that has zero to do with the "legality" of the product and whether the trademark examiner is thinking about that at all (Hint: not thinking about it). 

So (speaking from experience and without providing legal advice), in the scenario you presented, I would advise Client to get professional advice about whether the product requires FDA approval.  

If Client says "no," then I would go ahead and file the application(s). Unless the product itself is illicit, there should be no issues.  The examining attorney will not give one fleeting thought to FDA approval during examination. 

If Client says "yes," then I would file one or more ITU applications while the product undergoes regulatory review, and interface with the RAP once it/they are allowed, and/or once any pre-approval interstate shipments commence. If an Allegation of Use can be approved before FDA approval, it is possible that the first FDA-approved commercialized shipments can hit distribution with an "(R)" rather than "TM."

Oh, and I would have Client sign all documents submitted - especially the application(s) and any Affidavit(s)/Allegation(s)/Declaration(s) of Use. 

Kind regards,

Diane L. Gardner
Reg. No. 36,518
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Message: 30
Date: Tue, 5 Dec 2023 05:20:35 +0000
From: Daniel Kegan <dkegan at bhhlawfirm.com>
To: Oppedahl Carl <e-trademarks at oppedahl-lists.com>
Subject: Re: [E-trademarks] FDA approval
Message-ID: <701A2ADA-662B-4868-9053-2385C4F06D41 at BhhLawFirm.com>
Content-Type: text/plain; charset="utf-8"

Generally things that affect the function or function of the human body likely need FDA approval,
unless an explicit exception. What does your client descriptively call the product, is there also a
common medical term for it. Check the FDA regulations for a start. (Non-human animals may
have a slightly different over-simplistic summary.)

Daniel Kegan
Daniel Kegan *  847-452-2599
Baron Harris Healey, Of Counsel
<DKegan at BHHLawFirm.com>
<http://www.BHHLawFirm.com>
Balanced Counsel for Smart Clients?
29 Kendal Dr
Kennett Square PA 19348-2323 USA

On Dec 4, 2023, at 7:53?PM, Mark Kaufman via E-trademarks <e-trademarks at oppedahl-lists.com> wrote:

Client has a product that appears to be some sort of medical device (at least to me).  Let?s say it removes tattoos, without piercing the sling and without medical professional assistance.  If it does not have FDA approval, is it likely to be denied trademark registration? Certainly the denial of trademarks for all things containing CBD (despite the legality of CBD) would suggest an unhappy ending to this trademark application, too.

Let me know your thoughts, please!

Thanks,
Mark

Mark S. Kaufman
Kaufman & Kahn, LLP
Email:  kaufman at kaufmankahn.com<mailto:kaufman at kaufmankahn.com>
www.kaufmankahn.com<http://www.kaufmankahn.com/>

10 Grand Central
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Message: 31
Date: Tue, 5 Dec 2023 06:08:25 +0000
From: Alex Butterman <abutterman at dbllawyers.com>
To: "For trademark practitioners. This is not for laypersons to seek
	legal advice." <e-trademarks at oppedahl-lists.com>
Subject: Re: [E-trademarks] [EXT] Re:  FDA approval
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	<PH7PR15MB6502E894BD2BF9625ED09BC9BB85A at PH7PR15MB6502.namprd15.prod.outlook.com>

Content-Type: text/plain; charset="utf-8"

Right, that is why I think registration could be prevented but usually only in the context of an opposition where a third-party presents the necessary evidence, with the exception of course of the Controlled Substances Act. Or maybe a timely letter of protest would work to stop the approval of the application.

Alex Butterman
Partner
DUNLAP BENNETT & LUDWIG
211 Church St., SE; Leesburg, VA 20175
T: 703-777-7319 ? BIO<https://www.dbllawyers.com/attorney/alex-butterman/>
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From: E-trademarks <e-trademarks-bounces at oppedahl-lists.com> On Behalf Of Edward Timberlake via E-trademarks
Sent: Monday, December 4, 2023 09:02 PM
To: For trademark practitioners. This is not for laypersons to seek legal advice. <e-trademarks at oppedahl-lists.com>
Cc: Edward Timberlake <ed at timberlakelaw.com>
Subject: [EXT] Re: [E-trademarks] FDA approval

If no lawful use of the goods can be made, then wouldn't a registration of the mark as a trademark for the goods remain vulnerable to attack?

As for whether an application for registration of a trademark for such a device would result in a registration, mightn't that somewhat depend on whether the Trademark Examining Attorney was aware of lawfulness of use as an issue at the time of examination?

Sincerely,

Ed Timberlake
Board Certified Specialist in Trademark Law<https://www.nclawspecialists.gov/for-the-public/find-a-board-certified-specialist/results/detail/?id=29473>

Timberlake Law<http://timberlakelaw.com/>
Chapel Hill, NC

Schedule a call on Clarity<https://clarity.fm/edtimberlake>
ed at timberlakelaw.com<mailto:ed at timberlakelaw.com>
919.960.1950

[https://ci3.googleusercontent.com/mail-sig/AIorK4yqPkLcW3Y31kc85P6RS7NWfcWrwuOgQLDSt1RcISuArSpo9OMPIPpEM0gaFcPeg00KJcaNlw0]

On Mon, Dec 4, 2023 at 7:54?PM Mark Kaufman via E-trademarks <e-trademarks at oppedahl-lists.com<mailto:e-trademarks at oppedahl-lists.com>> wrote:
Client has a product that appears to be some sort of medical device (at least to me).  Let?s say it removes tattoos, without piercing the sling and without medical professional assistance.  If it does not have FDA approval, is it likely to be denied trademark registration? Certainly the denial of trademarks for all things containing CBD (despite the legality of CBD) would suggest an unhappy ending to this trademark application, too.

Let me know your thoughts, please!

Thanks,
Mark
Mark S. Kaufman
Kaufman & Kahn, LLP
Email:  kaufman at kaufmankahn.com<mailto:kaufman at kaufmankahn.com>
www.kaufmankahn.com<http://www.kaufmankahn.com/>

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Message: 32
Date: Tue, 5 Dec 2023 13:50:11 +0000
From: Helen Stanford <helen.stanford at outlook.com>
To: "E-trademarks at oppedahl-lists.com"
	<e-trademarks at oppedahl-lists.com>
Subject: [E-trademarks] Looking for Counsel in California
Message-ID:
	<LV3PR12MB9353C7796065D0F673BA4F9F8F85A at LV3PR12MB9353.namprd12.prod.outlook.com>

Content-Type: text/plain; charset="iso-8859-1"

We are looking for referrals to handle a trademark infringement matter in California (district to be determined). The client wants a small firm and very cost-conscious counsel (and would consider a contingent fee lawyer as well). Referring counsel would stay involved but in a more minor role - the chosen counsel will handle the case beyond just being local counsel.

Thanks,

Helen Stanford
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Message: 33
Date: Tue, 5 Dec 2023 11:08:58 -0500
From: Greg William <greg at danielsonlegal.com>
To: "e-trademarks at oppedahl-lists.com Carl"
	<e-trademarks at oppedahl-lists.com>
Subject: [E-trademarks] Looking for Process Server in the Miami Area
Message-ID:
	<CALdeGoHRQLj5r=_ze4wEWg+DY+zhavzTTJyRT+qckaV7hz-bXA at mail.gmail.com>
Content-Type: text/plain; charset="utf-8"

I am looking for recommendations for a process server in the Miami, FL
area.  As always, off-list pls.

Thank you,
Greg

Gregory S. William, Esq.*
Danielson Legal LLC
One Mifflin Place, Suite 400
Cambridge, MA 02138
w: www.danielsonlegal.com
e: greg at danielsonlegal.com
t: (617) 714-9579
direct: (508) 865-2204
f: (888) 742-8097

*Licensed to practice in Massachusetts

This message is intended only for the designated recipient(s). It may
contain confidential or proprietary information and may be subject to the
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Message: 34
Date: Tue, 5 Dec 2023 11:26:36 -0500
From: Michael Brown <michaeljbrownlaw at gmail.com>
To: e-trademarks <e-trademarks at oppedahl-lists.com>
Subject: [E-trademarks] Post reg email
Message-ID:
	<CAHoOZLQUy9NQAG8BfzCXUbm+huBvTfBUZY2C--op+1HfLaX=Uw at mail.gmail.com>
Content-Type: text/plain; charset="utf-8"

Is there a general email for the post registration unit? I would like to
just ping them on some post registrations filings that were submitted in
April and May, but have yet to be reviewed. It is definitely not worth
wasting time calling TAC and sitting on hold for hours.

Michael Brown
Michael J Brown Law Office
354 Eisenhower Parkway
Plaza I, 2nd Floor, Suite 2025
Livingston, NJ  07039

michaeljbrownlaw at gmail.com
www.mjbrownlaw.com
+1 973-577-6300  fax +1 973-577-6301
Google Voice +1 973-637-0358
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