Must Patent Numbers be Shown on Product Labels?

E

evilchilli_420

#1
Hello,

Can anyone please clarify if there are any requirements (US/EU) to indicate the patent number in the product label? I could not find any written requirements in 21 CFR 801 or MDD 93/42/EEC M5. Any help is appreciated and thanks in advance.
 
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M

MIREGMGR

#2
There is no such requirement as a part of medical device law/regulations in either USA or the EU.

In both jurisdictions, medical device regulatory law is separate from intellectual property law.

Intellectual property law however does require that applicable patent number(s), or another appropriate status-statement, be shown on a product so as to inform users and others of its patent status.

In medical device law, required labeling information is commonly allowed to be placed on the single piece packaging of a medical device that must be sterile at point of use and therefore is sterile barrier packaged, or is too small to carry the required information directly on the part itself. It's not clear to me that that special exception to the information-on-the-product rules extends to intellectual property law. You might want to check that point with your I.P. lawyer.
 
M

MIREGMGR

#5
Requires or allows?
In USA and EU, requires. If a patented product is not marked to indicate the specific patent(s), the enforceability of the patent is severely limited. An infringer can defend against an infringement action by showing that the product was marketed without being marked, or with incorrect-format or incorrect-content marking.
 

Ronen E

Problem Solver
Staff member
Moderator
#6
In USA and EU, requires. If a patented product is not marked to indicate the specific patent(s), the enforceability of the patent is severely limited. An infringer can defend against an infringement action by showing that the product was marketed without being marked, or with incorrect-format or incorrect-content marking.
Thanks for the explanation. Do you know of any case history where an allegedly infringing defendant successfully used that argument?

As far as I'm aware, the onus of verifying that a design is in the public domain is on the object maker, and lack of marking on a specific embodiment of the IP does not relieve of this duty. Patents hold even if there's no embodiment at all (obviously, no marking in such a case).

Cheers,
Ronen.

PS As far as I understand, in the USA enforceability is a characteristic of the issued (written) patent, and does not depend on an embodiment.
 
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M

MIREGMGR

#7
Do you know of any case history where an allegedly infringing defendant successfully used that argument?
IP law isn't my specialization, but see for instance http://www.dicksteinshapiro.com/fil...b5d7f-2ad1-4536-8ad7-01ab9485794d/marking.pdf, or for Europe http://www.firstthoughtip.com/iprlist.html, or do a Google search for "failure to mark patent". It's a well-settled area of law in countries that are parties to the major IP-law conventions.

As far as I'm aware, the onus of verifying that a design is in the public domain is on the object maker, and lack of marking on a specific embodiment of the IP does not relieve of this duty.
As above, I believe this is incorrect.
 
P

perim

#8
In USA and EU, requires. If a patented product is not marked to indicate the specific patent(s), the enforceability of the patent is severely limited. An infringer can defend against an infringement action by showing that the product was marketed without being marked, or with incorrect-format or incorrect-content marking.
This is incorrect. It is not required by any law to add patent numbers to product labeling, nor does failing to do so in any way invalidate a patent.

You can however claim willful infringement (which in the US can triple damages) if the infringing party knew about the patent. It helps to establish this if the patent numbers were visible on a product that the defendant has been in possession of.

Note that I am not a lawyer and this is not legal advice, I just took some patent courses a long while ago...
 
Last edited by a moderator:
M

MIREGMGR

#9
This is incorrect. It is not required by any law to add patent numbers to product labeling, nor does failing to do so in any way invalidate a patent.
There hasn't been any suggestion that failing to mark invalidates a patent. It however in general blocks the ability to be awarded damages for infringement prior to specific written notice from the patent holder, which in the general case diminishes the economic value of the patent...which after all is the point. See the above links, or do the suggested Google search, for more information...in many cases, posted by IP lawyers and law firms, who likely know something about this stuff.

Note that I am not a lawyer and this is not legal advice (...)
And neither am I, so I strongly suggest that any reader here who needs to understand IP-law issues like this should consult their (actual, qualified) IP lawyer for valid legal advice.
 
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