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The Iris Lightener Kit sold by Isis Cosmeceuticals contains MSM and Arbutin eye drops meant for modifying the pigment in the iris.

Doesn’t it infringe on patent US 2012/0207809 A1, “Method and system for effecting changes in pigmented tissue”?

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Before I dig into the patent application, I'll just note that the active ingredient in the product you mention (arbutin) is indeed a glycoside hydroquinone, which is directly claimed in dependent claim 2 of the application (which must be read in the context of independent claim 1):

  1. A method of lightening the color of the iris of a human subject, the method comprising administering to the iris of the human subject an amount of a composition comprising a tyrosinase inhibitor effective to lighten the color of the iris of the human subject.

  2. The method of claim 1, wherein the tyrosinase inhibitor is hydroquinone,

Unfortunately, now we need to dig deeper, which is a problem because this patent has a lengthy prosecution history, and an office action is currently pending on a non-final rejection. This means that the patent claims and the final outcome of the application are still undetermined, and your question is not answerable with 100% certainty.

Note that the claims as they are listed in Google Patents and the published application no longer reflect the currently pending claims, which can be found in the Image File Wrapper in the USPTO Public Pair database. Nor can we rely on the claims currently found in the Image File Wrapper, since after the next office action they will be modified again (I'm anticipating that this will occur based on a fairly recent Request for Continued Examination).

However, we can make a few educated guesses based on the examiner's notes on the non-final rejection. First, let's look at the most recent version of claim 1:

  1. A method of lightening the color of the iris of a human subject, the method comprising administering to the iris of the human subject an amount of a composition comprising a melanogenesis inhibitor effective to lighten the color of the iris of the human subject.

Now we need to determine whether arbutin is considered to be a melanogenesis inhibitor. Indeed, we can quickly find some references which classify arbutin as a melanogenesis inhibitor:

Sugimoto, K. (2003). α-Arbutin: a new skin-lightening agent for cosmetics (in Japanese). J. Appl. Glycosci. 50:109-110.

Sugimoto, K. et al. (2003). Syntheses of Arbutin-α-glycosides and a Comparison of Their Inhibitory Effects with Those of α-Arbutin and Arbutin on Human Tyrosinase. Chem. Pharm. Bull. 51:798-801.

Sugimoto, K. et al. (2005). Inhibitory Effects of Several Types of Hydroquinone Glycosides on Human Tyrosinase and Melanogenesis Inhibition of Alpha-Arbutin" Fragrance Journal 33(5) 60-66.

Note that the dates of the above publications are well before the priority date of the application (January 29, 2009), which makes these prior art to any claims on the use of arbutin as melanogenisis inhibitors. Now, if you read further into the office action response, the inventors are defending against the rejection by stating:

This rejection is not supported by these citations and should be withdrawn because disclosures relating to tissues and cells other than iris, such as skin, etc., are not applicable to the iris.

The examiner sidesteps the above argument by rejecting on the grounds of prior art from an earlier patent:

Claims 1, 19 and 20 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Drago et al (USPN 6,359,001).

Drago et al (USPN 6,359,001) teach methods of lightening the color of the iris in a human comprising administering a melanogenesis inhibitor, which human is healthy of afflicted with glaucoma (see entire document, esp. the abstract, col. 1, 2, claims 1-10).

Now, Drago et al. (US 6,359,001 B1) is a granted patent covering "Use of α-methyl-p-tyrosine to inhibit melanin production in iris melanocytes". The abstract is as follows:

The use of agents for blocking the synthesis of tyrosinase to prevent permanent pigmentation of the iris caused by melanin deposit induced by pharmacological treatments or by metabolic imbalance is described.

The claims of this earlier patent will effectively serve as prior art to prevent new patents in this space, so now the question becomes whether the product you mentioned infringes on the '001 patent. The claims in the '001 patent are far more complex, but fortunately we don't need to read them because the patent has lapsed (March 19, 2010) and is not currently enforceable. However, there are several caveats to that statement. First, although unlikely, the patent could once again become enforceable (through April 22, 2017) if the patent is revived and the fees are paid. I don't think this will occur because the assignee has now missed both the second (2010) and third (2014) fee payment dates. This means that the enforceable period of the grant in the United States was (I think) April 21, 1998 through March 19, 2010. Secondly, if that product were sold between the enforceable dates, the assignee (Pharmacia Ab) could potentially sue for damages retroactively. However, if the product were on the market prior to the priority date of the patent or after the enforceable date of the grant, then it should be in the clear. Of course, for all we know, the company that produces the product may be a subsidiary of the assignee, or may have already taken a license.

As a side note, the application you mentioned might set a record for the number of domestic benefit claims, which complicates the comprehension of this patent by making the ten non-provisional documents below required reading material if you are interested in further study of this application:

This application claims the benefit of the priority of

a. International Patent Application No. PCT/US10/00257, filed Jan. 29, 2010, and
b. International Patent Application No. PCT/US10/002051, filed Jul. 21, 2010.

Further, this application claims the benefit of the priority of

c. U.S. NonProvisional patent application Ser. No. 13/138,260, filed Jul. 25, 2011 and
d. U.S. NonProvisional patent application Ser. No. ______ filed Nov. 29, 2011.

Further, this application claims the benefit of the priority of

e. U.S. Provisional Patent Application Ser. No. 61/206,391, filed Jan. 29, 2009;
f. U.S. Provisional Patent Application Ser. No. 61/212,722, filed Apr. 15, 2009;
g. U.S. Provisional Patent Application Ser. No. 61/271,498, filed Jul. 22, 2009;
h. U.S. Provisional Patent Application Ser. No. 61/271,961, filed Jul. 29, 2009;
i. U.S. Provisional Patent Application Ser. No. 61/343,558, filed Apr. 30, 2010; and
j. U.S. Provisional Patent Application Ser. No. 61/418,570, filed Dec. 1, 2010.

This application is a continuation in part of

a. International patent application No. PCT/US10/00257, filed Jan. 29, 2010;
b. International patent application No. PCT/US10/002051, filed Jul. 21, 2010;
c. U.S. NonProvisional patent application Ser. No. 13/138,260, filed Jul. 25, 2011;
d. U.S. NonProvisional patent application Ser. No. ______, filed Nov. 29, 2011;
e. U.S. Provisional Patent Application Ser. No. 61/206,391, filed Jan. 29, 2009;
f. U.S. Provisional Patent Application Ser. No. 61/212,722, filed Apr. 15, 2009;
g. U.S. Provisional Patent Application Ser. No. 61/271,498, filed Jul. 22, 2009;
h. U.S. Provisional Patent Application Ser. No. 61/271, 961, filed Jul. 29, 2009;
i. U.S. Provisional Patent application Ser. No. 61/343,558, filed Apr. 30, 2010; and
j. U.S. Provisional Patent Application Ser. No. 61/418,570, filed Dec. 1, 2010.

Throughout this application various publications, published patent applications, 
and patents are referenced. The disclosures of these documents in their entireties 
are hereby incorporated by reference into this application in order to more fully 
describe the state of the art to which this invention pertains.
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    Wow, great response. I did not realize that the patent I mentioned was not granted yet. This is very interesting. How many times can the inventor Request Continued Examination and when does a "Final Rejection" actually become final? Also, I would like to ask, that since this patent is pending, if one were to use this technology, that would be alright and not infringing, correct? – Gia Sep 4 '15 at 0:43
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    @Gia That is a great question. I believe the inventor may continue filing RCEs (which cost money). However, as the prosecution continues, the inventor will find himself working in a decreasingly smaller space (that of the original specification), and accordingly smaller time (that of the original priority date). In this case, the date to watch for is April 22, 2017. This is not official legal advice, of course, but based on my interpretation of the prior art, this space will be public domain on that date. – vallismortis Sep 4 '15 at 1:25
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    Sorry, just to be clear because I don't understand legal jargon much, are you saying that any type of work involving tyrosinase inhibitors on iris melanin or anything else covered in this patent should be avoided until April 22, 2017, Does this inventor have legal right to sue me if I were to start using his technology tomorrow? – Gia Sep 4 '15 at 2:56
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    @Gia The inventor would need to petition the USPTO to reinstate the abandoned patent, the USPTO would need to approve it, and then the inventor would need to catch up on the maintenance fees. I believe it has been far too long since the patent lapsed for a petition to be successful, which means the patent is likely not enforceable after March 19, 2010. For the newer application, I do not see any clear way for the inventor to get past the examiner's rejections, and I believe the application will remain abandoned. – vallismortis Sep 4 '15 at 12:00
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    @Gia If you are looking for legal advice on freedom to operate, that is typically known as a clearance search, which can be expensive. – vallismortis Sep 4 '15 at 12:02

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