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This section is dedicated exclusively to your questions on animal patenting topics. You are invited to ask questions to our legal adviser, Dr. Erin R. Ogden. Just send your questions to andieeaap.org. Questions and answers shall be published in this page. 

 

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QUESTIONS

When and under what conditions can a patent application be opposed in the US after it has been published? Go

Is there a way to oppose a PCT patent application in Geneva before it is filed in member countries? Go

Can a person or organization patent an entire genomic region around one SNP?

Can a person or organization patent SNPs or SNP regions without evidence of any association with the traits of interest?  Go

What is the adviser's opinion with regard to the chances of success of the current MMI patent application by Monsanto based on the question above?  Go
The Geneva's preliminary report on patentability for the MA BLUP patent application made by Monsanto, was issued on Aug 14, a couple of weeks after Monsanto filed the patent application in Canada.  While many claims were rejected, some still stand, so I would appreciate receiving any comments that the PSAS lawyer may have to summarize this report and provide their opinion of the patent application status.   Go

 

 

 

Question

When and under what conditions can a patent application be opposed in the US after it has been published?

 

Answer

You cannot oppose a U.S. patent application in the traditional sense of arguing in front of the examiner and having him judge who is correct.  Instead, you can file information with the examiner that may affect patentability.  This is done either by protest or by simply citing prior art. 

According to the US Patent Office’s Manual of Patent Procedure, a protest may be filed by a member of the public against a pending application.  “As a practical matter, any protest should be submitted as soon as possible after the protestor becomes aware of the existence of the application to which the protest is to be directed. By submitting a protest early in the examination process, i.e., before the Office acts on the application if possible, the protestor ensures that the protest will receive maximum consideration and will be of the most benefit to the Office in its examination of the application. A protest submitted after the mailing of the notice of allowance will not knowingly be ignored if the protest includes prior art documents which clearly anticipate or clearly render obvious one or more claims. However, the likelihood of consideration of a protest decreases as the patent date approaches.  A protestor does not, by the mere filing of a protest, obtain the "right" to argue the protest before the Office. Active participation by a protestor ends with the filing of the protest, and no further submission on behalf of the protestor will be considered.”  MPEP Sec. 1900.  This usually needs to be done before publication.  Of course, it is difficult to know of a patent before publication, but you may always just cite prior art for the file.

“Any person at any time may cite to the Office in writing prior art consisting of patents or printed publications which that person believes to have a bearing on the patentability of any claim of a particular patent. If the person explains in writing the pertinency and manner of applying such prior art to at least one claim of the patent, the citation of such prior art and the explanation thereof will become a part of the official file of the patent.”  MPEP Sec. 2200.

Neither of these actions will ensure that the examiner will put any extra weight on the submitted material, but it at least makes the prior art part of the file.  This may effect any later litigation or reexamination.  Reexamination occurs after issuance of the patent.

 

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Question

Is there a way to oppose a PCT patent application in Geneva before it is filed in member countries?

 

Answer

I am not aware of any way to oppose the PCT filing before it is moved into the member countries nor could I find anything allowing it.  Given that the examinations occur at the national offices, not Geneva or the International Searching Authorities, it is not surprising they do not allow oppositions at that stage.  In addition, the International Bureau and the International Searching Authorities shall not allow access by any person or authority to the international application before the international publication of that application, unless it is requested or authorized by the applicant.  So you wouldn’t be able to look at the application to know what you were opposing unless the applicant published it or allowed you to look at it.

 

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Question

Can a person or organization patent an entire genomic region around one SNP?

Can a person or organization patent SNPs or SNP regions without evidence of any association with the traits of interest?

 

Answer

In order to obtain a patent on genetic sequences, whether a SNP, an EST, or a gene, the applicant must:

  1. Identify the novel genetic sequence;

  2. Specify the sequence’s product;

  3. Specify how the product function in nature: its use or utility; and

  4. Enable one skilled in the field of use to use the sequence for this stated purpose

SNP’s are difficult to patent because they have a hard time passing the “utility” test for patents.  The applicant has to state why the SNP is useful.  That statement has to be fairly explicit, especially for DNA sequences.  Gone is the time for “it makes a great probe.”  Patents are not granted on raw fundamental gene, EST or SNP sequence data.

In order for DNA sequences to be distinguished from their naturally occurring counterparts, which cannot be patented, the patent application must state that the invention has been purified or isolated, is part of a recombinant molecule, or is now part of a vector.  In addition, it must state how the patented sequence functions in nature.  The USPTO rules call for a statement giving “specific and substantial utility that is credible.”

Due to these requirements, in order to patent an entire genomic region around a SNP or any region whatsoever, you must be able to state what sequence is involved, what that region does, and why that sequence is useful.  Thus, if an applicant is able to do that for a region, then whether it is centered on a SNP, EST, or other sequence, it may be patentable.  As for evidence, it isn’t necessary to a given standard.  That is, you do not have to prove the utility beyond a reasonable doubt.  But applicant does have to state the use of the sequence with a good faith belief what he is saying is true.  If an applicant makes stuff up without any or a poor basis, they are opening themselves up to trouble.

http://www.sciencemag.org/cgi/content/full/280/5364/689 is a 1998 article written by John J. Doll, the Commissioner of Patents at the USPTO regarding the USPTO’s viewpoint of DNA patents.

 

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Question

What is the adviser's opinion with regard to the chances of success of the current MMI patent application by Monsanto based on the question above?

 

Answer

Assuming this is referring to US Patent App. No. 20050260603.

The first thing that is noticeable is the missing part of their first claim.  If that is truly how the application goes, they are certainly not going to get what they thought they were since an entire clause is missing.  I assume that they will try to amend and base it on disclosures given in the rest of the application, but I would hate to be the attorney that had to explain that oversight to their client. 

Overall, it seems broad.  It is hard to point to what exactly it is they are claiming.  If nothing else, the application will be pared down quite a bit.  In comparison is United States Patent No. 7,026,116, Ruddy, et al. that was registered April 11, 2006.  I think that the registered application will be much more specific, but I don’t think that it will be refused completely.  Basing the claimed sequence around a SNP should not cause it to not be patented.  However, it is difficult to figure out what sequences they are claiming.  I would bet they have a few patent applications get divided out of this one to handle the different issues separately. 

Some other patent documents of note are:

US Patent No. 7107963 – Device and method for animal tracking.  Registered Sept. 19, 2006

US Patent App. 20050287531 – Methods and systems for inferring bovine traits. Published December 29, 2005

From WIPO – International filings Click here

 

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Question

The Geneva's preliminary report on patentability for the MA BLUP patent application made by Monsanto, was issued on Aug 14, a couple of weeks after Monsanto filed the patent application in Canada.  While many claims were rejected, some still stand, so I would appreciate receiving any comments that the PSAS lawyer may have to summarize this report and provide their opinion of the patent application status.

 

Answer

This application was interesting.  First of all, I could not find it on the United States database.  Since it was a provisional application, it did not have to publish unless and until it was converted into a utility application.  It should have published by now if it had been converted so my guess is they abandoned it in the U.S.  They did convert the PCT into national stages in Canada (Ref. No. 2554517) on 25.07.2006 and Mexico (Ref. No. PA/a/2006/009037) on 09.08.2006.   

As for the claims remaining after the preliminary report, they all have one thing in common, PRKAG3, a “muscle specific isoform of the regulatory gamma subunit of adenosine monophosphate-activated protein kinase.”  I read that as it is possibly patentable to use these unpatentable techniques on that unique protein.  That is a bit odd given that the PRKAG3 was not claimed.  That means the protein was known, the methods were known, but the combination of the two is innovative.  Unless they can show that it is unlikely to combine the two, the application seems fairly troubled. 

The application tried to justify its innovation by claiming that by combining marker assisted selection with BLUP on a computer they came up with “unexpectedly useful and effective extensions and modifications of previously known techniques.”  They also claimed the “unique features” of an ability to use genetic information from any form of genetic analysis, a simultaneous analysis of 3 or more markers in “multi-trait” statistical models, and analysis of any type of population.

If this was not enough to allow the general claims, I am not sure how the addition of a specific protein, minus some teaching-away or long-term failure to use be able to use the protein, can now make it patentable.  The apparent choice not to continue the U.S. application might indicate that Monsanto thought the same thing.  I will keep an eye on this application and see if anything does pop up in the United States because I find it very odd that they are pursuing it elsewhere but not the U.S.  I would claim searcher error for not finding the U.S. application, but I had another patent attorney look as well.  We simply could not find it, and it is not listed as going national with the PCT at WIPO. 

Attached is a journal article from 2004, the year the provisional application was filed in the U.S. with some of the inventors cited as giving information to the author.  It is at that time that the novelty, non-obviousness, and inventive step would be judged so the paper can help put that into the correct framework.

Also attached are some patent abstracts that also involve BLUP in the application. 

 

 

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 Disclaimer

This information is provided for informational purposes only and does not constitute legal advice.  You should consult an attorney about your particular circumstances before you act on any of the information provided.

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