In Brazil it is possible to use a natural variant, since they can not be claimed in patents.

Hi Sheila,

How about the SEQ ID NO:1 that disclosed in US 8877461 B2? Once it is claimed in the patent it means that it is a patent eligible subject matter and do not meet the Association for Molecular Pathology v. Myriad Genetics, Inc Supreme Curt role.

Dr. Hayakawa, Is there any Patent law regarding to the protein glycozylation?

Hi Mahdi

No you cannot use SEQ ID NO:1 and neither any sequence which is at least 90% identical to the said sequence SEQ ID NO:1. But if you can have an alternate method of producing β-santalene i.e. without contacting FPP then you have freedom to operate in the light of Claim 1 of  US8877461 B2.

Claim 1 of US8877461 B2  is read as under:

1. A method for producing β-santalene comprising

a) contacting farnesyl pyrophosphate (FPP) with at least one polypeptide having β-santalene synthase activity and comprising an amino acid sequence at least 90% identical to SEQ ID NO:1;

b) optionally, isolating the β-santalene produced in step a).

Further Association for Molecular Pathology v. Myriad Genetics, wherein the Supreme Courts  concludes  naturally occurring DNA sequence to be non-patentable.  

Myriad Genetics, Inc. (Myriad), obtained several patents after discovering the precise location and sequence of the BRCA1 and BRCA2 genes, mutations of which can dramatically increase the risk of breast and ovarian cancer which, in turn, enabled it to develop medical tests useful for detecting mutations in these genes in a particular patient to assess the patient’s cancer risk.

Court granted summary judgment concluding that Myriad’s claims were invalid because they covered products of nature and synthetically created DNA (cDNA), contains the same protein-coding information found in a segment of natural DNA but omits portions within the DNA segment that do not code for proteins to be patent eligible.

Hence mere DNA sequence is patent ineligible whereas cDNA are.

Hi Shaklian,

"No you cannot use SEQ ID NO:1 and neither any sequence which is at least 90% identical to the said sequence SEQ ID NO:1. But if you can have an alternate method of producing β-santalene i.e. without contacting FPP then you have freedom to operate in the light of Claim 1 of US8877461 B2"

Would you please address the Articles of law or any other case laws that support your answer?

As you can see in the patent description there is no strong supporting experimental evidences that one be able to conclude that all sequences with bordering  identity of at least 90% similarity to SEQ ID NO:1 should be protected by this claim!

At least 90% identity means a broad range of protein sequence variants that never made, nor tested in this patent!

Hi Mahdi

Examples gives you an idea for the reduction to practice of the encompassed invention within the patent and its scope is defined by the claims therein.

However up to what percentage of variants have been tested needs to be evaluated and would require an expert opinion.

I would recommend if you want to work around US8877461  then please do focus on an alternate method which does not employ FPP since the claims of "461 are on the method. If FPP is something very general to be used the you will have to work around the claimed sequence and its variants.

Just to add upon Kou, claims have three components:

a. Preamble

b. body

c. link

Here the claims relates to the production of β-santalene wherein FPP and SEQ ID NO. 1 and its variant having at least 90% are being employed. Then in order to get rid of these kind of claims one has two option

a. first to look for alternative to FPP, if possible science permits

b. or select sequence which is not identical to SEQ ID NO.1 and its variants(90%)

Hi Shaklian,

Thank you for your notes but I am still waiting to see some actual references that supports you notes!

Also what do you think about the following example?

The granted patent, US 8993284 B2,  that filed 4 years after '461, claimed a range of protein variants that have at least 90% identity to three sequences set forth as SEQ ID NO:2,4 and 6. Surprisingly the core sequence of these polypeptide's  share about %93 identity and 100% coverage to SEQ ID NO:1 in '461.  Both cases used the claimed protein with the same substrate and same application!

Mahdi:

I agree with Shaklain. If you need to produce this protein, try to use a different method than the one that is claimed in the patent. This is not legal advice.

Thank you for advice, but I need to know how could I avoid a claimed sequence. As I previously posted how could it possible that two patent claimed a closely related protein sequence?

""""""Hi Shaklian,

Thank you for your notes but I am still waiting to see some actual references that supports you notes!

Also what do you think about the following example?

The granted patent, US 8993284 B2,  that filed 4 years after '461, claimed a range of protein variants that have at least 90% identity to three sequences set forth as SEQ ID NO:2,4 and 6. Surprisingly the core sequence of these polypeptide's  share about %93 identity and 100% coverage to SEQ ID NO:1 in '461.  Both cases used the claimed protein with the same substrate and same application!"""""""

Hi Mahdi

Sorry for the delay. Yes claims of the patent you are mentioning are not protecting the sequences per se instead they are being directed towards the method of making the final product which is being catalyzed by the corresponding enzymes (terpene synthase in '824 ) . Hence i would suggest if possible work around the method.

Hi Shaklin,

What did you mean by "claims of the patent you are mentioning are not protecting the sequences". How did you conclude that?

Hi Mahdi

Its not protecting the sequence per se instead protects method of production of the product being catalyzed by the enzyme encompassed within the sequence and variants thereof. That's what i meant.

I agree with Shaklain, please develop a new process and file your own patent application.

Hi,

Note that a Patent Must have these three attributes:

1. Novel

2. Inventive

3. Industrially applicable

otherwise it will not be granted Patent Status. The concept, method, formulation, device, invention, or alike must be considered NOVEL and INVENTIVE to those who are: "Skilled in the art".

Therefore, it should not be possible to protect any naturally occurring molecule by a Patent, copyright or Trade Mark. 

Hi Mozafari,

Patent-ability criteria is well taken.

Naturally occurring molecule is not-patent-able but the patent claims being discussed so far between me and Mahdi wherein the sequences very well qualifies to be a patent-able subject matter and reason for the same are as under:

Novelty: Amino acid  being encompassed within the claimed sequence are being coded by cDNA and not by naturally occurring DNA sequence.

Inventive: Since the cDNA codes for a functional enzyme hence manifest the inventive step.

Industrial application: These enzymes can be reproduced as many times required for industrial purpose.

Now what i meant was because of the wording of the claims (being discussed between me and Mahdi) the sequences per se and its variant thereof are not protected therein and its not because they do not qualify to be a patent-able subject matter.

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If you want monopoly on a product (molecule, method, formulation, device etc) then go on for patent instead of copyright or trademark.

Copyright: wherein the presentation of an idea is protected. 

Trademark: is a recognizable sign, design, or expression which identifies products or services of a particular source from those of others, although trademarks used to identify services are usually called service marks.

Sorry for delay in responding.

Thanks.