Wednesday, June 26, 2013

In Myriad the Supreme Court Has, Once Again, Increased the Uncertainty of U.S. Patent Law



On June 13 the U.S. Supreme Court issued a unanimous decision in Association for Molecular Pathology v. Myriad Genetics (Myriad) which essentially upheld the patent eligibility of claims reciting cDNA molecules encoding BRCA proteins, but struck down as patent ineligible claims encompassing isolated fragments of BRCA-encoding genomic DNA. Unfortunately, as a consequence of the manner in which the case was decided Myriad will in all likelihood only serve to increase the ambiguity and uncertainty plaguing the U. S. patent system. Clearly, the mere isolation of a naturally occurring biomolecule is no longer sufficient to confer patent eligibility on the isolated product, regardless of how useful, nonobvious or inventive the isolated product is relative to the prior art. What is less clear is the patent eligibility status of a synthetic molecule that shares a common, or highly similar, structure with a naturally occurring biomolecule.
 I have written an article that addresses some of the ambiguities created by the Myriad decision, and the practical implications for patenting in the life sciences arena.  The article, which appears in Biotechnology Law Report, is available here for the interested reader.

24 comments:

Anonymous said...

Thanks, Chris. In the article, you state:

"Thus, Myriad might plausibly be interpreted as
allowing the patent eligibility of synthetic DNA corresponding in sequence to naturally occurring DNA . . ."


The court actually says that such synthetic DNA is "indistinguishable from natural DNA" and is therefore not patent eligible:

"[T]he lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a 'product of nature' and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA."

Am I missing something?

Anonymous said...

Thanks Chris - one of the best articles on Myriad I have seen.

Jon Broughton

willie said...

What does this suggest about the future of patents for non-gene natural products, e.g. those with pharmacologic activity isolated from plants? To quote Wikipedia "Prominent historical examples of such patents on isolated products of nature include adrenaline, insulin, vitamin B12..."

David Koepsell said...

It seems clear that a product that is morphologically identical to a natural one, regardless of the process used to create it, is still a natural phenomenon. That is the reasoning seemingly employed, easily applied, and logical. No human intention or design went into the form of the product in either isolating or synthesizing it. It's not inventive. What's the problem?
incidentally, this is my reasoning here: http://prezi.com/yzwld1xci2tc/?utm_campaign=share&utm_medium=copy

Anonymous said...

What about the patents on antibodies that occur naturally in human beings? I am not only talking about therapeutic antibodies...There are a lot of patents out there on prominent proteins.

What about the other parts of the world like EU? Will they follow the Supreme Court?

Anonymous said...

The intention behind the Supreme's verdict was not to leave a massive loophole in the patenting of PCR products from genomic DNA--I.E. they aren't patentable. Every lower court will acknowledge this intention and rule accordingly. If Myriad wants to waste more of its balance sheet cash in proving this, so be it. (MoveOn.bio)

Office Rental NYC said...

This is an excellent post i seen.I have to thanks to you to share it. It is really what I wanted to see hope in future you will continue for sharing such a excellent post Office Rental NYC

Anonymous said...

It could be argued that the Myriad case was decided incorrectly. Please note the following. A gene is the combination of one or more regulatory sequences (promoters, enhancers, methyl groups) and an Open Reading Frame (ORF). It is therefore the case, that very few of the patents that putatively contain claims to genes actually have claims to genes. What company would want to make, use, and sell, a nucleic acid that is methylated? I would guess that almost no companies would want to patent a methylated nucleic acid. Instead, it is the case that nearly all of the so called "gene patents" have claims to ORFs. Also, it is the case that most of the discussions by the U.S. Supreme Court, and in the oral transcript of the U.S. Supreme Court, are arguably incorrect. The U.S. Supreme Courts decisions, thought-processes, comments during the oral hearing, are all arguably incorrect, because the participants failed to take into account that a "gene" is more than just a coding sequence. The U.S. Supreme Court failed to take into account that a gene includes one or more promoters, one or more enhancers, as well as the covalent methylation of the coding sequence, and covalent methylation of regulatory sequences. Please note that it would rarely be the case that any company would want to patent a coding sequence that is methylated. Because of the frequent, or perhaps even ubiquitous presence of covalently bound methyl groups on coding sequences, it can easily be argued that there do not exist any "gene patents" that claim a product of nature. It is possible, that there are a some "gene patents" where the claim requires the presence of methyl groups at naturally occurring positions, and requires the presence of naturally occurring promoters -- if so, then these patents would be claiming a product of nature and thus be not eligible for patenting. However, a claim to a nucleic acid that includes only coding sequences, and does not include any regulatory sequences (promoters) and does not include any methyl groups, should not be called a claim to a "gene."

Homebased Business Opportunity said...

Marvelous information here, I will be the normal precise guest of the website and in addition delight in a person finding the time to keep your amazing world-class website.Homebased Business Opportunity

Online Home Based Business Opportunity said...

Your post has an excellent and motivating content. We are just happy with your current. You added actually helpful information tips.Online Home Based Business Opportunity

Short Sale Dallas said...

This is an excellent post i seen.I have to thanks to you to share it. It is really what I wanted to see hope in future you will continue for sharing such a excellent post Short Sale Dallas

Poker Bonus said...

This outstanding articles is one of my favourite today. I like to read it. Stay shark all the time.
--------------
Free holdem poker
Free Full Tilt Poker
In texas holdem have four rounds of betting: pre-flop, which is after dealing each player two cards face down and flop, turn and river. Litz-tation rules are simple. The first player to the dealer starts the betting. It can pass without paying its operations to align (call), raise (raise) or wait (check) - if no one had ever raise. The exception to the rule is the phase of the order of betting pre-flop when the action begins with the first player after the big blind, and ends with the player to the big blind.
If you play limit hold'em in the formula, there is a maximum of one bet and three raises in each round of betting. If we play pot limit formula, each player can raise the size of the pot, that is so. pot - the amount of raises are unlimited, and the maximum bet is limited by the size of the pot and the amount of money that a player has on the table. The formula no limit, at any time, we can raise his head all the money that we are currently on the table.
Texas holdem poker
Play poker laptop
Once all bets are aligned, the center of the table are dealt three cards. It begins with ring-louse round of betting.
Once all bets have been equalized, a fourth community card is lined up on the table. A round of betting poker no deposit free money. As already completed all bets from the previous round, the fifth and final card is lined up and discovered the table. It begins with the last-ing round litz-tation. After the betting, the players who remain in Partu compare their systems (five-card combination of their two hole cards and the five community cards). The first person who shows his hand, the player who last put a bet and raise. St best hand wins the pot.
Online poker Tv
German Hindi www.viteo.org

Free Poker Money said...

Your website could be more interesting. I think You need more visitors, so please exchange link with us.
--------------
Poker bankroll
Titan Poker bonus code
Texas Hold'em Poker is one of the most interesting and most exciting poker games. It is currently the most popular poker in the world. Thoroughly explained the rules texas hold'em, you will find the site poker rules. Here I limit myself to only a snapshot of the game.
In Texas Hol-dem poker bonus participate up to 10 players. Each player must use a combination of at least three and a maximum of five community cards on the table and two, one or no hole cards (hole cards). Each poker hand in texas holdem must consist of five cards. Winner is the player who manages to complete the strongest five-card hand.
No deposit casino online for You.
Startowy kapitaƂ za free
Stamp "dealer" means the position of the dealer and after each hand moves one place to the left. Even before the cards are dealt, the players to the left must pay for their blinds, ie. small blind (small blind) and big blind (the big blind). In this way, even if the other players fold, then there is money in the pot to win.
All players have the option to fold (fold), check or adjustment to the last beat (call), no deposit bonus , free poker, raise or increase in the rate (raise) and waiting (check) if the earlier one in the pot did not make his bet.
No Deposit Poker
Poker start capital

Sell House San Antonio said...

Great post. One more great blog here with all of the valuable information in it. Keep up the good work of sharing blogs like this Sell House San Antonio

Porcelain Veneers said...

This website is so cool and full of constructive information. Keep sharing Porcelain Veneers

pimpmyviews said...

Hi

The Post was seems to be energy sources.And the Post Hopes Me to well versed in the Law in the Supreme court.

Buy youtube views

Archita Subhi said...

I think you would try to convey something but i missed something anyway try this site to know about SEO
organic SEO services

Anonymous said...

Can methylation be the key to challenging the interpretation of existing gene patent claims? And can a novel PCR method be used to enable the sequencing of hundreds of genes?

http://www.nature.com/nbt/journal/v31/n10/full/nbt.2703.html

PENNY STOCK INVESTMENTS said...

Great

Nellie June said...

Outstanding blog which is useful for everyone. Blog should make readers to get satisfaction. I can feel in your blog.

Hidemyass

Anonymous said...

you're really a crying idiot and massive tool

Marcellina Helen said...

I like your post and all you share with us is up to date and quite informative. Keep up the good work. essay writing by essay mall , dissertation writing by essaymall , do my coursework – essaymall.co.uk

fifa 15 coins said...

You can have Barbie group up with one more cartoon fifa 15 coins character in an outside adventure. You can have Barbie attend parties cheap fifa 15 coins and you may get to decide which dress she is wearing. Make her a Disney princess and be saved by a prince. You can even tag group buy fifa 15 coins with Barbie into beating the computer on the classic games for example puzzles, jigsaw puzzles, simple number games and others.

Alice Scarlet said...

It is really Post. I wanted to see hope in future you will continue for sharing such a excellent post. Writers lounge , Need someone to do my assignment