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USPTO Instructs Examiners to Reject


Written by Gene Quinn
President & Founder of IPWatchdog, Inc.
Patent Attorney, Reg. No. 44,294
Zies, Widerman & Malek
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Posted: June 13, 2013 @ 6:46 pm
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Earlier today the United States Supreme Court issued a decision that fundamentally changed the law of patent eligibility that has existed in the United States for the past 30 years, calling into question at least many tens of thousands of issued patents and many tens of thousands of pending patent applications. See Supremes Rule Isolated DNA and some cDNA Patent Ineligible.

With lightening speed, the United States Patent and Trademark Office has sent a memorandum to patent examiners relating to the aforementioned Supreme Court decision in Association for Molecular Pathology v. Myriad Genetics, Inc. The 1-page memorandum from Drew Hirshfeld, who is Deputy Commissioner for Patent Examination Policy, is direct. “Examiners should now reject…”



The memorandum in its entirety reads:

Today in Association for Molecular Pathology v. Myriad Genetics, Inc. (Myriad), the Supreme Court held that claims to isolated DNA are not patent-eligible under 35 U.S.C. § 101. Myriad significantly changes the Office’s examination policy regarding nucleic acid-related technology. The purpose of this memorandum is to provide preliminary guidance to the Patent Examining Corps.

As of today, naturally occurring nucleic acids are not patent eligible merely because they have been isolated. Examiners should now reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not, as being ineligible subject matter under 35 U.S.C. § 101. Claims clearly limited to non-naturally-occuring nucleic acids, such as a cDNA or nucleic acid in which the order of the naturally-occurring nucleotides has been altered (e.g., a man-made variant sequence), remain eligible. Other claims, including method claims, that involve naturally occurring nucleic acids may give rise to eligibility issues and should be examined under the existing guidance in MPEP 2106, Patent Subject Matter Eligibility.

In Myriad, the Supreme Court considered the patent eligibility of several claims directed to isolated DNA related to the human BRAC1 and BRCA2 cancer susceptibility genes. The Supreme Court held that certain of the Myriad Genetics’ claims to isolated DNA are not patent-eligible, because they read on isolated naturally-occurring DNA that is a “product of nature.” The Court held that isolating a “gene from its surrounding genetic material is not an act of invention.” The Supreme Court held that other claims are patent-eligible, because they are limited to cDNA, which is a type of man-made DNA composition that is not naturally-occurring. The Court held that “cDNA is not a ‘product of nature’ and is patent eligible under § 101.”

The USPTO is closely reviewing the decision in Myriad and will issue more comprehensive guidance on patent subject matter eligibility determinations, including the role isolation plays in those determinations.

The only thing I will observe here and now is that the ruling relative to cDNA is not as the USPTO has characterized. The Supreme Court did not make a blanket statement that all cDNA is patent eligible. In fact, the decision envisions that some cDNA will be unpatentable even though cDNA by definition is synthetically created. The Supreme Court said:

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.

Thus, at least some cDNA is not patent eligible. It is that caveat that scares me most. This will be used to say that even if something is synthetically created it cannot be patent eligible if it is identical to what is produced in nature. This will have a chilling effect on medical technologies that endeavor to create a replica of nature, such as grown organs that can be transplanted.

I have to wonder whether the phone lines to Members of Congress are burning up. The biotechnology industry is a very important industry to the U.S. economy and many promising companies have had the value of their patent portfolios erased today, which will make it impossible to raise much needed capital in order to continue ongoing operations. This is true because it easily takes 10 to 12 years for a biotech company to become profitable, and that is assuming they ever will become profitable. So look for many companies younger than 10 years old who operate in the gene space to suffer mightily and encounter much resistance when seeking investment necessary to keep the companies alive.

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Posted in: Biotechnology, Gene Patents, Gene Quinn, IP News, IPWatchdog.com Articles, Patents, US Supreme Court, USPTO

About the Author

is a Patent Attorney and the founder of the popular blog IPWatchdog.com, which has for three of the last four years (i.e., 2010, 2012 and 2103) been recognized as the top intellectual property blog by the American Bar Association. He is also a principal lecturer in the PLI Patent Bar Review Course. As an electrical engineer with a computer engineering focus his specialty is electronic and computer devices, Internet applications, software and business methods.

 

11 comments
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  1. Assuming that cloned human organs cannot be patented under the Myriad decision, methods of making and methods of using such organs would still be eligible for patents. And I’m guessing that there might be some companies willing to license such patented biotech methods, which would help mitigate the chill.

  2. Welcome to Idiocracy USA, we’ve got Electoral-[college]-lytes

    http://patentu.blogspot.com/2013/06/one-nation-under-isolated-diety-with.html

  3. This is going to present some fascinating challenges to patent practitioners. This is a patent on 20 year old technology. That’s like saying stone knives are patent ineligible in the era of iphones. Who cares.

    Meeting the fully synthetic requirement for inventive DNA should be no problem with current, and still explosively evolving, artificial DNA synthesis techniques. To give you an idea: Today, you can directly print any sequence of 10,000 bases of DNA you want for $2,500. You can get your name written into the DNA for $500. You can get a kit to insert that DNA into any plant you want for $250.

    Next year the price of that 10,000 base pair sequence is projected to drop to $250. The year after that it should drop to $25. Who knows where the bottom is.

    We are in the middle of a biological revolution. I can’t imagine how the patent system is going to keep up.

    But the patent bar – dedicated to serving our clients – will.

  4. To all:

    This memorandum by the USPTO to its patent examiner’s is unnecessarily “over the top.” I’ll be interested to see what the “comprehensive guidelines” will be, but if they’re anything like the guidelines that were provided after Bilski, expect a contentious battle over whether the USPTO’s guidelines on applying the Myriad holding are legally correct.

  5. I am in the midst of re-reading the SAP v Versata decision. – I have to re-read it as I simply cannot believe what I first read.

    There are so many things wrong going on… (yes, I know this is not that thread, but EG’s comment about legal correctness here pails in comparison to what I am reading).

  6. These recent court decisions are a shame and disappointment. Doesn’t the Supreme Court understand that without patents, absolutely no innovation will occur? Patent protection needs to be strengthened and expanded immensely to cover as much as possible according to the Constitution.

  7. These recent court decisions are a shame and disappointment. Doesn’t the Supreme Court understand that without patents, absolutely no innovation will occur? Patent protection needs to be strengthened and expanded immensely to cover as much as possible according to the Constitution.

    You’d best reread the Constitution. Article 1, Section 8 says:

    To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries;

    The only reason that Patents exist is to promote the Progress of Science and useful Arts. The real question is what will have the effect that the framers of the Constitution envisaged?

    Wayne

  8. Wayne,

    I wonder if you understand what the word ‘promote’ means in the sense that it was used here.

    Most people misunderstand it to mean strictly a linear advance in the state of technology.

    That would be a decidedly wrong view.

    Innovation is not linear – and the ‘promote’ in the constitutional phrase was never meant to be taken as necessitating only an improvement as worthy of patenting.

    Your view here also completely ignores the fact – and yes it is a fact – that a Quid Pro Quo not only exists, but is foundational.

    You do not reach a Quid Pro Quo state with your view. “The only reason“…? No. Not the only reason. This line of reasoning of ‘the only reason’ is simply dead wrong. Foundationally dead wrong.

    Mind you, I am not on the other side of the spectrum with Dale Halling – and he still has not addressed the points I have raised concerning his viewpoints. But your extreme view is not a view from which a discussion of law can start from. You need to re-calibrate your basic understanding first. You need to have a sure and steady foundation to build your understanding of law upon. Otherwise, you only invite disaster – and you will not even understand why.

  9. I wonder if you understand what the word ‘promote’ means in the sense that it was used here.

    Most people misunderstand it to mean strictly a linear advance in the state of technology.

    That would be a decidedly wrong view.

    Innovation is not linear – and the ‘promote’ in the constitutional phrase was never meant to be taken as necessitating only an improvement as worthy of patenting.

    Your view here also completely ignores the fact – and yes it is a fact – that a Quid Pro Quo not only exists, but is foundational.

    If you provided some details, I’d consider the idea. The wording of the Constitution is fairly straightforward. So were the actions of Congress, which formed a law with sections 102 and 103, both of which place strict limits on what can be patented.

    Wayne

  10. See the enrichment discussion as discussed by Giles S. Rich, Principles of Patentability, 28 Geo. Wash. L. Rev. 393, 398 et seq. (1959-1960).

    And I chuckle at your chutzpah of ‘will consider‘ and “fairly straightforward.’ I have noticed others who feel that merely sleeping at a Holiday Inn and quickly scanning the Constitution can give them a deep understanding of its meaning. Not to be disrespectful, but please, let’s not have you be disrespectful.

  11. }”a chilling effect on medical technologies”

    Malarky. You mean somebody might make less money and somebody might actually be able to afford the treatment that keeps them from dying.