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Federal Circuit Panel Rehears ACLU, Myriad Gene Patent Case

Written by: Ryan Chiromas
Westerman Hattori Daniels & Adrian, LLP
Posted: July 22, 2012 @ 12:47 pm

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In the immortal words of baseball great Yogi Berra, “It’s déjà vu all over again”.  A little more than a year after they previously heard AMP v. USPTO, the CAFC panel of Judges Lourie, Bryson and Moore have once again taken up the question of whether isolated DNA and related methods are patent eligible subject matter under 35 U.S.C. §101.

To recap, last year, the same panel ruled that the composition claims reciting isolated DNA were patent eligible, with Judges Lourie and Moore supporting patent eligibility and Judge Bryson dissenting.  All three Judges also agreed method claims involving “analyzing” or “comparing” DNA were not patent eligible.  Lastly, all three Judges agreed that a screening claim (claim 20 of the ‘282 patent) was patent eligible.  For a full discussion of last year’s decision (in English and Japanese), please click here.  After the decision, AMP appealed to the Supreme Court, who later vacated the CAFC decision and remanded the case to the CAFC for further consideration in view of their Mayo decision (English summary;Japanese summary).

The CAFC then invited further briefing on the following question:

What is the applicability of the Supreme Court’s decision in Mayo to Myriad’s isolated DNA claims and to method claim 20 of the ’282 patent?

As a reminder, representative isolated DNA claims are as follows:

1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.

5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.

The sole remaining method claim, which is a method of screening for a drug is as follows:

20. A method for screening potential cancer therapeutics which comprises:

growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic,

growing said transformed eukaryotic host cell in the absence of said compound,

determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells,

wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.

Myriad’s argument

First up was Myriad.  With respect to the composition claims, Myriad argued that as previously decided in this case, the composition claims are patent eligible because they pass the test of being non-naturally occurring human-made inventions which are products of human ingenuity.  Myriad argued that this is consistent with the test laid out inChakrabarty, and that the Supreme Court’s Mayo decision did not change this test.  Furthermore, Myriad argued that the plaintiffs avoided this question, and instead focused on a question of preemption.

Judge Lourie, who previously supported the isolated DNA claims, asked whether it was a “small move” from the prohibition on patenting laws of nature to a prohibition on patenting a composition which comes “proximately” from nature.  Myriad replied by commenting on the non-trivial nature of the selection of which bases of the native DNA should be included or excluded from the isolated molecule, explaining that this required an “enormous amount of human judgment.”  Returning to an analogy raised by Judge Bryson in the previous oral argument, Myriad argued that the isolated DNA in question is like a baseball bat carved from a tree—that is, although its source is a product of nature, the claimed invention is the result of human ingenuity as far as what portions of the source material were kept or discarded.

Next, Judge Lourie questioned Myriad about claim 20, asking how it is different from the claims of Mayo.  In response, Myriad argued that a key difference is that in Mayo, the claims start with a law of nature and add conventional steps.  Meanwhile, Myriad argues, the process of claim 20 begins with a non-naturally occurring starting material (transformed eukaryotic host cells) and then applies conventional steps.

The discussion of claim 20 was then muddled by two tangent points.  First, Judge Bryson sparred with Myriad regarding the procedural matter of whether claim 20 was actually removed by the pending case due to AMP’s not challenging the CAFC’s previous decision on this claim in their Supreme Court appeal.  Myriad was unable to present authority to support their position that claim 20 is excluded, while AMP later cited authority to support the inclusion of claim 20.  Additionally, there was some discussion about the phrase “causing cancer”, which Judge Bryson erroneously thought was an active step.  As later clarified by Myriad in their rebuttal time, this is not an active step, but rather a functional description of the gene inserted into the host cell.

Finally, Judge Moore inquired whether the patentability of claim 20 was tied to the patentability of the isolated DNA claims.  Myriad replied that even if the isolated DNA claims were not patent eligible, claim 20 was still patent eligible at least because it recites application of steps to a non-naturally occurring object (the transformed cell).

AMP’s argument

AMP et al., represented by Chris Hansen of the American Civil Liberties Union, argued their position next.  With respect to the composition claims reciting the isolated DNA, AMP argued that these claims have a breadth which is so large as to raise questions about preemption.  For example, AMP pointed out that the claims are broad enough to include all types of DNA:  genomic DNA, cDNA, synthetic DNA, RNA, methylated DNA, non-methylated DNA.

Judge Lourie then asked how AMP’s point about preemption was relevant to Mayo, and suggested that “by definition” the holding of Mayoregarding method claims was irrelevant to the composition claims.  AMP replied by stating that the law of nature/product of nature doctrine is meant to ensure that both products of nature and laws of nature are free for all to use, regardless of whether the subject matter in question is defined as a composition or method.

Judge Moore reacted very negatively to this point, and stated that AMP’s point about claim breadth undermines their argument about preemption.  Moore cited the Supreme Court’s statement in Mayo that “our cases have not distinguished among different laws of nature according to whether or not the principles they embody are sufficiently narrow.”  Judge Moore stated that breadth of the claim is wholly irrelevant to the question of subject matter eligibility, and harshly dismissed AMP’s arguments on this point as “a waste of time and space.”

In view of an apparent lack of receptiveness to their arguments regarding the isolated DNA claims and preemption, AMP then shifted to the screening claim 20.  As to the transformed cell used in the screening method, AMP alleged that Myriad buys this “off the shelf” like a test tube.  There seemed to be confusion with respect to what exactly a “transformed” host cell is, with AMP alleging that this is merely a cell which is receptive to receiving a DNA sequence (rather than a cell which had already taken up foreign DNA).  Although this seems to be a misreading of the claims, AMP did correctly point out that the phrase “causing cancer” in claim 20 refers to a feature of the gene inserted into the cell.

Judge Lourie then posited that the Mayo decision requires that claims recite “something more” than the underlying law of nature, and that the screening method claim in fact requires “something significantly more” than a law of nature.  AMP strongly disagreed, and argued that the claim does not recite any use of the transformed cell, but rather just recites “seeing what happens” after adding a test compound.  AMP also drew a contrast between Mayo’s requirement for a specific compound and the pending claim’s broad recitation of a test compound.  None of the Judges commented on the point that this is the very nature of the difference between a method of screening for a useful compound and a method of optimizing dosage of a compound known to be useful.

AMP’s final few minutes of argument were spent on a discussion about patentability of compositions per se versus the patentability of methods of use of compositions.  AMP acknowledged that the transformed host cell used in claim 20 was not naturally occurring.  But, AMP argued that even if it was permissible to patent a transformed host cell, it should not be permissible to patent the use of such a non-naturally occurring product.  AMP further argued that under Mayo, a method of treatment including administering a man-made product would be “clearly” not patentable.  After some comments from Judges Lourie and Bryson regarding a hypothetical involving penicillin, AMP seemed to backtrack on this slightly and clarify that their position was limited the point that a method of comparing relative effects of a composition and lack of a composition else was not patent eligible subject matter.

U.S. Government’s argument

Finally, like in last year’s hearing, the U.S. government, as represented by the Office of the Solicitor General, was given an opportunity to present their views.  It seems that these are primarily the views of the Department of Justice, and do not necessarily reflect the views of the USPTO.  The Government’s comments were limited to arguments regarding isolated, but otherwise unmodified, DNA.

Judge Moore, who last year mocked the Government’s “magic microscope” test as having “child-like simplicity,” asked whether the Government was still of the position that this is a valid test of patent eligibility.  The Government replied that they no longer viewed this as a formal test, but rather as a helpful “metaphor” to show, for example, the difference between merely isolated DNA and cDNA.

Judge Lourie then asked about how Mayo relates to isolated DNA, since isolated DNA is not itself a law of nature.  The Government echoed AMP’s arguments by expressing concern about preemption, arguing that both products of nature and laws of nature should remain free to public access.  Thus, the Government is of the position that the question of patent eligibility should be framed in the context of a question of preemption.

Moreover, the Government explains that they found it impossible to create a “principled line” that allows the isolated DNA claims to be patent eligible, but prohibits the patent eligibility of things like isolated coal or tungsten.  Although the Government acknowledges a difference between native DNA and isolated DNA, the Government is of the position that if the difference is only “incidental to extraction,” isolated DNA is not markedly different from that found in nature.

Judge Moore then inquired about the settled expectations of the biotechnology industry in view of decades of gene patenting.  The Government responded that the Court should not take this into consideration in making their decision, giving as an example the many patents which were invalidated in view of the Supreme Court’s Bilski decision.  The Government encouraged the Court to interpret §101 using a general rule which is not industry-specific, irrespective of how such a rule may positively or negatively affect various industries.

Finally, Judge Moore inquired whether the Government’s position varied between claims reciting whole genes and claims reciting primers or probes.  The Government responded by arguing that even if primers and probes have an additional utility not found in nature, this additional utility is reliant upon the inherent base-pairing properties of the DNA.  The Government drew a distinction the primers and probes, which it argues have new utilities merely uncovered or discovered by the inventors, and the genetically modified bacteria of Chakrabarty, which it argues had a new utility conferred by the inventor’s actions.

Myriad’s rebuttal comments

In their rebuttal, with respect to claim 20, Myriad pointed out that contrary to AMP’s comment that a method of treatment including administering man-made product is not patent eligible, the Supreme Court in Mayo stated that the new use of a known drug could be a patent-eligible method.  Myriad also analogized their insertion of a gene into a cell as similar to the genetic engineering in Chakrabarty.

Returning to the composition claims, Myriad stated that although the Government could not determine a line between patent eligible and patent ineligible subject matter, such a test is found in Chakrabarty—a line between “human made inventions” and “things that are not human made.”  Myriad again referred to human ingenuity in determining what portions of the source material were kept or discarded, using the term “inventive judgment.”  Judge Moore reacted very negatively to this, exclaiming “Inventive judgment?  That doesn’t even make sense to me.”

The Judges then returned to various analogies such the extraction of coal and removal of an organ from the body, pressing Myriad on the extent of human involvement and decision-making involved in such extractions.  Myriad argued that both isolated coal and an isolated organ should not be patentable eligible, and stated that “an invention is different from just making a decision.”  Judge Moore seemed very frustrated with this apparent inconsistency, stating “This is your whole case.  Just spend more time on it, please.”  However, Judge Lourie make a final comment that seemed to hint about the involvement of an obviousness question in the determination of patent eligibility.

Author’s analysis

Although predictions on the outcome of an unusual case such as this are probably worthless, I think that it is most likely that this panel will rule in 2012 the same way that it ruled in 2011.  It is probably safe to presume that the judges are fairly entrenched in their positions.  In my view, no arguments were presented which show that Mayo was a game-changer with respect to the isolated DNA claims and the screening method claim.  In particular, AMP’s main point about the relevance of Mayo—the preemption argument—was harshly criticized by Judge Moore.  Among the three members of the panel, Judge Moore would appear to be the most likely to change sides, and I do not see this happening.  Thus, I expect the same outcome as last year.   However, the long-term outcome is much murkier, with an en banc hearing and/or a Supreme Court appeal almost certain.

Perhaps it is overly optimistic, but I think it is even possible that Mayo may have strengthened Myriad’s position with respect to the isolated DNA claims.   Many in the patent community, including myself, were deeply disturbed by the importation of a §102/103 analysis into §101 inMayo, preferring instead Judge Rader’s simpler “coarse filter” viewpoint.  In last year’s hearing, much of the discussion centered on whether there are actual physical differences between the claimed isolated DNA and native DNA.  When this is the test for compliance with §101, it does seem very difficult to exclude from patent eligibility things like elements extracted from the earth.  However, this year, much of the discussion seemed to acknowledge some differences between native and isolated DNA, but addressed how the inventors arrived at the particular sequence of isolated DNA.  This may be a key shift.

Discussions of this case have been filled with many colorful analogies:  creation of a baseball bat from a tree, carving of Michelangelo’s Davidfrom a block of marble, extraction of coal or other minerals from the earth, surgical removal of a kidney from the body, plucking a leaf from a tree, etc.  In each, a smaller element is removed from its natural surroundings.  I think most would agree that the first to create a baseball bat or David is deserving of IP protection (copyright in the case of David, of course), but that the first to pluck a leaf from a tree or surgically remove a kidney is not deserving of IP protection.  What’s the difference?  In the first category, the creator is faced with an almost infinite set of options at the beginning of his efforts, and must use his creativity and ingenuity to decide which path to make.  On the other hand, in the second category, the creator is faced with a very limited set of options at the beginning of his efforts.  In this context, the non-obviousness (or, “inventive judgment” in the words of Myriad) of how and why something is removed from its natural context is perhaps a useful, although complicated, test.  So perhaps at the end of the day,Mayo’s importation of §103 into §101 is not the end of the world.

For those wish to listen to the approximately 45 minute oral hearing, please click here.

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Editor’s Note: This article was originally published on the WHDA CAFC Blog and is republished here with permission.  See Summary of Oral Arguments in AMP v. USPTO Remand.

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About the Author

Ryan B. Chiromas is a Partner in the Biotechnology group at Westerman Hattori Daniels & Adrian, LLP. Any questions or comments may be directed to him at: rchirnomas (at) whda.com. This article is for informational purposes only. The comments herein are the views of the author only and do not necessarily represent the views of Westerman Hattori Daniels & Adrian, LLP or its clients.

8 comments
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  1. The big news in this case is the amicus brief by James Watson:

    http://www.slate.com/blogs/future_tense/2012/07/19/james_d_watson_files_amicus_brief_in_case_over_myriad_genetics_brca_patent_.html

  2. Just as a reminder, the text of 35 USC 101 reads

    Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

    With the owrds “invents or discovers” in the statute, 103 considerations are hard-wired into 101, and the argument that 103 considerations are irrelevant seems unlikely to prevail..

    That said, argument by analogy is dangerous and often unhelpful. A gene is not the same as a baseball bat. It is no small matter to undo the settled expectations of the pharmaceutical and biotechnology industries over a period of more than 100 years. Penicillin was originally a naturally occurring molecule, its effectiveness was a law of nature so was patent-eligible (the scientists involved decided not to patent it, but that is another issue)

  3. I should have said was not patent-elegible on the arguments in this case.

  4. Paul,

    You just invented your own self-fabricated definition for the word “invent” and I applaud you for that.

    Indeed, each of us “invents” every day and almost by the minute as long as we do not fall back on route use of cliches and instead creatively choose which mix of words we will next utter. “It was the best of times, it was the worst of times, ..” Remember that scene from the movie, “Flash of Genius”? The author (Dickens) had taken a few simple words and cobbled them together in his own unique and inventive way.

    There is no mention of “obviousness” or definition of obviousness in section 101.

    So not only are you “inventing” your own private definition for the phrase “invents or discovers” but you are also inventing your own revision of what 101 actually says.

    In the past, the courts paid particular attention to the word “ANY” in 101.

    Now a days it seems as if their eyelids go into “shutter that one out” mode as they scan across the text of that section.

    It was the pick only what you like kind of times, it was the choose as you please kind of times, it was the epoch of anti-inventorism, it was the dawn of a new Dark Age, … it was a time when science and critical thinking gave way to voodoo magical thinking and crony capitulation, in short it was time like any other in the medieval centuries.

  5. Aw… no magic microscopes. It makes this case boring!

    I agree, I doubt there will be a reversal in the Court’s position. Also, ACLU’s position that the claims are so broad to encompass all DNA is incomprehensible. Perhaps if you throw out the preamble, and define “isolated” as the entire genome (which has been their position. However, based on precidence, pretty much in most jurisdictions, “isolated DNA” along with the sequence would limit the claims to a cut-out piece of DNA which includes the claimed sequence. Also, these claims may have been caught up in the “having” language flip-flop by the PTO where the term was considered open, then closed, then open again.

  6. Sounds like SCOTUS’ nonsense has turned patent law into ‘how many angels can dance on a pinhead’

  7. Gene, for reasons unknown, one of my comments here (too long?) got caught in the spam filter. May have a get out of jail pass please? :-)

  8. Step-

    Not sure why it was routed to spam. Perhaps it is an IP address issue? Anyway… it has been released and is now posted.

    -Gene