The Aussies Are At It Again

    By Kevin E. Noonan --

Last year, the Australian Senate rejected a call for banning patents on human genes in Australia.  This result came after almost a decade of debate, resulting in several Reports (including the 2011 ACIP Report on Patentable Subject Matter, the Senate Gene Patents Report, issued November 24, 2010, and the 2004 Australian Law Reform Commission's Report on Genes and Ingenuity: Gene Patenting and Human Health (ALRC 99 Report) (see "News from Abroad: The Gene Patents Debate in Australia -- An Update").  On November 23, 2011, the Australian government released a combined report (that can be accessed here).  And the Australian Senate determined that the Australian Patent Act of 1990 should not be amended to exclude human genes as patent-eligible subject matter, pursuant to a 124-page report that recommended against passage of the Patent Amendment (Human Genes and Biological Materials) Bill 2010, which was introduced by Senators Helen Coonan, Bill Heffernan, Rachel Siewert, and Nick Xenophon (see "Australian Senate Committee Issues Recommendation on Gene Patenting Bill").

Undaunted, another Member of Parliament (Melissa Parke, the Labor representative from Fremantle, Western Australia), is reported (by Intellectual Asset Management, "Gene patent opponents take the fight back to Parliament") to be ready to introduce a bill to amend Section 18(2) of the Patents Act, as follows:

18(2)  The following are not patentable inventions:
        (a)  human being, and the biological processes for their generation;
        (b)  genetic materials that exist in nature, or are the same as or not markedly different from those existing in nature whether such materials are in situ, isolated or purified;
        (c)  any method that involve the mere comparison of genetic materials or genetic sequences in the provision of a diagnosis for a human being.
18(2)(A)  A reference in subsection (2) to genetic materials includes, but is not limited to, DNA or RNA whether in whole or part or in fragments, however made.

While wrongheaded, this proposal has a few advantages over judicial solutions that may arise in the U.S., for example.  First, it is expressly limited to genetic material, and so avoids the risk of determining that "products of nature" are somehow patent ineligible.  While this bill shares the infirmity with Congressman Becerra's thrice-rejected (or maybe more correctly, ignored) bill to ban "gene patenting" in that it encompasses more than human DNA (thus threatening cucumber or tomato gene patents as well as human ones), it does avoid the risk of finding the antibiotics, anticancer drugs, improved lubricants or silicon formulations, or antibodies (the most common form of biologic drug) would become unpatentable.  It also permits any such ban to be considered by Australia's elected representatives, rather than judges without any particular expertise in technology (some of whom are comfortable overturning the opinions of judges that do have such "special expertise").

But unlike earlier proposals (including last year's), this bill would also ban "applications" of genetic technology, albeit only those that "mere[ly] compar[e]" genetic sequences.  Such claims have already been held unpatentable in the U.S. under the Bilski and AMP v. USPTO precedent.  It is unclear whether claims further reciting other affirmative steps in identifying a sequence would fall within the scope of the proposed ban.  Also precluded from patent protection would be synthetic DNA including oligonucleotide fragments (while blessedly being devoid of a reference to a "magic microscope" as justification for the ban).  It is unclear whether cDNA would be considered "markedly different" under the bill, although this would depend on whether the chemical or informational properties of DNA are considered.

The prospect of the bill being introduced is another testament to the persistence of the anti-gene patenting proponents on the issue, reminiscent of other motivated political factions.  Whether this bill gains sufficient traction to have a chance of passage, or whether political fatigue or indifference prevent its passage will be closely monitored, here and anywhere the issue is seriously considered.

Comments

[Skeptical]

Dr. Noonan,

In part, you state "and so avoids the risk of determining that 'products of nature' are somehow patent ineligible."

I am somewhat confused and do not want to misinterpret this statement.

Do you mean to imply that products of nature are somehow patent eligible?

[Kevin E. Noonan]

Dear Skeptical:

In a word, yes. But of course a word is insufficient in these conversations, so let me clarify.

I agree with Judge Dyk that a leaf from a tree is not patent eligible per se. That is clearly true. But no one ever claims a leaf from a tree per se, so it is also a red herring to use this as an example. What is claimed is usually something that has been isolated and purified from nature, having some property or characteristic that evinces the "hand of man." To illustrate, what is the logical distinction regarding patent eligibility amongst the following:

Isolated chemical compound from crude oil useful as a lubricant

Isolated antibiotic produced by bacteria

Isolated chemical compound from a plant useful as a drug

Isolated protein from an animal useful to cure/ameliorate human disease

Isolated cucumber gene that extends freshness

Isolated Human gene (erythropoietin)

If your view is that there is none then we part company; not only do I think such a conclusion not to be mandated or sanctioned by the Court, I think it impractical: it would foreclose on weak philosophical grounds the benefits of patenting (most importantly, disclosure) for medicinal chemistry and any naturally derived material.

Moreover, it would have the consequence of having a molecule become less patent eligible the closer it came to the naturally occurring molecule (in structure), ignoring the actions of human invention to convert the natural product into a useful pharmaceutical, for example.

And if it is just a matter of artful drafting we fall into the trap identified by Justice Breyer in Mayo.

Just a few thoughts. Thanks for the comment.

[Skeptical]

Thank you Dr. Noonan.

I disagree with you - but only on semantics.

I think that a product of nature is not patent eligible under any circumstance.

However, I do not think that something that evinces the Hand of Man (and is changed in kind rather than mere degree) should be called a product of nature. Such an item is rightfully a product of man, and is thus patent eligible.