Australia Releases Guidelines on Patentability of Genetic Material – Now That’s How It’s Done

By Sue D. Nym
December 17, 2015

australia_flagThe Australian Patent Office yesterday released its new guidelines in response to Australia’s High Court decision on the patentability of genetic material. Many were watching this Australian copy-cat case to the US Supreme Court’s AMP v. Myriad decision from June 2013 and, similarly, many worried about the implications of another jurisdiction reversing decades of property rights based on spurious public policy concerns.

These concerns were reasonable in view of the US Patent and Trademark Office’s (USPTO’s) and the Federal Circuit’s response to the Myriad decision. The Federal Circuit has struck down everything challenged in front of it under § 101 except the claims in one outlier case (DDR Holdings). The USPTO has given Myriad (and more troublingly Mayo v. Prometheus) the broadest unreasonable interpretation, despite at least in the case of Myriad language that could not have made the decision’s narrow intended scope any clearer (“We merely hold…”).

The good news for Australia, though cold comfort for us on the other side of the Pacific, is that the Australian Patent Office has shown our counterpart US institutions the correct way to interpret and apply an important new case carving specific subject matter out of the broad default of patent eligibility. Rather than declaring ineligible from patenting everything under the sun “involving” a law or product of nature, Australia has instead read the High Court’s decision faithfully yet narrowly to exclude exactly what it said it excluded.


 

What’s Out

The following excerpts, with emphasis added, show the reasonable approach applied by the Australian Patent Office. They also give our own institutions a lesson in how to not dramatically overextend a narrow court decision to eviscerate the patent system.

Following the High Court’s decision claims to the following subject matter are clearly excluded because in substance they can only be considered as a claim to genetic information that is not made:

  • Isolated naturally occurring nucleic acid molecules whether:
    • DNA or RNA.
    • Human or non-human.
    • Coding or non-coding.

Notice how simple and limited this statement of the High Court’s holding is: “Isolated naturally occurring nucleic acid molecules […] are clearly excluded.” Our own USPTO could and should have analogously summarized the US Supreme Court’s Myriad decision. The USPTO instead decided to sua sponte exclude anything “involving” or “directed to” a judicial exception, e.g.,

In particular, claimed subject matter that must be analyzed under Question 3 to determine whether it is a natural product includes, but is not limited to: chemicals derived from natural sources (e.g., antibiotics, fats, oils, petroleum derivatives, resins, toxins, etc.); foods (e.g., fruits, grains, meats and vegetables); metals and metallic compounds that exist in nature; minerals; natural materials (e.g., rocks, sands, soils); nucleic acids; organisms (e.g., bacteria, plants and multicellular animals); proteins and peptides; and other substances found in or derived from nature.

See 2014 Procedure For Subject Matter Eligibility Analysis Of Claims Reciting Or Involving Laws Of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products, page 3.

The USPTO’s conscious decision to broadly summarize and interpret Myriad is particularly frustrating because the Supreme Court itself gave the USPTO a ready-made summary of the very limited scope of the decision: “We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.” As the Australian Patent Office’s guidance shows, this reasonably could have been the entirety of the USPTO’s guidance in response to the Myriad case.

While the Australian Patent Office’s application of High Court’s decision is narrow, it is not robotic. They appear to have given faithful meaning to the High Court’s discussion of genetic information by the following additional exclusions:

Claims to the following are excluded where they merely replicate the genetic information of a naturally occurring organism:

  • cDNA and synthetic nucleic acids.
  • Probes and primers.
  • Isolated interfering/inhibitory nucleic acids.

But even this additional carve out is properly limited: “Subject matter of this type may be patentable where the utility of the invention lies in genetic information that has been “made” (eg non-naturally occurring chimeric nucleic acid).

Again the Australian Patent Office has shown our USPTO and Federal Circuit how to properly balance narrowly and yet faithfully interpreting a decision of ineligibility against a background of default eligibility. This was the central theme repeated by at least one party in two iterations of written comments submitted to the PTO during its guidance process:

The Courts have made clear that the default under § 101 is eligibility. Only if subject matter clearly fits within a category of excluded matter is it ineligible for patenting. And those categories should be interpreted faithfully but narrowly to exclude only that which is clearly a product, law or phenomenon of nature or an abstract idea.

See Comments on PTO AMPMayo March 2014 Guidance from the Coalition for 21st Century Medicine.

The statute itself sets forth a very broad, inclusive paradigm of eligibility. This broad eligibility is the default, from which court decisions have created limited exceptions that are to be interpreted faithfully yet narrowly based on a close reading of the decisions themselves.

See Comments of Coalition for 21st Century Medicine on USPTO’s December 2014 Interim Eligibility Guidance.

 

What’s In

The Australian Patent Office goes further by expressly indicating what subject matter is unaffected by the High Court’s decision:

In general the Courts have indicated that, subject to other requirements, patents are available for products, methods of making and using products, and methods that otherwise result in a new and useful effect. Technical subject matter that has been previously considered by Courts without rejection include:

  • Recombinant or isolated proteins.
  • Pharmaceuticals and other chemical substances.
  • Methods of treatment.
  • Methods of applying herbicides.
  • Applications of computer technology.

In other words, the Australian Patent Office has gone the opposite direction from our USPTO. The USPTO chose to issue guidance that at best vaguely, and some would argue clearly, suggested many of these things would be ineligible. For instance, Example F and the above-quoted language from the March 2014 Guidance strongly suggests isolated proteins would be ineligible and Example C suggests gunpowder would be ineligible. Example B of the March 2014 Guidance, which suggests natural compounds would be ineligible even if purified to yield a new therapeutic effect, is particularly problematic in view of the Australian Patent Office’s statement to the opposite effect: “Isolation or purification can represent making or modification when the substance of a claim is properly directed to a chemical product.

 

Democracy Wins… In Australia

There is one important point in the USPTO’s defense. It did not enjoy the backstop of a recent legislative statement in support of broad patent eligibility in this space the way the Australian Patent Office did. In 2011 a committee of the Australian Senate issued a report specifically recommending against banning gene patents. The last time the US Congress substantively addressed what can or cannot be patented was 1952. This doesn’t give the USPTO a free pass, however, since § 101 of the 1952 Patent Act unequivocally declared: “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….” (Emphasis added.)

There is a greater point about democracy here. It appears that many are denouncing the Australian Patent Office’s guidance as too lenient in allowing too much subject matter to be patented. But the Australian Patent Office’s guidance is not only consistent with the High Court’s decision, but also very much in line with Australia’s legislative position. The Australian Senate committee’s report specifically objected to what was then a proposed bill as going too far and excluding too much subject matter:

While previous inquiries and public discussions have focused on the patenting of human genes, the Bill goes further and proposes a specific exclusion for biological materials which are identical or substantially identical to such materials ‘as they exist in nature’. The evidence received during the inquiry indicates that this exclusion is likely to have significant implications for a broad range of sectors and industries in Australia, including healthcare, pharmaceuticals, agriculture, food manufacturing and biotechnology. Extensive inquiries by the ALRC, the Senate Community Affairs Committee and ACIP have not revealed any persuasive evidence that would justify this type of broad exclusion from patentability for all biological materials.

See Australian Senate Committee Report, Chapter 5, Paragraph 5.9 (September 21, 2011).

Knowing this background, criticism of the Australian Patent Office’s guidance by those who failed to legislatively destroy life science incentives is not surprising. “Test cases” in the courts and arbitrary administrative action have long been favorite end-runs around democracy, with the court cases providing a foothold to erode a democratically enacted regime. But court decisions are by their very nature limited to the facts presented and attempts to twist and expand them beyond those facts should be seen for what they are. And the imperative of administrative agencies is to enforce democratically enacted laws rather than to bureaucratically modify them. The Australian Patent Office apparently understands these bedrock democratic principles better than most.

 

Conclusion

The Australian Patent Office ends its guidance precisely where it should have, and where the USPTO was urged by written comments, by stating the default of eligibility:

Other biological inventions should be considered according to the same general principles above. If what is claimed properly falls within the requirements for existing categories of products and processes (eg is not for or merely replicates the genetic information of a naturally occurring organism) it will be patent eligible.

(Emphasis added.)

Now that’s how to interpret a high court decision declaring specific subject matter ineligible for patenting.

The Author

Sue D. Nym

Sue D. Nym  

As you have probably guessed, Sue D. Nym is not a real person. Occasionally we receive an article and the author wishes to remain anonymous. All such anonymous posts, whether contributed by a man or a woman, are attributed to Ms. Nym.

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Discuss this

There are currently 1 Comment comments.

  1. SHAKLAIN KHURSHID December 17, 2015 10:57 pm

    Hi!
    Yes agreed upon that the genetic material which does not merely replicates the genetic information of a naturally occurring organism will be patent eligible. As for example the mere rearrangement of exons by means of alternate splicing resulting into a new product would be eligible for patent protection.

    Regards
    Shaklain