Source: https://www.gordonrees.com/publications/2016/gordon-rees-carlsbad-attorney-published-in-life-sciences-intellectual-property-review-
Timestamp: 2019-04-22 10:00:06+00:00

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Gordon & Rees Carlsbad Attorney Published: "How to Succeed in the Business of Biotech Patentability"
Gordon & Rees Carlsbad senior counsel Kathryn Hull recently published an article in Life Sciences Intellectual Property Review providing best practices on biotech patentability.
To view this article, click here or continue reading below.
The US Supreme Court has thrown down the gauntlet for patent eligibility in the biotechnology field. In spite of (or due to) their significant contributions to medicine, Mayo v. Prometheus, Association for Molecular Pathology v. Myriad Genetics, and Ariosa Diagnostics v. Sequenom exemplify the harsh reality of recent changes in defining patent-eligible subject matter. These recent changes have left companies wondering how best to protect their products.
In the U.S., patent eligibility is defined under 35 USC §101, which states that “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”. Historically, patents have been issued for compounds purified from nature such as adrenaline, acetyl salicylic acid (aspirin), and the antibiotic streptomycin.
Furthermore, in Diamond v. Chakrabarty, the Supreme Court set the precedent that “anything under the sun that is made by the hand of man” is patent-eligible subject matter. Post Diamond, tens of thousands of biotech-based patents have been issued—most notably, patents directed to ‘purified’ matter such as nucleic acid or amino acid. Roughly 30 years after Diamond, the courts have begun to severely restrict what is considered patentable subject matter in the biotech field.
The first major change in the patent eligibility of biotech subject matter came in 2012 in Mayo. This decision focused on the patentability of a method of optimizing the therapeutic efficacy of a drug based on the level of metabolites in the patient’s blood. The claims at issue were summarized as (1) administering the drug to a patient, (2) determining the drug or metabolite levels in the patient’s blood, and (3) adjusting the drug dosage based on the blood levels.
The court noted that “at the time the discoveries embodied in the patents were made, scientists already understood that the levels in a patient’s blood of certain metabolites ... were correlated with the likelihood that a particular dosage of thiopurine drug could cause harm or prove ineffective ... But those in the field did not know the precise correlations between metabolite levels and the likely harm or ineffectiveness”.
In explaining its decision, the court stated that “to transform an unpatentable law of nature into a patent-eligible application of such law, one must do more than simply state the law of nature while adding the words ‘apply it’.” It added: “Beyond picking out the relevant audience, namely those who administer doses of thiopurine drugs, the claim simply tells doctors to: (1) measure (somehow) the current level of the relevant metabolite, (2) use particular (unpatentable) laws of nature (which the claim sets forth) to calculate the current toxicity/inefficacy limits, and (3) reconsider the drug dosage in light of the law.
To add to the confusion, the court acknowledged that the ‘administering’, ‘determining’ and ‘wherein’ steps “are not themselves natural laws but neither are they sufficient to transform the nature of the claim.” This leads to the question of what is sufficient to transform the nature of the claim? According to the court, the answer lies somewhere between Diamond v. Diehr and Parker v. Flook. The patents in Diehr were directed to the use of the Arrhenius equation to determine curing time in molded rubber products. The patents in Flook were directed to the use of an algorithm to monitor the catalytic conversion of hydrocarbons. The claims in question for each case are shown in Table 1.
4) adjusting said alarm limit to said updated alarm limit value.
The decision in Mayo opened the door for invalidating biotech patents by showing that the application of ‘natural law’ involved purely conventional steps and broad coverage.
Last, the court noted that the Myriad decision was limited to genes and the information they encode, and specifically carved out three areas that the decision does not affect, namely method claims, new applications, and DNA with an altered sequence order. The decision in Myriad opened the door for invalidating biotech patents directed to isolated nucleic acid and amino acid.
The application of Mayo and Myriad came in June 2015 in Ariosa. Here, the court focused on the patentability of cell-free fetal DNA (cffDNA) circulating in maternal blood.
The US Patent and Trademark Office has issued several interim guidances on subject matter eligibility to help examiners navigate these Supreme Court cases that have changed the landscape. The 2014 guidance set out three questions, which are shown below.
1. Is the claim to a process, machine, manufacture or composition of matter? If no, the claim is not eligible subject matter under 35 USC §101. If yes, proceed to step 2A.
2A. Is the claim directed to a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions)? If no, the claim qualifies as eligible subject matter under 35 USC §101. If yes, proceed to step 2B.
2B. Does the claim recite additional elements that amount to significantly more than the judicial exception? If no, then the claim is not eligible subject matter under 35 USC §101. If yes, the claim qualifies as eligible subject matter under 35 USC §101.
According to the guidance, ‘significantly more’ can be demonstrated by (i) improvements to another technology or technical field; (ii) adding a specific limitation other than what is well-understood, routine and conventional in the field; (iii) adding unconventional steps that confine the claim to a particular useful application; and (iv) other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment.
Additionally, the following should be considered: combinations of natural elements that produce unnatural results; specific chemical isomers; modified chemical structures; and treatment of specific medical conditions. When in doubt, be specific (e.g., include information on a specific disease, specific techniques, or specific applications).
What does this mean for a biotech company looking to protect its products? First, we go back to the beginning, Diamond, and think about ways to modify ‘naturally occurring’ compounds to introduce the ‘hand of man’. For example, this may include adding non-naturally occurring substitutions into naturally occurring nucleic acid or amino acid sequences; vectors containing naturally occurring nucleic acid; or recombinant proteins; or adding detectable labels to naturally occurring nucleic acid or amino acid sequences.
If you are unable to introduce the ‘hand of man’, then add as much specificity as possible. Table 2 illustrates claim amendments that were successful in overcoming a rejection of patent-eligible subject matter.
6. A method for diagnosing of type 1 diabetes mellitus comprising a step of detecting an anti-alanyl tRNA synthetase antibody, an anti-glycyl tRNA synthetase antibody, and an anti-asparaginyl tRNA synthetase antibody from an individual test sample.
wherein detecting the binding of two or more of the antibodies with the two or more purified recombinant proteins indicates that the subject has type 1 diabetes mellitus.
comparing the measured level of SETDB1 to a reference, wherein an increase of at least 10% in the SETDB1 level in the biological sample compared to the reference is indicative of malignant cancer in the subject.
determining whether the subject has cancer and therefore requiring cancer treatment or whether the subject has a benign growth based upon the comparison wherein an increase of at least 10% in the SETDB1 level in the biological sample compared to the reference level is indicative of cancer in the subject.
identifying a capability of the cultured stem cell to differentiate into a chondrocyte, based on the measured concentration.
wherein the selected stem cell is capable of differentiating into a chondrocyte or inducing chondrocyte differentiation.
Gone are the days when you could broadly claim isolated genetic material and any technique known in the art to manipulate the genetic material. For now, best practices dictate that you avoid claim language such as ‘isolated’ or ‘purified’ that will trigger a rejection based on subject matter ineligibility and keep method claims as specific as possible while still covering your product.

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