Many biological products that have been purified from their natural state have been patented in the United States over the decades. Adrenaline is probably the first human hormone patented in 1906 in its purified form,1 and other important products purified and patented include insulin2 and vitamin B123. Even today, a significant percentage of drugs have natural origins. In fact, a review covering thirty years showed that roughly 30 to 40% of new drugs each year are either natural products or directly derived therefrom.4
Yet in Association of Molecular Pathology v. Myriad Genetics, Inc.,5 the Supreme Court held that a gene is not patentable "merely because it has been isolated."6 The difficulty of obtaining patent protection for drugs with natural origins is further compounded by Mayo Collaborative Services v. Prometheus Laboratories, Inc.,7 where a unanimous Supreme Court held that methods of treatment optimization were ineligible for patent protection on the basis that the claims recited a law of nature.8 Unfortunately, the Court's analysis introduced novelty and non-obviousness concepts into the patent eligibility analysis:
To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of wellunderstood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.9
The damage potential of an eligibility test that conflates novelty and obviousness with patent eligibility issues, and has a synergy10 requirement is very high. If we don't consider any routine, conventional steps, and we require that 2 + 2 = 5 to meet the synergy requirement,11 what can be patented anymore?
Together with the earlier Alice case12, any patent claim reciting math or a computer (abstract idea), a biological product (natural product), or a diagnostic method (natural law) is patent ineligible. Indeed, since the Alice-Mayo-Myriad trio, large percentages of patent applications have been rejected as patent ineligible and issued patents have been summarily invalidated as ineligible in courts.13 As a result, patent filings have been abandoned, parked in appeal hoping for a change in the law, licenses terminated, patents not filed in favor of trade secrets, or the natural origins of new drugs simply omitted from patent applications.14
However, the Federal Circuit has begun to turn the tide. In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd.,15 for example, claims directed to particular methods of treating schizophrenia were held patent eligible.16 The claims first required determining if a patient had a particular genotype, and based on the results, a particular dosage of the drug was administered to reduce side effects. Importantly, the court held that the claims were not "directed to" the natural correlation between the genotype and side effects, but were "directed to" specific treatment methods. Mayo was distinguished as not requiring any follow-up treatment–no action being required in response to the diagnosis.
This is excellent news for diagnostic claims as specific treatment steps can be included to gain patent allowance. The issue of divided infringement remains–a diagnostic company providing the tests, whilst a doctor provides treatment–but arguably this can be addressed by noting that in most cases the tests are undertaken at the doctor's direction. Although practitioners are forced into less than ideal claiming formats, and bad case law continues to exist,17 at least some patent claims can issue whilst awaiting legislative correction.18
In addition, a new Guidance19 has been provided by the USPTO. Together with abstract idea20 and life science examples,21 these provide a useful language to combat rejections at the USPTO–the main improvement lying in the admonishment that merely including a natural product, natural correlation or computer does not automatically implicate the devasting Mayo analysis. Instead, Examiner are cautioned to ensure the claim is "directed to" the offending natural product, natural law or abstract idea. If not, the damaging Mayo analysis is avoided, and the invention is patent eligible.
Unfortunately, the examples for natural products date from 2014 and also need updating based on this new approach, but in the interim, at least one natural product has proceeded to patent. Teixobactin is heralded as the first new class of antibiotic in 30 years.22 The patent was originally rejected as not patent eligible. However, patentee narrowed the claims to recite a teixobactin that was formulated to have increased solubility. Together with a declaration establishing that the drug had much improved solubility when correctly formulated, the patentee was able to gain allowance.23
These new opinions and Guidance should encourage the health care industry that natural drugs and diagnostics will once again become patent eligible in the U.S., although experienced practitioners, clever drafting and more technical detail are still needed to jump the eligibility hurdle. Indeed, albeit early, the data seems to indicate improvement in allowance rates,24 although the possibility always remains that a court will decide against eligibility.25 In addition, a bipartisan effort is underway to legislatively overrule the Alice-Mayo-Myriad opinions.26 With these efforts, the Alice-Mayo-Myriad dark days may soon be over, and for now, the horizon is brighter than it used to be.
- US2563794. See also Merck & Co. v. Olin Mathieson Chem. Corp., 253 F.2d 156 (4th Cir. 1958) (upholding Vitamin B12 patent US2703302 and stating "The patentees have given us for the first time a medicine which can be used successfully in the treatment of pernicious anemia, a medicine which avoids the dangers and disadvantages of the liver extracts, the only remedies available prior to this invention, a medicine subject to accurate standardization and which can be produced in large quantities and inexpensively, a medicine which is valuable for other purposes, as well as for the treatment of pernicious anemia. It did not exist in nature in the form in which the patentees produced it and was produced by them only after lengthy experiments. Nothing in the prior art either anticipated or suggested it.").
- David J. Newman & Gordon M. Cragg, Natural Products As Sources of New Drugs over the 30 Years from 1981 to 2010, J. Natural Prods. 75:311-335 (2012), FIG. 5.
- 569 U.S. 576 (2013) [hereinafter Myriad].
- Myriad at 580.
- 566 U.S. 66 (2012) (hereinafter Mayo).
- >No law of nature was at issue in the Mayo claims–only the correlation between a biological data-point and a medical response. Most practitioners politely rephrase this part of the Courts holding as relating to a "natural correlation."
- Mayo, at 79-90.
- The invention must provide something significantly more than the sum of the parts.
- Giles S. Rich, Laying the Ghost of the "Invention" Requirement, 1 AM. PAT. L. ASS'N Q. J. 26, 44 (1972) ("The laws of physics and chemistry in accordance with which all inventions perform do not permit of the judicially imagined magic accordingly to which 2+2=5. Wherever such a spurious test prevails all patents are invalid.").
- Alice Corp. v. CLS Bank International, 573 U.S. 208, 134 S. Ct. 2347 (2014) [hereinafter Alice] (financial transaction patent invalid because the claims were drawn to an abstract idea).
- Sachs, R., A Survey Of Patent Invalidations Since Alice, online at http://www.law360.com/articles/604235/a-survey-of-patent-invalidations-since-alice. Robert Sachs, An Update On Section 101 Rejection Rates At The USPTO, online at http://www.law360.com/articles/716742/an-update-on-section-101-rejection-rates-at-the-uspto.
- Guerrini, C.J., et al., Constraints On Gene Patent Protection Fuel Secrecy Concerns: A Qualitative Study, J Law Biosci. 2017 Dec; 4(3): 542–564, online at https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5965503/.
- 887 F.3d 1117 (Fed. Cir. 2018).
- Other useful cases include Enfish LLC v. Microsoft Corp., 822 F.3d 1327 (Fed. Cir. 2016) (claims directed to a specific improvement to the way computers operate patent eligible); McRO, Inc. v. Bandai Namco Games America, Inc., 837 F.3d 1299 (Fed. Cir. 2016) (claims for software for automatically animating lip synchronization and facial expressions not "directed to" an abstract idea and thus patent eligible); Rapid Litigation Management, Ltd. v. Cellzdirect, Inc., 827 F.3d 1042 (Fed. Cir. 2016) (claims not directed to the ability of hepatocytes to survive multiple freeze-thaw cycles, but rather, to a new and useful laboratory technique for preserving hepatocytes and thus patent eligible); Endo Pharmaceuticals Inc. v. Teva Pharmaceuticals USA, Inc., No. 2017-1240, 2019 WL 1387988 (Fed. Cir. Mar. 28, 2019). (Fed. Cir. 2019) (diagnostic step plus treatment step claims patent eligible).
- Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371 (Fed. Cir. 2015) (cert. denied) (diagnosis claim with no treatment step not patent eligible); Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 915 F.3d 743, 747 (Fed. Cir. 2019) (petition for cert. filed) (following Ariosa in rejecting diagnostic claims lacking any treatment step as ineligible).
- A legislative correction has been proposed. See Noonan, K., Senate Proposal for Section 101 Reform: Effect on Biotech/Pharma Inventions (2019), online at https://www.patentdocs.org/2019/05/senate-proposal-for-section-101-reform-effect-on-biotechpharma-inventions.html#comments.
- 2019 Revised Patent Subject Matter Eligibility Guidance, 84(4) FR 50-57 (2019), online at https://www.govinfo.gov/content/pkg/FR-2019-01-07/pdf/2018-28282.pdf
- Subject Matter Eligibility Examples: Abstract Ideas (2019), online at https://www.uspto.gov/sites/default/files/documents/101_examples_37to42_20190107.pdf.
- Nature-Based Products (2014), online at https://www.uspto.gov/sites/default/files/documents/mdc_examples_nature-based_products.pdf, and Subject Matter Eligibility Examples: Life Sciences (2016), online at https://www.uspto.gov/sites/default/files/documents/ieg-may-2016-ex.pdf.
- Ling L.L., et al., A New Antibiotic Kills Pathogens Without Detectable Resistance, Nature 517: 455–9 (2015).
- Cf. McDermott, E., Don't Give Up: Section 101 Allowances Are Up at USPTO (2019), online at https://www.ipwatchdog.com/2019/03/14/section-101-allowances-will-courts-continue-trend/id=107306/ ("Section 101 allowances at the USPTO are on the rise after a long period of decline"); The PTAB sets Another Record for Reversing Abstract Idea Rejections, online at https://blog.anticipat.com/2019/05/14/the-ptab-sets-another-record-for-reversing-abstract-idea-rejections/ ("March 2019 saw the PTAB break another record for total abstract idea rejections reversed."); #ALICESTORM: August 2018 Update, online at https://www.bilskiblog.com/2018/08/alicestorm-august-2018-update/ ("percentage of decisions invalidating patents under § 101 . . . has fallen slightly–from 67.5% to 66.0%–year over year.").
- See e.g., Cleveland Clinic Found. v. True Health Diagnostics. LLC, 760 Fed. Appx. 1013, 2019 U.S. App. LEXIS 9451 (Fed. Cir. 2019) (following Ariosa and rejecting USPTO guidance example 29 in holding assay claim ineligible).
- FN. 19, infra.