HerbalEGram: Volume 11, Issue 10, October 2014

On March 4, 2014, The United States Patent and Trademark Office (USPTO) issued its 2014 “Guidance for Determining Subject Matter Eligibility of Claims Reciting Or Involving Laws of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products.”¹

This 2014 guidance, which may be revised and reissued, incorporates changes in determining eligibility of natural products meant to align current procedure with the Supreme Court’s rulings in the cases Association for Molecular Pathology v. Myriad Genetics, Inc. (2013), and Mayo Collaborative Services v. Prometheus Laboratories (2012). In the former, the Supreme Court decided specifically that human DNA — more than 4,300 genes of which previously had been patented² — was not eligible for patent because “[a] naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated….” According to the USPTO’s new guidance, products submitted for patent protection now must be “markedly different” from what exists in nature, meaning that chemicals that are merely isolated from natural sources are forthwith ineligible for patent.

On July 21, 2014, the officers and executive committee of the American Society of Pharmacognosy (ASP), “the premier organization of scientists specializing in the isolation and characterization of natural product chemicals in the United States,” submitted official comments to the USPTO in response to the new guidance.³

“ASP is concerned that the present interpretation of the Guidance may have the inadvertent outcome of hindering the development of new medicines,” the organization wrote, adding that between the years of 1981 and 2010, just 36% of all drugs were “purely synthetic structures that were derived without reliance on natural products.”³ Further, ASP noted in its comments that “70% of clinically used antibiotics are natural products” and that USPTO’s new guidance will “impede future drug discovery and development.”³

According to former ASP president and American Botanical Council Advisory Board member John Cardellina, PhD, the USPTO’s current guidance — should it stand — would have a devastating impact on the United States’ position in the global drug development market (email, September 29, 2014). “If the US is the only country to adopt such a short-sighted policy, the American position in the global drug development market would be severely impaired, if not crippled,” he said.

“Given that roughly 75% of the pharmaceuticals in use today are natural products or natural product derived/inspired,” wrote Dr. Cardellina, “the rest of the world would leave the US in its ‘laboratory dust.’ Further, I would envision US pharmaceutical companies moving their headquarters and operations out of the US to seek haven in countries without such an ill-advised patent policy.”

The USPTO defines “natural products” as “[c]hemicals 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.”¹

In determining patent eligibility, three questions are utilized¹:

1. Is the claimed invention directed to one of the four statutory patent-eligible subject matter categories: process, machine, manufacture, or composition of matter?
   
   
2. Does the claim recite or involve one or more judicial exceptions (abstract ideas, laws of nature/natural principles, natural phenomena, and natural products)?
   
   
3. Does the claim as a whole recite something significantly different than the judicial exception(s)?

Judicial exceptions, according to the guidance, “reflect the judicial view that … fundamental tools of scientific and technological work are not patentable.”¹

In order to illustrate the “significantly different” element of a claim, the USPTO guidance states that “(1) the claim includes elements or steps in addition to the judicial exception that practically apply the judicial exception in a significant way, e.g., by adding significantly more to the judicial exception; and/or (2) the claim includes features or steps that demonstrate that the claimed subject matter is markedly different from what exists in nature (and thus not a judicial exception).”¹

Under these guidelines, a newly discovered plant-derived chemical alone would not be eligible for patent; however, a novel process for extracting the chemical or a structurally and/or functionally different derivative of the chemical could be. Process claims including specific doses, administration lengths, and patient types also could be considered “[b]ecause the specific dosage and treatment period limitations narrow the scope of the claim, others are not substantially foreclosed from using [the natural product] in other ways.”¹

A variety of natural products have been patented in the past. For scientists and the pharmaceutical and dietary supplements industries — among others — the new guidance may result in decreased monetary incentive to discover and/or develop new beneficial natural products.

Intriguingly, ASP mentions penicillin in its public comments' section on the history of patented natural products.³ Alexander Fleming, the Scottish scientist credited with discovering penicillin in 1928, did not pursue a patent on the natural antibiotic.⁴ “I did not invent penicillin. Nature did that,” he said.⁴ Andrew Moyer later patented a process for penicillin mass production in the United States.⁵

Under the USPTO’s new guidelines, penicillin certainly would not be patent-eligible in the United States today. According to natural products attorney Ashish Talati, it is possible that even Moyer’s process for mass production could be ineligible for patent protection under the 2014 guidelines. “However,” he said, “methods using recombinant cells may still be patentable if the organisms are structurally altered, assuming that the method meets the standards of novelty and non-obviousness” (email, September 26, 2014).

According to Talati, US patent seekers may be wise to focus on methods and processes rather than natural product compositions by themselves, at least for right now.

“[T]he impact of the weakening of eligibility for many classes of natural materials should not be minimized,” said Talati. “Until the USPTO issues its revised guidelines, current strategies may include relying on novel synthetic analogues of natural materials (a common practice in pharmaceutical research), or inclusion of non-natural components in order to patent a new composition or formulation.” Talati continued, “In any case, the expected revised guidelines (anticipated by the end of 2014) will hopefully, at a minimum, clarify what approaches may be best employed going forward, if not expand the options to a more reasonable framework.”

Talati, Dr. Cardellina, and ASP characterize USPTO’s interpretation of the aforementioned Supreme Court ruling on Myriad as overly broad. “The USPTO guidelines surprised observers by expanding the holding to compositions found in nature, and even novel combinations of such compositions, though still welcoming applications for methods of using such compositions,” said Talati. “This has struck many observers,” he added, “as an overreach precluding patents on truly innovative discoveries.”

Where, then, is a reasonable place for the line to be drawn? “If such an isolated composition, or combination of natural compositions,” proposed Talati, “is truly ‘new and useful’ (the standard set forth in the patent statutes), I think the USPTO should consider that rather than apply a per-se rule.”

“We assert that the association of a novel bioactivity with a previously unknown discrete chemical entity derived from a natural source should be sufficient evidence of the ‘hand-of-man’ to allow composition of matter claims based on its chemical structure and the associated biological activity,” stated ASP in its comments, which concluded: “We believe that such an interpretation will be consistent with the Supreme Court decision by limiting the broad claims associated with patents on genes as in Myriad while still allowing for discrete composition of matter claims on bioactive natural product chemicals.”

“No matter what the final guidance is, there will be displeased, negatively affected parties,” said Dr. Cardellina. “However,” he continued, “I think it is imperative that USPTO revises this guidance to permit patents on natural products, including proteins/peptides, discovered to have impacts on human society not to be anticipated by their mere presence in the producing organism, whether that organism is a microbe, plant, or invertebrate.”

—Ash Lindstrom

References

1. United States Patent and Trademark Office. Guidance for Determining Subject Matter Eligibility of Claims Reciting Or Involving Laws of Nature/Natural Principles, Natural Phenomena, And/Or Natural Products. Available here. Accessed September 4, 2014.
   
   
2. Dwyer J. In patent fight, nature, 1; company, 0. New York Times. March 30, 2010. Available here. Accessed September 9, 2014.
   
   
3. American Society of Pharmacognosy officers and executive committee. Response to Request for Written Comments on Guidance for Determining Subject Matter Eligibility of Claims Reciting or Involving Laws of Nature, Natural Phenomena, & NaturalProducts. USPTO website. Available here. Accessed September 4, 2014.
   
   
4. Alexander Fleming (1881-1955). Education Scotland website. Available here. Accessed September 26, 2014.
   
   
5. Bellis M. The history of penicillin. Inventors.about.com. Available here. Accessed September 26, 2014.