The following contribution to our gene patenting symposium come from Susan McBee and Bryan Jones. Ms. McBee is the Chair of the Life Sciences Intellectual Property Team for Baker, Donelson, Bearman, Caldwell, and Berkowitz, P.C. Bryan Jones is a registered patent attorney in the Washington D.C. office of Baker, Donelson, Bearman, Caldwell, and Berkowitz, P.C.
In April, the Supreme Court will hear oral argument in Association for Molecular Pathology v. Myriad, ostensibly on the question whether so-called “gene patents” satisfy 35 U.S.C. § 101. However, Myriad is about more than whether “genes” can be patented. It is about what types of activities justify patent protection. Does one need to create something that is unlike anything else that has ever existed in order to justify a patent? Or is it enough to discover something that was previously unknown, remove it from its natural environment, and show that it has a practical application?
This is a critical question to the biotechnology industry, because many biotechnological products are not novel chemical structures, but naturally occurring products. Between 1981 and 2006, approximately forty percent of all pharmaceuticals approved for use by the FDA were a biologic, natural product, or derived from a natural product. Moreover, for start-up biotechnology companies, patents covering such products are incredibly important, “as they are often the most crucial asset they own in a sector that is extremely research-intensive and with low imitation costs.” Strong and enforceable patents to these core products therefore are vitally important to the healthy development of the biotechnology industry.
Before the Myriad case, the Court has not had an opportunity to consider the patentability of such products. Therefore, this case has the potential to have an enormous impact on the viability of the business model in this industry.
In Myriad, Judge Lourie and Judge Moore both found “isolated” nucleic acids to be patentable, but for different reasons. Judge Lourie was convinced that isolated nucleic acids are patentable because isolation “breaks covalent bonds” relative to the longer native nucleic acid, thereby resulting in a new chemical entity. Judge Moore reasoned that, if analyzed on a blank slate, she would require the product to have a “substantial new utility” relative to its natural function in order to satisfy 35 U.S.C. § 101. While we agree that the generation of a novel chemical entity or demonstration of a new utility would be sufficient to satisfy 35 U.S.C. § 101, we do not believe these to be necessary requirements.
Consider, for example, Taq polymerase. The inclusion of Taq into a process called polymerase chain reaction (PCR) has often been credited as being the single most important technological advance to the modern biotechnology industry. PCR uses repeated cycles of increasing and decreasing temperatures in the presence of a polymerase to amplify a target nucleic acid. In the original iteration of PCR, new polymerase enzyme had to be added to the reaction mixture after each heat cycle, because the high temperature permanently deactivated the enzyme. Taq, however, is heat stable and thus does not lose activity when subjected to high temperatures. Because of this stability, Taq only needs to be added to a PCR reaction mixture once, thus greatly reducing the costs and the time of performing the process, and permitting easy automation. Clearly, then, the identification and characterization of this enzyme is a significant technological advance, from which the public obtains a significant benefit. Yet the properties of Taq that make it so attractive for PCR are a consequence of its structure and function in the natural world. Taq is naturally produced by Thermus aquaticus, a bacterium that is naturally found in hot springs. Therefore, in nature, just like in PCR, Taq functions as a thermostable enzyme that catalyzes the amplification of a nucleic acid. Why should this render Taq unpatentable?
The Constitution does not require a claimed compound to have a formally “new” chemical structure or new function to justify a patent. Article I, section 8 of the Constitution authorizes patents “[t]o promote the Progress of Science and useful Arts . . . .” As explained by the Court:
Congress may not authorize the issuance of patents whose effects are to remove existent knowledge from the public domain, or to restrict free access to materials already available. Innovation, advancement, and things which add to the sum of useful knowledge are inherent requisites in a patent system which by constitutional command must ‘promote the Progress of useful Arts.’ This is the standard expressed in the Constitution and it may not be ignored.
Thus, the Constitution only limits patents that “remove existent knowledge from the public domain” or “restrict free access to materials already available.” Assuming that Taq was not previously known, a claim to it in isolated form simply cannot “remove existent knowledge from the public domain.” Because Taq naturally exists only in the context of a living organism, claiming it in “isolated” form cannot “restrict free access to” its source. Thus, constitutional limits cannot justify a prohibition on patents covering isolated naturally occurring products.
Nor does 35 U.S.C. § 101 clearly prohibit such patents. The statute specifically encompasses “discoveries,” so long as those discoveries relate to processes, compositions of matter, or articles of manufacture that are “new” and “useful.” In most cases, naturally occurring products are found in very minute quantities in complex association with other molecules inside living organisms. The act of isolating the natural product removes them from this context, thereby inevitably resulting in a composition that is materially different than anything that exists in nature. An “isolated” natural product therefore is “new” compared to the same product in its natural state. Its discovery thus could justify a claim under 35 U.S.C. § 101.
Finally, Supreme Court precedent does not clearly prohibit patenting of such claims. Under the closest Supreme Court precedent, a patent that is limited to a “non-naturally occurring article of manufacture or composition of matter” satisfies 35 U.S.C. § 101. Although it is often convenient to describe naturally occurring compounds in terms of chemical structure or nucleotide or amino acid sequence, they rarely if ever exist in nature as isolated compositions. Rather, they are found in complex associations with other compositions, usually within living organisms. The removal of these products from their natural context sometimes results in distinct chemical entities, such as the isolated nucleic acids in Myriad. Other times, the result is a highly purified form of the compound, such as isolated adrenaline or purified vitamin B12. In each case, however, the intervention of man is required to produce the “isolated” composition. Claims directed to “isolated” natural compounds thus are limited to purely artificial, non-naturally occurring compositions of matter. This should make them patentable, irrespective of whether they have a novel chemical structure or new utility in isolated form.
It is our sincere hope that the Court will not only find isolated nucleic acids to be patentable, but that it will do so under a rationale which allows for other naturally derived products to similarly be patentable. In as much as a possible test can be garnered, our recommendation is to find that a naturally derived product satisfies 35 U.S.C. § 101 as long as it is claimed in a purely man-made form (and thus is “new”), and the form in which it is claimed has a practical utility disclosed in the Specification (and thus is “useful”). This test closely aligns with the plain language of 35 U.S.C. § 101. Challenges to the eligibility of such claims could then focus on two clear issues: (1) whether the claim encompasses the product in its natural state; and (2) whether the claim is reasonably commensurate in scope with the disclosed utility (i.e., is the claim narrowly tailored to products that possess the disclosed utility?). This allows overly broad claims to be invalidated without resorting to a categorical ban on a broad class of subject matter. Moreover, it would not require courts to answer the philosophical question of whether something has enough of a structural or functional change to justify a patent.