Myriad's Possible Impact on Patent Eligibility of Isolated Non-DNA Chemical Substances

by Dechert LLP

Over a century ago, in the famous Parke-Davis adrenaline patent infringement case, Judge Learned Hand articulated what many consider the origin of the legal premise that isolated components or purified extracts of natural products may be patent eligible:

[E]ven if [patentee Takamine’s purified adrenaline] were merely an extracted product without change, there is no rule that such products are not patentable. Takamine was the first to make it available for any use by removing it from the other gland-tissue in which it was found, and, while it is of course possible logically to call this a purification of the [adrenaline], it became for every practical purpose a new thing commercially and therapeutically. That was a good ground for a patent.1

While subsequent authors and courts may have differed on whether Judge Hand’s proclamation was dicta,2 the Parke-Davis decision has been often cited over the years in support of the validity of patent claims to chemical substances isolated or purified from their natural state,3 most recently by Respondents, Myriad Genetics et al., in the Supreme Court’s June 13, 2013 decision in Ass’n for Molecular Pathology v. Myriad Genetics, 569 U.S. ____ (2013) (“Myriad”).4

The unanimous Myriad Court did not specifically discuss Parke-Davis or its progeny in finding that isolated genomic DNA is ineligible for patent protection. Yet some of the rationale in the Court’s opinion may cast doubt on the patent eligibility of non-DNA chemical substances that are isolated or purified from natural sources, although other aspects of the Court’s rationale may leave the door to patent eligibility open.5

Myriad’s Rationale for Patent Ineligibility of Isolated Genomic DNA Applied to Isolated Non-DNA Chemical Substances

In Myriad, the Supreme Court, reversed the Court of Appeals for the Federal Circuit and held that a naturally-occurring genomic DNA segment – “isolated” from its chromosomal components by severing the chemical bonds linking the termini of the segment to the rest of the chromosome – is a product of nature and is therefore not patent eligible.6 In reaching this conclusion, the Court rationalized from a variety of facts from Myriad’s discovery and isolation of the natural BRCA1 and BRCA2 genes that encode for BRCA proteins. These facts can be analogized to the isolation or purification of non-DNA chemical substances from their natural state – substances such as small molecule pharmaceuticals as well as larger structures including proteins, such as antibodies – and raise questions about the patent eligibility of these non-DNA chemical substances.

For example, the Court noted that “Myriad’s principal contribution was uncovering the precise location and genetic sequence of the BRCA1 and BRCA2 genes within [the relevant] chromosomes,” yet the “location and order of the [claimed] nucleotides existed in nature before Myriad found them” and “that discovery, by itself, does not render the BRCA genes ‘new … composition[s] of matter,’ § 101, that are patent eligible.”7

Applying these findings to a hypothetical situation of a small molecule or protein isolated or purified from a natural source, the hypothetical patentee may similarly have discovered “the location” of such a small molecule or protein in a rare plant in the Amazon or a tunicate deep in the South Pacific after isolation and extraction from the natural source. Moreover, analogous to Myriad’s identification of the sequence of the BRCA1 and BRCA2 genes, the hypothetical patentee may also have determined the chemical structure of the small molecule or the peptide sequence of the protein. Nevertheless, the location and structure/sequence of the small molecule or protein would have “existed in nature before [the patentee] found them,” and the discovery of the location and structure/sequence may therefore not render the small molecule or protein “new compositions of mater” satisfying § 101’s requirements for patent eligibility.

The Myriad Court also noted that “Myriad [did not] create or alter the genetic structure of DNA” and, more bluntly, therefore that “Myriad did not create anything.”In locating and isolating or purifying a small molecule or protein from its natural state, the hypothetical patentee too may not have “create[d] or alter[ed] the [chemical or peptide] structure” of the small molecule or protein. In short, the patentee may “not [have] create[d] anything,” and, although the patentee may have “found an important and useful” small molecule or protein, “separating [either] from its surrounding [natural state] is not an act of invention.”9 Even though, like Myriad, the hypothetical patentee may have engaged in “extensive research efforts” to identify and isolate the small molecule or protein, “extensive effort alone is insufficient to satisfy the demands of § 101.”10

Myriad’s Lack of Deference to Past USPTO Practice

The Myriad Court was equally unpersuaded by the U.S. Patent and Trademark Office’s past practice of awarding gene patents. Although Judge Moore of the Federal Circuit considered the PTO’s position to be influential in concluding Myriad’s isolated genomic DNA to be patent eligible,11 the Myriad Court disagreed, finding that “Congress has not endorsed the views of the PTO in subsequent legislation” and placing weight instead on the administration-dependent views of the Department of Justice over that of the Department of Commerce.12

In considering patent eligibility of a small molecule or protein isolated or purified from a natural source, at present, the latest edition of the PTO’s Manual of Patent Examining Procedure (“MPEP”)13 instructs that “[p]urer forms of known products may be patentable” and that “[p]ure materials are novel vis-à-vis less pure or impure materials because there is a difference between pure and impure materials,”14 suggesting potential patent eligibility of purified substances from natural sources. To the extent that such guidelines support patentability of a small molecule or protein isolated or purified from a natural source, and to the extent that the PTO has previously granted claims to such substances, Myriad suggests that these current and past practices by the agency may not be entitled to deference.

Myriad’s Possible Opening for Patent Eligibility of Isolated Non-DNA Chemical Substances

Interestingly, the Myriad Court expressly acknowledged that Myriad’s isolation of the BRCA1 and BRCA2 genomic DNA severs chemical bonds “and thereby creates a nonnaturally occurring molecule.”15 While this process, which admittedly “technically creates new molecules with unique chemical compositions,”16 was sufficient to convince at least Judge Lourie of the Federal Circuit of the patentability of Myriad’s isolated genomic DNA,17 the Myriad Court disagreed and found that the chemical bond cleavage incident to separation of the claimed genomic DNA could not confer patent eligibility because

Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes.”18

As noted by the Myriad Court, Myriad’s claims to genomic DNA are functional in format, claiming, for example, “[a]n isolated DNA coding for a BRCA1 polypeptide,” i.e., an isolated DNA sequence with the genetic information that instructs a cell to produce a BRCA1 polypeptide.19 Due to the natural degeneracy of the genetic code, a large number of genomic DNA sequences may encode for a BRCA1 polypeptide, which is a likely reason that Myriad’s claims were drafted using functional language that encompasses all such sequences. Yet this decision to define the claimed genomic DNA by function/information instead of “in terms of chemical composition” or as a “unique molecule” seems to be an important factor that led the Myriad Court to conclude that an isolated genomic DNA segment is a patent ineligible natural product, even though through isolation the segment becomes a “new” and “nonnaturally occurring molecule.”20

In contrast, small molecule pharmaceuticals exist as unique chemical entities amenable to patent claiming by more traditional chemical formulas and nomenclature that delineate particular structures. Claiming small molecules purified or isolated from natural sources in a defined structural way (coupled with a limitation specifying a measure of isolation or purity) may overcome the Myriad Court’s pronouncement against claiming via information in lieu of chemical composition. Similarly, claiming peptides and proteins isolated or purified from their natural state via sequence homology to a specified sequence/structure (again, coupled with a limitation specifying a level of purity or isolation) may instill sufficient chemical structure into such claims to distinguish from Myriad.

Of course, as endorsed by the Myriad Court, such claimed isolated or purified small molecules or proteins should still comport with the Court’s prior holding in Chakrabarty in that they should have “markedly different characteristics from any found in nature,”21, i.e., from their natural or unpurified forms. This is in contrast to the claimed Myriad genomic DNA, wherein the informational characteristic of the DNA – the nucleotide sequence – was unchanged on isolation, leading to the conclusion that “Myriad did not create anything.”22 Compliance with Chakrabarty also steers the focus of the claimed substances to their practical differences from what existed before in nature, potentially leading to the conclusion that the purified or isolated forms are “for every practical purpose a new thing commercially and therapeutically.”23, 24

Continued Patent Eligibility of Methods Using Isolated Non-DNA Chemical Substances

The Supreme Court appears to have made some effort to highlight that method claims were not at issue in Myriad and that methods of using the isolated genes could potentially be patent eligible,25 the Court’s prior holding in Prometheus26 notwithstanding.

By analogy, Myriad may have little impact on the patent eligibility of methods of using small molecules or proteins isolated or purified from nature, provided that the methods themselves are novel and unobvious. Of course, a composition of matter claim to the isolated or purified substance itself is more valuable than a claim to, for example, a particular method of treatment. Moreover, claims to relatively broad methods (for example, a method of treating cancer generally) may encounter barriers under § 112 not otherwise posed by composition of matter claims, leaving patentees with narrower and less valuable method claims (such as, a method of treating a specific cancer) that are more readily enabled and adequately described.


Many are predicting that Myriad will have a limited impact for the biotechnology industry because other aspects of the Court’s holding (patentability of cDNA27 and the potential patentability of method claims) leave adequate incentives for developing gene technologies and because isolated DNA patents are generally older and nearer to expiration and are being issued by the PTO at a declining rate. However, Myriad may significantly impact other areas in chemistry and biotechnology that rely on isolation or purification of non-DNA chemical substances from nature – such as small molecules and proteins – areas the unanimous court may not have intended. Whether Myriad leaves open an avenue to patent eligibility for such non-DNA chemical substances remains to be seen.


1. Parke-Davis & Co. v. H. K. Mulford Co., 189 F. 95, 103 (C.C.D.N.Y. 1911). 

2. See, e.g., Ass’n for Molecular Pathology v. USPTO, 702 F. Supp. 2d 181, 225 (S.D.N.Y. 2010) (concluding that the validity question in Parke-Davis was one of novelty and not patentable subject matter because Judge Hand found claims to the free base of adrenaline to be novel over the prior art and naturally occurring salt form); Harkness, J. M. “Dicta on Adrenalin(e): Myriad Problems with Learned Hand’s Product-of-Nature,” J. Pat. Trademark. Off. Soc., 93:4, 363-99 (2011); but see Robert P. Merges & John F. Duffy, Patent Law and Policy: Cases and Materials 110 (LexisNexis 2007) (noting that Judge Hand found valid and infringed also a claim to a purified salt of adrenaline, which “requires Hand’s reasoning that purified and concentrated adrenaline salt is a ‘new thing commercially and therapeutically’ and therefore patentable notwithstanding the existence of the ‘natural salt’ in living organisms”). 

3. See, e.g., Merck & Co. v. Olin Mathieson Chem. Corp., 253 F.2d 156, 160, 163-64 (4th Cir. 1958) (noting “[t]he fact, however, that a new and useful product is the result of processes of extraction, concentration and purification of natural materials does not defeat its patentability” and holding a patented version of purified vitamin B-12 to be “new and useful” although the product “is produced in minute quantities in the bodies of cattle [and also] by certain microorganisms”); In re Bergy, 596 F.2d 952, 975 (C.C.P.A. 1979) (“The law has long and unhesitatingly granted patent protection to new, useful, and unobvious chemical compounds and compositions, in which category are to be found such important products of microbiological process as vitamin B-12 and adrenalin and countless other pharmaceuticals.”) (emphasis in original) (citations omitted).

4. See Brief of Respondents at 5.

5. However, some, including the District Court in Myriad, may question whether the patentability of such purified or isolated substances was in question even before MyriadAss’n for Molecular Pathology, 702 F. Supp. 2d at 222-27; see also Ass’n for Molecular Pathology v. USPTO, 689 F.3d 1303, 1328 (Fed. Cir. 2012) (noting that “purified natural products thus may or may not qualify for patent under § 101”).

6. Myriad, slip op. at 1, 14.

7. Id. at 12-13.

8. Id.

9. Id. at 12.

10. Id. at 14.

11. Ass’n for Molecular Pathology 689 F.3d at 1346.

12. Myriad, slip op. at 15-16.

13. Revision 9, 8th Edition, August 2012.

14. MPEP § 2144.04(VII).

15. Myriad, slip op. at 14.

16. Id. at 8.

17. Id; see also Ass’n for Molecular Pathology 689 F.3d at 1328.

18. Myriad, slip op. at 14-15.

19. Id. at 5.

20. Id. at 14-15.

21. Id. at 12.

22. Id. However, in concluding that Myriad’s claimed isolated genomic DNA did not satisfy Chakrabarty and provide “markedly different characteristics” from natural chromosomal genomic DNA, the Myriad Court focused exclusively on the informational characteristics dictated by the claims, and not on other characteristics, properties, or structure that may have exhibited “markedly different characteristics.”

23. Parke-Davis, 189 F. at 103; Merck, 253 F.2d at 164 (holding that “[f]rom the natural fermentates, which, for this purpose, were wholly useless and were not known to contain the desired activity in even the slightest degree, products of great therapeutic and commercial worth have been developed,” and, thus, “[t]he new products are not the same as the old, but new and useful compositions entitled to the protection of the patent”); see also In re Bergstrom, 427 F.2d 1394, 1401 (C.C.P.A. 1970) (finding purified prostaglandins to be more useful, not “naturally occurring,” and therefore to be “new” within the meaning of § 101).

24. A related question in light of Myriad that is unique to small molecules is the patent eligibility of an enantiomer “purified” or “isolated” from the naturally occurring racemic mixture. If possible, the case for patent eligibility of the enantiomer or enantiomerically-enriched mixture may require a showing in line with Chakrabartythat the enantiomer has “markedly different characteristics” from the natural racemate and that these characteristics are commercially or therapeutically beneficial as per Parke-Davis and related cases.

25. Myriad, slip op. at 17 (“Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent.”).

26. Mayo Collaborative Services v. Prometheus Laboratories, Inc.,132 S. Ct. 1289 (2012).

27. Myriad, slip op. at 16-17.


DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Dechert LLP | Attorney Advertising

Written by:

Dechert LLP

Dechert LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
Custom Email Digest
Privacy Policy (Updated: October 8, 2015):

JD Supra provides users with access to its legal industry publishing services (the "Service") through its website (the "Website") as well as through other sources. Our policies with regard to data collection and use of personal information of users of the Service, regardless of the manner in which users access the Service, and visitors to the Website are set forth in this statement ("Policy"). By using the Service, you signify your acceptance of this Policy.

Information Collection and Use by JD Supra

JD Supra collects users' names, companies, titles, e-mail address and industry. JD Supra also tracks the pages that users visit, logs IP addresses and aggregates non-personally identifiable user data and browser type. This data is gathered using cookies and other technologies.

The information and data collected is used to authenticate users and to send notifications relating to the Service, including email alerts to which users have subscribed; to manage the Service and Website, to improve the Service and to customize the user's experience. This information is also provided to the authors of the content to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

JD Supra does not sell, rent or otherwise provide your details to third parties, other than to the authors of the content on JD Supra.

If you prefer not to enable cookies, you may change your browser settings to disable cookies; however, please note that rejecting cookies while visiting the Website may result in certain parts of the Website not operating correctly or as efficiently as if cookies were allowed.

Email Choice/Opt-out

Users who opt in to receive emails may choose to no longer receive e-mail updates and newsletters by selecting the "opt-out of future email" option in the email they receive from JD Supra or in their JD Supra account management screen.


JD Supra takes reasonable precautions to insure that user information is kept private. We restrict access to user information to those individuals who reasonably need access to perform their job functions, such as our third party email service, customer service personnel and technical staff. However, please note that no method of transmitting or storing data is completely secure and we cannot guarantee the security of user information. Unauthorized entry or use, hardware or software failure, and other factors may compromise the security of user information at any time.

If you have reason to believe that your interaction with us is no longer secure, you must immediately notify us of the problem by contacting us at In the unlikely event that we believe that the security of your user information in our possession or control may have been compromised, we may seek to notify you of that development and, if so, will endeavor to do so as promptly as practicable under the circumstances.

Sharing and Disclosure of Information JD Supra Collects

Except as otherwise described in this privacy statement, JD Supra will not disclose personal information to any third party unless we believe that disclosure is necessary to: (1) comply with applicable laws; (2) respond to governmental inquiries or requests; (3) comply with valid legal process; (4) protect the rights, privacy, safety or property of JD Supra, users of the Service, Website visitors or the public; (5) permit us to pursue available remedies or limit the damages that we may sustain; and (6) enforce our Terms & Conditions of Use.

In the event there is a change in the corporate structure of JD Supra such as, but not limited to, merger, consolidation, sale, liquidation or transfer of substantial assets, JD Supra may, in its sole discretion, transfer, sell or assign information collected on and through the Service to one or more affiliated or unaffiliated third parties.

Links to Other Websites

This Website and the Service may contain links to other websites. The operator of such other websites may collect information about you, including through cookies or other technologies. If you are using the Service through the Website and link to another site, you will leave the Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We shall have no responsibility or liability for your visitation to, and the data collection and use practices of, such other sites. This Policy applies solely to the information collected in connection with your use of this Website and does not apply to any practices conducted offline or in connection with any other websites.

Changes in Our Privacy Policy

We reserve the right to change this Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our privacy policy will become effective upon posting of the revised policy on the Website. By continuing to use the Service or Website following such changes, you will be deemed to have agreed to such changes. If you do not agree with the terms of this Policy, as it may be amended from time to time, in whole or part, please do not continue using the Service or the Website.

Contacting JD Supra

If you have any questions about this privacy statement, the practices of this site, your dealings with this Web site, or if you would like to change any of the information you have provided to us, please contact us at:

- hide
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.