Biopharmaceutical Companies Weigh-In on Myriad Case

by McDonnell Boehnen Hulbert & Berghoff LLP
Contact

[author: Andrew Williams]

In addition to the various associations, academics, and interest groups that filed "supplemental" amici curiae briefs in Association for Molecular Pathology v. U.S. Patent and Trademark Office ("the Myriad case"), two briefs were filed by companies that would be directly negatively impacted if either "the isolated DNA claims [or the] method claim 20 of the '282 patent" were found to be patent ineligible.  This is because, as one of the briefs put it, a broad application of patent ineligibility "could disrupt the expectations of large numbers of chemical and biotechnology patent holders and researchers who have depended on the patent system to secure rights to valuable intellectual property and to attract necessary capital and investment."  Therefore, these organizations have "a strong interest in ensuring the stability of the patent system as it relates to chemical and biotechnology inventions."

Gilead SciencesThe above language comes from an amici brief filed by research-based biopharmaceutical companies Gilead Sciences, Inc., Confluence Life Sciences, Inc. and Euclises Pharmaceuticals, Inc. (collectively "Gilead").  Gilead's brief is directed solely to the issue of "whether a synthetic, man-made sequence of nucleotides forming a 'composition of matter,' which is both 'new and useful," is § 101-includable," and therefore it focuses exclusively on the cDNA sequence defined in claim 2 and recited as SEQ ID NO:1 of U.S. Patent No. 5,747,282 ("the '282 patent").  However, Gilead is quick to point out that this is not a "gene patenting" case -- most likely because the synthetic sequence of nucleotides invented by Myriad Genetics, Inc. ("Myriad") never existed in nature prior to its invention.  Gilead alleges that the lower court (the District Court of the Southern District of New York) erred as a matter of law for failing to recognize the "made-by-man" standard for determining whether a new chemical substance satisfies 35 U.S.C. § 101, and erred as a matter of fact by misapplying the "markedly different" test.  Gilead concludes by arguing that nothing in the Supreme Court's Prometheus decision changes the Federal Circuit's July 2011 decision that claim 2 of the '282 patent is § 101-eligible.

Gilead begins by pointing out all of the transformative steps that Myriad had to undergo in order to make SEQ ID NO:1.  First, Myriad researchers identified that genetic defects in the BRCA1 gene were the likely source of a pre-disposition to breast and ovarian cancer.  Further, before any chemical transformative step was undertaken, the researchers used natural product genomic screening to narrow Chromosome 17 (with about 81 million base pairs) to a 100,000 base pair isolated BRCA1 gene.  This gene, of course, includes both introns and exons (with 23 coding exon segments).  Therefore, Myriad had to chemically manipulate, or transform, the isolated gene to derive its cDNA construct (as shown in the below figure from Gilead's brief).

Gilead Image
Gilead alleges legal error on the part of the lower court because, as the Supreme Court reiterated in Diamond v. Chakrabarty, "Congress intended statutory subject matter to 'include anything under the sun that is made by man.'"  In fact, Gilead provides a reminder of the broad statutory goal of the patent system, pointing out that it was Jefferson's philosophy that "ingenuity should receive a liberal encouragement."  Therefore, even though patent eligibility has clear limits, the fundamental question "should be whether the invention is truly 'made by man," i.e., whether the invention is 'the result of human ingenuity and research.'"  Gilead supports this proposition by citing to eleven Federal Circuit, CCPA, and District Court cases that found synthetic compounds and materials patent eligible, and six Federal Appellate and District Court cases that found purified compounds to be patent eligible.

In contrast, the Gilead brief does not spend much effort explaining why the lower court erred as a matter of fact by misapplying the "markedly different" test.  Instead, it simply points out that, to the extent the Chakrabarty decision imposed a "markedly different characteristics" requirement into § 101, the Federal Circuit had already found that this requirement was satisfied in its July 2011 decision.  The brief also reiterates the practical utility of new DNA molecules at least as a diagnostic tool, which is evidenced by Myriad's medical and economic success using the synthetic cDNA compound as a predictor of genetic pre-disposition to cancer.

Gilead's conclusion, however, focuses exclusively on explaining why the Prometheus decision does not apply to Myriad's synthetic cDNA.  First, unlike Prometheus's method claims, there were at least 20 transformative steps that resulted in a sequence of nucleotides that had not, and could not, exist in nature.  Second, these transformative steps fully meet the Diehr standard of not being mere applications of "mathematical formula" or "laws of nature."

Protein SciencesProtein Sciences Corporation ("PSC), another biopharmaceutical company, filed a separate amicus brief.  However, instead of limiting its analysis to the DNA claims, PSC addresses all of the claims that were originally at issue.  Importantly, PSC explains how the "Growth Rate Claim" continues to be patent eligible, even after the Prometheus decision.

According to PSC, Prometheus reduced the patent-eligibility question to the following test:

(1)  Is the claim a method or process claim?  If yes, then:
(2)  Does the method or process call for applying a law of nature?  If yes, then:
(3)  Do the steps of the method or process:

a.   Merely call for a particular audience to apply the law of nature or for applying the law of nature in a particular technological environment, or
b.  Call for "[p]urely 'conventional or obvious' '[pre]-solution activity'"?

If the answer to either (3)(a) or (3)(b) is "yes," then the method or process fails to be patent eligible, and also fails to meet § 112, ¶ 1.  If either question cannot be answered because of an insufficient record as to whether the steps are "conventional or obvious," the case should be remanded to develop the record.  This is, of course, a very narrow reading of Prometheus (suggesting that any composition of matter would be patent eligible), but PSC's application of Prometheus to the present claims is rooted in this understanding.  PSC also finds it necessary to define "law of nature," which according to the 1993 New Shorter Oxford English Dictionary is a "scientific generalization based on empirical observation" (as paraphrased by PSC).

Therefore, the analysis as to whether isolated DNA or cDNA are patent eligible according to Prometheus is simple -- they are compositions of matter, and therefore Prometheus does not apply.  However, apparently to be safe, PSC also explains that "isolated DNA molecules are chemical compositions that possess physical, chemical and structural properties that differ from their naturally-occurring counterparts, and are molecules that man must create."  In addition, PSC points out that isolated DNA has new properties not shared by its native counterpart, including uses as a probe, a diagnostic tool, a primer, and in sequencing.  Thus, as to part 2 of the alleged Prometheus test, they are not products of nature.  To further bolster its conclusion, PSC points out that this conclusion comports with the longstanding practice of the PTO and the Federal Circuit.  PSC's analysis of cDNA is similar to that of isolated DNA, and the same conclusion is reached -- cDNA is patent eligible.

As for the method claims, PSC first notes that Myriad's "analyzing" and "comparing" claims, which the Federal Circuit previous held to be not patent eligible, would also fail the Prometheus test.  However, the Growth Rate Claim, claim 20 of the '282 patent, would be patent eligible under this test.  The claim at issue reads:

20.  A method for screening potential cancer therapeutics which comprises: growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.

Because this claim is a method claim, question (1) of the test is answered in the affirmative.  However, according to PSC, the method uses transformed cells that contain an altered BRCA1 gene, which are not naturally occurring (after all, even the claim language itself indicates a "transformation" has occurred).  Moreover, because these cells do not occur naturally, they cannot be calling for the application of a law of nature.  Therefore, PSC concludes that this claim is more akin to the claim in Diehr (applying the Arrhenius equation) than the claims in Prometheus.

It is unclear if either of these briefs adds anything new to the discussion.  However, it is clear that each of these four companies, and many others like them, have invested substantial research and development (and therefore money and time) with the understanding that the patent system will protect their investments.  If the Federal Circuit were to take a narrow view of patent eligibility after the Prometheus case, it could seriously negatively impact the development and investment of future biopharmaceuticals and vaccines.  As such, hopefully the Federal Circuit will at least consider the perspective of these companies.

For additional information regarding this topic, please see:

• "Health Care Professionals Contend That Isolated DNA and cDNA Are Patent Ineligible," July 16, 2012
• "Coalition of Amici File Brief in Support of Myriad," July 15, 2012
• "Dr. James Watson: Human Genes Should Not Be Patented," July 12, 2012
• "Scientist-Law Professor Files Amicus Brief in Myriad Case," July 11, 2012
• "U.S. Government: Mayo Decision Supports Prior Argument That Isolated Genomic DNA Is Not Patent Eligible," July 10, 2012
• "IPO Amicus Brief Argues for Patent Eligibility of Myriad's Isolated DNA Claims and Method Claim 20," July 9, 2012
• "Eli Lilly & Co. File Amicus Brief in AMP v. Myriad," June 27, 2012
• "Parties and Amici File Briefs in Myriad Case," June 17, 2012

 

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.

© McDonnell Boehnen Hulbert & Berghoff LLP | Attorney Advertising

Written by:

McDonnell Boehnen Hulbert & Berghoff LLP
Contact
more
less

McDonnell Boehnen Hulbert & Berghoff 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.
Privacy Policy (Updated: October 8, 2015):
hide

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.

Security

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 info@jdsupra.com. 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: info@jdsupra.com.

- 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.