There is no denying that sexual misconduct on campus is a major issue for all institutions today, from both a campus “quality of life” and a risk management perspective.  With all the attention sexual misconduct cases are generating, an appropriate question to consider is what role should the Board of Trustees play in these issues?  The Association of Governing Boards of Universities and Colleges (“AGB”) recently addressed this question.  In its Advisory Statement on Sexual Misconduct, the AGB suggested several practices for governing boards and institutional administrative leadership.    Recognizing the Board’s fiduciary duty to address issues related to the overall campus culture, including sexual misconduct, AGB advises that: 

• governing Boards should monitor sexual misconduct issues consistent with their oversight of other forms of institutional risk (which requires a balancing that avoids micromanagement but permits being adequately informed so that it can assess institutional effectiveness);
• Boards should regularly request formal reports from administration detailing the nature of the risk, the likelihood of its occurrence, and the existence and effectiveness of internal controls for risk mitigation (from an overall perspective and not necessarily in terms of any individual case);
• Boards should encourage dialogue on sexual misconduct, and other issues that are important to the institution’s well being (AGB points out that “scrutinizing information, asking difficult questions, challenging assumptions, and introducing innovative ideas[,] improves the quality of institutional outcomes.”);
• Boards should promote this dialogue by:
  • discussing legal developments and national trends related to Title IX and sexual misconduct, and making sure they are sufficiently informed as to where their institution stands in terms of compliance with those developments and in light of national trends;
  • discussing these issues with the institution’s administrative leadership and planning for discussions of these issues on an ongoing basis with that leadership (as part of this effort, Boards need to determine what form these discussions will take – will they be with the full board or a board committee -- and establish an appropriate expectation for the administration to keep the Board (or appropriate committee informed);
  • reviewing the institution’s policies in this area and being aware of how they are implemented;
  • confirming that a Title IX Coordinator has been named (and who it is), appropriate training is being provided to members of the institutional community, all parties (complainant and accused) are being treated equally, fairly, and adequately, and the institution is monitoring its overall climate as it relates to sexual misconduct. 

With respect to administrative leadership, AGB suggests: 

• the institution’s chief executive (with support from others) ensure that the Board receives relevant information regarding these issues and engage the Board in periodic briefings about this topic, both in terms of legal developments and the institution’s response;
• the chief executive ensure that the Board receives sufficient information to facilitate its effective review of institutional response to sexual misconduct and that this issue is properly part of the Board’s agenda and part of the orientation for new Board members; and
• the chief executive also ensure that the rest of the institutional community – staff, faculty and students – are aware of the Board’s commitment to campus safety and oversight of related policies. 

These guidelines provide an excellent starting point for ensuring that the Board is properly engaged on this very important topic.  While, as noted by AGB, caution needs to be exercised to avoid micromanagement of the institution, the issue of sexual misconduct is simply too big an issue, on any number of levels, for the Board to fail to get involved and exercise appropriate oversight.

The recent case of Boyd v. State University of New York at Cortland (2013 WL 5640959 3d Dept. 2013) demonstrates the importance of properly documenting decisions reached during student disciplinary proceedings.  This Article 78 proceeding arose out of the dismissal of the petitioner, a student at SUNY Cortland, following a disciplinary hearing where it was determined that petitioner violated the student code of conduct by harassing a student at another institution and violating Delaware law (where the harassed student attended school).  Following the disciplinary hearing, SUNY Cortland’s suspension review panel upheld the hearing panel’s decision and sanctions. The petitioner challenged the determination on the grounds that (1) SUNY Cortland failed to follow its published rules in connection with the disciplinary process, alleging that the harassed student’s failure to participate violated SUNY Cortland’s rules because the rules require the “complainant” to present his or her own case, and (2) he was denied due process because he was not provided a detailed statement of the hearing panel’s factual findings. The Court found the petitioner’s first claim unavailing.  A “complainant” under SUNY Cortland’s rules is “any person or persons who have filed disciplinary charges against a student.”  Here, the fact that the harassed student did not participate was of no consequence, the Court held, because SUNY Cortland filed the disciplinary charges against the petitioner, and thus it (not the harassed student) was the “complainant.” The petitioner was successful on his due process claim.  The Court first observed that due process in connection with a public institution’s disciplinary proceeding requires accused students to be provided with a detailed statement of the factual findings and the evidence relied upon in reaching a determination.  The Court found that the hearing panel failed in this regard, as its decision contained only a conclusory statement that the petitioner violated the code of conduct and lacked any detail regarding the petitioner’s specific conduct as it related to harassment or violating Delaware law.  The Court also found the suspension review panel’s determination deficient because it simply upheld the hearing panel’s “findings” without further discussion.  The Court remitted the matter to the hearing panel for preparation of detailed factual findings in support of its determination. This case does not identify at what stage of the disciplinary process detailed findings of fact must be documented (i.e., hearing panel stage, review panel stage, or both), but confirms that this must be done at some stage of the proceedings in order to afford due process to an accused student because this provides a meaningful opportunity for the student to challenge the disciplinary decision. This case should serve to remind public institutions of the need to properly document disciplinary decisions with detailed findings of fact, not only to afford due process, but also with a view more generally towards withstanding potential legal challenge.  Although private institutions are not required to extend these same due process protections (e.g., detailed findings of fact) to students as public institutions, this case also provides a reminder to private institutions to ensure that their disciplinary processes are carried out in compliance with published policies and procedures.

The recent experience of Dominican College in New York should serve as a reminder to all institutions of the importance of accurate Clery Act reporting.  In 2009, Dominican College was subjected to a U.S. Department of Education program review for the 2006 and 2007 periods.  In 2013, the Department of Education finally determined that the College had failed in its Clery Act reporting obligations in several respects, notwithstanding the College’s efforts at correcting those errors upon notification of the deficiencies by the Department.  According to the Department’s findings, the College reported inaccurate crime statistics, it did not properly define and report crimes statistics separately for non-contiguous facilities, it did not properly and timely distribute its Annual Security Report and its report did not contain required policy statements, and it did not maintain accurate daily crime logs. The College was initially fined $262,500 for these violations.  Following an appeal, the fine was reduced a few weeks ago by the Department to $200,000 by way of a settlement agreement between the Department and the College. Understanding, and complying with, the requirements of the Clery Act and its reporting obligations is not only “the law,” but it should be clear given Dominican College’s recent experience that it just makes good economic sense. Speaking of the Clery Act, the Department has recently announced its intention to establish a negotiated rulemaking committee to prepare proposed regulations to address the changes to the campus safety and security reporting requirements in the Clery Act as a result of the Violence Against Women Reauthorization Act of 2013 (VAWA).

In a unanimous decision issued on October 31, 2013, the Virginia Supreme Court, in the case of Commonwealth of Virginia v. Peterson, held that as a matter of law, officials at Virginia Tech were not negligent in failing to warn students who were killed by a gunman on its campus in April 2007.  Specifically, the court ruled that the danger to students from the gunman’s second round of killings was not known or reasonably foreseeable to officials. The Court reasoned as follows:

In this case, the Commonwealth knew that there had been a shooting in a dormitory in which one student was critically wounded and one was murdered.  The Commonwealth also knew that the shooter had not been apprehended.  At that time, the Commonwealth did not know who the shooter was, as law enforcement was in the early stages of its investigation of the crime.  However, based on representations from three different police departments, Virginia Tech officials believed that the shooting was a domestic incident and that the shooter may have been the boyfriend of one of the victims.  Most importantly, based on the information available at that time, the defendants believed that the shooter had fled the area and posed no danger to others (emphasis in original).

The decision set aside a 2012 jury verdict against the Commonwealth which awarded $4,000,000 to the families of two students who were killed (which was subsequently reduced to $100,000 per family). Although this decision provides some comfort to institutions, the standard of vigilance expected of colleges and universities has indisputably changed since the Virginia Tech shooting (as have their obligations to warn their campus communities); in addition Department of Education enforcement proceedings arising out of the incident remain unresolved.  As a result, institutions should remain vigilant in designing, testing and deploying systems and processes to ensure the timely dissemination of information in emergency situations.

At the end of last week, the U. S. Department of Education announced that its Office for Civil Rights (“OCR”) had entered into a Resolution Agreement with the State University of New York (“SUNY”) dealing with Title IX compliance issues.  Significantly, the Agreement arose out of an OCR initiated investigation and was not based on the filing of any complaint against SUNY.  OCR’s Resolution Agreement and accompanying letter of findings are significant because, as with OCR’s Resolution Agreement earlier this year involving the University of Montana, they provide a roadmap as to what OCR considers to be the requirements of Title IX in the sexual harassment context. OCR’s latest pronouncements start with its basic operating premises:

1. if a recipient of federal financial assistance knows or has reason to know about sexual harassment which creates a hostile environment, it must take immediate action to eliminate it, prevent its recurrence and address its effects;
2. when responding to any complaint of sexual harassment, a recipient must take immediate and appropriate action to investigate or otherwise determine what occurred;

• if that investigation reveals that discriminatory harassment occurred, the recipient must take prompt and effective steps reasonably calculated to end the harassment, eliminate any hostile environment and its effects, and prevent recurrence;

1. these duties exist regardless of whether a student has complained, asked the recipient to take action, or identified the harassment as a form of discrimination.

From there, these documents offer important insight into OCR’s perspective of the full scope of a recipient’s obligations under Title IX.  First, of course, the institution must have a policy expressly providing that it does not discriminate on the basis of sex in its educational programs or activities, that this prohibition extends to employment, and that  inquiries concerning the application of Title IX may be referred to the institution’s Title IX Coordinator or to OCR.  The Title IX Coordinator should be clearly identified by name or title, with contact information (phone number, address, email).  Notice of this policy must appear, at a minimum, in announcements, bulletins, catalogs and application forms used in connection with the recruitment of students and employees and should be published broadly including on the institution’s website.  Notice of the institution’s non-discrimination policy must also be provided to any unions representing the institution’s employees. Second, the institution must maintain procedures for resolving sexual harassment complaints.  These procedures can be either the same as those used for resolving other types of complaints or can be dedicated to the resolution of sexual harassment complaints, but in either event they must provide for the prompt and equitable resolution of complaints, whether brought by students, employees or third parties.  As in the University of Montana agreement, this Resolution Agreement and letter of findings set forth OCR’s view of what should be included in these policies:

1. an appropriate definition of sexual harassment and examples of harassing conduct;
2. clear notice of where complaints may be filed, including the name or title, phone, address and email information of those individuals;
3. notice that students, employees and third parties may access these procedures (based on information we have received in other instances from OCR, we do not believe that OCR requires that the same procedure must apply to all three categories);
4. designated and reasonable prompt timeframes for major steps of the grievance/complaint process;
5. notice of the availability of interim measures to assist the complainant and the nature of those measures (such as the availability of counseling and academic assistance, steps that can be taken if the alleged perpetrator lives on campus and/or attends classes with the victim, etc.).  Pending the outcome of the investigation, a recipient must take steps to protect the complainant from further harassment, and must ensure that such interim measures will not disproportionately impact the complainant;
6. notice of a complainant’s Title IX rights and any available resources, such as counseling services and their right to file a complaint with local law enforcement;
7. in the event the policy provides for informal resolution procedures (such as mediation) the policy it cannot require a complainant to work the matter out directly with an alleged perpetrator, the complainant must know that he or she can end informal resolution at any time, and if the allegations include sexual assault/violence, mediation is not appropriate even on a voluntary basis (as was the case in OCR’s 2011 “Dear Colleague Letter,” OCR’s letter of findings refers to mediation as one example of informal procedures that may be available, but then provides only that mediation is not appropriate in cases of sexual assault/violence;  presumably other informal procedures may be);
8. any hearing processes must be equally available to both parties, including the opportunity to present relevant witnesses and other evidence and if an appeal process is provided (based on the Resolution Agreement, it appears that OCR does not require an appeal procedure), it must be available to both the complainant and the respondent;
9. written notice to the parties of the outcome of the proceedings, including any appeals (if appeals are provided for);
10. assurances that the institution will take steps to prevent further harassment and to correct its discriminatory effects on complainant if appropriate;
11. protections against retaliation, including ensuring that complainants know how to report any subsequent problems (and the institution should follow up with complainants to determine whether any retaliation or new incidents of harassment have occurred);
12. assurances of confidentiality to the extent possible, but even if the complainant requests confidentiality or asks that a complaint not be pursued, an institution must nonetheless take all reasonable steps to investigate and respond consistent with that request for confidentiality or request not to pursue an investigation (although OCR has given little guidance explaining how an institution is to strike that balance appropriately);
13. if the incident involves potential criminal conduct, the recipient must determine consistent with state and local law whether law enforcement should be notified (but it should not wait - more than temporarily - for law enforcement to carry out its responsibilities).

In addition to these provisions, OCR apparently expects an institution to maintain documentation of all proceedings (although OCR does not indicate how long).  Institutions also must provide training regarding the grievance process to any employees likely to witness or receive reports of sexual harassment and violence (e.g. faculty, campus security, university administrators, counselors, health personnel and resident advisors).  Training can be in person or on line for all staff responsible for recognizing and reporting incidents. Responsible persons are to report not only complaints brought directly to them, but also conduct they observe first-hand or learn about in some other way. The Resolution Agreement also requires SUNY to conduct an annual review of all complaints to identify patterns or systemic problems and to conduct annual climate checks. Simply because OCR required the above in its Resolution Agreement with SUNY does not mean it necessarily will require all of these items from every other institution, nor does an institution incorporating all of these items into its policies ensure that OCR will not require something more or different in a review of its policies.  Nevertheless, the above should provide a useful checklist for institutions to consider.

Many colleges and universities require applicants to provide information on arrests and convictions as part of the application process.  A recent case, Matter of Powers v. St. John’s University School of Law, illustrates just how costly it can be for the applicant to be less than completely forthcoming. The St. John’s University School of Law, in its 2005 application form, required applicants to disclose whether they had ever been charged with, pleaded guilty to, or been found guilty of, a crime.  The application required the individual to certify that his or her answers (to any application inquiry) were “complete and accurate” and noted that the failure to provide truthful answers could result in “denial of admission, dismissal, or rescission of an awarded degree….” Long after a student was admitted to the Law School, the School learned of information that led it to conclude that the student had not been completely forthcoming in his original application for admission with respect to a criminal conviction.  Although the student had noted his conviction for possession of a controlled substance during the application process, it was only later that the School learned that he was originally charged with intent to distribute.  Upon learning of this information, the School required the student to supplement his application information with respect to the incident.  Based on this supplemental information, the School determined that the student’s original application contained “material omissions and misrepresentations” involving the actual criminal charges that had been brought against him.  Although by this time the student had successfully completed three semesters of law school, the School rescinded his admission and, in effect, denied his application for admission nunc pro tunc. Not surprisingly, the student commenced a proceeding, claiming that the School’s actions were arbitrary and capricious and should be overturned.  In a split decision, New York’s Appellate Division for the Second Department ruled in the School’s favor.  The Court determined that the School’s decision involved an appropriate exercise of discretion after a full review of the facts and circumstances and as a result it was not arbitrary and capricious.  And, given that the original charges (which the student acknowledged were true) involved distribution and possession with the intent to distribute a controlled dangerous substance, the Court found that the penalty was not disproportionate to the offense.  One Justice in dissent felt that the School, in several respects, had gone too far and would have remanded the case back to the School to reconsider.  The dissent found that the actual penalty imposed – retroactive denial of admission – was even more severe than dismissal, since it effectively wiped the student’s record clear of his three successful semesters as if the student had never gained admission to the School (without any evidence that the School correspondingly returned the student’s three semesters of tuition). While it may not be surprising that the Court recognized the School’s right to deny admission to a student who it believed had not been fully forthcoming in the application process, what stands out about this case, of course, is that the School only made that determination halfway through the student’s successful completion of its law school program.  Given the holding in the case (and the specific language of the School’s application), it is possible that had the School learned of this deception only after the student had completed his course of studies (even years later), the Court might still have recognized the School’s right to rescind his degree. The decision certainly highlights the value of requiring applicants to certify the accuracy of the information they submit.

On October 28, New York State released information necessary for private colleges and universities to begin applying to participate in the Start-Up NY Program.  As you may recall, the Start-Up NY Program was enacted during the Summer of 2013, and provides very substantial benefits to certain businesses that open within designated areas proximate to qualifying higher educational institutions. The amount of space available for private institutions to participate in the Program is limited. Given the limit on available space, any delay in submission of the requisite application materials may cause an institution to be left out of the Program.  As a result, now that the State has clarified the application process for private colleges and universities, institutions interested in participating in the Start-Up NY Program should act immediately to submit their application materials.

The United States Department of Justice and the United States Department of Education recently issued a jointly-authored Dear Colleague Letter  and accompanying “Questions and Answers” document discussing the Supreme Court’s June 2013 decision in Fisher v. University of Texas at Austin. This joint guidance reaffirmed the Departments’ mutual belief in the value of efforts by colleges and universities to create racially diverse student bodies “in a lawful manner,” and observed that the Supreme Court “did not change” what institutions must do to narrowly tailor their efforts to meet the compelling interest in diversity.  After Fisher, as before, institutions must not make race the defining feature of a candidate’s application for admission, and must demonstrate that the consideration of an individual applicants’ race in admissions is necessary because workable race-neutral alternatives do not suffice. This characterization is consistent with the Supreme Court’s opinion in Fisher.  However, the most significant aspect of Fisher is its emphasis on a reviewing court’s obligation to perform a searching inquiry to determine the necessity of race-conscious measures and, correspondingly, the need for institutions to be able to prove that they have engaged in an ongoing consideration of race-neutral alternatives.  In this regard, one question left unanswered by the Supreme Court was whether an institution must actually attempt to implement race-neutral alternatives before implementing race-conscious policies, or whether an institution need only demonstrate that a race-neutral alternative cannot be expected to work under prticular circumstances. While the Dear Colleague Letter and Q&A did not address this question or otherwise provide direct guidance on what level of consideration must be given to race-neutral alternatives, a senior Office of Civil Rights official remarked publically the same day that such alternatives “don't have to be tried and used” before implementing race-conscious practices.  This provides a welcome degree of comfort to colleges and universities that OCR will not require them to put affirmative action policies on hold in order to first experiment with race-neutral measures, but institutions should nevertheless ensure that they can demonstrate the basis for their conclusions that those policies are necessary to create the desired diversity in their respective student bodies. However, there is some concern that this message may be unrealistically comforting.  Already in some states, either as a result of litigation, laws passed by state legislatures or the impact of public referendums, public institutions are prohibited from considering race at all in the admissions process.  The Supreme Court is poised to rule on the legality of such a ban via referendum in Michigan.  In oral argument in that case, at least some justices expressed skepticism that such a ban was prohibited.  Where the Court may go in the future on the permissibility of race conscious admissions decisions for private institutions is not free from doubt.  As a result, some schools are looking more closely at implementing race-neutral practices where possible.

On July 25, 2013, Governor Andrew Cuomo signed into law the Kerry Rose Fire Sprinkler Notification Act, which requires the immediate disclosure of residential fire safety system information by colleges and universities in New York State. The Act is named for Kerry Rose Fitzsimons, a college student who died, along with two others, in a 2012 fire in her off-campus residence.

The Act adds a new Section 6438 to the New York Education Law, requiring institutions to disclose in writing to students residing in an institutionally-owned or operated housing facility a description of the facility’s fire safety system, including whether the facility is (or is not) equipped with a sprinkler system. The written notification must also indicate how students may access the institution’s Campus Fire Safety Report published pursuant to the federal Higher Education Opportunity Act.

The Act is effective immediately. Accordingly, colleges and universities in New York should take steps to inform all current and future residential students of the information described above, taking care to ensure that the disclosed information provides an accurate description of their fire safety capabilities. The Act does not specify the precise timing or means by which notice must be provided, other than to require that the notice be in writing. We anticipate that in the future, most institutions will choose to provide this information as part of the documentation by which students elect to reside in their residential facilities; however, an ad hoc notification process may be necessary for those students who have already completed the housing registration procedure for the 2013-2014 academic year.

The use and compensation of commissioned agents to recruit students from outside the United States has been debated at length in recent years.  On September 21, 2013, the debate took its latest turn when the Assembly of the National Association for College Admission Counseling (NACAC) voted to approve a change to its ethical standards that would allow member colleges and universities to use commissioned agents to recruit students outside the United States. The use of such agents has been divisive in recent years given arguable conflicts of interest that result from the prevailing practice of compensating them based on the success of their efforts (through tuition sharing or per capita payments based on enrollment). As a result, opponents had at times advocated a complete ban on the practice – in 2011, the NACAC Board had proposed a policy prohibiting incentive-based recruiting in the international context; that proposal was withdrawn following subsequent protest, and NACAC pronouncements have generally disfavored, but not prohibited, the practice. As amended, NACAC’s Statement of Principles of Good Practice provides that member institutions will “not offer or accept any reward or remuneration from a secondary school, college, university, agency or organization for placement or recruitment of students in the United States.” Member institutions using such agents outside the United States are admonished to “ensure accountability, transparency, and integrity” in their agent relationships. The prohibition on the use of commissioned agents to recruit within the United States does not necessarily represent an independent value judgment by NACAC, as the practice is already prohibited under the United States Department of Education’s Title IV program integrity rules, specifically 34 CFR § 668.14(b)(22)(i). The new standard will become effective following a one-year moratorium during which NACAC will consider its implications and, potentially, propose further refinements. Some colleges and universities have refrained from enlisting overseas recruiting agents pending NACAC guidance, and the delayed effectiveness of the amendment may cause some of these institutions to continue to wait. However, others may proceed, as many of their peers have already done given the nonbinding nature of prior NACAC pronouncements on the topic. In any event, a college or university that chooses to use agents to conduct foreign recruiting activities should take steps (including obtaining binding contractual commitments) to ensure that the agents conduct themselves in a manner consistent with the institution’s mission and values, and that there is appropriate recourse if an agent fails to do so.

The Supreme Court today released its decision in the Association for Molecular Pathology, et al. v. Myriad Genetics, Inc. patent case.   The court unanimously held that"a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring.  Accordingly, the Federal Circuit'sMyriad holding was affirmed-in-part and reversed-in-part. According to the Court, finding the location of the BRCA1 and BRCA2 genes did not render the genes patent eligible “new . . . composition[s] of matter,” under §101.  cDNA, on the other hand, was found to be patent eligible because it is an exons-only molecule, which according to the Court is not naturally occurring. Stay tuned for an in-depth analysis of the Myriad holding here at the Higher Education IP Law Report.

The Supreme Court today released a unanimous decision in the Association for Molecular Pathology, et al. v. Myriad Genetics, Inc. patent case regarding the human BRCA1 and BRCA2 genes associated with breast cancer, holding that while a naturally occurring DNA segment is a product of nature and therefore not patent eligible, synthetic molecules called “cDNA” are patent eligible because they are not naturally occurring. Background A group of physicians, patients and researchers challenged the Myriad patents in the Southern District of New York, seeking a declaration that certain claims of the patents are invalid under 35 U. S. C. §101.  The Court granted summary judg­ment to the petitioners on the claims at issue, holding that the claims were directed to products of nature and where therefore invalid. In 2012, the Federal Circuit – on remand from the Supreme Court in light of in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc. – reversed the district court and held that both isolated DNA and cDNA are indeed patent eligible under §101.  The Supreme Court granted certiorari and oral argument was held on April 15, 2013. Isolated DNA Sequences Are Not Patent-Eligible Subject Matter In holding that the mere isolation of naturally occurring DNA sequences does not result in patent eligible subject matter under §101, the Court noted that “Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes,” and that “[t]he location and order of the nucleotides existed in nature before Myriad found them.”  Although Myriad’s discoveries may have been “[g]roundbreaking, innovative, or even brilliant,” this was not sufficient to satisfy the §101 inquiry.  According to the Court, merely identifying the BRCA1 and BRCA2 genes and isolating them from the “surrounding genetic material” was not an act of invention. Indeed, the issue of whether isolating DNA from a chromosome renders the isolated sequence patent eligible was largely dismissed despite comprising a substantial portion of the Federal Circuit’s decision.  These claims are not expressed in terms of chemical composition, the Court reasoned, and do not rely on any chemi­cal changes that may result from the isolation of a particular section of DNA.  Instead, the claims focus on the genetic information encoded in the DNA. Synthetic cDNA Sequences Are Patent-Eligible In contrast to isolated DNA sequences, the Court held that cDNA sequences are patent eligible because the “creation of a cDNA sequence from mRNA results in an exons-only molecule that is not natu­rally occurring.”  Although the petitioners argued that the sequence of cDNA is dictated by nature rather than by a scientist, the Court rejected that argument and reasoned that “the lab technician unquestionably creates something new when cDNA is made.” The Court did highlight at least one situation where cDNA may in fact be naturally occurring and therefore not patent eligible: when a very short DNA sequence may have no intervening introns to remove when creating cDNA, in which case “a short strand of cDNA may be indistinguishable from natural DNA.” Myriad Does Not Implicate Method or Application Claims, or Modified DNA Sequences The Court carefully noted that this decision does not implicate method claims, although the Court did echo its recent decision in Mayo.  While Myriad might have sought a method patent directed to some “innovative method of manipulating genes” if it had created such a method, the Court noted that the processes used by Myriad to isolate the BRCA1 and BRCA2 genes were “well understood, widely used, and fairly uniform” and were not at issue in this case. Similarly, the decision does not implicate claims directed to applications of knowledge about the BRCA1 and BRCA2 genes.  Indeed, many of the unchallenged claims in the Myriad patents are directed to such applications. Further, the decision does not consider the patentability of modified DNA sequences, since “[s]cientific alteration of the genetic code presents a different inquiry.” Conclusions Although the Court’s decision may seem far-reaching, the ultimate impact may be limited. Indeed, one recent study found that there are relatively few patents directed to naturally occurring human gene sequences.  As a result, it may only be Myriad and a limited number of similar patentees that feel the impact of the Court’s holding. In light of Myriad, patent portfolio strategies should focus on applications of knowledge about identified DNA sequences rather than on the DNA sequences themselves.  This strategy will steer clear of Myriad while providing valuable patent protection for uses of the discovery.