Myriad Back in Court on Patent Subject Matter Eligibility

On June 13, 2013, the Supreme Court issued a unanimous decision holding that “genes and the information they encode are not patent eligible simply because they have been isolated from the surrounding genetic material.” See Association for Molecular Pathology v. Myriad Genetics Corp. (AMP), 133 S. Ct. 2107, 2120 (2013). Attorney Sewell’s publication entitled “Unanimous U.S. Supreme Court and Angelina Jolie: BRCA1 & BRCA2 Patentability” is widely disseminated, well-received by his peers, and sparks considerable commentary.

Background

In somewhat of a twist, the Supreme Court’s decision against the patentability of isolated DNA prompted more—not less—litigation by Myriad regarding gene patents. Between 1997 and 2013, Myriad’s revenue from its BRACAnalysis test steadily increased, and totals more than $2 billion. BRACAnalysis is a genetic test that confirms the presence of BRCA1 or BRCA2 gene mutations, responsible for the majority of breast and ovarian cancers. Myriad earned that revenue by carefully guarding its patent rights and preventing others from providing screening tests for the BRCA1 and BRCA2 genes. From the mid-1990s, until the Supreme Court’s AMP decision, Myriad was the lone provider of full-sequence BRCA1 and BRCA2 tests in the United States. Within days of the Supreme Court’s AMP decision, Defendant Ambry Genetics Corporation announced plans to sell tests less expensive than Myriad’s to screen BRCA1 and BRCA2 genes. Ambry Genetics Corporation is a clinical diagnostic and genomic services company in Aliso Viejo, California. Defendant now offers a menu of at least six tests that include screening for BRCA1 and BRCA2: a combined BRCA1/BRCA2 test, BRCAPlus, BreastNext, PancNext, Ova Next, and CancerNext. Defendant’s BRCA1/BRCA2 test is available for $2,200—substantially less than the price for comparable testing offered by Myriad.

Soon after Defendant Ambry made its announcement, Myriad filed a complaint in the District Court of Utah alleging that Ambry’s genetic testing infringes several of Myriad’s patents. Myriad also moved for a preliminary injunction to enjoin Defendant Ambry from sales or offers to sell “genetic tests including a BRCA1 or BRCA2 panel”. Ambry opposed the motion, alleging that the claims were invalid under 35 U.S.C. § 101 et seq. The district court divided the Myriad gene patent claims at issue into the Primer Claims and the Method Claims.

On March 20, 2014, the Utah District Court held that Plaintiffs are not entitled to a preliminary injunction because “although Plaintiffs have shown they are likely to be irreparably harmed if an injunction does not issue, Defendant has raised substantial questions concerning whether any of the patent claims at issue in Plaintiffs’ Motion are directed toward patent eligible subject matter under 35 U.S.C. § 101”. Myriad then appealed to the Federal Circuit the denial of its motion for a preliminary injunction.
 
U.S. Federal Circuit Court of Appeals

On October 6, 2014, Chief Judge Prost and Judges Dyk and Clevenger of the U.S. Court of Appeals for the Federal Circuit heard oral argument in the interlocutory appeal of the Utah district court’s denial of Myriad’s motion for preliminary injunction against Ambry Genetics. In re BRCA1- and BRCA2- Based Hereditary Cancer Test Patent Litigation, Case Nos. 14-1361, -1366. The two main issues that dominated the argument are: 1) the correct implementation of the test for patent eligibility; and 2) the application of this test to probes and primers. The impact on the biotechnology industry was also discussed.

Jonathan E. Singer, counsel for Myriad, began by arguing that both the Federal Circuit and the Supreme Court had previously acknowledged that Myriad was entitled to patent some applications of their newly-discovered gene sequence and tools designed specifically to utilize that sequence. Myriad argues that primer pairs are patent subject matter eligible under 35 U.S.C § 101 because the pairs are structurally and functionally different than a single fragment of DNA. Counsel for Myriad also argued that, as a whole, the method of screening for alterations on the BRCA genes involves steps of the method claims, when considered together, effect an improvement in a technical field – by using Myriad’s probes and primers that Myriad invented.

With respect to the primer claims, Ambry argues that these claims are patent-ineligible because, in addition to reciting patent-ineligible products of nature, the claims fail under Alice because they are a generic component used to amplify a person’s gene sequence to access the sequence information for the patent-ineligible sequence comparison. As for the method claims, Ambry argues that under Alice, “the combination of unpatentable subject matter and a generic physical application is no more patent eligible than a claim reciting only the unpatentable subject matter.” See Ambry Supplemental Brief at page 3.

Conclusion

What is clear from the district and appellate court arguments is that it does not appear likely that Myriad will be successful in its attempts to preliminarily enjoin Ambry. Additionally, the biotechnology industry is looking towards the Federal Circuit for guidance on the correct implementation of patent subject matter eligibility under Myriad, Mayo, and Alice.
 
Intellectual property (patents, trademarks, copyrights, trade secret) is all around us and is valuable. The things that we use, watch, and buy are items that were thought of and then put into practice. Attorneys at the New York LAW FIRM OF DAYREL SEWELL, PLLC protect your intellectual property Law, so that you can maximize value. The majority of our attorneys possesses scientific training and is well-experienced in the litigation and prosecution aspects of patents, trademarks, copyrights, trade secrets, licensing, unfair competition, and more. Our passion and commitment is unmatched and is one of several aspects that set us apart from our peers. We care. As a result, our clients receive legal expertise with individualized attention by attorneys who are invested in the outcome of your matters. Our clients realize the value that this law firm delivers and are committed to a long-term, rewarding, attorney-client relationship.

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About sewellnylaw

Mr. Sewell continuously distinguishes himself as a top litigation attorney. He has twice been selected by New York Super Lawyers as a "Rising Star". Additionally, he is recognized as "Superb" and a "Top Litigation Attorney" by the lawyer-rating service Avvo. Moreover, he has been prominently featured as a preeminent legal authority on CNN. Attorney Sewell has several years of transactional experience as well as significant, state and federal litigation practice. Moreover, he is well-versed in prosecution matters before the United States Patent & Trademark Office and the United States Copyright Office. He has represented the spectrum of patent, trademark, and copyright owners, food and drug companies, business owners, non-institutional clients, and more. While at a top 100 law firm, Mr. Sewell's foci were in the areas of litigation and intellectual property. Prior to large firm practice, he honed his skills in Manhattan at a litigation boutique that specialized in intellectual property, food & drug law, and litigation. Mr. Sewell is also an alumnus of the distinguished Innocence Project at the Benjamin N. Cardozo School of Law. He drafted motions and briefs regarding reopening criminal cases and reversing convictions using DNA evidence. Ultimately, his efforts culminated in the exoneration of one of his clients. Dayrel also completed a legal internship at Bristol-Myers Squibb Company. While at Bristol-Myers, he gained patent litigation and prosecution experience through the Court of Appeals for the Federal Circuit litigation and training seminars, respectively. He also worked on several regulatory matters including corporate consultant agreements, conflicts of interest, clinical trials, and co-marketed pharmaceutical contracts. To continuously expand his expertise, Attorney Sewell has several years of experience providing counsel and litigation representation to real estate entities and individuals. Mr. Sewell recognizes the systemic real estate crisis and its affects on both investors and individuals, and is well-prepared to continue to assist clients with the crisis' persistent havoc that affects the millions of people involved. Prior to law school - with academic, medical background, and practicum requirements being met - Mr. Sewell received his M.P.H. from Columbia University and was a Director for medical research studies in New York City. Dayrel received his B.A. from The Johns Hopkins University, majoring in both Natural Sciences and Public Health. Mr. Sewell has also found time to do pro bono work. Of note, Dayrel is proficient in Spanish. Some examples of Attorney Sewell's work include: Litigation involving contracts, patents, real estate, securities, foreclosures, trademarks, copyrights, licenses, LLCs, and torts Negotiating/authoring business contracts and settlement agreements issuing patent and trademark opinions drafting and registering patents, trademarks, and copyrights counseling clients regarding food & drug product registration, compliance, and other regulatory matters advising startup companies and creating their business entity structure real estate transactions (i.e., conveyances, leases, title searches, deeds, assignments, recordings, etc.) Bar admissions United States Supreme Court New York District of Columbia United States Patent Bar United States Court of Appeals for the Second Circuit United States Court of Appeals for the Federal Circuit United States District Court for the Southern District of New York United States District Court for the Eastern District of New York Degrees J.D., Benjamin N. Cardozo School of Law M.P.H., Columbia University B.A., The Johns Hopkins University Awards & Distinctions Two-time Super Lawyers NYC Metro Rising Star Who's Who in American Law Notes Editor, Cardozo Journal of Law & Gender Alumnus, The Innocence Project, Benjamin N. Cardozo School of Law NIEHS Community & Preventive Medicine Fellow, Mount Sinai School of Medicine Recipient, Phoenix Fellowship, Columbia University Alumnus, Council on Legal Education Opportunity Winner, Black Bar Association of Bronx County Writing Competition Federal Acquisition Regulations Certificate HIPAA Research Compliance Certificate Publications Dayrel S. Sewell, Amulya Appalaraju, The Duality of the U.S. Supreme Court's Janus Decision, American Bar Association, Securities Litigation, 2015 Fall Newsletter. Dayrel S. Sewell, Andrew Fine, The "Redskins" Trademark: Turn-over on Downs, IPFrontline, October 2015. Dayrel S. Sewell, Ivan Ng, Pharrell Williams and Robin Thicke told they "Got To Give It Up", IPFrontline, May 2015. Dayrel S. Sewell, Ivan Ng, A ?Generic' Victory for Specific Fact-Findings, Intellectual Property Today, March 2015, at 34. Dayrel S. Sewell, Ivan Ng, A ?Generic' Victory for Specific Fact-Findings, IPFrontline, February 2015. Dayrel S. Sewell, Myriad Back in Court on Patent Subject Matter Eligibility, The Brooklyn Barrister, January/February 2015, at 9. Dayrel S. Sewell, The Ignominious Patent Troll, The Brooklyn Barrister, November 2013, at 5. Dayrel S. Sewell, The Ignominious Patent Troll, Intellectual Property Today, November 2013, at 12. Dayrel S. Sewell, Unanimous U.S. Supreme Court and Angelina Jolie: BRCA1 & BRCA2 Patentability, Intellectual Property Today, July 2013, at 24. Dayrel S. Sewell, Marc S. Ullman, The Regulation of Advertising for Dietary Supplements in the United States, KENKO SANGYO RYUTSU SHIMBUN (Health Trade Newspaper), April 8, 2007, at Issue 661. Tam T. Nguyen, Dayrel S. Sewell and Adrian S. Dobs. Oral Methyltestosterone Given to Post-menopausal Women Decreases Adipose Tissue and Increases Lean Muscle Mass with No Change in Muscle Strength. ENDO 2000 Abstracts. Category: Clinical Science: Aging. Medicine, Johns Hopkins University (2000). Speaking Engagements Dayrel S. Sewell, Brooklyn Bar Association Continuing Legal Education Speaker, Intellectual Property Fundamentals: What Every Attorney Needs to Know, May 2014. Dayrel S. Sewell, Legal Analyst (en espa?ol ), CNN "Realidades En Contexto": Nueva Jersey Agentes Inmobiliarios haber supuestamente Relaciones repetidas Dentro de una casa en venta, March 2014. Dayrel S. Sewell, Panelist, Managing Career Changes in a Changing Global Market, Union League Club, November 2013. Dayrel S. Sewell, Presenter, Professional Development, Bristol-Myers Squibb Legal Department Conference, June 2009. Other Licenses New York State Real Estate Broker New York State Notary Public Organizations Brooklyn Bar Association Vice-Chair, Intellectual Property Committee Vice-Chair, Real Property Committee New York County Lawyers' Association The Johns Hopkins University Law Affinity Committee
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