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.



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.


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.

patent, trademark, copyright, trade secret, intellectual property, unfair competition

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, 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.

After Patent Life, FDA says NO to Generic OxyContin

After Patent Life, FDA says NO to Generic OxyContin



Under the Food, Drug, & Cosmetic (FD&C) Act and implementing regulations, the Food and Drug Administration (FDA) is responsible for ensuring that all new drugs are safe and effective. FDA also regulates the advertising and promotion of prescription drugs under the FD&C Act.


Purdue Pharma L.P., based in Stamford, CT, is a privately held pharmaceutical company founded by physicians. The FDA approved Purdue Pharma’s controlled-release pain reliever OxyContin in 1995. OxyContin (oxycodone hydrochloride controlled-release) is an opioid analgesic supplied in various dosages for oral administration. OxyContin is Purdue’s brand for time-release oral oxycodone. OxyContin followed Purdue’s older product, MS Contin, a morphine-based product that was approved in 1984 for a similar intensity and duration of pain and during its early years of marketing was promoted for the treatment of cancer pain.




OxyContin’s time-release formula could be used over 12 hours to maintain a steady level of the narcotic oxycodone in patients suffering from moderate-to-severe pain. By 2001, sales had exceeded $1 billion annually, and OxyContin had become the most prescribed brand name narcotic medication for treating moderate-to-severe pain. OxyContin has long been one of the nation’s top-selling prescription painkillers with sales of more than $2.8 billion last year, according to prescription tracker IMS Health.


However, in early 2000, reports began to surface about abuse and diversion for illicit use of OxyContin. Several factors thought to be early contributors to the abuse and diversion of OxyContin are: 1) the active ingredient in OxyContin is twice as potent as morphine, which may have made it an attractive target for misuse; 2) the original label’s safety warning advising patients not to crush the tablets because of the possible rapid release of a potentially toxic amount of oxycodone may have inadvertently alerted abusers to methods for abuse; and, 3) the significant increase in OxyContin’s availability in the marketplace may have increased opportunities to obtain the drug illicitly in some states.


After the problems with often-abused OxyContin began to surface, FDA and Purdue collaborated on a risk management plan to help detect and prevent abuse and diversion. Although risk management plans were not in use when OxyContin was approved, they are now an optional (or, at times, required) feature of new drug applications.


Recent Developments


Purdue stopped making its classic OxyContin pills — first released to the market in 1995 and easy to crush, snort and abuse — in 2010. In April 2010, the FDA approved a reformulated version of OxyContin, which was designed to be more difficult to manipulate for purposes of misuse or abuse. Purdue stopped shipping original OxyContin to pharmacies in August 2010. Various sources estimate that this new ‘tamper-proof’ pill’s patent term will expire about 2025.


Purdue Pharma’s patent on its original OxyContin formulation expired on April 16, 2013. That very same day, the FDA issued an immediate press release stating that it will not approve generic formulations to the original OxyContin. The FDA says that:


“because original OxyContin provides the same therapeutic benefits as reformulated OxyContin, but poses an increased potential for certain types of abuse, the FDA has determined that the benefits of original OxyContin no longer outweigh its risks and that original OxyContin was withdrawn from sale for reasons of safety or effectiveness. Accordingly, the agency will not accept or approve any abbreviated new drug applications (generics) that rely upon the approval of original OxyContin.”


The FDA also approved updated labeling for Purdue’s reformulated OxyContin tablets. The new labeling indicates that the product has physical and chemical properties that are expected to make abuse via injection difficult and to reduce abuse via the intranasal route (snorting).


The decision is the first time that the agency has allowed a manufacturer to state that a narcotic drug has tamper-resistant properties, said an agency official, Dr. Douglas C. Throckmorton. Dr. Throckmorton further stated that the F.D.A. had looked at data from several studies, some of it underwritten by Purdue, in arriving at its decision. He said that while the data was not perfect, the agency had concluded that it was enough to show that the new version of OxyContin was safer, in its abuse resistance, than the original version.




The public health position is clear. Dr. Throckmorton says that “[t]he development of abuse-deterrent opioid analgesics is a public health priority for the FDA.” The public health aspect is self-evident, but what about the ramifications of the FDA’s decision?


Pharmaceutical companies invest vast sums of money into their Research & Development (R&D) programs, including safety and efficacy testing. The exclusive monopoly of a patent offers these companies means to recoup some of that investment while also promoting the progress of science and providing full disclosure of the invention (which in this case is a composition of matter). Typically, when a drug loses patent, revenues plunge quickly because such expirations open the door to a slew of cheaper versions from generic drug manufacturers that can rely on abbreviated new drug applications (ANDA) containing safety and efficacy data previously submitted to the FDA.


In general, generic drug companies are not built upon the model of conducting extensive R&D. It is this axiomatic principle that the FDA decision effectively protects Purdue from lower-price competition by requiring generic companies to develop their own abuse-deterrent designs. The ‘catch 22’ here is that generic drug companies, in part, are able to offer more competitive drug pricing because of the ANDA’s cost-saving reliance on the brand-name drug’s safety and efficacy data that was already submitted to—and relied on—by the FDA.


Economics teaches us that when supply is limited and demand outpaces supply (which it undoubtedly has for OxyContin), the price for goods generally increases. So, too, is the case with reformulated Oxycontin. When reformulated OxyContin was introduced to the market in late 2010, the price of the new version of OxyContin was about $6 per 40 milligram tablet, the same then as the price for the non-tamper resistant pill. Since then, the price of the new version has risen to about $6.80 for a tablet of that strength. Roughly a 13% increase in product price in less than three years of being on the market is not too shabby for Purdue’s profits.




Reformulated Oxycontin adds greater understanding of the affects and interplay between law and economics. The advertisement-like, ‘all-new’ OxyContin is a strikingly, interesting demonstration of the interconnection of patent law, food & drug law, public health, pharmaceuticals, and marketplace economics. Metaphorically-stepping back from the trees to see the entire forest is an invaluable lesson.