Welcome to Skilled in the Art. I'm Law.com IP reporter Scott Graham. Today is going to be life sciences day at SitA. I've got a few quick hits involving CRISPR gene editing patents, a battle between cancer treatment biopharmas, and the latest patent eligibility dispute in the medical diagnostics space. As always you can email me your own thoughts and follow me on Twitter.

Photo: Wikimedia Commons

CRISPR Battle Is Back on at the PTAB

Summer's here, which means it's sequel season. “Toy Story 4.” “Godzilla: King of the Monsters.” “CRISPR Interference II: Return to the PTAB.”

Yes, the University of California will once again battle it out with Harvard and MIT's Broad Institute over who was first to patent the gene editing system that's been described as the century's biggest (and potentially most lucrative) biotech story.

If you're thinking, “Wait a minute, didn't they just have this fight, including an appeal to the Federal Circuit, from 2014 through 2018?” you're right. But that was just a preview of coming attractions.

The Patent Trial and Appeal Board found in 2017 that there was no interference-in-fact. The technology described by UC researchers and others in a 2012 articlewas patentably distinct from the subject matter later claimed by the Broad. That's because UC's initial patent application described the use of CRISPR-Cas9 in a lab environment, while the Broad's patents described it in a human cell line.

But UC didn't just take its gene editing tools and go home. It too has been prosecuting CRISPR patents on human cells, and claiming priority back to the early part of the decade. The PTAB on its own motion declared an interference Monday and will now start the process of hashing out priority between 10 UC applications versus 13 patents and one application held by the Broad.

“The initiation of this interference proceeding highlights that previous decisions involving the Broad did not determine who was the first to invent this technology, and it lays out a pathway for resolving this important issue,” Sterne, Kessler, Goldstein & Fox partner Eldora Ellison, who represents UC, said in a written statement. “We are confident that the USPTO will ultimately recognize that the Doudna and Charpentier team hold the priority of invention specific to eukaryotic cells, as well as other settings covered by previous patents.”

Jennifer Doudna of Cal and Emmanuelle Charpentier, now of the Max Planck Institute for Infection Biology, are the researchers Ellison was referring to. MIT's Feng Zhang is the lead researcher for the Broad.

The Broad said Monday that it welcomes the action, but also put out a statement Tuesday saying it's “time for all institutions to move beyond litigation and instead work together to ensure wide, open access to this transformative technology,” such as through patent pools or joint licensing.

So the University of California is talking toughest for now. Of course, it also talked tough during Round 1.

No Clinical Trial, No Injunction in Trade Secret Case

A Colorado federal judge has just made it a little tougher for biopharma companies to get pretrial injunctions based on trade secret allegations.

U.S. District Judge Philip Brimmer on Wednesday turned away Array BioPharma's attempt to immediately stop nine former employees from working with former collaboration partner Loxo Oncology. Without evidence that the partnership has produced a drug ready for clinical trials, there were no grounds for an injunction. “Irreparable harm that may occur years in the future, and certainly not before a trial on the merits, does not warrant injunctive relief,” Brimmer wrote.

The decision handed an early win to Eli Lilly subsidiary Loxo and its attorneys at Fenwick & West and Wilmer Cutler Pickering Hale and Dorr.

Loxo and Boulder-based Array struck a five-year collaboration deal in 2013 to develop new cancer drugs. Loxo opened its own lab in Boulder in 2017 and hired two of Array's scientists, then added seven more last fall after the deal expired.

Array and its Quinn Emanuel Urquhart & Sullivan counsel accuse Loxo of misappropriating the know-how on which Array built its drug discovery business. They sought to enjoin Loxo from letting the employees continue to work on “the subject matter of Array's trade secret programs and platforms.”

Loxo replied that it retains exclusive rights under the deal to continue the collaboration work, and that Array was attempting to manufacture non-compete agreements where none exist. It also argued that Array hadn't made a case for imminent or actual harm.

Brimmer ruled for Loxo following a June 11 evidentiary hearing. Though Array submitted evidence of a “very far advanced” compound, it did not show that Loxo has developed a drug based on Array's trade secrets “that is ripe for clinical trials, that such drug will soon be submitted for FDA approval, or that such drug is soon to hit the market.”

In the uncertain world of drug development, “a remote possibility of future injury is not enough.”

Fenwick partners Robert Counihan and Jedediah Wakefield and associate Jeffrey Ware represented Loxo at the June 11 hearing along with Wilmer partner Gina Rodriguez. Fenwick partner Patrick Premo is also counsel to Loxo.

Ed Reines

Standing Pat on Provisional Patents

One last IP thread from the Supreme Court's Term 2018 that's worth, um, illuminating: The justices denied certiorari on Monday in Ariosa Diagnostics v. Illumina, one of the many tributaries of litigation flowing from patents on non-invasive fetal diagnostics.

The Supreme Court had requested the solicitor general's views on the case, which involves the level of detail necessary in a provisional patent application to establish priority for a subsequent non-provisional. The solicitor general and the PTO arguedthat key Federal Circuit precedents are wrongly decided, but recommended against granting cert, in part because such disputes apply only to pre-AIA applications.

The cert denial was valuable to Illumina, though. It closes the books on Ariosa's IPR challenge to U.S. Patent No. 7,955,794. A San Francisco jury awarded Illumina $15 million last year for Ariosa's infringement of the '794.

That's a win for Weil Gotshal & Reines partner Ed Reines, who has litigated the '794 before the PTAB, the San Francisco jury, and at the Supreme Court.

Reines and Illumina still have a few more hurdles to clear to collect the $15 million (plus $11 million that was awarded for a second patent). Ariosa, which is represented by Wilmer Cutler Pickering Hale and Dorr and Irell & Manella, is contending at the Federal Circuit that it long ago redesigned its Harmony diagnostic test to avoid infringing the '794. It's also trying to renew its attack on the '794's validity, arguing that U.S. District Judge Susan Illston erred by letting Illumina invoke assignor estoppel as a shield.

Illumina and Reines are arguing that Illston should have enjoined Ariosa from marketing the Harmony test.

Charles Verhoeven

Diagnostic Dustup in Delaware

Earlier this year I wrote about a lawsuit between rival diagnostics companies over new technology for assessing organ transplant rejections via a blood test.

Where diagnostics go, Section 101 motions usually follow, and CareDx v. Natera is no exception. A Quinn Emanuel Urquhart & Sullivan team headlined by partner Charles Verhoeven is asking U.S. District Judge Colm Connolly to rule that CareDx's Stanford-developed patents are ineligible for patenting.

“The Patents rest entirely on observing natural phenomena inherent to organ transplants: the presence of an organ donor's nucleic acids (such as DNA) in the transplant recipient's circulation (such as blood), and a correlation of that presence to rejection of the transplanted organ by the recipient's body,” states Natera, which is also represented by Morris, Nichols, Arsht & Tunnell. These natural phenomena are detected using “conventional methods well known in the art, which is not patentable.”

They sound like the kinds of patents that Sens. Thom Tillis and Chris Coons say ought to be covered by revamped Section 101 legislation. But Weil Gotshal & Manges partner Ed Reines and attorneys from Farnan are tasked with preserving them under current law.

Transplanting an organ from one person to another is “strikingly unnatural,” CareDx argues in its June 10 opposition. The same goes for determining a concentration of donor-specific cell-free DNA through high-throughput sequencing or digital polymerase chain reaction. “In short,” CareDx argues, “both the context for the use of the claimed method and the specific method steps themselves are the product of human ingenuity.”

That's all from Skilled in the Art this week. I'll see you all again on Tuesday.