Welcome to Skilled in the Art. I’m Law.com IP reporter Scott Graham, and I’m back from a week’s hiatus and ready to catch up on some IP news. A quick rundown:

• Amgen’s defense of rheumatoid arthritis drug adds $10 billion to its market cap.

• The PTAB still thinks patent claims asserted against Lyft and Uber are indefinite.

• Olive oil companies’ dispute over 51-49 won’t be fought.

As always you can email me your feedback and follow me on Twitter.

 

Sidley Austin partners Vern Winters, left, and David Pritikin.

 

Amgen Has 10 Billion Reasons to Cheer Validity Ruling

Suppose I told you that Amgen had just won a $10 billion verdict—that’s billion with a “B.” Something like “Biggest Patent Damages Award Ever” would probably be the headline, right?

Well, no damages are in play in Immunex v. Sandoz, but Amgen’s market cap popped $10 billion Monday on news that it successfully defended two patents on its rheumatoid arthritis drug Enbrel.

Following a two-week bench trial last fall, U.S. District Judge Claire Cecchientered a permanent injunction against Sandoz, which has been gunning for Enbrel’s validity since 2013. Amgen rings up nearly $5 billion a year in domestic sales of Enbrel—about 20% of its U.S. revenues—and the patents still have nearly a decade to run.

So Cecchi’s 85-page opinion rejecting a host of Sandoz validity challenges was big enough to make Amgen Investor Business Daily‘s Stock of the Day on Tuesday. It’s also a huge win for Amgen’s trial team, which was headed up by S.F./Silicon Valley Sidley Austin partner Vern Winters and Chicago partner David Pritikin. It also included D.C. partner Jeff Kushan and local counsel from Walsh Pizzi O’Reilly Falanga.

Amgen CEO Robert Bradway said in a written statement that the company was pleased with the outcome. “Protecting intellectual property is critical to incentivize innovation and the large investments in research and development” needed to fully develop new medicines, he said.

Sandoz vowed to appeal to the Federal Circuit and said the parties have agreed to expedite it. Sandoz was represented by Winston & Strawn, Williams & Connolly and Gibbons PC.

Enbrel is the first FDA-approved fusion protein, according to Cecchi’s opinion. The protein is made by combining the extracellular region of a 75 kilodalton Human Tumor Necrosis Factor receptor, known by the shorthand p75 TNFR, with a portion of IgG1 immunoglobulin. Hoffmann-La Roche filed the original applications in the 1990s but eventually licensed the invention to Amgen and its subsidiary Immunex. The FDA approved Enbrel in 1998. U.S. Patent 8,063,182, on the protein, and No. 8,063,522, on the method of manufacture, issued in 2011 and 2012 respectively.

Sandoz, which is the generic and biosimilar division of Novartis, launched its initial attack in the Northern District of California in 2013. U.S. District Judge Maxine Chesney ruled, and the Federal Circuit agreed, that it was premature because Sandoz hadn’t yet applied for FDA approval of its competing product, which it calls Erelzi.

In the meantime, Kyle Bass’ Coalition for Affordable Drugs and Coherus BioSciences brought validity challenges at the PTAB, but the board declined to institute proceedings in either case.

As Sandoz closed in on FDA approval in 2016, Amgen, Immunex and Roche brought the present suit in New Jersey. Sandoz conceded infringement but argued that Amgen’s patents are invalid for written description, enablement, obviousness and obviousness-type double patenting.

Cecchi found the patents provided plenty of information that would lead a POSITA to Enbrel. The claim specification refers to a 1990 research article, which in turn notes that the entire nucleotide sequence of the p75 TNFR had been deposited with the National Institute of Health’s genetic sequence database.

“Because the p75 TNFR sequence and the IgG1 sequence were well known and accessible to a POSA, a reproduction of the known sequences was not required to be explicitly included in the Patents-in-Suit in order to claim a novel combination of those sequences,” Cecchi wrote.

As for obviousness, Cecchi found that Enbrel was met with praise and commercial success and that it satisfied a long-felt need. Amgen also argued that Sandoz’s copying of the Enbrel pointed to non-obviousness, but Cecchi ruled that because biosimilars have to be almost identical to obtain FDA approval, copying could not be held against it.

But regardless of how that factor played out, she noted, “such finding would not have any material impact on the outcome of the Court’s obviousness analysis.”

 

 

PTAB Passes Again on Transit Patent

It looks as if a retired Georgia Tech professor’s patent infringement suit against Lyftis nearing the end of the route.

The Patent Trial and Appeal Board ruled for a second time Monday that Professor Stephen Dickerson‘s 2004 patent on a “communications and computing based urban transit system” contains indefinite claims.

Monday’s decision is technically a loss today but probably a win tomorrow for Lyft and its counsel at Baker Botts. The same PTAB panel issued a nearly identical opinion in July that turned away a petition by Unified Patents.

The upshot is that the suits by Dickerson and his company RideApp will proceed against Lyft in San Francisco federal court and against Uber Technologies in Georgia federal court, but under the cloud of the PTAB’s claim construction rulings. Those rulings aren’t binding on the district courts, but if found persuasive they would doom the lawsuits.

Lyft moved to dismiss Dickerson’s amended complaint in June on eligibility grounds. U.S. District Judge Jon Tigar had scheduled an August 8 hearing on Lyft’s motion, but vacated the hearing last week and said he will rule on the papers. Uber, which is represented by Fish & Richardson, filed a similar motion to dismiss on Friday.

Baker Botts’ team at the PTAB was led by partners Eliot Williams, Jeremy Taylorand former associate Chris Han. RideApp was represented by Kasowitz Benson Torres.

 

Corto Olive, whose packaging is on the left, has persuaded Gemsa Enterprises to abandon the packaging on the right.

 

Olive Oil Makers Settle Trademark Spat

I just returned from a vacation that involved around 500 highway miles across the middle of the country. I became convinced that craft beer and designer olive oil must be holding up middle America’s economy.

Against that backdrop I bring news that two California olive oil competitors have settled a year-old trademark dispute. Corto Olive of Stockton sued La Mirada’s Gemsa Enterprises in December, accusing Gemsa of infringing its 51-49 mark. 51-49 refers to a blend of olive and canola oil that is popular in the restaurant and food service business. Corto Olive had accused Gemsa of “egregious copying” of its distinctive trade dress, among other things.

The parties announced Monday that Gemsa has agreed to stop using its allegedly infringing packaging and create new designs, which Corto Olive has approved. Corto Olive has dismissed its lawsuit with prejudice.

“Corto is committed to protecting its intellectual property and to protecting our customers,” said Tom Cortopassi, Senior Managing Partner of Corto Olive. “This agreement achieves that objective.”

“Gemsa Oils has now taken steps to differentiate our packaging from that of Corto Olive,” said Emilio Viscomi, founder and co-owner of Gemsa Oils. He added, “We are glad to put this dispute behind us, so that we can focus on our commitment to providing high quality blended oils to consumers.”

That’s all from Skilled in the Art today. I’ll see you all again on Friday.