Back to top

Image: Bigstock

Mylan (MYL) Gets Positive Copaxone USPTO Ruling Yet Again

Read MoreHide Full Article

In a favorable development for Mylan N.V. , the U.S. Patent and Trademark Office (PTO) once again ruled in favor of the company in its inter partes review (IPR) proceeding. According to the company’s recent announcement, the PTO found that the U.S. Patent No. 8,969,302 that covers Teva Pharmaceuticals Industries Ltd.’s TEVA multiple sclerosis drug, Copaxone (40 mg/mL), is unpatentable.

We note that this is the third patent related to Copaxone (40 mg/mL) to be found unpatentable in the last week. On Aug 24, the PTO's Patent Trial and Appeal Board (PTAB) found Teva's first two patents – U.S. Patent Nos. 8,232,250 and 8,399,413 – unpatentable in Mylan's IPR challenge of these patents.

Mylan had also filed a petition against a fourth Copaxone (40 mg/mL) patent, U.S. Patent No. 9,155,776. However, on Aug 15, the PTAB found the company’s petition against this patent ineligible for post-grant review due to procedural reasons. Given the favorable rulings in the IPR against the '302, '250 and '413 patents, the company will continue to challenge the '776 patent.

In fact, Mylan believes that it is one of the first companies to have filed a substantially complete abbreviated new drug application, which contains a paragraph IV certification for the 40 mg/mL thrice-weekly formulation of Copaxone. This makes the company eligible for 180 days of marketing exclusivity in the U.S., subject to FDA approval.

As per IMS Health data, Copaxone (40 mg/mL) generated annual sales of approximately $3.3 billion in the U.S. as of Jun 30, 2016. The latest favorable ruling also raises optimism. If everything goes well, the FDA approval of a generic version of Copaxone (40 mg/mL) will be a huge positive for Mylan and boost the performance of the company’s generics business.

However, Mylan has been making it to the headlines for all wrong reasons in recent times. Of late, the company faced extensive criticism from all over, including U.S. senators and Democratic Presidential candidate Hillary Clinton, for over pricing its epinephrine auto-injector, EpiPen.

Reeling under pressure from the issue, earlier this week, the company announced that it will launch the first generic to EpiPen at a list price of $300 per generic EpiPen two-pack carton. This represents a discount of more than 50% to the list price, of the branded medicine. Mylan expects to launch the generic version in several weeks, pending completion of labeling revisions.

The company also announced that both the augmented patient assistance program and the $300 savings card that were announced late last week will remain in place for the branded product.

Mylan is currently a Zacks Rank #3 (Hold) stock. A couple of better-ranked stocks in the health care sector are ANI Pharmaceuticals, Inc. ANIP and Geron Corporation GERN. Both the stocks sport a Zacks Rank #1 (Strong Buy).

Confidential from Zacks

Beyond this Analyst Blog, would you like to see Zacks' best recommendations that are not available to the public? Our Executive VP, Steve Reitmeister, knows when key trades are about to be triggered and which of our experts has the hottest hand. Click to see them now>>

Published in