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Mylan (MYL) Obtains Favorable USPTO Ruling for Copaxone
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Positive news flowed in at Mylan N.V. when the U.S. Patent and Trademark Office (PTO) ruled in favor of the company in its inter partes review proceeding. The PTO found that the two patents (U.S. Patent Nos. 8,232,250 and 8,399,413) covering Teva Pharmaceuticals Industries Ltd.’s (TEVA - Free Report) multiple sclerosis drug, Copaxone (40 mg/mL), are unpatentable.
Meanwhile, a decision from the PTO's Patent Trial and Appeal Board (PTAB) on Mylan's third petition, seeking an inter partes review of U.S. Patent No. 8,969,302 is anticipated on or before Sep 1. Earlier this month, however, the PTAB has determined Mylan's application against the fourth Copaxone 40 mg patent, U.S. Patent No. 9,155,776, ineligible for post-grant review due to procedural reasons.
Nevertheless, 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 (ANDA), containing a paragraph IV certification, for the 40 mg 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) generated annual sales of approximately $3.3 billion in the U.S. as of Jun 30, 2016.
The latest development is encouraging. If all goes well, FDA approval of a generic version of Copaxone (40 mg) will be a huge positive for Mylan and boost the performance of the company’s generics business.
Democratic Presidential candidate Hillary Clinton posted a tweet, saying “EpiPens can be the difference between life and death. There's no justification for these price hikes”. This led to a 5.5% decline in Mylan’s shares yesterday. (Read More: Did Hillary Clinton's Tweet Cause the Sell-Off in Mylan Stock?).
Teva’s shares were down almost 3% after the company confirmed that the PTAB had invalidated all claims of the ‘250 and ‘413 patents for Copaxone (40 mg). Teva plans to appeal to the U.S. Court of Appeals for the Federal Circuit. The company intends to defend four patents (‘250, ‘413, ‘302 and ‘776) against a number of ANDA filers in the U.S. District Court for the District of Delaware with the trial scheduled to begin in Sep 2016. All of these patents are listed in the Orange Book with expiry dates running through 2030.
The company believes that the four patents remain valid and enforceable, as does a fifth patent (‘874) which was recently issued and listed in the Orange Book.
We note that the 40 mg thrice-weekly formulation of Copaxone accounted for 82% of total Copaxone scrips in the U.S. at the end of the second quarter of 2016. Earlier-than-expected entry of generic versions of Copaxone 40 mg would be a major setback for the company. Glatopa, a generic version of Copaxone 20 mg, entered the market in Jun 2015.
Both Mylan and Teva are Zacks Rank #3 (Hold) stocks. A couple of better-ranked stocks in the health care sector are ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Geron Corporation (GERN - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy).
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Mylan (MYL) Obtains Favorable USPTO Ruling for Copaxone
Positive news flowed in at Mylan N.V. when the U.S. Patent and Trademark Office (PTO) ruled in favor of the company in its inter partes review proceeding. The PTO found that the two patents (U.S. Patent Nos. 8,232,250 and 8,399,413) covering Teva Pharmaceuticals Industries Ltd.’s (TEVA - Free Report) multiple sclerosis drug, Copaxone (40 mg/mL), are unpatentable.
Meanwhile, a decision from the PTO's Patent Trial and Appeal Board (PTAB) on Mylan's third petition, seeking an inter partes review of U.S. Patent No. 8,969,302 is anticipated on or before Sep 1. Earlier this month, however, the PTAB has determined Mylan's application against the fourth Copaxone 40 mg patent, U.S. Patent No. 9,155,776, ineligible for post-grant review due to procedural reasons.
Nevertheless, 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 (ANDA), containing a paragraph IV certification, for the 40 mg 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) generated annual sales of approximately $3.3 billion in the U.S. as of Jun 30, 2016.
The latest development is encouraging. If all goes well, FDA approval of a generic version of Copaxone (40 mg) will be a huge positive for Mylan and boost the performance of the company’s generics business.
Recently, Mylan made the headlines for over pricing its epinephrine auto-injector, EpiPen. (Read More: Mylan Draws Flak for Over Pricing EpiPen, Stock Down).
Democratic Presidential candidate Hillary Clinton posted a tweet, saying “EpiPens can be the difference between life and death. There's no justification for these price hikes”. This led to a 5.5% decline in Mylan’s shares yesterday. (Read More: Did Hillary Clinton's Tweet Cause the Sell-Off in Mylan Stock?).
MYLAN NV Price
MYLAN NV Price | MYLAN NV Quote
Teva Suffers due to the Unfavorable Ruling
Teva’s shares were down almost 3% after the company confirmed that the PTAB had invalidated all claims of the ‘250 and ‘413 patents for Copaxone (40 mg). Teva plans to appeal to the U.S. Court of Appeals for the Federal Circuit. The company intends to defend four patents (‘250, ‘413, ‘302 and ‘776) against a number of ANDA filers in the U.S. District Court for the District of Delaware with the trial scheduled to begin in Sep 2016. All of these patents are listed in the Orange Book with expiry dates running through 2030.
The company believes that the four patents remain valid and enforceable, as does a fifth patent (‘874) which was recently issued and listed in the Orange Book.
We note that the 40 mg thrice-weekly formulation of Copaxone accounted for 82% of total Copaxone scrips in the U.S. at the end of the second quarter of 2016. Earlier-than-expected entry of generic versions of Copaxone 40 mg would be a major setback for the company. Glatopa, a generic version of Copaxone 20 mg, entered the market in Jun 2015.
TEVA PHARM ADR Price
TEVA PHARM ADR Price | TEVA PHARM ADR Quote
Both Mylan and Teva are Zacks Rank #3 (Hold) stocks. A couple of better-ranked stocks in the health care sector are ANI Pharmaceuticals, Inc. (ANIP - Free Report) and Geron Corporation (GERN - Free Report) . Both the stocks sport a Zacks Rank #1 (Strong Buy).
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