Teva Pharmaceutical Industries experienced a setback when a US agency invalidated two patents for the company’s multiple sclerosis drug, Copaxone (glatiramer acetate injection). Copaxone accounted for $4.0 billion (including $3.2 billion in the US), or 20% of Teva’s revenues in 2015. Teva plans to appeal to the United States Court of Appeals for the Federal Circuit

The Patent Trial and Appeal Board (PTAB) decisions from an inter partes eview (IPR) invalidated all claims of two US patents ( US Patents 8,232,250 and 8,399,413) for 40 mg/mL Copaxone, a three-times a week dosing regime for Copaxone that replaced a daily 20-mg/mL version that faced generic competition. The US Orange Book patents covering Copaxone 20 mg/mL expired in May 2014, and in most of the rest of the world in May 2015. The 40-mg/mL Copaxone was launched in the United States in January 2014 and was approved in Europe in December 2015 with continuing approvals underway in the rest of the world. 

The 40-mg/mL formulation allows for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of MS. Teva’s business strategy for Copaxone relies heavily on the continued migration of a substantial percentage of current daily Copaxone patients to the new 40- mg/mL, three-times-a-week version. Since the launch of Copaxone 40 mg/mL three times a week in the US, over 78% of the total US Copaxone prescriptions are now filled with the 40-mg/mL version, according to the company’s 2015 annual filing.

Copaxone 40 mg/mL is protected by three US Orange Book patents that expire in 2030, which are the subject of challenges in Paragraph IV litigation and in the patent office proceedings in the US, and a fourth US Orange Book patent expiring in 2030 that was issued in October 2015 and is also being challenged in Paragraph IV litigation. It is also protected by one European patent expiring in 2030, the validity of which was confirmed by the European Patent Office in December 2015, which rejected all invalidity claims.

The US Patent and Trademark Office (PTO) ruled in favor of Mylan in its inters partes review proceeding and found all claims of two related Copaxone 40 mg/mL patents (8,232,250 and 8,399,413) to be unpatentable. These patents are owned by Yeda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals Industries Ltd. A decision by the PTAB on Mylan’s third petition seeking inter partes review of US Patent No. 8,969,302 is expected on or before September 1, 2016.

On August 15, 2016,, the PTO’s Patent Trial and Appeal Board (PTAB) found Mylan’s application against a fourth Copaxone 40 mg/mL patent, US Patent No. 9,155,776, ineligible for post-grant review for procedural reasons. However, Mylan said it “believes that the favorable ruling in the IPR [inters partes review] against the the ‘250 and ‘413 patents strongly undermines the ‘776 patent as well. As such, Mylan will proceed with pursuing all avenues to challenge the ‘776 patent.”

Teva said it will defend four patents (‘250, ‘413, ‘302 and ‘776), all listed in the Orange Book with expiry dates into 2030, against a number of abbreviated new drug application (ANDA) filers in US District Court for the District of Delaware trial scheduled to begin in September 2016. The four patents remain valid and enforceable as does a fifth patent (‘874) recently issued and listed in the Orange Book.

“We remain confident in the strength of our intellectual property surrounding Copaxone 40 mg. We are prepared to defend the full suite of our intellectual property through the PTAB and the US courts regardless of the time required,” said Erez Vigodman, president and CEO of Teva, in a company statement.

Source: Teva Pharmaceutical Industries