Zytiga final patent invalidated

Johnson & Johnson’s prostate cancer drug Zytiga will be facing generic competition from as early as October 2018 after a US Patent Trial and Appeal Board hearing stripped away the company’s final 2027 patent on the treatment. The inter partes review challenge was issued by Argentum Pharmaceuticals and the case was heard on 17 January 2018. Argentum Pharmaceuticals have plans to issue a generic version of Zytiga at a lower price, so will be celebrating the success of their challenge.

The Appeal Board struck down the patent, which expired in 2027, on the basis that it referred to general treatment administration and it was fairly obvious how the drug should be used. Zytiga has been approved in the United States for use to treat advanced prostate cancer since 2011 and generated sales of $1.1 billion in the US alone in 2016. Figures for 2017 showed the drug netted $826 million in the United States for the first nine months of the year. It is the top-selling cancer drug from Johnson & Johnson’s pharma unit Janssen.

Commenting on the decision, the company said they strongly disagreed with the result and would be evaluating their options regarding a request for a rehearing or appealing to the Court of Appeals for the Federal Circuit. Argentum commented that they believed the decision would be upheld and it will save the US healthcare system billions of dollars over the coming decade. They added that the decision will benefit American patients by ensuring ease of access to high quality, effective and safe FDA-approved generic alternatives.

Zytiga is likely to remain a high earning drug for Johnson & Johnson, however. The drug has a large customer base outside of the United States and is protected by patent until 2022. Over 50% of Zytiga sales come from outside the US, although it is in fierce competition with Pfizer’s prostate cancer treatment Xtandi. At present Xtandi and Zytiga are used across the same patient groups but both companies are endeavoring to widen reach.

CONTENT SPONSORED BY

WSGR_HORIZ_CMYK2

In today’s fast-growing, highly regulated generic pharmaceutical market, companies increasingly require specialized legal guidance as their products are developed, launched, and litigated. Wilson Sonsini Goodrich & Rosati’s attorneys address this need by providing expert counsel to companies in the global generics industry, offering sophisticated representation far beyond the scope of general corporate and securities counsel.

We have assembled a highly experienced team of experts from a cross-section of the firm’s key practice areas, including intellectual property, litigation, antitrust, FDA/regulatory, technology transactions, exports and FCPA, trade secret, and trademark and copyrights. Led by the former chief legal officer of Mylan Pharmaceuticals, one of the world’s leading generic and specialty pharmaceutical companies, our attorneys work closely with our generic pharmaceutical clients’ legal and scientific personnel and senior management to understand and meet their specific needs both in the U.S. and abroad.