Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.
Merck Sharp & Dohme Corp. convinced an administrative patent review board a patent on Pfizer Inc.'s Prevnar 13, the world’s best-selling vaccine, is invalid.
Twenty-one of U.S. Patent No. 8,562,999‘s 22 claims are invalid as obvious, the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board ruled in three related decisions. To be valid, a patent must not be obvious—the idea that an invention wouldn’t have been apparent to someone versed in the technology at the time based on existing patents on publications.
The loss is a blow to Pfizer, whose Prevnar 13 (diphtheria CRM197 protein)—which will remain on the market—earns more than any other vaccine in the world. It’s also the company’s best-selling product, bringing in $5.6 billion in 2017, according to the company’s most recent annual report, although sales have dropped 8 percent over the past two years. Immediately behind Prevnar 13 in 2017 was Lyrica (pregabalin), which generated $5.1 billion for the company. The next-best seller was Ibrance (palbociclib), at $3.1 billion.
Prevnar 13 is a pneumococcal 13-valent conjugate vaccine first approved for children from six weeks to 17 years old for immunization against diseases caused by the Streptococcus pneumoniae bacteria, including meningitis. It’s also approved for prevention of otitis media, or middle ear infection, in children from six weeks to 5 years old, as well as for those ages 50 and older to prevent pneumonia. Pneumonia is the most common disease caused by S. pneumoniae in adults.
If Pfizer appeals, the U.S. Federal Court of Appeals for the Federal Circuit would review the PTAB’s decision. Merck brought the case against Wyeth LLC, which Pfizer acquired in 2009.
Attorneys for Merck declined to comment. Attorneys for Pfizer didn’t immediately respond to Bloomberg Law’s request for comment.
The cases are Merck Sharp & Dohme Corp. v. Wyeth LLC, P.T.A.B., IPR2017-00390, 6/8/18, Merck Sharp & Dohme Corp. v. Wyeth LLC, P.T.A.B., IPR2017-00380, 6/8/18, and Merck Sharp & Dohme Corp. v. Wyeth LLC, P.T.A.B., IPR2017-00378, 6/8/18.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to firstname.lastname@example.org.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to email@example.com.
Put me on standing order
Notify me when new releases are available (no standing order will be created)