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J&J Remicade Patent Found Invalid in U.S. Victory for Pfizer

A federal judge in Boston invalidated a key patent on Johnson & Johnson’s blockbuster arthritis drug Remicade, increasing the odds that Pfizer Inc. will sell a rival copy in the U.S. J&J pledged to appeal.

U.S. District Judge Mark Wolf in Boston said the antibodies covered by the patent, which expires in 2018, were already disclosed in an earlier patent. The judge also is considering the validity of a second J&J patent, which lawyers said expires in 2027. The hearing is scheduled to continue Thursday.

In a separate proceeding regarding the 2018 patent, the U.S. Patent and Trademark Office came to a similar conclusion, a decision that J&J’s Janssen Biotech unit is appealing. J&J said it is awaiting a hearing date before the patent office. The next step from that would be an appeals court in Washington that specializes in patent law, which also will be asked to review Wolf’s ruling.

“Today’s ruling is clearly a negative with the implication being that Pfizer will potentially move forward’ with a risky launch in the fourth quarter, Joshua Jennings, an analyst with Cowen & Co., said in a note to clients. He has an “outperform rating” on J&J shares.

Blockbuster Sales

Remicade, used to treat Crohn’s disease, rheumatoid arthritis, psoriatic arthritis, ulcerative colitis and ankylosing spondylitis, is J&J’s biggest seller. Last year it generated $6.6 billion in sales or 9.5 percent of the company’s revenue, an amount that would drop if there is a copy of the drug, known as a biosimilar, on the market.

While generics are exact copies of drugs with simple chemical structures, biosimilars replicate more complex compounds made from living organisms, and aren’t called generics because no two batches are exactly the same.

Pfizer’s Hospira has exclusive U.S. marketing rights to a biosimilar called Inflectra that would be made by Celltrion Inc., a South Korean drugmaker. Celltrion has U.S. regulatory approval to make its copy, though both Celltrion and Hospira have agreed not to begin sales before Oct. 3 at the earliest.

Celltrion’s biosimilar is available in some countries outside the U.S. In a statement, Pfizer said it was “committed to bringing biosimilars to patients in the U.S. as quickly as possible, and are continuing with the preparation of our launch plans for Inflectra for 2016.”

‘At-Risk Launch’

Should Celltrion and Hospira enter the market, and then J&J later prevail on the patent issues, they could be forced to reimburse J&J for any lost profits.

“Janssen will continue to defend its intellectual property rights relating to its innovative medicines,” J&J said in a statement. “A commercial launch of an infliximab biosimilar prior to the outcome of the appeals would be considered an at-risk launch.”

Even if Pfizer starts selling Inflectra, insurers may hesitate to pay for the biosimilar “until the legal landscape is settled,” Geoff Meacham, an analyst with Barclays PLC, said in a note to clients. He has the equivalent of a buy rating on J&J and a hold on Pfizer.

AbbVie Inc. whose arthritis drug Humira that generated $14 billion in sales last year, also is trying to fend off biosimilar competition in the U.S. from Amgen.

The case is Janssen Biotech Inc. v. Celltrion Healthcare Co., 15-cv-10698, U.S. District Court for the District of Massachusetts (Boston).

August 17, 2016

Source: http://www.bloomberg.com/

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