Attorneys, Others Discuss Current Trends in Biosimilar Development

What do in-house attorneys as well as other experts in intellectual property say about the biosimilar patent dance?

At a panel earlier this week at the ACI 10th Summit on Biosimilars, industry insiders discussed current trends about the patent dance as well as proposed legislation that could affect biosimilar development.

Rachel Moodie, PhD, vice president, intellectual property at Fresenius Kabi Biosimilars, noted that after July 2016, as a result of the Amgen v Apotex case, the Federal Circuit addressed the 180-day notice provision of the Biologics Price Competition and Innovation Act (BPCIA), ruling that if the reference product sponsor should have included a patent in its (3)(A) list or its (7) supplement but it “was not timely included then the owner of that patent may not sue for infringement under 35 USC § 271 with respect to the biological product at issue.”

This has given rise to “list it or lose it,” as the value of the 3A list has increased, she said, and more biosimilar applicants are engaging in the dance.

Larger patent portfolios give rise to more dancing, she said, noting the number of companies that have more than 20 patents on the (3)(A) list. However, dancing reduces the number of patents.

However, Moodie said, “it is still not clear if from case law if you start to dance, get a 3A list, and then hop out, is it still binding, that’s still not clear, and hopefully that will be cleared up in the future.”

She also highlighted the variety of “dancing postures” taken by Sandoz around its biosimilar program.

After Moodie presented more specific examples around filgrastim and pegfilgrastim, the moderator of the panel, John Molenda, PhD, of Steptoe & Johnson LLP, asked Julia Pike, JD, vice president of intellectual property of Sandoz, to comment.

Pike said the company did not want to be surprised on the day of an FDA approval to be hit with a lawsuit. In the case of its dealings with Amgen, it said it did not want to operate under the BPCIA rubric, and was transparent in telling Amgen, “if you are going to sue us, we want you to sue us now.”

In other words, Sandoz wanted to “dance as fast as it could,” she said.

The panelists recognized that the rules under the BPCIA could change again, and with that Colman B. Ragan, JD, vice president and general counsel for

Teva Pharmaceuticals, reviewed some proposed legislation and its impact on biosimilar development.

One bill, S. 1416, the Affordable Prescriptions for Patients Act, was introduced by Senator John Cornyn, R-Texas, and Richard Blumenthal, D-Connecticut. It originally looked to give the Federal Trade Commission the authority to deal with patent thickets and product hopping unfair methods of competition.

But according to those on the panel, the bill shifted course on the FTC, and instead now proposes to replace the provisions that deal with patent thickets with a new section that will limit the scope and number of patents that can be asserted through a patent dance, if the biosimilar applicant complies with the provisions of the dance, including providing its application to the innovator.

Among other things, according to new draft, the proposal would limit the number of asserted patents that: are included in the original patent list; have an expiration date 4 years after the date of a biosimilar application; and do not claim a process used to manufacture the innovator product.

Patents that cover the innovator product’s active ingredient, formulation, methods of use, or process used to make the innovator, are exempt from the limitation. In addition, the bill defines product hopping as all improvements made to existing drug/biologic products in the “competition window” as presumptively anticompetitive.

The bill defines a “competition window” for both small molecule and biologic drug products that begins before the expiry of regulatory exclusivities (8 years before for small molecules and 6 years before for biologics) and ends a year after a generic/biosimilar product enters the market place.