Stakeholders Thinking About US Patent System Reform in 2019

Although current attention in Washington, DC, is focused on the government shutdown and other issues, 2 senators began stakeholder sessions last month to gather thoughts on what changes might be needed, if any, in legislation regarding the filing of patents.

According to Bloomberg, tech companies, the Biotechnology Innovation Organization, and Pharmaceutical Research and Manufacturers of America, known as PhRMA, were invited by Senators Chris Coons, D-Delaware, and Thom Tillis, R-North Carolina, for a closed-door meeting to discuss recent case law and see if Congress needs to intervene.

An intellectual property attorney at Fenwick & West shared his opinion on the issue in an interview with The Center for Biosimilars^®. Stuart P. Meyer, JD, said the issue is a nonpartisan one, as seen by the bipartisan nature of the stakeholder talks.

Some groups, like the Initiative for Medicines, Access & Knowledge (I-MAK), want patent policy changed so that there is a higher standard for inventions, as opposed to innovations.

Meyer said the issue stems from a change in the way courts and the patent office patent applications in the aftermath of the 1998 State Street Bank & Trust Co. v Signature Financial Group, Inc., case, which found that so-called “business method” inventions must produce a “useful, concrete and tangible result” in order to be patentable.

Over time, Meyer said, “another series of court cases came along that began to narrow the scope of what can be patented.” The cases essentially said, “There’s a whole range of things in the area of innovation that patents should not cover.”

Did Congress intend for the Patent Act to be broad or narrow? Are courts substituting their own judicial doctrine? “That’s what the current debate in the Senate is starting to address,” Meyer said.

“The problem is there are really divergent views on what should be done. And, surprisingly, the players are not necessarily who you might expect,” he said, citing independent and small inventors, the pharma industry, and nonpracticing entities, which may have no plans to invent anything but file patents anyway.

He said he thinks many technology firms lean towards the side of wanting a narrow definition of what is patentable, even though they have plenty of innovations, as well.

The concern of a restrictive US patent system, compared with China or Europe, is that it will lead to less investment here, he said. Patents tend to lead to greater investments where there is concentrated activity of them, he said.

On the flip side of that issue, I-MAK has indicated that scenario can lead to overpatenting. In a report released in August 2018, it said more than half of the top 12 drugs in the United States have more than 100 attempted patents per drug. Those repeat attempts block biosimilar develpment, as in the case of Humira. I-MAK has said AbbVie has raised prices 144% since 2012. Humira biosimilars lauched in Europe last year, but they are not expected to launch in the United States until 2023.