The benefits that come from cancelling low-quality patents are significant. When patent monopolies end, generic alternatives, which typically cost 80 percent less than their brand-name counterparts, can then compete. Patents also block additional, related research while they are in effect. When a patent is valid, this exclusivity is justified; however, when a patent is invalid, exclusivity prevents new innovation and reduces consumer choices. Data cannot capture the economic cost or lives lost due to innovations that go undiscovered because of patents that should never have been granted. By not completing the review of an Ozempic patent that the agency itself had determined was likely invalid, the USPTO failed to fulfill its mission to “drive U.S. innovation and global competitiveness for the benefit of all Americans.” Something needs to change. The USPTO has the power and the tools to stop the proliferation of low-quality patents; instead, it has moved in the opposite direction. In fact, interim USPTO leadership recently enacted several procedures that make it more difficult for low-quality patents to be challenged and invalidated.

In a separate brief, making a somewhat similar argument, was the Public Interest Patent Law Institute, a small nonprofit started a few years ago by the former Electronic Frontier Foundation lawyer Alex Moss. "Removing prosecution laches, however, will increase the risk of liability and litigation for everyone,"" read this brief. In a statement circulated from the group, Moss says ""we hope the Federal Circuit confirms that prosecution laches protects the public when unreasonably delayed patent claims threaten harm."

As for why the case was pursued with both the ITC and the federal court system, I asked Alex Moss, a noted patent attorney and executive director of the Public Interest Patent Law Institute. She explains: "The ITC is an administrative tribunal ... It has become a very attractive venue for patent litigation because, in 2006, the Supreme Court said that you don't automatically get a preliminary injunction, like a ban on sales or imports, in intellectual property cases." Moss continued, "And so the ITC actually can't award damages. It can only issue import bans, but it becomes very useful as leverage because, if you're importing, it's basically a nationwide sales ban. It gives you a ton of leverage for settlement." She concluded, "When you've got a real competitor fight, you're going to go to the ITC. The proceedings are very fast."

Alexandra Moss, executive director at the Public Interest Patent Law Institute, said that Medicare will make sure that the pharmaceuticals will make substantial profit, which is why the agency has gathered comprehensive data from the companies to make price analysis. “Medicare is getting all this information from them because they don’t want to prevent the companies from making profits,” Moss said. “The big reason [the drug companies] are upset is because they don’t want to give out the information about what [the drugs] cost.” A report by the prescription drug pricing analysts at SSR Health suggests the cost savings predictions are misleading.

Alexandra Moss, executive director at the Public Interest Patent Law Institute, said that while PBMs play a role in high drug prices, they are not the root cause but rather an "upstream cause.” “Patent ownership is the main driver for high drug prices, and that’s really missing in the guideline,” she says. The FTC can address mergers when the effect may be "substantially to lessen competition or to tend to create a monopoly.” According to Moss, the FTC can also address situations where anticompetitive outcomes or monopolies arise from the assertion of patents or threats related to patents that a merger would enable or facilitate. Moss cites the example of the Johnson & Johnson’s acquisition of Momenta as a case where a merger involving patents could yield anticompetitive consequences.

Alexandra Moss, executive director at the Public Interest Patent Law Institute, told Inside Health Policy that “the policy statement is a huge step in the right direction -- stronger and better than expected.” “It also meaningful that the statement says submitting a false certification may constitute a criminal violation, and that FTC may refer such conduct to the Department of Justice,” she adds. “We hope the FTC follows up this strong statement with equally strong action. If it does, this will be a watershed moment for generic drug competition, innovation, and access,” said Moss.

“FTC getting involved in the Orange Book is a positive step, and a significant one, but not at the level of major development,” says Alex Moss, executive director at the Public Interest Patent Law Institute.

As the U.S. Patent and Trademark Office (USPTO) weighs new proposals that critics warn would further flood courts with meritless lawsuits, it’s important to remember who benefits from tilting the rules of legal engagement in favor of patent infringement plaintiffs. Advocates for the USPTO’s proposed rules, and similar measures in the recently introduced PREVAIL Act, frame their position as standing up for small inventors. But claims about small inventors hide the ball. These changes would make USPTO processes for reviewing invalid patents harder to access as an alternative to litigation. Who really benefits when litigation is the only way to resolve patent validity disputes? Not small inventors who could knock down bad patents (or flawed challenges) at the USPTO more cheaply and quickly than they could in court. The real beneficiaries are powerful interests — including some of the nation’s biggest law firms — that profit from lawsuits, no matter how meritless.

Ten think tanks and consumer groups have lined up in opposition to a Senate bill that proposes substantial changes to how patent challenges operate at the Patent Trial and Appeal Board, saying the measure will ensure “Americans continue paying more than the rest of the world for prescription drugs.” “What brings [these proposals] together is that both directly attack the rules for accessing and the implications of accessing the proceedings for challenging patents.”

Alex Moss, executive director of the Public Interest Patent Law Institute, said the report “is heartbreaking to read” but convinced her that “the Federal Circuit has done the right thing in suspending Judge Newman’s bench assignments.”

“[T]he U.S. Patent and Trademark Office has determined that both patents at the heart of VLSI Technology’s litigation against Intel Corp. are invalid, wiping out the patents along with two massive damages awards. The USPTO eventually got this one right, but [its] long-awaited decision is raising important questions about why it refused to review VLSI’s patents before these pointless trials.”

“So if Amgen argues for limits on J&J patents, their arguments could be used against them in another case.”

“Everyone who cares about US innovation and competitiveness should be thankful that invalidated patents cannot drain money from domestic businesses that make products we desperately need, like semiconductor chips.”

“If the U.S. were to win and score a royalty from Gilead, the funds could provide money for PrEP treatment, HIV testing and related care.”

“Congress specifically gave any entity or person a right to challenge a patent at the PTAB, but it’s practically difficult for nonprofits to regularly litigate there because each case costs at least $200,000. Lawmakers wanted groups or people to challenge bad patents; Unified does that successfully.”