Patent Law Practice Center

Hatch files Amendment to Fix IPRs for Pharma

Senator Orrin Hatch (R-UT), co-author of the Hatch-Waxman Act, filed an amendment in the Senate Judiciary Committee to address what many characterize as abusive inter partes review (IPR) filings relating to brand name pharmaceuticals. According to Senator Hatch, his amendment is intended to fix IPRs and restore the careful balance the Hatch-Waxman Act struck to incentivize generic drug development. The Hatch-Waxman Act encourages generic drug manufacturers to challenge patents of brand name drugs by filing Abbreviated New Drug Applications with the Food and Drug Administration, which can and typically does result in patent infringement litigation in federal district court.

“As the coauthor and namesake of Hatch-Waxman, I have a keen interest in ensuring we have a well-functioning generic drug industry,” said Senator Hatch in a press release published last night. “My amendment will ensure that Hatch-Waxman continues to operate as originally intended by protecting the ability of generic drug companies to develop low-cost drugs while at the same time ensuring brand-name companies have sufficient protections in place to recoup their investments.”

In recent years inter partes review (IPR) at the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademark Office (USPTO) has created an alternative path to challenge the patents of brand name drugs; a path alternative to the path envisioned in Hatch-Waxman. Those who support the Hatch-Waxman regime view IPRs as upending the careful Hatch-Waxman balance.

Senator Hatch’s amendment, the Hatch-Waxman Integrity Act of 2018, would require a generic manufacturer wishing to challenge a brand-name drug patent to choose between Hatch-Waxman litigation, which affords certain advantages such as being able to rely on the drug innovator’s safety and efficacy studies for FDA approval, and IPR, which is cheaper and faster than Hatch-Waxman litigation but does not provide the advantages of a streamlined generic approval process. Parties would not be able to use both. In this way, the amendment aims to fix the misuse of IPRs by generics as parallel and duplicate proceedings to disputes already in place under Hatch-Waxman.

Politically, this Hatch “pick a path“ amendment is going to be paired with S. 974, The CREATES Act of 2017 (H.R. 2212).  This legislation aims to enable the sharing of samples so that generics can compete more effectively.  You can learn more about the substance of the CREATES Act by reading Senator Leahy’s summary here. The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act enjoys broad, bipartisan support from Senators Leahy, Grassley, Feinstein, Graham, Durbin, Lee, Whitehouse, Cruz, Klobuchar, Kennedy, and Blumenthal.  Generics want the CREATES Act, and there are 28 co-sponsors.  The bill was voted out of the Judiciary Committee favorably, but Hatch voted against it.

Raising and connecting the Hatch-Waxman IPR fix to the CREATES Act balances two major interests of both the brand and generic industries.  Brand needs this Hatch-Waxman IPR fix and generics want CREATES.  Like Hatch’s original objective with Hatch-Waxman, each side gains something…resolving a major problem for them…and neither loses anything that they had any reasonable expectation that they would, or should, be able to maintain.

Andrei Iancu unanimously approved by Senate Judiciary Committee

On Thursday, December 14, 2017, President Trump’s nominee to become the new Under Secretary of Commerce for Intellectual Property and the Director of the United States Patent and Trademark Office was unanimously approved by the Senate Judiciary Committee.

“Mr. Iancu has a proven record in the field of intellectual property law,” Senator Chuck Grassley (R-IA) said moments before the vote. “He has an excellent academic and professional background in intellectual property law. He’s extremely knowledgeable about the patent system. He’s well respected in the legal community.”

“We congratulate Mr. Iancu on his support from the U.S. Senate Judiciary Committee to be Director of the U.S. Patent and Trademark Office,” said Innovation Alliance Executive Director Brian Pomper. “We believe he will heed the views of independent inventors, entrepreneurs, and various industry groups—all those that form our U.S. innovation ecosystem.” Pomper would go on to urge the full Senate to approve the Iancu nomination as soon as possible. “We look forward to working with Mr. Iancu in creating a strong and stable U.S. intellectual property landscape for entities of all sizes, enabling the U.S. to reassert its position as an international leader in innovation,” Pomper said. (more…)

An interview with Congressman Thomas Massie

“I can tell you, every day Congress is in session, there are lobbyists here trying to weaken the patent system,” Congressman Thomas Massie explained to me when I interviewed him on June 28, 2017.

In Massie’s words, those companies that come to Capitol Hill and lobby to weaken the patent system want to get into new fields, but the problem is they didn’t invent in those fields, so they face problems. Patent problems. A lot of those companies want to become automobile manufacturers, or cell phone manufacturers, or they want to write software for operating systems, but they didn’t invent in those areas and they don’t own the patents that have historically been the touchstone of innovation ownership. “They’d love to just come in and start playing in those fields and start using their size and scale as an advantage, and to them, patents look like a hindrance,” Massie explained. “They are here in Congress looking to weaken patents and they are not just interested in weakening patents issued in the future, they are looking to weaken all patents.”

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Congress moves to divert agency fees, but not Patent Office fees

In early February 2017, Congressman Gary Palmer (R-AL) and Senator Mike Lee (R-UT)(shown left) introduced the Agency Accountability Act of 2017 (AAA) in both the House of Representatives (HR 850) and the Senate (S. 299), respectively. The AAA is a bill that would direct most fines, fees, and other unappropriated proceeds to the Treasury, making them subject to the appropriations process.

Senator Lee and Congressman Palmer explained that the Agency Accountability Act is designed to reestablish Congressional authority over agencies. Palmer and Lee believe that at least some agencies have been spending money on programs that Congress has not approved.

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115th Congress: Meet the Key Republicans on IP Reform

On January 3, 2017, the 115th Congress officially convened. In the Senate, it will be the Senate Judiciary Committee where any action relating to intellectual property reform will play out during the 115th Congress. In the House of Representatives, it will be the House Judiciary Committee that will be the body of primary importance insofar as any intellectual property reforms are concerned. Unlike the Senate, in the House, the front line action will take place in subcommittee, specifically the Subcommittee on Courts, Intellectual Property, and the Internet will take the lead for the full House Judiciary Committee.

Unlike in previous years, we enter 2017 without much support for a fresh round of patent reform, but at least some patent reform measures are sure to be introduced during the 115th Congress. In fact, just recently Congressman Bob Goodlatte, who is once again Chair of the House Judiciary Committee, put forth his legislative agenda which included patent litigation reform. Senator Chris Coons (D-DE) is also talking about it being time for Congress to amend 35 U.S.C. 101.

Senator Chuck Grassley (R-IA), pictured left, will once again be chair of the Senate Judiciary Committee. Grassley is a strong supporter of the development of wind, solar, biodiesel, biomass and ethanol as a sustainable, domestic, renewable energy source, which is not surprising since he comes from the heart of America’s farmland. Grassley is a pragmatic politician. In April 2014, when large entities were pushing hard for the latest round of patent reform to pass, Grassley pumped the breaks, acknowledging that there were significant differences of opinion on the need for additional reform. “Sometimes it takes more time than we’d like, but, the end result is a better product. I’m willing to sacrifice a little time to develop a bipartisan bill that we can all support.”  Grassley’s pragmatic approach slowed things down during the 113th Congress, but Grassley introduced the PATENT Act in the 114th Congress. Throughout the 114th Congress, Grassley’s staff was aggressively searching for stories about small businesses being abused by patent trolls, which he could use to give patent reform momentum. Such momentum never materialized, despite the fact that the PATENT Act was able to pass the Judiciary Committee. It is believed that Grassley remains supportive of patent reforms that most inventors would deem unacceptable. (more…)