Patent Legislation Champion Hatch Won’t Run for Re-election

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By Malathi Nayak

Retiring seven-term Utah Republican Sen. Orrin G. Hatch has been a significant voice in Congress on intellectual property-related efforts, especially in issues involving pharmaceutical and life sciences industries.

The eponymous Hatch-Waxman Act of 1984 provides a legal framework for generic drug market approval and the resolution of related patent disputes. Hatch also helped author the America Invents Act of 2011 that spawned administrative proceedings at the Patent and Trademark Office that allow parties to challenge the validity of granted patents.

“He has been an absolute champion for his whole career for all IP rights holders,” Brian Pomper, executive director of ACTION for Trade, a trade group representing film, recording, technology and pharmaceutical industries, said. “He has always been a big believer in innovation and making sure innovation is properly protected and rewarded.”

Hatch announced Jan. 2 he would not seek re-election in November.

The Biotechnology Innovation Organization, a trade group that represents biotechnology companies and research groups, lauded Hatch’s legacy in the biomedical field.

“As we reflect on the many policy achievements Senator Hatch has accomplished over his long and distinguished career, it’s important to consider his efforts in the health care sector which have personally touched the lives of millions of patients across the globe,” BIO’s chief executive, Jim Greenwood, said in a statement.Greenwood pointed out Hatch’s support to fund the National Institutes of Health’s medical research initiatives and the Biologics Price, Competition, and Innovation Act, a statute providing a relatively quick path for makers of biosimilars, which are “highly similar” copies of complex name-brand biologic drugs, to get new drug products to market.

IP Concerns

Hatch, 83, has raised some concerns in recent months about possible conflicts between some of the legislation he worked on.

Hatch, who chairs the Senate Republican High-Tech Task Force, has called on Congress to review how patent validity challenges at the Patent and Trademark Office are affecting the older mechanism for resolving drug-related patent disputes under the Hatch-Waxman Act.

The legislation created the current streamlined process for generic drug approval, established certain market and patent exclusivity periods for both branded and generic drug companies, and created a specific patent litigation process. However, Patent challenge proceedings running parallel to Hatch-Waxman patent disputes in court can result in conflicting decisions, he told practitioners at the American Intellectual Property Law Association’s annual meeting in October.

Hatch has also called for stronger intellectual property protections for American businesses, including the entertainment and biotechnology industries, in a renegotiated North American Free Trade Agreement.

Bills Pending

Two Hatch-sponsored intellectual property bills are pending in Congress.

The Orphan Products Extension Now Accelerating Cures and Treatments Act of 2017 was introduced by Hatch in June. The legislation aims to extend the market exclusivity of drugs that are re-purposed and approved by the U.S. Food and Drug Administration to treat rare diseases by six months.

Hatch reintroduced legislation in April aimed at reducing car collision repair costs by shortening the term of design patents for parts like fenders, hoods and tail lights. The Promoting Automotive Repair, Trade, and Sales (Parts) Act of 2017 would prevent automakers from enforcing design patents against automotive repair part manufacturers 30 months after the first sale of a patented component.

To contact the reporter on this story: Malathi Nayak in Washington at

To contact the editor responsible for this story: Mike Wilczek at

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