Jessica Karmasek Sep. 28, 2015, 1:56pm


SAN FRANCISCO (Legal Newsline) - Two groups representing California’s life sciences sector say they are disappointed with recent remarks by U.S. Rep. Darrell Issa about a House-introduced patent reform bill.

The California Life Sciences Association, or CLSA, and Biocom said in a Sept. 17 letter delivered to Issa, a California Republican and chairman of the U.S. House Intellectual Property Subcommittee, that his comments dismiss the “very real and serious” concerns of life sciences companies, research universities, institutes and venture capital firms.

Issa’s district currently covers the northern coastal areas of San Diego County and a small portion of southern Orange County, representing one of the state’s leading clusters of life sciences research and development.

Earlier this month, Issa told Politico that supporters of H.R. 9, the Innovation Act, were working on rebuilding support for the bill. The federal lawmaker said “misinformation led to people not supporting the bill that they had previously voted for.”

Issa also said the bill would not be amended to protect biopharmaceutical patents from the inter partes review, or IPR, process.

“These remarks seem to suggest a lack of understanding of the extraordinary value and complexity of life sciences innovation, as well as the fundamental importance that companies, and their investors, place on patents and the ability to protect and enforce them,” said Sara Radcliffe, president and CEO of CLSA, and Joe Panetta, president and CEO of Biocom.

The two non-profit associations represent more than 1,000 life sciences organizations in California.

“In addition to developing life-saving treatments and therapies, California’s biomedical sector is also an increasingly important element of our state’s economy,” Radcliffe and Panetta noted. “California is the world leader in life sciences innovation, with over 2,500 companies employing nearly 300,000 Californians, paying over $27 billion in annual salaries and wages and accounting for $22 billion in global exports.

“It is crucial to protect and promote these jobs and the innovation they generate, not discredit or dismiss our ecosystem’s concerns.”

The two groups argue that patent reform legislation must balance the need to correct abusive or so-called patent “troll” practices with the reliance of a full spectrum of industries and sectors on a “well-functioning” U.S. patent system.

“In its current form, H.R. 9 falls far short of that goal,” Radcliffe and Panetta said.

Radcliffe and Panetta wrote in their letter to Issa that they are “deeply concerned” by the documented abuses of the IPR system, arguing they threaten future investment in innovation and the ability of patients to gain access to breakthrough medicines and technologies.

IPR is a procedure for challenging the validity of a patent before the PTO. The procedure, which allows third parties to challenge bad patents, is conducted by the Patent Trial and Appeal Board, or PTAB.

The review was enacted in September 2012 as part of the America Invents Act. The procedure replaced a previous review procedure called inter partes reexamination.

“Indeed, more than 100 well-informed patient organizations recently wrote to Senate and House leaders calling for improvements to patent reform legislation that properly address current abuses in the IPR system,” they pointed out.

Earlier this month, the Epilepsy Foundation, Alzheimer’s Association, Hepatitis Foundation International, Kidney Cancer Association, Lupus Foundation of America, National Alliance on Mental Illness, Parkinson’s Action Network, The AIDS Institute and The ALS Association, among others, sent a letter to Senate Judiciary Committee Chairman Chuck Grassley, Ranking Member Patrick Leahy, House Judiciary Committee Chairman Bob Goodlatte and Ranking Member John Conyers.

The groups argue in their letter, dated Sept. 8, that the Innovation Act does little to address current abuses in the IPR process that threaten the Drug Price Competition and Patent Term Restoration Act -- commonly referred to as the Hatch-Waxman Act -- and the Biologics Price Competition and Innovation Act, or BPCIA.

Radcliffe and Panetta, in their letter to Issa, said CLSA and Biocom will continue to “engage” with the California delegation, congressional leadership, along with their stakeholders, to protect patent rights and oppose “misguided” legislation.

CLSA serves more than 750 biotechnology, pharmaceutical, medical device and diagnostics companies, research universities and institutes, investors and service providers.

Biocom is one of the largest regional life science associations in the world, representing more than 680 member companies in Southern California.

From Legal Newsline: Reach Jessica Karmasek by email at jessica@legalnewsline.com.

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