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Merck Gilead Patent Trial 3/9/16
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Gilead Tries to Block Merck’s Patent Claims on New Hepatitis C Drugs
Mar 9, 2016 | Wall Street Journal
By Pete Loftus
A high-stakes battle between two drug companies over the multibillion-dollar sales of new hepatitis C treatments is kicking off in a California courtroom this week. -
VA expands hepatitis C treatment to all patients with the virus
Mar 9, 2016 | Military Times
By Patricia Kime
The Veterans Affairs Department will begin providing hepatitis C treatment to all veterans in its health system who have the virus, regardless of their disease stage, VA officials said Wednesday. -
Gilead Tries to Block Merck's Patent Claims on New Hepatitis C Drugs
Mar 9, 2016 | Nasdaq
By Peter Loftus
A high-stakes battle between two drug companies over the multibillion-dollar sales of new hepatitis C treatments is kicking off in a California courtroom this week.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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Gilead Tries to Block Merck’s Patent Claims on New Hepatitis C Drugs
Mar 9, 2016 | Wall Street Journal
By Pete Loftus
A high-stakes battle between two drug companies over the multibillion-dollar sales of new hepatitis C treatments is kicking off in a California courtroom this week.
Gilead Sciences Inc. hopes to convince a jury in federal court in San Jose that it shouldn’t have to share any of the sales of its blockbuster hepatitis C drugs Sovaldi and Harvoni with rival Merck & Co., which wants a cut. Last year, combined U.S. sales of the two drugs were $12.5 billion, out of a global haul of $19.1 billion.
Merck is staking a claim because it says sofosbuvir, which is the active ingredient shared by Gilead’s drugs, infringes two Merck patents that cover related compounds, and it wants royalties from Gilead. In the trial, which arose from Gilead’s 2013 lawsuit against Merck, Gilead seeks a judgment that the Merck patents are invalid and that it owes Merck nothing. Merck recently began selling its own hepatitis C drug, Zepatier,
The case is one of several legal battles that have erupted over a new wave of effective but expensive hepatitis C drugs, as companies try to assert the patent rights they’ll need to grab a piece of the pie.
Patent battles in the drug industry usually involve branded drugmakers trying to block generic competitors from selling cheap copies of their drugs. This battle is unusual because it pits branded drugmaker against branded drugmaker, in disputes more typical of high-tech companies.
“The value of the market and the profit that Gilead has made has put such a target on them,” says Gaston Kroub, a patent attorney and co-founder of Markman Advisors, which advises investors on patent law. “Everybody’s trying to get a piece of that revenue stream and they’re looking at patents as a potential tool for that revenue.”
Gilead also is embroiled in litigation with AbbVie, which claims Gilead’s drugs infringe its U.S. patents covering various combinations of drugs to treat the liver-damaging hepatitis C virus. AbbVie began selling a combination hepatitis C product, Viekira Pak, in 2014. Gilead denies the allegations. Lawsuits the companies filed against each other are scheduled for trial in federal court in Delaware in September.
Beyond hepatitis C drugs, a patent battle is also brewing between makers of expensive brand-name cancer therapies. Bristol-Myers Squibb Co. sued Merck in 2014, claiming Merck’s cancer immunotherapy Keytruda infringed patents held by Bristol and Ono Pharmaceutical Co., which co-developed a competing drug, Opdivo. Merck has argued the patents are invalid; the case is pending.
In the current hepatitis C trial, Merck said in a court document last month that it filed applications in 2002 for patents covering the use of certain compounds to fight hepatitis C infection. At trial, it is trying to “rebut Gilead’s challenge to the validity of the asserted claims and will seek damages for Gilead’s infringement in the form of a reasonable royalty on Gilead’s U.S. sales” of Sovaldi and Harvoni, Merck’s attorneys wrote. Merck co-owns the patents with Ionis Pharmaceuticals Inc., formerly known as Isis Pharmaceuticals.
An Ionis spokesman didn’t immediately respond to a request for comment Wednesday.
In 2013, Merck proposed to license its patents to Gilead in exchange for a royalty of 10% of U.S. sales of products containing sofosbuvir, according to Gilead’s lawsuit against Merck. Gilead countered in a court document that a 10% royalty is a “prohibitive demand.”
Gilead said in a court document last month that the original applications for the Merck patents weren’t specific enough to cover Gilead’s drugs. Gilead also said certain claims in the Merck patents weren’t added until several years after the original applications, following patent applications and research publications by scientists from Pharmasset, the company that developed sofosbuvir and was acquired by Gilead for more than $11 billion.
“Simply put, Merck’s asserted patents claim work Merck never did, and ideas Merck never had,” Gilead said in the court filing. “The asserted claims are invalid and Merck should collect nothing.”
A Merck spokeswoman said the company and its partners conducted many years of research and made investments that led to “significant advances” in the treatment of hepatitis C, “and were appropriately granted patent protection.”
A Gilead spokeswoman said the company believes Merck’s patents “are invalid and we will continue to take measures to protect sofosbuvir’s intellectual property.”
Opening statements were made Monday in the trial, which is expected to end by late March.
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VA expands hepatitis C treatment to all patients with the virus
Mar 9, 2016 | Military Times
By Patricia Kime
The Veterans Affairs Department will begin providing hepatitis C treatment to all veterans in its health system who have the virus, regardless of their disease stage, VA officials said Wednesday.
Having received a boost in funding from Congress late last year for the costly medications needed to cure hepatitis C, the VA is now able to treat the 174,000 veterans in its health system who have the disease, according to a VA release.
VA Under Secretary for Health Dr. David Shulkin said that while the cost previously was too prohibitive to treat all but the sickest patients, VA now can treat all veterans with the virus who are eligible for VA health care, either in a VA facility or through the Veterans Choice program.
“We’re honored to be able to expand treatment for veterans who are afflicted with hepatitis C,” Shulkin said. “Additionally, if veterans are currently waiting on an appointment for community care through the Choice program, they can now turn to their local VA facility for this treatment or elect to continue to receive treatment through Choice.”
An estimated 200,000 veterans have hepatitis C, including 174,000 veterans enrolled in the VA health system. Hepatitis C is spread by shared needles or by contact with the bodily fluids of an infected person, and those most at risk include people who received a blood transplant or organ transplant before 1992, when widespread screening became available in the U.S.
Roughly 60 percent of veterans who have hepatitis C served during the Vietnam era.
Since 2014, VA has treated 42,000 hepatitis C patients with the medication sofosbuvir. In fiscal 2015, the department designated $696 million, or 17 percent of its total pharmacy budget, for the drug. It expects to spend $1 billion for medications containing sofosbuvir in fiscal 2016.
The company had been charging the federal government up to $68,000 for a treatment regimen that costs about $1,400 to make. As a result, public health officials, including the VA, could afford to treat only the sickest patients.
California-based Gilead Sciences, the maker of the sofosbuvir, including brand names Sovaldi and Harvoni, has come under fire from lawmakers, who have accused the company of price-gouging. (Photo: AP)
The person who led the scientific team that created sofosbuvir, Raymond Schinazi, was a senior research career scientist who worked for the VA from the late 1980s until Feb. 1 of this year, when he retired. He requested his retirement on Jan. 21, the day he received an invitation to testify before the House Veterans Affairs Committee on his role in developing the medication and growing the company that profited from its sales.
The Food and Drug Administration in January approved a different medication, Zepatier, made by Merck, to treat the disease. In a release on Wednesday, Merck executives said they priced the medication "to broaden and accelerate access to treatment for patients covered in commercial or public plans, including our country’s veterans."
“This is a good example of how government and industry can work together toward a shared goal in the best interests of public health — particularly for our veterans who are so deserving," Merck chairman and CEO Kenneth Frazier said.
A Merck spokeswoman said it was too early to tell whether Zepatier will become the favored treatment within VA to treat hepatitis C but that the company priced it appropriately to ensure that it could be accessed by all veterans.
In a statement released by Merck, VA Deputy Secretary Sloan Gibson praised the company for its role treating veterans.
“We are grateful to Congress and to pharmaceutical leaders like Merck that are committed to our veterans who have nobly served our nation," Gibson said.
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Gilead Tries to Block Merck's Patent Claims on New Hepatitis C Drugs
Mar 9, 2016 | Nasdaq
By Peter Loftus
A high-stakes battle between two drug companies over the multibillion-dollar sales of new hepatitis C treatments is kicking off in a California courtroom this week.
Gilead Sciences Inc. hopes to convince a jury in federal court in San Jose that it shouldn't have to share any of the sales of its blockbuster hepatitis C drugs Sovaldi and Harvoni with rival Merck & Co., which wants a cut. Last year, combined U.S. sales of the two drugs were $12.5 billion, out of a global haul of $19.1 billion.
Merck is staking a claim because it says sofosbuvir, which is the active ingredient shared by Gilead's drugs, infringes two Merck patents that cover related compounds, and it wants royalties from Gilead. In the trial, which arose from Gilead's 2013 lawsuit against Merck, Gilead seeks a judgment that the Merck patents are invalid and that it owes Merck nothing. Merck recently began selling its own hepatitis C drug, Zepatier,
The case is one of several legal battles that have erupted over a new wave of effective but expensive hepatitis C drugs, as companies try to assert the patent rights they'll need to grab a piece of the pie.
Patent battles in the drug industry usually involve branded drugmakers trying to block generic competitors from selling cheap copies of their drugs. This battle is unusual because it pits branded drugmaker against branded drugmaker, in disputes more typical of high-tech companies.
"The value of the market and the profit that Gilead has made has put such a target on them," says Gaston Kroub, a patent attorney and co-founder of Markman Advisors, which advises investors on patent law. "Everybody's trying to get a piece of that revenue stream and they're looking at patents as a potential tool for that revenue."
Gilead also is embroiled in litigation with AbbVie, which claims Gilead's drugs infringe its U.S. patents covering various combinations of drugs to treat the liver-damaging hepatitis C virus. AbbVie began selling a combination hepatitis C product, Viekira Pak, in 2014. Gilead denies the allegations. Lawsuits the companies filed against each other are scheduled for trial in federal court in Delaware in September.
Beyond hepatitis C drugs, a patent battle is also brewing between makers of expensive brand-name cancer therapies. Bristol-Myers Squibb Co. sued Merck in 2014, claiming Merck's cancer immunotherapy Keytruda infringed patents held by Bristol and Ono Pharmaceutical Co., which co-developed a competing drug, Opdivo. Merck has argued the patents are invalid; the case is pending.
In the current hepatitis C trial, Merck said in a court document last month that it filed applications in 2002 for patents covering the use of certain compounds to fight hepatitis C infection. At trial, it is trying to "rebut Gilead's challenge to the validity of the asserted claims and will seek damages for Gilead's infringement in the form of a reasonable royalty on Gilead's U.S. sales" of Sovaldi and Harvoni, Merck's attorneys wrote. Merck co-owns the patents with Ionis Pharmaceuticals Inc., formerly known as Isis Pharmaceuticals.
An Ionis spokesman didn't immediately respond to a request for comment Wednesday.
In 2013, Merck proposed to license its patents to Gilead in exchange for a royalty of 10% of U.S. sales of products containing sofosbuvir, according to Gilead's lawsuit against Merck. Gilead countered in a court document that a 10% royalty is a "prohibitive demand."
Gilead said in a court document last month that the original applications for the Merck patents weren't specific enough to cover Gilead's drugs. Gilead also said certain claims in the Merck patents weren't added until several years after the original applications, following patent applications and research publications by scientists from Pharmasset, the company that developed sofosbuvir and was acquired by Gilead for more than $11 billion.
"Simply put, Merck's asserted patents claim work Merck never did, and ideas Merck never had," Gilead said in the court filing. "The asserted claims are invalid and Merck should collect nothing."
A Merck spokeswoman said the company and its partners conducted many years of research and made investments that led to "significant advances" in the treatment of hepatitis C, "and were appropriately granted patent protection."
A Gilead spokeswoman said the company believes Merck's patents "are invalid and we will continue to take measures to protect sofosbuvir's intellectual property."
Opening statements were made Monday in the trial, which is expected to end by late March.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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Full Text of Stories Below
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