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Merck Gilead Patent Trial 5/06/16
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Gilead Judge Re-Opens Case Amid Claim Merck Scientist Lied
Apr 29, 2016 | Bloomberg
By Kartikay Mehrota
A federal judge re-opened Merck & Co.’s patent case against Gilead Sciences Inc. over a hepatitis C drug amid claims that a witness for Merck lied to a jury that awarded the company $200 million in damages. -
Judge Allows More Evidence in Patent Dispute After Gilead Says Merck Attorney Lied
May 2, 2016 | The Wall Street Journal
By Peter Loftus
A federal judge has allowed Gilead Sciences Inc. to submit additional evidence in a drug-patent dispute with Merck & Co., after Gilead claimed a former Merck patent attorney lied under oath in the case. -
Gilead OK'd To Show Merck Atty Lied In $200M Patent Win
Apr 30, 2016 | Law360
By Erin Coe
A California federal judge ruled Friday that Gilead can reopen the record following a jury’s $200 million patent infringement verdict against it and admit more evidence to show a Merck attorney lied to access Gilead’s confidential information, saying a fuller record will help her decide whether Merck has unclean hands. -
New contention a Merck scientist lied sends Gilead hep C patent fight back to court
May 2, 2016 | FiercePharma
By Eric Palmer
That patent fight that Merck ($MRK) recently won entitling it to a significant piece of Gilead Sciences' ($GILD) huge hep C drug profits? Well, you can forget that for now. A disclosure that a Merck scientist may have “lied” during sworn testimony has led the judge to reopen the case. -
Gilead Sciences Shares Slip as Judge Re-Opens Merck Patent Case
May 2, 2016 | Sonoran Weekly
By Robin Reyes
Gilead Sciences (NASDAQ:GILD) shares were lower 1% on Monday after Bloomberg reported a federal judge has re-opened Merck & Co’s (MRK) patent case against the company over a hepatitis C drug amid claims that an ex-Merck scientist lied to a jury that awarded the Merck $200 million in damages. The report said the scientist claimed a patent he obtained for Merck was the result of his own work while Gilead said he actually relied on an earlier patent developed by Pharmasset Inc, before that company was acquired by Gilead in 2011.
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Gilead Judge Re-Opens Case Amid Claim Merck Scientist Lied
Apr 29, 2016 | Bloomberg
By Kartikay Mehrota
A federal judge re-opened Merck & Co.’s patent case against Gilead Sciences Inc. over a hepatitis C drug amid claims that a witness for Merck lied to a jury that awarded the company $200 million in damages.
U.S. District Judge Beth Labson Freeman said Friday she’s “outraged” about an allegation a now-retired Merck scientist deceived jurors with testimony that he was responsible for early breakthroughs on compounds that led to a cure for the liver disease. Gilead’s development of its Sovaldi and Harvoni medicines helped it become the world’s largest biotechnology firm by market value.
While the scientist, Phil Durette, said a patent he obtained for Merck was the result of his own work, Gilead said evidence shows he actually relied on an earlier patent developed by Pharmasset Inc., before that company was acquired by Gilead in 2011.
“It’s the sad truth that people lie in court every day,” Labson said at a hearing Friday in San Jose, California. “I am outraged by what I think is untruthful testimony.”
She also called the allegations extreme. “It may be the case, it may not,” the judge said.
‘Not Merck’s Conduct’
Bruce Genderson, a lawyer for Merck, reminded the judge it was Gilead that called Durette to the stand and that his testimony was “not Merck’s conduct.”
“I respectfully disagree that his testimony wasn’t truthful,” Genderson said.
Durette declined to comment Friday when asked on the phone about the accuracy of his testimony.
At trial, Gilead and Merck each tried to show the other was claiming credit for scientific advances that wasn’t due. Over two weeks, a parade of doctors and scientists for Gilead, Pharmasset and Merck and its partner Ionis Pharmaceuticals Inc. testified about their roles in the patent process.
After siding with Merck on all the patent claims, jurors rejected Merck’s bid for a 10 percent royalty on the $20.7 billion revenue that Gilead’s hepatitis C drugs generated from 2013 through 2015.
The judge gave both sides until Monday to file more arguments over the Durette’s testimony.
The case is Gilead Sciences Inc. v. Merck & Co., 13-cv-04057, U.S. District Court, Northern District of California (San Jose).
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Judge Allows More Evidence in Patent Dispute After Gilead Says Merck Attorney Lied
May 2, 2016 | The Wall Street Journal
By Peter Loftus
A federal judge has allowed Gilead Sciences Inc. to submit additional evidence in a drug-patent dispute with Merck & Co., after Gilead claimed a former Merck patent attorney lied under oath in the case.
In March, a federal jury in San Jose, Calif., ordered Gilead to pay Merck $200 million after finding that two U.S. patents held by Merck and its partner, Ionis Pharmaceuticals Inc.,were valid and infringed by Gilead’s multibillion-dollar hepatitis C drugs, Sovaldi and Harvoni. The trial arose from Gilead’s 2013 lawsuit seeking a judgment that the Merck patents were invalid.
The patents cover a range of compounds treating hepatitis C. Merck recently began selling its own hepatitis C drug, Zepatier.
After the jury verdict and award in March, U.S. District Judge Beth Labson Freeman presided over a bench trial in which Gilead argued it shouldn’t have to pay Merck because Merck was dishonest in obtaining its patents. Gilead said that in 2004, Merck patent attorney Philippe Durette had a conference call with employees of Pharmasset Inc., in which he learned the chemical structure of an experimental hepatitis C drug that Pharmasset was developing, code-named PSI-6130. Gilead later spent more than $11 billion to acquire Pharmasset and its hepatitis C drugs.
Gilead said Mr. Durette misused what he learned on the call to subsequently change claims in pending Merck patent applications in a way that would cover Pharmasset’s technology.
A Merck spokeswoman said the jury reached the correct verdict, and Merck believes the court will uphold it. Merck said Gilead’s arguments about Merck’s conduct in obtaining its patents are without merit.
Judge Freeman’s final decision in the bench trial is pending. On April 22, Gilead asked the judge to reopen the record for the bench trial to allow it to submit additional information, claiming Mr. Durette “lied on a critical issue in this case.” At a hearing Friday, the judge granted Gilead’s request.
The 2004 call was part of confidential negotiations over a potential deal for Merck to license PSI-6130 from Pharmasset, a deal that never materialized, Gilead said.
In a deposition last year, Mr. Durette said he wasn’t involved in any such call, according to a Gilead court document.
But at the March trial, he changed his story and testified he now remembered he was present for the call and learned the structure of the compound, according to Gilead. He said he had earlier forgotten about the call, according to Gilead.
Gilead wants to submit to the court additional excerpts of Mr. Durette’s deposition to give the judge a more complete record on which to assess his conduct and candor.
Merck said in a court document that Mr. Durette initially didn’t remember being on the 2004 conference call, and that he acted properly because he waited to change Merck’s patent applications until after Pharmasset published the structure of PSI-6130.
Mr. Durette couldn’t immediately be reached to comment Monday.
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Gilead OK'd To Show Merck Atty Lied In $200M Patent Win
Apr 30, 2016 | Law360
By Erin Coe
A California federal judge ruled Friday that Gilead can reopen the record following a jury’s $200 million patent infringement verdict against it and admit more evidence to show a Merck attorney lied to access Gilead’s confidential information, saying a fuller record will help her decide whether Merck has unclean hands.
During a Friday hearing, U.S. District Judge Beth Labson Freeman granted Gilead Sciences Inc.’s bid to admit additional deposition testimony from retired Merck & Co. Inc. patent prosecutor Philippe Durette, who Gilead accuses of lying about not recalling his participation in a 2004 call on licensing discussions with the developers of what later would become Gilead’s top-selling hepatitis C drugs Sovaldi and Harvoni. Gilead asserts that he got access to the call under false pretenses and then used information from the call to help Merck secure patents that blocked competitors in the hepatitis C virus drug space.
Merck has argued that Durette clarified during the 2015 deposition under further questioning that he did not deny participating in the conference call, but rather that he could not specifically recall his participation in an event that had occurred 11 years prior to the probe.
The judge on Friday also allowed Merck to submit additional deposition excerpts that it claims show Durette had not made untruthful statements.
“I think it’s beneficial to reopen the record,” the judge told the parties.
She noted that it was a “sad truth of life” that witnesses lie in the courtroom every day, but at the same time, Gilead’s motion claiming that Merck obtained its two patents with unclean hands was an extreme one.
“This is an extraordinary remedy, and it’s an enormous punishment for unclean hands if I find it,” she said.
The judge said she would have to determine from the full record whether Durette intended to lie at the time of the deposition to cover up any wrongdoing in 2004.
“He was prosecuting the Merck patents and he shouldn’t have been on that call, he should have recused himself from the subject matter or got off the call once he was aware the conversation was one he wasn’t entitled to hear, but he did none of that,” she said. “That’s one way of looking at this.”
She also said Durette’s deposition testimony was inconsistent and that his initial statements that he wasn’t on the call were untruthful.
However, she said she was still unsure whether Durette’s alleged lies would be a game changer for Gilead.
“[Gilead] could win the battle and lose the war,” she said. “[It] might prove every fact and it doesn’t add up to unclean hands.” She added that it remained to be seen whether the alleged lies tainted the litigation to the level necessary.
Gilead lawyer Jonathan Singer of Fish & Richardson PC told the judge that while an accusation of unclean hands was extreme, it was warranted in this case.
“It’s an extraordinary remedy for extraordinary misconduct,” he said. “This is a member of the bar. This is an attorney. … The public’s confidence in attorneys is at stake here.”
In the call, Pharmasset Inc. purportedly disclosed the structure of its lead nucleoside compound as part of a potential licensing deal with Merck, under the impression that participants from Merck were firewalled, meaning they had no involvement with Merck’s hepatitis program. Pharmasset has since been acquired by Gilead, and the structure at issue is a central part of Gilead’s drugs.
Gilead claims Durette was “intricately involved” with Merck’s hepatitis program and asserts that he told the participants on the call that he was part of the firewall when he really wasn’t.
“What would have happened if he was truthful that day?” Singer said. “If he had said he was not in the firewall and that he was prosecuting competing patents for methods treating [the hepatitis C virus]? Imagine if he was truthful. … But he didn’t act accordingly … and Merck didn’t take any corrective action here.”
Merck lawyer Bruce Genderson of Williams & Connolly LLP argued that Durette’s testimony wasn’t untruthful and that upon further questioning during the deposition, Durette said while he didn’t recall being on the 2004 call, he acknowledged the email records indicated that it was possible he had been a participant.
He said Gilead was focusing on Durette’s deposition testimony to make it seem like Merck had done something underhanded.
“Merck wasn’t hiding anything,” he said. “[Gilead and Pharmasset] derived the invention from us, they knew they infringed and continued to develop anyway.”
He argued that this case was far removed from other cases where unclean hands had been found.
“This isn’t even a close case,” he said.
Gilead, which originally sued in 2013, had sought a ruling that it didn’t infringe Merck’s patents or alternatively that U.S. Patent Numbers 7,105,499 and 8,481,712 were invalid.
A jury in March found the patents to be valid and ordered Gilead to pay $200 million, a fraction of the $2 billion that Merck had sought in the suit, according to court records.
The asserted claims of the two patents cover the drug ingredient sofosbuvir, a critical configuration of atoms known as a nucleoside that is found in Gilead’s hepatitis C drugs Sovaldi and Harvoni, which logged combined sales of $19.1 billion last year.
The patents-in-suit are U.S. Patent Numbers 7,105,499 and 8,481,712.
Gilead is represented by Juanita R. Brooks, Jonathan E. Singer, Douglas E. McCann, John M. Farrell and Michael E. Florey of Fish & Richardson PC.
Merck is represented by Bruce R. Genderson, Jessamyn S. Berniker, Stanley E. Fisher, Jessica Bodger Rydstrom, Sanjiv P. Laud and Jessica Palmer Ryen of Williams & Connolly LLP, Stephen S. Rabinowitz, Patrice P. Jean and Mitchell Epner of Hughes Hubbard & Reed LLP, and Joshua H. Lerner and Laura E. Miller of Durie Tangri LLP.
The case is Gilead Sciences Inc. v. Merck & Co. Inc. et al., case number 5:13-cv-04057, in the U.S. District Court for the Northern District of California.
--Editing by Aaron Pelc.
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New contention a Merck scientist lied sends Gilead hep C patent fight back to court
May 2, 2016 | FiercePharma
By Eric Palmer
That patent fight that Merck ($MRK) recently won entitling it to a significant piece of Gilead Sciences' ($GILD) huge hep C drug profits? Well, you can forget that for now. A disclosure that a Merck scientist may have “lied” during sworn testimony has led the judge to reopen the case.
On Friday, U.S. District Judge Beth Labson Freeman gave lawyers until today to file additional pleadings, Bloomberg reports. She said she was “outraged” that retired scientist Phil Durette may have deceived jurors when he testified that he had made early scientific advancements that led to development of hepatitis C drugs that are now curing the disease.
In the legal proceedings, the two have been fighting over which was first to develop a compound used in the hepatitis C drugs. Gilead got its technology for Sovaldi and Harvoni when it acquired Pharmasset in 2011. Merck has done in-house development of its drug but at one point looked into buying Pharmasset, and therein lies the question over Merck’s scientist.
During deposition testimony, Durette had said he was not on a call with Pharmasset officials when Merck was looking into buying the company and Pharmasset’s compound was discussed,Bloomberg said. But during the trial in March, he referred to notes and said he was reminded that he had been on that call. Merck claims he did not intentionally deceive jurors and that his testimony did not equate to Merck’s conduct.
But the judge said that was to be sorted out in court. “It may be the case, it may not,” Bloomberg reports Judge Labson Freeman saying at the hearing.
The jury had awarded Merck $200 million in March after factoring out Gilead's R&D investment and factoring in a 4% royalty. Gilead is appealing the verdict, and the final outcome could be years away unless the two reach a settlement.
Gilead got to market first with its drugs and has dominated the category. U.S. sales for its two drugs from launch through Dec. 31 totaled $12 billion for Sovaldi and almost $11 billion for Harvoni. Merck, which recently won FDA approval for its third-to-market hep C contender Zepatier, has sales expectations much more modest than those for Sovaldi and Harvoni. But its drug is already having an impact on Gilead's sales.
Last week, Foster City, CA-based Gilead reported Q1 revenues of $1.28 billion and $3.02 billion for Sovaldi and Harvoni, respectively. That was below analyst forecasts of $1.37 billion in sales for Sovaldi and $3.13 billion for Harvoni.
In a call with analysts, Gilead Executive VP Paul Carter attributed some of the miss to greater discounts offered to payers. He said after Merck’s Zepatier entered the market, Gilead offered some payers “a little bit of discount” to keep Harvoni on formularies without restricting patients’ access.
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Gilead Sciences Shares Slip as Judge Re-Opens Merck Patent Case
May 2, 2016 | Sonoran Weekly
By Robin Reyes
Gilead Sciences (NASDAQ:GILD) shares were lower 1% on Monday after Bloomberg reported a federal judge has re-opened Merck & Co’s (MRK) patent case against the company over a hepatitis C drug amid claims that an ex-Merck scientist lied to a jury that awarded the Merck $200 million in damages. The report said the scientist claimed a patent he obtained for Merck was the result of his own work while Gilead said he actually relied on an earlier patent developed by Pharmasset Inc, before that company was acquired by Gilead in 2011.
Bloomberg noted the jury sided with Merck on all patent claims but only awarded the company 10% royalty on the $20.7 billion revenue that Gilead’s hepatitis C drugs generated from 2013 through 2015. Merck only got a tenth of what it sought, Bloomberg said. GILD trades in the lower half of the 52-week range between $81.89 and $123.37. MRK trades in the upper half of the 52-week range between $45.69 and $61.70.
The stock is down 0.07% or $0.06 after the news, hitting $88.94 per share. About 13.48 million shares traded hands or 19.82% up from the average. Gilead Sciences, Inc. (NASDAQ:GILD) has declined 13.95% since September 24, 2015 and is downtrending. It has underperformed by 20.84% the S&P500.
Gilead Sciences, Inc., a research-based biopharmaceutical company, discovers, develops, and commercializes medicines in areas of unmet medical needs in North America, South America, Europe, and the Asia-Pacific. The companyÂ’s products include Genvoya, Stribild, Complera/Eviplera, Atripla, Truvada, Viread, Emtriva, Tybost, and Vitekta for the treatment of human immunodeficiency virus (HIV) infection in adults; and Harvoni, Sovaldi, Viread, and Hepsera products for the treatment of liver diseases. It also offers Zydelig, a PI3K delta inhibitor, in combination with rituximab, for the treatment of certain blood cancers; Letairis, an endothelin receptor antagonist for the treatment of pulmonary arterial hypertension; Ranexa, a tablet used for the treatment of chronic angina; Lexiscan/Rapiscan injection for use as a pharmacologic stress agent in radionuclide myocardial perfusion imaging; Cayston, an inhaled antibiotic for the treatment of respiratory systems in cystic fibrosis patients; and Tamiflu, an oral antiviral capsule for the treatment and prevention of influenza A and B.
In addition, the company provides other products, such as AmBisome, an antifungal agent to treat serious invasive fungal infections; and Macugen, an anti-angiogenic oligonucleotide to treat neovascular age-related macular degeneration. Further, it has product candidates in various stages of development for the treatment of HIV/AIDS and liver diseases, such as hepatitis B virus and hepatitis C virus; inflammation/oncology; serious cardiovascular; and respiratory conditions, as well as diabetic nephropathy and ebola. The company markets its products through its commercial teams and/or in conjunction with third-party distributors and corporate partners. Gilead Sciences, Inc. has collaboration agreements with Bristol-Myers Squibb Company, Janssen R&D Ireland, Japan Tobacco Inc., and Galapagos NV. The company was founded in 1987 and is headquartered in Foster City, California.
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