Posts Tagged: "Merck"

The lead story in last weekend’s Wall Street Journal made an exciting announcement: “Merck Covid-19 Pill Cuts Risks of Hospitalizations and Death”: “Merck & Co. and its partner Ridgeback Biotherapeutics LP said their experimental Covid-19 pill helped prevent high-risk people early in the course of the disease in a pivotal study from becoming seriously ill and dying, a big step toward providing the pandemic’s first easy-to-use, at home treatment.” In case its readers missed the significance, the same issue included an editorial, “There May Soon Be a Covid Pill”, stating: “In what is rare good news these days, Merck and Ridgeback Biotherapeutics said Friday that their Covid pill molnupiravir reduced hospitalizations by about half… Since the beginning of the pandemic, doctors have been hoping for an oral antiviral that could prevent recently infected patients from getting sicker… Merck has also signed licensing agreements with generic manufacturers to accelerate the pills availability world-wide. Manufacturers in low-income countries don’t need special expertise and supervision to produce the pills, unlike with Covid vaccines. Molnupirvir can be easily distributed in poorer countries… Evidence also indicates that the drug is effective against different variants and is unlikely to produce viral resistance.” The partnership between Emory University, Ridgeback Biotherapeutics and Merck could turn out to be one of the most significant Bayh-Dole alliances ever, yet just a few months ago all three were under fire. And the critics are renewing their attacks.

Last month, business news outlets were reporting that stock prices for pharmaceutical firms Pfizer and Merck took a tumble after financial analysts downgraded the performance of both firms over concerns about impending patent cliffs or exclusivity issues – although more recent reports paint a mostly promising picture for the companies, thanks to upcoming acquisitions. A pharmaceutical analyst for UBS downgraded Pfizer from buy to neutral, citing the loss of patent protection in the 2025 to 2029 timeframe for several drugs which contributed 30 percent of Pfizer’s total revenue in 2015. For Merck, although patent expiry wasn’t cited in a note from a pharmaceutical analyst from BMO, that analyst dropped Merck’s rating from outperform to market perform based on the expectation that the company’s blockbuster cancer drug Keytruda would face increased competition in the immuno-oncology field during 2019. As of January 30, stock prices for both firms were down by at least a dollar per share from their closing price on January 23. The downgrades for both firms are further proof of the importance of maintaining exclusivity through patent protection to pharmaceutical firms.

On Wednesday, April 25th, the Court of Appeals for the Federal Circuit issued a precedential decision in Gilead Sciences v. Merck & Co. et. al., which affirmed a lower court’s ruling that Merck could not assert claims from two patents against Gilead because Merck had unclean hands regarding the patents. The case, coming out of the Northern District of California, involves patents covering methods for effectively treating the hepatitis C virus (HCV)… Reviewing the facts of the case, the Federal Circuit panel found sufficient evidence supporting the district court’s findings of serious business misconduct by Merck, that Merck’s misconduct was related to the litigation and that litigation misconduct had occurred based on false testimony provided by Merck’s non-firewalled patent lawyer, who had originally testified that he was not a party to the March 2004 phone call with Pharmasset.

In invalidating the Idenix patent, the Delaware district court effectively overturns what had been the largest award for royalty damages in a U.S. patent infringement case ever handed out. After a two-week trial in December 2016, the jury had awarded Index $2.64 billion in damages, which was based on finding Gilead infringed the Idenix patent – U.S. Patent No. 7,608,597 — by selling the hepatitis C virus (HCV) treatments Harvoni and Sovaldi.

Merck appealed the lower court’s finding of non-infringement of U.S. Patent No. 6,127,353 (“the ‘353 patent”), which is directed toward mometasone furoate monohydrate (“MFM”), commercially used in Merck’s Nasonex… Merck further contended that the district court erred by basing its non-infringement ruling on the “Day 1 Batches” rather than the “A Batches” because the focus must be on what will be the final commercial product. However, the Federal Circuit rejected this argument by pointing out Merck’s failure to prove a material difference between the “Day 1 Batches” and the “Day 4 Batches” and “A Batches.”

On January 20th, NYC-based drugmaker Bristol-Myers Squibb Co. (NYSE:BMY) and Kenilworth, NJ-based pharmaceutical firm Merck & Co. (NYSE:MRK) announced that the two companies had entered into a settlement and licensing agreement resolving worldwide patent litigation over a cancer treatment. As per the announced terms of the settlement, Merck will make a one-time payment of $625 million to Bristol-Myers Squibb and will also pay future royalties through 2026 on sales of Merck’s Keytruda.

On Thursday, December 15th, a subsidiary of Kenilworth, NJ-based pharmaceutical developer Merck & Co. (NYSE:MRK) was awarded $2.54 in royalty damages in a case involving one of the most popular available treatments for combating the hepatitis C virus (HCV). A federal jury decided that Gilead Sciences Inc. (NASDAQ:GILD), an American biotech firm headquartered in Foster City, CA, owed these royalties as a result of its infringement of patents for HCV treatments held by Merck’s Cambridge, MA-based subsidiary Idenix Pharmaceuticals. According to coverage of the verdict by Bloomberg, this $2.54 billion royalties award is the largest verdict for patent infringement in the history of the United States. The case was decided by jury in the U.S. District Court for the District of Delaware (D. Del.).

The FDA has been pretty active this year in approving new tests and treatments designed to help identify and eliminate the hepatitis C virus in patients. Swiss healthcare developer Roche (VTX:ROG) received FDA approval this March for a new quantitative RNA test which can help physicians see exactly what level of HCV exists in a patient’s blood instead of simply confirming an active infection. Earlier this year, in late January, the FDA granted approval to Merck & Co. (NYSE:MRK) for a once-daily single tablet treatment branded as Zepatier. Zepatier is another combination drug therapy which incorporates elbasvir and grazoprevir, both HCV RNA inhibitors, and is designed to treat patients having one of two strains of HCV, including the most common strain. A 12-week regimen of the treatment costs $54,600.

The early months of 2015 have been interesting ones for the pharmaceutical industry, an incredibly valuable industry sector that comes under our focus from time to time here at IPWatchdog. The first quarter of this calendar year has seen a number of mergers and acquisitions which are showing us that the patent market for pharmaceuticals is quite active right now.…

Merck & Co. (NYSE: MRK), which is headquartered in Whitehouse Station, NJ, and also does business under the name Merck Sharp & Dohme MSD, is one of the world’s largest and most renowned pharmaceutical development companies. The company just made a major acquisition in the middle of December, investing $8.4 billion in the purchase of Cubist Pharmaceuticals, a deal which…