Patent infringement lawsuits were in focus in the biotech sector this week with some important jury rulings affecting companies like Gilead GILD, Amgen AMGN and Regeneron REGN. While Amgen was on the winning side, Gilead and Regeneron suffered setbacks with the jury rulings going against them.
Recap of the Week’s Most Important Stories
1. Gilead suffered a setback with a jury ruling against the company in a patent dispute covering Gilead’s sofosbuvir-based medicines for the treatment of hepatitis C virus (HCV) — this includes the company’s blockbuster drugs, Harvoni and Sovaldi. The jury found in favor of Merck and Ionis IONS, the co-inventors on the disputed patents.
Gilead may well have to pay royalties to Merck on sofosbuvir-based product sales. Not just that, the next phase of the trial will decide the amount of damages that Gilead will have to give Merck as compensation for its past and future infringement. However, chances are high that Gilead will appeal the ruling.
2. The U.S. Patent and Trademark Office said that it will conduct an inter partes review of a patent covering Biogen’s BIIB oral multiple sclerosis drug, Tecfidera. The PTAB had earlier denied a petition to institute an inter partes review.
3. Meanwhile, Amgen fared better on the patent litigation front with the company getting a favorable ruling in its patent infringement lawsuit against Regeneron and Sanofi related to PCSK9 inhibitors. The next step involves a decision regarding damages and a possible injunction against Sanofi and Regeneron. Not surprisingly, Sanofi and Regeneron said that they intend to appeal the ruling.
Currently, Amgen’s PCSK9 inhibitor, Repatha, and Sanofi and Regeneron’s PCSK9 inhibitor, Praluent, are fighting for a share in the market. However, sales of both treatments are yet to take off as expected. Depending on how the legal situation pans out, Sanofi and Regeneron may end up paying royalties to Amgen on Praluent sales (Read More: Amgen Wins PCSK9 Lawsuit, Sanofi and Regeneron to Appeal).
4. BioMarin’s BMRN shares were down with the company reporting mixed results from a late-stage study on its experimental treatment, pegvaliase, for a rare genetic disorder, phenylalanine hydroxylase (PAH) deficiency. Although the study met the primary endpoint, no benefit was observed in inattention or mood scores leading to concerns regarding the drug’s commercial potential (Read More: BioMarin Down on Phase III Data on Pegvaliase).
5. Kite Pharma KITE is collaborating with Roche for the evaluation of the safety and efficacy of its lead pipeline candidate, KTE-C19, in combination with Roche’s atezolizumab in patients with refractory, aggressive non-Hodgkin lymphoma (NHL). This collaboration brings together two companies focused on oncology – while Kite is focused on immune-oncology treatments, Roche has a strong position and expertise in the oncology market.
Performance
While Amgen gained (3.32%) the most last week among major biotech stocks, Gilead and Regeneron’s shares were down slightly. Meanwhile, Regeneron lost 31.9% over the last six months with Amgen recording a gain (3.32%) during this period.
| Company | Last Week | Last 6 Months |
| AMGN | 3.32% | 3.32% |
| BIIB | 1.75% | -14.45% |
| GILD | -0.22% | -13.82% |
| CELG | 2.45% | -14.63% |
| REGN | -0.84% | -31.90% |
| ALXN | 2.13% | -16.29% |
| VRTX | 1.07% | -28.35% |
The NASDAQ Biotechnology Index was up 1.58% over the last five trading days (See the last biotech stock roundup here: GW Pharma Soars on Epidiolex Data, Gilead's Zydelig in Trouble?).
What's Next in the Biotech World?
Watch out for the usual pipeline updates and data presentations from biotech companies.
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