One company cannot own all passive immunotherapies for Alzheimer’s disease, courts in Europe and the UK ruled June 24 and 25, respectively. Specifically, the decisions overturned a 1997 patent, 1,994,937, held by Janssen Alzheimer Immunotherapy (JAI). This document laid claim to any IgG1 antibody to amyloidβ used to prevent or treat AD. That would cover several antibodies under active development by other companies, including Eli Lilly and Company’s solanezumab, currently in Phase 3 clinical trials. Lilly, joined by F. Hoffmann-La Roche and Biogen Idec, challenged the patent. Passive immunotherapy is arguably the most advanced strategy for slowing the progression of AD, and a successful treatment could be worth billions of dollars, according to financial analysts. The courts’ decisions open the door for other companies to develop proprietary treatments in this field without infringing on intellectual property rights. The rulings could also presage challenges to other AD immunotherapy patents, including those held by JAI in the U.S.

“I think it’s a very good thing for the field that the decision went as it did,” said Thomas Wisniewski, New York University Langone Medical Center. Wisniewski served as an expert witness for Lilly in the UK and European lawsuits. If the patent had stood, it would have hindered the development of AD immunotherapies, because it would have left companies little incentive to pour money into this field, he told Alzforum.

JAI’s patent names Dale Schenk, formerly at Elan Pharmaceuticals, as the inventor. Schenk, who now runs the Elan spinoff Prothena Biosciences, was one of the first to propose using Aβ immunotherapy to treat AD (see ARF related news story ). In 2009, Johnson & Johnson affiliate JAI acquired Elan Pharmaceuticals’ immunotherapy program, and partnered with Pfizer Inc. to develop and commercialize it. In addition to numerous patents, the program assets included the anti-Aβ antibody bapineuzumab. Bapineuzumab failed to meet its primary endpoints in a Phase 3 trial, and JAI largely discontinued development of the drug for AD, although a subcutaneous formulation is still in Phase 2 trials (see ARF related news story; ARF related news story).

Meanwhile, Lilly’s solanezumab entered a second Phase 3 trial in patients with mild AD after the first trial missed its primary endpoints but slightly slowed cognitive decline in this population (see ARF related news story; ARF related news story; and ARF related news story). Solanezumab was also selected for the Phase 2/3 prevention trial and for A4’s prevention study (see ARF related news story; ARF related news story).

In court, representatives for JAI argued that solanezumab infringed on their patent. Had they won, they could have claimed all profits from future marketing of solanezumab. Lilly’s lawyers countered that the patent was invalid under a legal principle known as “insufficiency.” Patent law states: “The specification must disclose the invention clearly and completely enough for it to be performed by a person skilled in the art,” and this must not require “undue burden.” Lilly argued that the patent did not meet this test because it did not specify the sequence or formulation of the antibody, describe a clear mechanism of action, or provide any data indicating efficacy.

The judges agreed, ruling that the patent did not spell out the invention sufficiently well for the hypothetical “skilled team” of researchers to perform the work without undue burden. The judges noted that not all anti-Aβ antibodies will successfully treat AD, as shown by the failure of bapineuzumab in Phase 3. To develop a successful antibody would require considerable time and expense, they ruled. The development costs for bapineuzumab were estimated in court to run into the hundreds of millions of dollars.

In the UK decision, Judge Richard Arnold wrote, “The upshot is that the patent does no more than invite the skilled team to perform what Prof. Wisniewski rightly described as a ‘very significant research project with a high prospect of failure’ and, if they succeed, claims the fruits of their research. It is therefore insufficient.” The European court came to the same conclusion, noting, “One can have a monopoly for concrete technical innovation, but not monopolize a whole field of research.”

It is unclear how the ruling will affect JAI’s 18 U.S. patents. JAI spokesman Greg Panico told Alzforum there has been no challenge to these patents. He offered no comment on whether JAI would appeal the European decisions. “We are disappointed over the outcome of this case, and we are considering our options,” Panico wrote to Alzforum.

Likewise, Lilly declined to discuss any future litigation plans. “At Lilly, we are pleased with the decisions from the European Patent Office and the UK trial court. However, we cannot speculate or draw conclusions on the potential impact of these rulings on U.S. patents,” Lilly communications director Mark Taylor wrote to Alzforum.

Wisniewski surmised that the decision could lead to several challenges to current immunotherapy patents, including some that he himself holds. Future patents “will be limited to specific antibodies for a specific mechanism of action,” Wisniewski predicted. This would bring AD immunotherapy in line with other types of vaccinations, where companies can patent only a particular drug formulation, not a whole class of vaccines. “That is a more reasonable state of affairs,” he said.

How the U.S. courts might rule on immunotherapy patents remains to be seen. In another recent high-profile ruling, the U.S. Supreme Court unanimously ruled that human DNA cannot be patented simply because it has been identified (see NY Times story). The Association for Molecular Pathology brought the case against Myriad Genetics’ patent on the human breast cancer gene BRCA1. “As someone who has been involved in patenting genetic mutations, I think that the decision not to allow these patents is the correct one," wrote John Hardy, University College London, U.K., to Alzforum about the Myriad dispute. "Unfortunately, I think these patents have impeded research more than they have helped research.”––Madolyn Bowman Rogers.

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References

News Citations

  1. Vaccinating Against Plaques
  2. No Pony in There: Bapi Fails Mild to Moderate ApoE4 Carriers
  3. Clinical Trials of Intravenous Bapineuzumab Halted
  4. Phase 3 Solanezumab Trials "Fail"—Is There a Silver Lining?
  5. The Solanezumab Benefit: Oh, So Small, But Probably Real
  6. Solanezumab Heads for New Phase 3 Trial
  7. DIAN Trial Picks Gantenerumab, Solanezumab, Maybe BACE Inhibitor
  8. Solanezumab Selected for Alzheimer’s A4 Prevention Trial

External Citations

  1. 1,994,937
  2. Phase 2/3 prevention trial
  3. NY Times story

Further Reading