Allison Inserro

Although current attention in Washington, DC, is focused on the government shutdown and other issues, 2 senators began stakeholder sessions last month to gather thoughts on what changes might be needed, if any, in legislation regarding the filing of patents.

, tech companies, the Biotechnology Innovation Organization, and Pharmaceutical Research and Manufacturers of America, known as PhRMA, were invited by Senators Chris Coons, D-Delaware, and Thom Tillis, R-North Carolina, for a closed-door meeting to discuss recent case law and see if Congress needs to intervene.

An intellectual property attorney at Fenwick & West shared his opinion on the issue in an interview with The Center for Biosimilars

. Stuart P. Meyer, JD, said the issue is a nonpartisan one, as seen by the bipartisan nature of the stakeholder talks.

Initiative for Medicines, Access & Knowledge

 (I-MAK), want patent policy changed so that there is a higher standard for inventions, as opposed to innovations.

Meyer said the issue stems from a change in the way courts and the patent office patent applications in the aftermath of the 1998 

State Street Bank & Trust Co. v Signature Financial Group, Inc.

, case, which found that so-called “business method” inventions must produce a “useful, concrete and tangible result” in order to be patentable.

Over time, Meyer said, “another series of court cases came along that began to narrow the scope of what can be patented.” The cases essentially said, “There’s a whole range of things in the area of innovation that patents should not cover.”  

Did Congress intend for the Patent Act to be broad or narrow? Are courts substituting their own judicial doctrine? “That’s what the current debate in the Senate is starting to address,” Meyer said.

“The problem is there are really divergent views on what should be done. And, surprisingly, the players are not necessarily who you might expect,” he said, citing independent and small inventors, the pharma industry, and nonpracticing entities, which may have no plans to invent anything but file patents anyway.

He said he thinks many technology firms lean towards the side of wanting a narrow definition of what is patentable, even though they have plenty of innovations, as well.

The concern of a restrictive US patent system, compared with China or Europe, is that it will lead to less investment here, he said. Patents tend to lead to greater investments where there is concentrated activity of them, he said.

On the flip side of that issue, I-MAK has indicated that scenario can lead to overpatenting. In a 

, it said more than half of the top 12 drugs in the United States have more than 100 attempted patents per drug. Those repeat attempts block 

, as in the case of Humira. I-MAK has said AbbVie has raised prices 144% since 2012. Humira biosimilars lauched in Europe last year, but they are not expected to launch in the United States until 2023.

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Closed-door sessions began last month on possible patent law reform in 2019 in the United States.

Stakeholders Thinking About US Patent System Reform in 2019

Late last month, Alexion Pharmaceuticals received early FDA approval for ravulizumab-cwvz (Ultomiris), for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH), a debilitating and ultra-rare blood disorder characterized by complement-mediated destruction of the red blood cells (hemolysis).

It’s Alexion’s second C5 complement inhibitor. The first, eculizumab (Soliris), is currently used to treat patients with PNH. However, the existing biologic must be administered every 2 weeks, versus every 8 weeks for ravulizumab.

Another possible advantage is that the newer drug also has the benefit of new patent exclusivities that could help Alexion stave off the impact of competition from oncoming eculizumab biosimilars. Ravulizumab is also being proposed as a once-weekly subcutaneous dosing option that will be the subject of an upcoming phase 3 study.

, Credit Suisse analyst Martin Auster said that Soliris is protected by US patents until 2027. European patents end earlier, in 2024.

PNH can cause a wide range of debilitating symptoms and complications, including thrombosis, which can occur throughout the body, and result in organ damage and premature death. The FDA decision had been slated for an FDA meeting next month.

In a statement, Alexion said the approval was based on positive phase 3 data from 2 phase 3 studies that included 441 patients who had either never been treated with a complement inhibitor before, or who had been stable on eculizumab. The company said the efficacy of ravulizumab administered every 8 weeks was noninferior to the efficacy of eculizumab administered every 2 weeks on all 11 endpoints. Safety profiles were similar.

Regulatory authorities in the European Union and Japan have accepted and are reviewing applications for the approval of for ravulizumab as a treatment for adults with PNH.

At a list price of approximately $500,000 per patient per year, eculizumab, which is also approved to treat atypical hemolytic uremic syndrome and generalized myasthenia gravis, is one of the most expensive therapies in the world. It sells for $6543 per vial; the wholesale acquisition cost of ravulizumab is slightly lower at $6404 per vial, the company said in a recent filing, 

. Reuters also noted that the newer drug has an FDA black box warning for the risk of life-threatening meningococcal infections and sepsis, the same as eculizumab.

Eculizumab competition could come from Amgen, which is currently engaged in a 

 in Spain that evaluates the efficacy and safety of its proposed biosimilar, ABP 959, versus the reference eculizumab in patients with PNH. Also developing a biosimilar is Samsung Bioepis, with its SB12.

Eculizumab must be administered every 2 weeks, versus every 8 weeks for the newly approved ravulizumab. Another possible advantage for Alexion is that the newer drug also has the benefit of new patent exclusivities that could help Alexion stave off the impact of competition from oncoming eculizumab biosimilars. 

Alexion's Second C5 Complement Inhibitor Requires Less Frequent Dosing, Carries New Patents

Civica Rx, the nonprofit generic drug company 

 by 5 health systems in order to combat drug shortages and high prices for generic drugs, added 12 additional health systems this week, bringing the total to 750 hospitals in the United States joining the venture so far.

“We are thrilled to welcome these highly-regarded health systems to Civica as founding members,” said Martin VanTrieste, Civica Rx’s chief executive officer, in a statement. “Drug shortages have become a national crisis where patient treatments and surgeries are canceled, delayed, or suboptimal. We thank these organizations for joining us to make essential generic medicines accessible and affordable in hospitals across the country.”

The aim of the initiative is to reduce costs and create a more predictable supply of many medicines.

The 12 systems joining as founding members are:

The latest members join the previously announced governing members, which include Catholic Health Initiatives, the Gary and Mary West Foundation, HCA Healthcare, Intermountain Healthcare, Laura & John Arnold Foundation, Mayo Clinic, the Peterson Center on Healthcare, Providence St. Joseph Health, SSM Health, and Trinity Health.

In 2019, Civica Rx hopes to bring over 14 hospital-administered generic drugs to hospitals and healthcare systems. Additional medications, as prioritized by the healthcare systems, will be the next phase of focus. The company is working toward becoming an FDA approved manufacturer and will either directly manufacture generic drugs or sub-contract manufacturing.

Hospitals have been struggling with drug shortages and the problem is getting worse, Martin Makary, MD, MPH, a surgical oncologist, said on a 

 the expiration dates of IV saline fluids in order to help hospitals cope with the shortages.

If Civica RX is successful, hospitals could see price reductions of 50%, 

 reported Friday. The new company will initially focus on selling to hospitals, but may eventually expand to offer products more broadly. 

Civica Rx, the nonprofit generic drug company formed last year by 5 health systems in order to combat drug shortages and high prices for generic drugs, added 12 additional health systems this week, bringing the total to 750 hospitals in the United States joining the venture so far.
 

Allison Inserro

Stakeholders Thinking About US Patent System Reform in 2019

Alexion's Second C5 Complement Inhibitor Requires Less Frequent Dosing, Carries New Patents

Hospital Group Making Generic Drugs Adds 12 Additional Members