THIS year we no longer cover USPTO affairs like we did in past years. Most of the material on the topic goes directly into our daily links. At the start of the year we said we would observe the situation with regards to 35 U.S.C. ۤ 101 and various court decisions. We'd only become more vocal again if the Federal Circuit changed course or the Patent Trial and Appeal Board (PTAB) was abolished (the inter partes review (IPR) procedure was repeatedly defended by SCOTUS, so it's unlikely to go away).
"It's generally about patent scope."Earlier today we saw this puff piece titled "BARD1 Life Sciences’ European Patent No 2606358 Validated In France, Germany, Italy, Spain, Switzerland And UK". It's not exactly news that the EPO makes cancer treatment a monopoly [1, 2, 3], which in turn prices various procedures way out of reach, causing poor cancer patients to needlessly die -- an ethical dilemma if not breach of human rights. In their own words: "The company has advised that this patent family (PCT/IB2011/053635) is protecting the sequence of various BARD1 isoforms specific to lung and colorectal cancer. The granted EP260663 claims are directed towards lung cancer."
When we write about software patents we rarely deal with "life and death" situations; this is why many public interest groups revolve around patents on life/nature rather than software patents, which is understandable. It has gotten so bad that patent trolls can now kill a lot of patients for profit. Yes, in the age of PTAB cutbacks and Iancu's facts-free regime (trolls are still a very major problem which Trump's circus clown is arrogantly dismissing/denying) it can be very profitable to attack the poor, holding them hostage. "19 of the 24 patent suits filed Friday were filed by #patenttrolls, according to RPX Corp. That's 79%," said United for Patent Reform earlier this week. Imagine how bad it would be if 35 U.S.C. ۤ 101 did not exist or got watered down.
Last night I stumbled upon this post from ACLU. I read all of their posts (over RSS) and we link to virtually all of their articles in our daily links, so I was very surprised to find them writing about patents, which is unusual. They ask the public to help them stop patenting of life itself. Even ACLU, which typically focuses on civil liberties and minorities, has become fed up with patent extremists. Here's a portion of what it wrote:
Draft Legislation Will Try to Undo Supreme Court Precedent Forbidding Patenting of Human Genes
This morning the ACLU, along with 169 other civil rights, medical, scientific, patient advocacy, and women’s health organizations, including the Mayo Clinic, Breast Cancer Action, Lung Cancer Research Foundation, the Huntington’s Disease Society of America, the Women’s March, University of Washington, and many others sent a letter to the Senate Judiciary Committee’s Subcommittee on Intellectual Property strongly opposing a draft bill that would allow companies to patent our genes. Yes. You read that right.
The draft bill is deeply concerning because if it becomes law, it would allow private companies to hold patents granting them 20-year monopolies over genes, their links to disease, other products of nature and abstract ideas. Patent-holders could control who can provide testing for genetic mutations associated with diseases like cancer, muscular dystrophy, Alzheimer’s disease, heart disease, and other rare and common diseases, driving up prices for testing and jeopardizing patients. They could also control which researchers could examine and study the gene, stifling the free exchange of information and impeding the progress of developing treatments.
Beginning early this year, Senators Tillis and Coons, held closed-door roundtables with industry representatives and others interested in changing the law to discuss radically rewriting Section 101 of the Patent Act, which currently prohibits patents on laws of nature, products of nature, and abstract ideas. Now, the Senators, along with Reps. Johnson, Collins, and Stivers, have released the draft bill, which removes this prohibition and erases all related prior court precedent. Senators Tillis and Coons will be holding three hearings this month, starting tomorrow, calling 45 witnesses to discuss changes to Section 101. Disturbingly, of the 30 witnesses testifying so far, very few organizations will speak on behalf of patients (the ACLU will be one of the exceptions) and the broader scientific community, .
Let’s back up a bit. Genes are fundamental to who we are. They can determine our hair color, our height, whether we have seasonal allergies. Mutations in them also are associated with disease. For example, mutations in the BRCA1 and BRCA2 genes are correlated with a 50-80% higher risk of breast cancer and a 20-50% higher risk of ovarian cancer, as well as elevated risks of pancreatic and prostate cancers. People with certain personal or family histories of cancer may wish to be tested so they can assess their options.
Now, consider this. What if only one lab can do the testing, because it has patented the genes?
This week marks the start of three separate hearings on a draft €§ 101 bill introduced by Senators Tillis (R-NC) and Coons (D-DE). The draft bill—analyzed last week by Patent Progress—is fundamentally flawed. Fortunately, it’s only a draft bill, and there’s still time for it to be modified to make it less harmful to innovation.
Unfortunately, based on the announced witness list for the first hearing, that might not happen.
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Three professors and two representatives from think tanks. Unfortunately, we again have an academic representative who has most salient research on the topic is based on fatally flawed data and poor interpretations.
Prof. Adam Mossoff, of the GMU Center for the Protection of Intellectual Property, wrote a paper a few years ago. That paper claimed to have identified 1,700 applications—from a set of 17,000 applications—that were denied in the U.S. because of €§ 101 but allowed in other jurisdictions. Setting aside whether the foreign jurisdiction patents were truly equivalent, which is not guaranteed, there’s a few problems with his conclusions.
In particular, many of the applications Mossoff identified didn’t actually illustrate what he claimed they did—that the U.S. patent system, based on €§ 101, was preventing these applications from being patented. Examining a set of 14 applications called out as exemplary in his paper, only one was abandoned solely because of €§ 101. But three of those applications overcame a €§ 101 rejection and were abandoned, either because the prior art prevented patentability or in favor of a continuation. And the remainder had significant rejections, either based on the prior art or based on lack of written description or enablement. Reviewing a larger set of 100 applications in the dataset of 17,000 applications supposedly abandoned because of €§ 101, the trend holds. 19% had overcome their €§ 101 rejection when abandoned and 11% never received a patentable subject matter rejection under €§ 101. Only 14% were clearly abandoned due to €§ 101.
Some of Mossoff’s errors may derive from the dataset he was provided. (The data was provided by Bob Sachs and David Kappos, who you might remember from the discussion above.) That dataset claims to be of 17,000 applications which were rejected under €§ 101 and then abandoned. That description implies that the abandonment was based on €§ 101—but that’s far from the case. Examining the dataset, 529 (3%) of the 17,000 had been allowed at the time they were abandoned—hardly €§ 101’s fault. And 2,106 (13%) had no €§ 101 rejection remaining when they were abandoned. And of the remainder, a number had non-subject matter €§ 101 rejections, such as being rejected for claiming a perpetual motion machine or a cold fusion device. Only 1,685 (11%) were clearly abandoned due to €§ 101 rejections.
With source data as flawed as this, it shouldn’t be any surprise that Mossoff reached incorrect conclusions. But incorrect or misleading data isn’t the kind of thing Congress should use to decide what is and isn’t patent eligible.