Tag: biotech

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Biotech Patent Law

Forty Years Since Diamond v. Chakrabarty: Legal Underpinnings and its Impact on the Biotechnology Industry and Society

U.S. Supreme Court buildingCPIP has published a new policy brief celebrating the fortieth anniversary of the Diamond v. Chakrabarty decision, where the Supreme Court in 1980 held that a genetically modified bacteria was patentable subject matter. The brief, entitled Forty Years Since Diamond v. Chakrabarty: Legal Underpinnings and its Impact on the Biotechnology Industry and Society and written by Matthew Jordan, Neil Davey, Maheshkumar P. Joshi, and Raj Davé, is dedicated to the late Dr. Ananda Chakrabarty, a pioneer in the biotechnology world, who passed away in July 2020.

Chakrabarty had a great impact on the biotechnology revolution, ushering in a new era of technological advances that have benefited humankind. Through interviews with Randall Rader, former Chief Judge of the Federal Circuit, and Dr. Chakrabarty himself, as well as case studies on genetically modified seeds, polymerase chain reactions, and monoclonal antibody therapies, the policy brief explores the importance and enduring implications for society of the Chakrabarty decision.

The introduction and conclusion sections are copied below:

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I. Introduction: The Diamond v. Chakrabarty (1980) Supreme Court Decision

In 1972, Ananda Chakrabarty—a genetic engineer at General Electric—filed a patent application for genetically modified bacteria capable of breaking down crude oil. Dr. Chakrabarty introduced genetic fragments into the Pseudomonas bacterium, altering the bacteria to decompose hydrocarbon components of crude oil. Dr. Chakrabarty intended the bacteria to assist in cleaning up oil spills. The engineered bacteria were especially suited for bioremediation given their resistance to adverse environments and safety as a non-pathogen.

The examiner rejected the application under Section 101 of the Patent Act, which covers patentable subject matter, because living things were not patentable. The Board of Patent Appeals and Interferences (now known as the Patent Trial and Appeal Board) affirmed the examiner’s decision, however, the U.S. Court of Customs and Patent Appeals (now part of the U.S. Court of Appeals for the Federal Circuit) sided with Dr. Chakrabarty. The Court of Customs, in an opinion by Judge Giles Rich, reasoned that only naturally occurring articles, not all living things, were ineligible for patenting. Importantly, the court said, “the fact that microorganisms are alive is a distinction without legal significance” for purposes of the patent law. Then, U.S. Patent and Trademark Office (USPTO) Commissioner Sidney Diamond appealed the case to the Supreme Court.

The Supreme Court of the United States held that Dr. Chakrabarty’s invention consisted of patentable subject matter. Section 101 states: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.” The Court ruled in a landmark 5-4 decision that Dr. Chakrabarty’s invention was a patentable, manmade, “composition of matter” or “manufacture.” Chief Justice Warren Burger famously quoted a Senate Report that was part of the legislative history for the Patent Act of 1952: patentable subject matter included “anything under the sun that is made by man.”

This decision had immense implications for biotechnology. It resulted in patents for genetically modified seeds, DNA amplification technology, and monoclonal antibody therapy. The rise of biotechnology has impacted many technological fields and society as a whole. The Supreme Court’s distinction between manmade and naturally occurring phenomena was clarified in Mayo v. Prometheus and AMP v. Myriad. The Court found that naturally occurring biological relationships and isolated DNA sequences were not eligible for patenting.

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V. Conclusion

Diamond v. Chakrabarty revolutionized the biotechnology industry in the United States by incentivizing the advancement of inventions that are beneficial to human life. However, as noted by Judge Randall Rader: “This whole patent eligibility question—which was so clear and well-defined, was practically implementable and understandable, and gave life to our whole biotech industry after Chakrabarty—now has had a heavy cloud cast over it in recent jurisprudence such as Myriad.”

When asked if our legislature should take action to clear up the confusion, Judge Rader stated: “If the statute was the written law that was being interpreted by the Supreme Court, we wouldn’t need legislative change. But the sad truth is that the Supreme Court has created a whole overlay of doctrine that makes the statute almost irrelevant. And now we don’t look at whether there’s a process, a machine, an article of manufacture, or a composition of matter. Instead, we look at whether there’s something more beyond the conventional and the routine and the well-known. We argue over what is something and what is more, and what is an inventive concept. And so in that state of confusion, yes, we’re probably going to need legislation.”

Within the dire context of the COVID-19 pandemic and other countries racing past the United States in biotechnology, it is crucial for Congress to clarify what currently qualifies as patentable subject matter.

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To read the policy brief, please click here.

Categories
Patent Law

Mark Schultz: Weaker Patent Protection Leads to Less Venture Capital Investment

The following post comes from David Ward, a 2L at Scalia Law and a Research Assistant at CPIP.

a lit lightbulb shatteringBy David Ward

Venture capitalists pouring money into a small startup has become a sort of new American Dream for many innovators. The success stories of big American companies starting with nothing more than an idea have pervaded their way into pop culture, inspiring TV shows, movies, and the like. However, CPIP Senior Scholar Mark Schultz has released a new report for USIJ entitled The Importance of an Effective and Reliable Patent System to Investment in Critical Technologies showing that this dream may be harder to attain today due to recent shifts that have weakened the patent system and driven away venture capital investment.

Background

There has been an ongoing debate in the past two decades about whether patents should be stronger or weaker. Proponents of stronger and more effective patents have made the case that they are more valuable, incentivizing investors and innovators to fund and create valuable innovations. On the flip side, critics of the patent system have stated that stronger patents inhibit innovation since they create a web of restrictions and licenses, inhibiting access to important innovations.

This ongoing debate has resulted in several landmark changes to our patent laws and rules in recent years. Prof. Schultz points out several key changes:

These changes have weakened patents by making them easier to challenge, less accessible for smaller companies, and harder to obtain overall. However, with all these changes, there is now data to explore whether weaker patents really do allow for more innovation as patent critics have contended.

Weak Patents Don’t Attract Funding

The short answer is the data doesn’t support the patent critics’ contention that weaker patents clear the way for more innovation because investors no longer see many patent-intensive industries as a good investment. From 2004 to 2017, the share of funding received in patent-intensive industries dropped from over 50% to about 28%. Prof. Schultz is cognizant of the fact that correlation is not causation, but there is an ever-growing pile of evidence that points to one simple explanation: weaker patents result in less funding for innovation.

Patents and intellectual property are critical to venture capitalists (VCs) who want more certainty of a return on their investments. Pending patents that have a lower chance of being granted or patents that could be challenged at any moment create uncertainty for both the patents’ validity and the future costs of litigation. Hence, the weaker patent laws of recent years have led to a decrease in funding for many patent-heavy sectors.

Prof. Schultz’s report doesn’t just rely on the data to reach this conclusion. It also includes several case studies, surveys, and interviews with innovators and investors alike. Perhaps the most telling is a survey by Prof. David Taylor of SMU Law investigating how recent patent cases changed VC and private equity behavior. Of the 475 investors surveyed, 74% said that patent eligibility is an important consideration in firms’ investment decisions, and 62% said that their firms were less likely to invest if patent eligibility changes make patents unavailable. Almost one-third of investors who knew about recent court decisions said it had affected investment decisions away from biotech, medical devices, and pharmaceuticals.

The data again backs this up, as Prof. Schultz’s report shows that those industries have seen some of the biggest loses in VC funding since 2004. In a world where biotech, medical devices, and pharmaceuticals could quite literally be the most important sectors needing innovation and funding to tackle the COVID-19 pandemic, this is less than ideal. Typically, medical treatments cost hundreds of millions of dollars and have a 10-year road ahead of them. The prospect of reaching the end of the road without being able to protect the investment with a strong and effective patent has spooked many investors to other sectors. As a result, there has been less innovation in live-saving treatments, and more of a focus on safer, quality-of-life investments.

Looking Ahead

There is some trend in the positive direction, however. Prof. Schultz notes that USPTO Director Andrei Iancu has demonstrated strong support for the role of patents in the economy with several policy changes aimed at strengthening patent protection. It is also of note that many policymakers are realizing the changes have gone too far, and there are now several pending legislative proposals aimed at fixing these issues. These realizations, coupled with Prof. Schultz’s quantitative and qualitative data, paint a clear picture that all but proves a single point: strong patents promote innovation more than weaker patents. In the words of Prof. Schultz: “Society needs its most successful people working on its most compelling problems. The patent system should support such work.”

To read the report, please click here.

Categories
Biotech Gene Patents Patent Law Uncategorized

A Critique of a Recent Article Which Found That Sequence Patents Cover the Entire Human Genome

By Professor Christopher Holman

[The following is a blog posting by Christopher Holman, a patent law scholar at UMKC School of Law, that he originally posted on April 5, 2013 at his blog, Holman’s Biotech IP Blog, where Professor Holman regularly blogs on important issues in biotech and IP law.  Professor Holman kindly gave us permission to repost his blog posting here.]

A Critique of a Recent Article Which Found That Sequence Patents Cover the Entire Human Genome
By Christopher Holman

I recently fielded a phone call from a reporter with a leading international scientific journal, asking for my opinion of an article entitled “Pervasive Sequence Patents Cover the Entire Human Genome,”recently published in a publication called Genome Medicine. I have published several articles debunking the myth that 20% of human genes are patented, and the reporter thought that the article in Genome Medicine, authored by a researcher affiliated with Yale Law School’s The Information Society Project, contradicted the results of my study. I took a look at the “Pervasive Sequence Patents” article and found it to be a fundamentally flawed empirical study that will sadly be used to further support the widespread misperception that access to a large percentage of the human genome is precluded by a thicket of gene patents.

The “Pervasive Sequence Patents” article does cite to my 2012 Nature Biotechnology article Debunking the Myth That Whole Genome Sequencing Infringes Thousands of Gene Patents, but the authors apparently missed the main point I was trying to make. The myth that 20% of human genes are patented was born out of a 2005 article published in Science by Jensen and Murray that found that the sequence of 20% of human genes (or in some cases the protein encoded by human gene) is mentioned in a US patent claim. The problem arose when people assumed that the mention of a gene’s DNA sequence in a patent claim is equivalent to the patenting of the gene, which led to an assumption that any use of or research on any of these genes would result in patent infringement. In my article, I explained that in patent law “the name of the game is the claim “(to quote Judge Rich), and that when one actually reads the patent claims in the patents identified by Jensen and Murray it is clear that few if any of the patents would be infringed by many forms of research or genetic testing, including diagnostic testing and whole genome sequencing.

Unfortunately, the authors of “Pervasive Sequence Patents” have apparently fallen into the same trap, assuming that mention of a gene’s DNA sequence in a patent claim results in the patenting of the gene in a manner that totally blocks access to the gene. Even more problematically, the authors seem to assume that every patent with a claim mentioning a gene sequence also claims every 15mer present in the sequence, i.e., every contiguous 15 nucleotide sequence appearing in the gene. Presumably they made this assumption because the Myriad gene patent litigation includes a patent claim directed to 15mers of the BRCA1 encoding sequence, including Claim 5 from US patent number 5,747,282:

An isolated DNA having at least 15 nucleotides of the DNA of claim 1.

There are two fundamental problems with this empirical approach. One is that it does not necessarily follow that the mention of a gene’s DNA sequence in a claim equates with the patenting of the gene – that was the main point of my Nature Biotechnology article. The other is to assume that all of these patents include claims analogous to Claim 5 of the ‘282 patent.

In my experience, claims of this type are extremely rare. I looked at hundred patents identified as gene patents in the Jensen Murray study and found that most only claim the full-length gene sequence, and if fragments were claimed the fragments are much larger than 15 nucleotides. In fact, I looked through hundreds of gene patents trying to find another 15mer claim analogous to those in the Myriad patents and could not find one. The patent claims at issue in the Myriad case will be expiring within the next few years I believe, and I doubt that this sort of broad 15mer claim has been issued by the patent office in recent years, or if it has it seems to be extremely rare.

In any event, in 2010 Keppler et al. published an article entitled “Metastasizing Patent Claims in BRCA1” which showed that if the BRCA 15mer claims are interpreted so broadly as to cover any DNA sequence comprising any 15mer appearing in a BRCA gene, there appears to be a wealth of prior art that would invalidate the claim regardless of the claims patent eligibility.

The flawed methodology used in the “Pervasive Sequence Patents” article is readily apparent from the results of their empirical study. Here is what they reported as the result of their study:

[W]hen we took existing gene patents and matched their 15mers to known genes, we found that 100% of known genes have at least one 15mer claimed in a known patent. Current gene patents were observed to match each gene many times, with 1,295 matches to other genes on average (standard deviation 1,208). When we examined the amount of total sequence space in human genes that is covered by 15mers in claims from current patents (Additional file 2), we found 58 patents whose claims covered at least 10% of the bases of all human genes. The top patent was US7795422, whose claims’ sequences matched 91.5% of human genes. Interestingly, we also observed a patent for improving bovine traits (US7468248) with explicit claims for 15mers that matched 84% of human genes. This patent was not even aimed at any human sequence, yet covered a majority of human genes once we examined the claim’s matches at the 15mer scale.

First off, let’s look at the “top patent” they found, US7795422, “whose claims sequences matched 91.5% of human genes.”  The ‘422 patent has only one independent claim:

1.       A chemically modified short interfering nucleic acid (siNA) molecule, wherein: (a) the siNA molecule comprises a sense strand and an antisense strand, each strand having one or more pyrimidine nucleotides and one or more purine nucleotides; (b) each strand is independently 18 to 27 nucleotides in length, and together comprise a duplex having between 17 and 23 base pairs; (c) the antisense strand is complementary to a human Hypoxia Inducible Factor 1 (HIF1) RNA sequence comprising SEQ ID NO:567; (d) a plurality of pyrimidine nucleotides present in the sense strand are 2′-deoxy-2-fluoro pyrimidine nucleotides and a plurality of purine nucleotide present in the sense strand are 2′-deoxy purine nucleotides; and (e) a plurality of pyrimidine nucleotides present in the antisense strand are 2′-deoxy-2′-fluoro pyrimidine nucleotides and a plurality of purine nucleotides present in the antisense strand are 2′-O-methyl-puine nucleotides.

When one reads the claim, it is apparent on the face that the claim is limited to “chemically modified” molecules comprising 2′-deoxy-2-fluoro pyrimidine nucleotides and 2′-deoxy purine nucleotides.  DNA does not contain 2′-deoxy-2-fluoro pyrimidine nucleotides and 2′-deoxy purine nucleotides, these are synthetic analogues to the nucleotides that appear in DNA. This patent that the authors found to match 91.5% of human genes does not cover any gene or any DNA molecule, only chemically modified synthetic molecules for use in RNA interference.

Next the authors reported that US7468248 contains “explicit claims for 15mers that matched 84% of human genes.” In fact, the ‘248 patent has only two independent claims, both of them method claims:

1.       A method for inferring a trait of a bovine subject from a nucleic acid sample of the bovine subject, comprising identifying in the nucleic acid sample, a nucleotide occurrence of a single nucleotide polymorphism (SNP) at position 300 of SEQ ID NO:21645, thereby inferring the trait, wherein the trait is marbling, tenderness, fat thickness, red meat yield, or average daily weight gain.

22. A method for determining a nucleotide occurrence of a polymorphism in a bovine sample, comprising: a) contacting a bovine polynucleotide in the sample with an oligonucleotide that binds to a target region, wherein the target region comprises a position at position 300 of SEQ ID NO:21645 or wherein the target region is within 3000 nucleotides of a nucleotide at position 300 of SEQ ID NO:21645, and b) determining the nucleotide occurrence of a single nucleotide polymorphism (SNP) at position 300 of SEQ ID NO:21645, wherein the determination comprises analyzing binding of the oligonucleotide or detecting an amplification product generated using the oligonucleotide, thereby determining the nucleotide occurrence of the polymorphism.

Both of these claims would only be infringed by someone performing a specific genetic test on a bovine subject (colloquially a cow). The patent does not include any claim covering any DNA sequence, and the authors’ assumption that the patent “explicitly claims 15mers that matched 84% of human genes” implies that they either did not read the claims or do not understand the basics of claim interpretation.

The problems with this article are pretty apparent once one reads the claims of the patents that were identified as “matching” human genes. Unfortunately, it is just the latest installment of a prolific stream of fundamentally flawed academic articles that are being cited in support of the notion that human gene patents are a pervasive problem.  I don’t doubt that the authors meant well, but it’s dangerous to conduct empirical patent studies without appreciating and understanding the critical role of the patent claim. And the publication of the article highlights the limitations of peer review (assuming Genome Medicine engages in peer review).