Taste of Nature started the summary proceedings in early December 2011. They were of the opinion that Cresco, by selling their Red Radish Cress (purple Radish sprouts), was infringing the patent of Taste of Nature.

Taste of Nature developed a seedling of radish (Raphanus sativa) that is characterized by a high anthocyanin level. Anthocyanin is an antioxidant that gives the plant a red, purple or black color, and is regarded as a favorable substance from a health perspective.

Taste of Nature holds European patent EP 1 290 938 (the “Raphanus Patent” or “EP 938”),” which relates to a plant and a sprout of a plant of the radish species Raphanus sativa with an increased anthocyanin level, and to methods for its production.

Claim 1 reads as follows.

1. A Raphanus sativa plant, obtainable by screening Raphanus sativa plan far [this should probably be: “plants for”; Summary Proceedings Judge] their ability to produce sprouts with at least some purple coloring, selfing and/or crossing said plants for several generations and selecting progeny having sprouts with purple coloring, characterized in that the sprout of said plant comprises anthocyanins at a level of at least 800 nmol per gram fresh weight of sprout.

The description of EP 938 includes the following sections:

[0012] The Raphanus plant of the invention preferably is a plant of the species Raphanus sativa, more preferably the plant is obtained through breeding and selection from the Raphanus sativa lines CGN 6924, CGN 7240, or both. Most preferably, the Raphanus plants of the invention are obtained through breeding and selection from the Raphanus sativa line V33, (i.e. ATCC No. PTA-3630).

In respect of the patentability of essentially biological processes within the meaning of Article 53, opening lines and (b), of the European Patent Convention (the “EPC”), the Enlarged Board of Appeal (the “EBA”) of the European Patent Agency ruled as follows:

 Hence, in more general terms, the conclusion to be drawn is that a process for the production of plants, which is based on the sexual crossing of whole genomes and on the subsequent selection of plants, in which human intervention, including the provision of a technical means, serves to enable or assist the performance of the process steps, remains excluded from patentability as being essentially biological within the meaning of Article 53(b) EPC.

However, if a process of sexual crossing and selection includes within it an additional step of a technical nature, which step by itself introduces a trait into the genome or modifies a trait in the genome of the plant produced, so that the introduction or modification of that trait is not the result of the mixing of the genes of the plants chosen for sexual crossing, then that process leaves the realm of the plant breeding, which the legislator wanted to exclude from patentability. Therefore, such a process is not excluded from patentability under Article 53(b) EPC but qualifies as a potentially patentable teaching.

The above applies only where such additional step is performed within the steps of sexually crossing and selection, independently from their number of repetitions. Otherwise the exclusion of sexual crossing and selection processes from patentability under Article 53(b) EPC could be circumvented simply by adding steps which do not properly pertain to the crossing and selection process, being either upstream steps dealing with the interpretation of the plant(s) to be crossed or downstream steps dealing with the further treatment of the plant resulting from such crossing and selection process.

Taste of Nature argued that a patentable invention is involved because EP 938 relates to products (a plant, a sprout, a holder with sprouts or plants and material of a plant) obtained by using a certain method, rather than that method itself.

The Summary Proceedings Judge disagreed:

In its provisional opinion it is plausible that under Article 53, opening lines and (b), of the EPC, not only an essentially biological method is unpatentable, such as the “classical breeding” in this case, but also a product directly obtained by using that method, because a method claim also protects the product directly obtained using that method (see Article 64(2) of the EPC). If it were to be ruled that a product-by-process claim is admissible for the directly obtained product of an unpatentable essentially biological method, that would render the exclusion in Article 53, opening lines and (b), of the EPC as interpreted by the EBA in G1/08 pointless, because in that case the same situation would be involved as if the EBA had considered the process claims admissible, which is not the case. The view proposed by Taste of Nature – which, when requested, it was unable to substantiate otherwise than arguing that that the EBA did not expressly state its opinion on a product-by-process claim – is not a useful interpretation of, and does not do justice to, what must be regarded according to the EBA, as stated in its judgment substantiated in detail, as the purpose and scope of Article 53, opening lines and (b), of the European Patent Convention, and is dismissed.

Cresco can now start nullity proceedings, in which the Court is asked to nullify the patent of Taste of Nature in The Netherlands.

Related posts:

1. EPO Enlarged Board of Appeal: Method Patentable By Disclaiming Unpatentable Step
2. FDA Bans Import of Generic Drugs From Two Ranbaxy Plants
3. EU’s Court of Justice: Stem Cells Unpatentable If An Embryo Is Destroyed

James Greenwood, President & CEO of the Biotechnology Industry Organization (BIO) gave the keynote speech at the BioOhio conference yesterday outlining his conviction that biotechnology is not the enemy in the global economic crisis but may be a great tool to help curb it.

First, it’s important to know that new drug approvals are not keeping pace with R&D spending.  While global biotech R&D spending more than doubled to $127 million in the last ten years, the number NME + BLA FDA approvals went from 29 in 2000 to just 24 in 2010.

At the same time, drug development times are steadily increasing. During the period 1982-89, the average time for the clinical phase was 2.5 years and the average approval time was 1.6 years.  Contrast that with the period 2005-09 where the average time for the clinical phase was 7.1 years and the average approval time was 1.1 years.  The time for approval has actually gotten shorter but the time required to satisfy the approval requirements has lengthened considerably.

Simultaneously, 39% of VC firms reported decreases in their healthcare investments in the last 3 years versus just 17% that saw an increase.  And it’s very easy to see where that money is going.  Venture capitalists reported that, in the next three years, they expect to shift investments away from technologies having high FDA regulation (biopharma, medical devices, diagnostics) to technologies having low FDA regulation (healthcare services, consumer health, healthcare IT).

Of all the factors cited as having the highest impact on VC investment, FDA regulatory challenges were cited as the greatest impact on VC investment decisions over reimbursement concerns, availability of capital and capital requirements.

With $14 trillion in debt, Greenwood expressed concerns that the recent deficit troubles and the actions of the Joint Select Committee on Deficit Reductions, the so-called “super committee” that is charged with finding $1.5 trillion in savings over the next ten years, means there could be an across-the-board cut of some $1.2 trillion — putting drug reimbursement and medical innovation in the crosshairs.

On Jan. 1, 2011, the first 6,000 of eligible Baby Boomers will turn 65 and begin receiving Medicare. The number of beneficiaries is expected to increase by 3% annually. The government estimates 76 million baby boomers in all will enroll in Medicare, causing the program to grow from 47 million beneficiaries to 80 million beneficiaries in 2030.

The total cost of Medicare is expected to expand to $929 billion in 2020 — an 80% increase over 10 years. The program is slated to become insolvent in 2017, but the federal health law could extend funding until 2029 if payments to physicians and other providers are cut back.  What’s really scary is the cost of treating chronic disease:  75 cents of each health care dollar goes to treating patients with chronic disease.

How do we help fight this monster?

Greenwood is advocating that we act quickly to promote investment in innovation.  Greenwood is proposing the following incentives:

• Angel investor tax credit
• R&D partnership structures
• Improved capital gains treatment
• Matching grants for start-up investments
• Net operating loss reform
• Tax holiday for repatriated investments
• Faster cost recovery for intangible assets

How do you get involved?  Contact your congressperson.  All federal officials have offices in their home districts as well as an office in Washington, DC.   A face-to-face meeting has the potential to have more impact than a letter; a letter, more than a phone call; a phone call, more than an e-mail.

For details about your U.S. Representative — including mailing address for the district and capitol offices — use the House of Representatives, Find Your Representative page.

The Senate website contains an alphabetical list of all Senators, with their capitol addresses and a link to their Senate website, which will have information about state offices and telephone numbers.

Related posts:

1. BIO: Unleashing the Promise of Biotechnology (pt.4)
2. BIO: Unleashing the Promise of Biotechnology (pt.1)
3. Who Should Bear the Burden of a Heathcare Crisis?

The Federal Circuit handed down a decision on the Myriad Genetics appeal from the decision of the US District Court holding that a gaggle of medical organizations, researchers, genetic counselors, and patients have standing to challenge Myriad’s patents. See:  Assoc. for Molecular Pathology v. U.S. Patent & Trademark Office, 669 F. Supp. 2d 365 (S.D.N.Y. 2009). Myriad also appealed the district court’s decision granting summary judgment that all of the challenged claims are drawn to non-patentable subject matter under 35 U.S.C. § 101.

1. On the issue of jurisdiction, the Federal Circuit concluded that at least one plaintiff, Dr. Harry Ostrer, has standing to challenge the validity of Myriad’s patents.
2. On the merits, the Federal Circuit reversed the district court’s decision that Myriad’s composition claims to “isolated” DNA molecules cover patent-ineligible products of nature under § 101 since the molecules as claimed do not exist in nature.
3. The Federal Circuit also reversed the district court’s decision that Myriad’s method claim to screening potential cancer therapeutics via changes in cell growth rates is directed to a patent-ineligible scientific principle.
4. The Federal Circuit did, however, affirm the court’s decision that Myriad’s method claims directed to “comparing” or “analyzing” DNA sequences are patent ineligible; such claims include no transformative steps and cover only patent-ineligible abstract, mental steps.

Association For Molecular Pathology v. US Patent And Trademark Office and Myriad Genetics

This whole brouhaha has to do with U.S. Patent Nos. 5,747,282; 5,837,492; 5,693,473; 5,709,999; 5,710,001; 5,753,441; 6,033,857.

The composition claims cover two “isolated” human genes, BRCA1 and BRCA2 and certain mutations in these genes associated with a predisposition to breast and ovarian cancers. Representative composition claims include claims 1, 2, and 5 of the ’282 patent:

1.  An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

2.  The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.

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

SEQ ID NO:2 depicts the amino acid sequence of the BRCA1 protein, and SEQ ID NO: 1 depicts the nucleotide sequence of the BRCA1 DNA coding region.

All but one of the challenged method claims cover methods of “analyzing” or “comparing” a patient’s BRCA sequence with the normal, or wild-type, sequence to identify the presence of cancer-predisposing mutations. Representative method claims include claim 1 of the ’999:

1. A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Tables 12A, 14, 18 or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1.

The final method claim challenged by Plaintiffs is directed to a method of screening potential cancer therapeutics. Specifically, claim 20 of the ’282 patent reads as follows:

20. A method for screening potential cancer therapeutics which comprises: growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.

The challenged claims relate to isolated gene sequences and diagnostic methods of identifying mutations in these sequences.

Declaratory Judgment Jurisdiction

The first question addressed was whether the district court correctly exercised declaratory judgment jurisdiction over this suit:

Although no bright-line rule exists for determining whether a declaratory judgment action satisfies Article III’s case-or-controversy requirement, the Supreme Court has held that the dispute must be “definite and concrete, touching the legal relations of parties having adverse legal interests,” “real and substantial,” and “admi[t] of specific relief through a decree of a conclusive character, as distinguished from an opinion advising what the law would be upon a hypothetical state of facts.” MedImmune, 549 U.S. at 127 (quoting Aetna Life, 300 U.S. at 240-41). “Basically, the question in each case is whether the facts alleged, under all the circumstances, show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.”

Myriad challenged jurisdiction on the grounds that Myriad and the Plaintiffs do not have adverse legal interests and that Plaintiffs failed to allege a controversy of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.

The Plaintiffs responded that they have standing because, not only are they undisputedly prepared to immediately undertake potentially infringing activities, but also Myriad took sufficient affirmative acts with respect to the patents in suit. Regarding the latter, the Plaintiffs cried that Myriad sued, threatened to sue, or demanded license agreements from every known institution offering BRCA clinical testing, including university labs directed by plaintiffs Kazazian, Ganguly, and Ostrer.

Under the facts alleged in this case, we conclude that one Plaintiff, Dr. Ostrer, has established standing to maintain this declaratory judgment suit. All Plaintiffs claim standing under the Declaratory Judgment Act based on the same alleged injury: that they cannot undertake the BRCA-related activities that they desire because of Myriad’s enforcement of its patent rights covering BRCA1/2.³ Only three plaintiffs, however, allege an injury traceable to Myriad; only Drs. Kazazian, Ganguly, and Ostrer allege affirmative patent enforcement actions directed at them by Myriad. Of these three, Dr. Ostrer clearly alleges a sufficiently real and imminent injury because he alleges an intention to actually and immediately engage in allegedly infringing BRCA-related activities.

The court said that Dr. Ostrer could have proceeded with his BRCA-related clinical activities without taking a license from Myriad because he thinks that the patents are invalid since  genes are patent ineligible products of nature. This put Myriad and Dr. Ostrer in adverse legal positions regarding whether or not Ostrer can engage in BRCA genetic testing without infringing any valid claim to “isolated” BRCA DNAs or methods of “analyzing” or “comparing” BRCA sequences, as recited in Myriad’s patents.

 The Supreme Court has required only that it is “likely,” rather than “merely ‘speculative,’” that the alleged injury will be “redressed by a favorable decision.” Lujan, 504 U.S. at 561. The Court has not required certainty.

Patentable Subject Matter

Under the Patent Act, “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.” 35 U.S.C. § 101.

The Supreme Court has consistently construed § 101 broadly, explaining that “[i]n choosing such expansive terms . . . modified by the comprehensive ‘any,’ Congress plainly contemplated that the patent laws would be given wide scope.” Bilski v. Kappos, 130 S. Ct. 3218, 3225 (2010) (quoting Chakrabarty, 447 U.S. at 308).

Supreme Court  precedents provide three judicially created exceptions to § 101’s broad patent-eligibility principles: “laws of nature, physical phenomena, and abstract ideas.”

Here, the Plaintiffs challenge Myriad’s composition claims directed to “isolated” DNA molecules and method claims directed to “analyzing” or “comparing” DNA sequences under § 101.

Composition Claims: Isolated DNA Molecules

Myriad argued that the district court found the claims unpatentable by (1) misreading Supreme Court precedent as excluding from patent eligibility all “products of nature” unless “markedly different” from naturally occurring ones; and (2) incorrectly focusing not on the differences between isolated and native DNAs, but on one similarity: their informational content.

Myriad argued that an isolated DNA molecule is patent eligible because it is, as claimed, “a nonnaturally occurring composition of matter” with “a distinctive name, character, and use.”

The Plaintiffs argued that claims to isolated DNA molecules fail to satisfy § 101 because such claims cover natural phenomena and products of nature. The Plaintiffs assert that to be patent eligible a composition of matter must also have a distinctive name, character, and use, making it “markedly different” from the natural product.

In sum, although the parties and the government appear to agree that isolated DNAs are compositions of matter, they disagree on whether and to what degree such molecules fall within the exception for products of nature. As set forth below, we conclude that the challenged claims to isolated DNAs, whether limited to cDNAs or not, are directed to patent-eligible subject matter under § 101.

Because isolated DNAs, not just cDNAs, have a markedly different chemical structure compared to native DNAs, we reject the government’s proposed “magic microscope” test, as it misunderstands the difference between science and invention and fails to take into account the existence of molecules as separate chemical entities.

Method Claims

The district court’s decision predated the Supreme Court’s decision in Bilski, which rejected this court’s machine-or-transformation test as the exclusive test for determining whether an invention is a patent-eligible process under§ 101, although the test remains “a useful and important clue.”

Methods of “Comparing” or “Analyzing” Sequences

Myriad argued that its claims to methods of “comparing” or “analyzing” BRCA sequences satisfy the machine-or-transformation test as applied in Prometheus because each requires a transformation–extracting and sequencing DNA molecules from a human sample–before the sequences can be compared or analyzed.

The Plaintiffs argued that these method claims are drawn to the abstract idea of comparing one sequence to a reference sequence and preempt a phenomenon of nature–the correlation of genetic mutations with a predisposition to cancer.

We conclude that Myriad’s claims to “comparing” or “analyzing” two gene sequences fall outside the scope of § 101 because they claim only abstract mental processes. The claims recite, for example, a “method for screening a tumor sample,” by “comparing” a first BRCA1 sequence from a tumor sample and a second BRCA1 sequence from a non-tumor sample, wherein a difference in sequence indicates an alteration in the tumor sample.

This claim thus recites nothing more than the abstract mental steps necessary to compare two different nucleotide sequences: look at the first position in a first sequence; determine the nucleotide sequence at that first position; look at the first position in a second sequence; determine the nucleotide sequence at that first position; determine if the nucleotide at the first position in the first sequence and the first position in the second sequence are the same or different, wherein the latter indicates an alternation; and repeat for the next position.

Method of Screening Potential Cancer Therapeutics

The Plaintiffs challenged Myriad’s method claim directed to a method for screening potential cancer therapeutics via changes in cell growth rates as directed to the abstract idea of comparing the growth rates of two cell populations and as preempting a basic scientific principle — that a slower growth rate in the presence of a potential therapeutic compound suggests that the compound is a cancer therapeutic.

The Federal Circuit disagreed:

Starting with the machine-or-transformation test, we conclude that the claim includes transformative steps, an “important clue” that it is drawn to a patent-eligible process. Bilski, 130 S. Ct. at 3227. Specifically, the claim recites a method that comprises the steps of (1) “growing” host cells transformed with an altered BRCA1 gene in the presence or absence of a potential cancer therapeutic, (2) “determining” the growth rate of the host cells with or without the potential therapeutic, and (3) “comparing” the growth rate of the host cells. The claim thus includes more than the abstract mental step of looking at two numbers and “comparing” two host cells’ growth rates.

Related posts:

1. Blinded By Science: Myriad Loses Breast Cancer Test Patents
2. IPO’s Amicus Among Myriad of Briefs Filed in AMP v. USPTO
3. Mind Your P’s & Q’s, Not to Mention Your G,C,A & T’s

The workshop was the first of a series of meetings intended to open communication and establish a relationship between the two groups. BIO will work with the SIPO to strengthen China’s regulatory system to encourage innovation and protect intellectual property within the country. The commitment of SIPO will be critical for sending a message to companies that want to do business in China.

“Since most Chinese attendees are examiners of intellectual property, [the workshop] provides an opportunity to share experiences and ideas with our American counterparts,” said Yang Xiaowei, deputy Director General of International Cooperation Department of SIPO.

In each of three panels, USPTO and SIPO speakers discussed how each issue is handled by the pertinent provisions in their current patent law and rules. They also addressed office practice and shared practical experiences with the different technical arts in biotech.

The workshop featured the following panels:

• The first panel focused on taking a balanced approach to written description and enablement requirements, which are necessary for preventing impediments to patenting activity. Panelists also discussed the type of information that is required for an invention to satisfy the written description and enablement requirements.
• The second panel focused on issues arising from claims with sequence homology. Panelists discussed the scope of claims using homology or percent of sequence identity language and issues that often arise during examination.
• The third panel addressed meeting discussed China’s new requirements for patent disclosure for genetic resources, stakeholders’ experiences with China’s new genetic disclosure requirement, and alternative ways to ensure appropriate access and benefit sharing.

See more at BIOtechNOW

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3. See the Global Reach of Biotechnology at BIO 2008 in San Diego

In its brief, IPO argued:

1. the plaintiffs do not have standing sufficient to establish declaratory judgment jurisdiction in the suit against patent owner Myriad, whose patent rights are being challenged, and
2. isolated human DNA is patent-eligible.  IPO’s brief said the consequences of the district court decision are not limited to isolated human DNA or biologic drugs produced from such DNA, but extend to any “natural product.”

In summary:

IPO believes that the declaratory judgment plaintiffs lack standing to challenge the validity of the patents in suit because: (1) Myriad has not directed any action toward the plaintiffs that would create an actual controversy of sufficient immediacy and reality to warrant declaratory judgment jurisdiction; (2) Myriad’s actions from over ten years ago are not of sufficient immediacy to create a justiciable controversy between the parties in this case; and (3) the plaintiffs’ mere formations of intent to potentially engage in undefined conduct that may or may not infringe any particular claim of the patents at some unspecified time in the future do not amount to “meaningful preparation” to conduct infringing activity. As a result, there is no substantial controversy in the present case of sufficient immediacy and reality to warrant declaratory judgment jurisdiction. Indeed, if the facts of this case provide adequate foundation for standing, then nearly anyone might seek to file a declaratory judgment action to challenge the validity of any patent — a result that would place a heavy burden on patent owners and on the already overburdened judicial system.

IPO also believes that claims directed to isolated DNA constitute patentable subject matter under 35 U.S.C. § 101. The standard for patent eligibility was enunciated by the Supreme Court in Diamond v. Chakrabarty, 447 U.S. 303 (1980), to include “anything under the sun made by man.” The Supreme Court has never overruled this standard and has never promulgated a categorical exclusion from patent eligibility for products derived from nature. Under this controlling Supreme Court precedent, claims to isolated DNA are patentable under Section 101.

If the standard for patentable subject matter applied by the District Court were adopted, it could render broad categories of important inventions patent-ineligible, including most biologic drugs, antibodies, antibiotics, hormones, metabolites, proteins, and genetically-modified organisms and food. This in turn would have a devastating effect on the viability of large portions of the biotechnology, pharmaceutical and other industries, industries that are built upon the availability of valid and enforceable patent protection for the fruits of their costly and risky research efforts.

Although isolated DNA molecules clearly are “composition[s] of matter,” the district court ruled them unpatentable because it believed them to be the “purification of a product of nature” and patentable only if they possessed “markedly different characteristics” from naturally-occurring DNA.

IPO argues that the district court’s decision that isolated human DNA is patent-ineligible is based on an interpretation of the Patent Act having a broader impact than merely the patents-in-suit or similar patents claiming isolated human DNA, but would extend in principle to any patent claim encompassing a “natural product.”

A Ban on Patenting Isolated Human DNA Would Encompass More Than Human Genes

While isolated human DNA is the only DNA at issue in this case, a ban on isolated human DNA does not rely wholly on its status as being from a human being. The district court’s decision that isolated human DNA is the “physical embodiment of [genetic] information” applies with equal force to isolated DNA from other organisms. Banning patenting of isolated DNA from all known organisms would mean such a ban would apply to almost a thousand U.S. patents that claim isolated plant DNA, almost 25,000 U.S. patents on isolated animal DNA, almost 3,000 U.S. patents on isolated bacterial DNA, over 3,000 U.S. patents on isolated viral DNA, and 50 U.S. patents claiming vaccines based on isolated DNA.

The Vast Majority of Human Therapeutics Are Also “Natural Products”

Patents on isolated human DNA also support the development of biologics, i.e., drugs based on “naturally-occurring” human proteins. If the district court’s decision that patents on isolated human DNA are directed to patent-ineligible “natural products,” then biologics perforce would be patent-ineligible as well. Indeed, proteins like human Blood Clotting Factors VIII and IX, insulin, human growth hormone, erythropoietin, tissue plasminogen activator, and all monoclonal antibodies are “isolated” in substantially homogeneous form, are structurally unchanged from their sources in blood and other bodily fluids, and are less altered than the isolated human DNAs that are the subject of the claims to isolated human DNA that were invalidated as “natural products” by the district court.

District Court’s Decision Extends to Any “Natural Product”

Despite the district court’s attempt to limit the scope of the ban on isolated human DNA as a “natural product,” the rationale used by the court could logically be extended to any other invention produced as the result of exploitation of naturally-occurring compounds or substances. These include any naturally-occurring chemical compound, including compounds isolated from petroleum and other sources of organic matter, the products of fermentation by microorganisms, and chemical compounds produced by microorganisms, plants or non-human animals that can be adapted for human use.

Taken to its logical conclusion, the district court’s “natural products” ban on patent eligibility would extend even to inorganic matter, such as ultrapure silicon used to produce computer microchips, isolated metal products prepared from ore and other natural sources, minerals and glasses produced from silicon and other natural sources, and any other compound produced from any naturally-occurring source. Such a determination would categorically exclude such inventions from patent-eligibility regardless of how novel, useful and non-obvious such inventions may be.

IPO believes such a broad ban is not justified, since there is no other source for these materials but nature. Whether materials are “natural” should not determine whether such inventions are patent-eligible, but rather whether the hand of man has been used to invent them.

The IPO brief was approved by the Board of Directors and drafted by IPO members Paul Berghoff, Kevin Noonan, and Jeffrey Armstrong of McDonnell Boehnen Hulbert & Berghoff.

See the entire IPO Brief here:  IPO Myriad Brief

Related posts:

1. Blinded By Science: Myriad Loses Breast Cancer Test Patents
2. US Government Intervenes in Patentability of Genes
3. BIO and AUTM Fire Back at Gene Patent Foes