Leading the Way in Life Science Technologies

GEN Exclusives

More »

Feature Articles

More »
Oct 1, 2011 (Vol. 31, No. 17)

Highlighting the Course of Biotech Law

Patent Decisions Have Played a Pivotal Role in the Growth of the Industry

  • Junk Patents

    In the years since Judge Rich’s passing, some in the technology community (particularly those working in information technology) have cried out with increasing vehemence against the flood of “junk patents” they say have been granted improvidently by the PTO for subject matter they find obvious. This outcry inspired the chiefs of the PTO during the George W. Bush administration to incite patent examiners to increase the rate of rejection of patent applications.

    Moreover, the Supreme Court has recalibrated the “nonobviousness” standard in U.S. patent law and seems to have raised the bar somewhat higher than Judge Rich would have preferred.

    In the 2007 case of KSR Inc. v. Teleflex, the Court said that the hypothetical “person having ordinary skill in the art” described in section 103 should be taken as having “common sense” and not be thought of as merely an “automaton” who is unable to make a mental connection between two sources of prior art without a “teaching, suggestion or motivation” to do so. But this supersedes a countervailing concept Judge Rich had expressed in the 1985 Standard Oil v. Cyanamid case.

    It is noteworthy that Judge Rich and his colleagues on the Court of Customs and Patent Appeals were transferred en masse to the Court of Appeals for the Federal Circuit (CAFC) in October 1982 when Congress mandated those judges to decide appeals not only from the patent office but also patent cases that had been tried in a federal court anywhere in the U.S.

    The goal was to create a unified American jurisprudence on patents, rather than a variety of views (frequently pro-competition but antipatent) as expressed by the regional federal circuits (except for the rare unifying decision by the Supreme Court).

    The sense of Congress in 1981 and 1982 seemed to be that patents are a good thing and should be encouraged and made more predictable. The public regarded technology favorably, as exemplified by the IBM personal computer (remember those Charlie Chaplin ads?), and expected healthcare advances arising from biotechnology.

    More recently, Congress has been singing a different song, to the tune of “patent reform.” When I wrote about this in the April 1, 2011, issue of GEN, the Senate had passed a bill that was touted as being the first “overhaul” of patent law since Judge Rich’s handiwork in 1952.

    Since then, a similar bill has passed the House, now named the “Leahy-Smith America Invents Act.” Despite hype about the magnitude of the proposed changes and the need to harmonize U.S. patent principles with those of other countries, the Leahy-Smith Act wouldn’t touch a hair on the “nonobviousness” language adopted in 1952, nor would it affect what subject matter is eligible to be considered for a viable patent claim.

  • Rearranging the Furniture

    Click Image To Enlarge +
    In 1954, science fiction writer Damon Knight wove a futuristic tale in which gene splicing would create a cornu­copia of ecologically sustainable benefits—including such wonders as plants that grow into houses. [Illustration by Tim Durning, inspired by Damon Knight’s novella Natural State.]

    To me, it’s not so much an overhaul of patent law as a rearrangement of the furniture. And unless the PTO is fully funded (a proposition not assured in the version adopted by the House of Representatives) that furniture might soon be looking like the deck chairs of the Titanic.

    The Chakrabarty case of 1980 seems to have been the high-water mark of pro-patent-eligibility jurisprudence, when the Supreme Court affirmed the opinion Judge Rich had written for the Court of Customs and Patent Appeals. But even at that time, there were loudly dissenting public voices, notably Jeremy Rifkin, whose Foundation on Economic Trends successfully used a combination of authorship, publicity-seeking, and litigation to raise questions in the public mind as to the safety and appropriateness of biological technologies, yet all the while acknowledging their importance and potential.

    Though Rifkin’s attention seems now to have turned primarily to empathic civilization and sustainability, his current successor would be Daniel B. Ravicher, whose Public Patent Foundation has been waging war against the patent-eligibility of genetic testing, and particularly, claims to isolated polynucleotides having human genetic sequences.

    With a team of American Civil Liberties Union attorneys representing a coalition of medical specialists seeking to free the diagnosis of genetic abnormalities from the fetters of the patent system, he achieved success last spring in the Federal court in New York City. But on July 29, the CAFC ruled 2 to 1 that isolated polynucleotides are potentially patent-eligible. Yet the three-judge panel agreed with Ravicher’s assertion that claims reciting certain diagnostic method steps were not patent-eligible.

    This probably won’t be the end of the appellate process for this case. Those following the matter may be interested in a debate scheduled for October 13, 2011, between Ravicher and Hans Sauer, intellectual property counsel of BIO, entitled “Do Gene Patents Kill? The Controversy Surrounding DNA Patenting” at the University of Missouri-Kansas City School of Law.

    Further aspects of patent eligibility involving diagnostic testing arise in the Mayo Collaborative Services v. Prometheus Labs case pending before the Supreme Court.

    I also take this opportunity to remember another former colleague of the BLR editorial board, Bertram I. Rowland, who prosecuted the patents on the gene-splicing technique invented by Stanford University professor Stanley N. Cohen and the University of California’s Herbert W. Boyer.

    During the 1980s, Niels Reimers’ Office of Technology Licensing at Stanford University implemented a highly acclaimed licensing program for this platform technology. Rowland used the term “biologically active molecular chimera” to describe the constructs generated by the Cohen-Boyer technique of recombinant DNA.

    Learning of this, I recalled a science fiction tale I’d read in early 1954 that I believe to be the first documented conception that spliced genes could be functional. Though it took me quite a while in those pre-Internet days to track it down from my memory of the story, I found that it was written by Damon Knight and originally published in the January 1954 issue of Galaxy Science Fiction as “Natural State,” just months after James D. Watson and Francis Crick had published in Nature the double-helix structure of DNA.

    Recently, Liebert graciously invited me to include an advertisement for my law firm in this June’s issue of BLR. I elected to commission the accompanying illustration, which fancifully transports me into the biotechnological civilization of Knight’s “muckfeet,” where a “houseplant” is a creation from which you’d grow a house.

Related content

Be sure to take the GEN Poll

Cancer vs. Zika: What Worries You Most?

While Zika continues to garner a lot of news coverage, a Mayo Clinic survey reveals that Americans believe the country’s most significant healthcare challenge is cancer. Compared to other diseases, does the possibility of developing cancer worry you the most?

More »