Isolation of DNA and patent protection of mecco

Business news on October 15 the patentability topic continues to plague the biotechnology industry, especially in the field of method claims In the United States, the subject of patentability or "patentability" is defined in Article 101 of the United States Patent Law as "any new and practical method, machine, manufactured product or composition" These four categories have been widely used by the court in history, so as to "include everything made by human under the sun." However, there are exceptions to the "patent eligibility" under Article 101, which has been described in important US Supreme Court decisions, i.e "natural laws, physical phenomena and abstract concepts", such as Bilski case in 2010 and Mayo collaborative services v Prometheus laboratories in March 20, 2012, Inc ("Prometheus") These exceptions are mentioned in the recent judgment of the United States Court of Appeals for the Federal Circuit on "patent eligibility", namely "myriad gene company case" In this case, the Civil Liberties Union and the public patent union filed a lawsuit against the U.S patent and Trademark Office, arguing that DNA, like air or water, is a natural product and therefore not patentable In the meliard case, the claims in dispute include the claims of the cDNA composition, the method claims of screening potential cancer therapy and the method claims of "comparing" or "analyzing" DNA sequence In the first instance, the Federal District Court found that all claims of merriard company did not have the subject of "patent eligibility" On the first appeal, the United States Court of Appeals for the Federal Circuit partially overturned the judgment of the Federal District Court for the first time, and held that the claims of merriard company on the cDNA composition and the claims on the diagnostic method list the subject of "patent eligibility" The case was transferred to the Federal Circuit Court of Appeals for the second time, and was remanded by the Supreme Court of the United States in reference to the judgment of Prometheus case In the Prometheus case, the Supreme Court of the United States held that the claims of medical diagnosis methods did not have the subject of "patent eligibility", because they were interpreted as the methods of listing and observing natural phenomena Judge Lourie of the Federal Circuit Court of appeals wrote a majority opinion for the second time after the Supreme Court sent it back for retrial According to the established case law of the Supreme Court, he pointed out that the problem the court faced in this case is the subject of "patent eligibility", which is a threshold test, rather than determining whether the invention can be patented Determining whether an invention can be patented is a test of a number of other statutory requirements It is worth mentioning that the Federal Circuit Court of appeals reached the same conclusion in its early judgment on patent eligibility: 1 The claims on the composition of cDNA and "separated" DNA molecules belong to the subject of "patent eligibility", because the claimed molecules represent unnatural compositions, not just "purified" DNA 2 The method claim for screening potential cancer therapy through the change of cell growth rate of transformed cells belongs to the subject of patent eligibility 3 The method claim of "comparing" or "analyzing" DNA sequence does not have "patentability", the claim does not include the transformation step, and only covers the step in the brain which does not have patentability For the composition claim, the claim of the separated DNA molecule, as the composition, according to Article 101, Title 35 of the United States Code, "is clearly recognized as the appropriate subject with patent applicability," and "Prometheus case" has not changed or affected this point Judge Laurie stated: "the composition here is not a natural product They are man-made products, although, like all materials, they follow the laws of nature " At the same time, the cDNA claims have "patent eligibility" because they lack the non coding intron in the BRCA1 gene of chromosome The "comparison" and "analysis" claims of the abstract thought process are very similar to the claims which are considered not to have "patent eligibility" in "Prometheus case" In addition to the secondment of judge Moore, judge Bryson wrote a different opinion He found that the isolated DNA claim does not have patent eligibility because "the claimed molecular nucleotide sequence is exactly the same as that found in naturally occurring human genes." However, judge Bryson added the opinion of the majority that the claim of the screening method has the patent eligibility, because it requires "transformed cells" made by human beings, which is in sharp contrast to natural substances Another request to the U.S Supreme Court may be made by the plaintiff in the meliard case If the Supreme Court of the United States agrees to hear the case, it may follow judge Bryson's claim that the separated DNA sequence cannot be distinguished from its naturally occurring equivalent sequence, so it does not have "patent eligibility" The U.S Supreme Court is likely to stay within the reasonable scope of the previous case on which judge Laurie is based, and proposes that the patentability of unnatural genes should be left to Congress At present, the final result of the Mailyard case is that biotechnology companies can obtain patent protection for the "separated genes" In this case, the "isolated genes" are BRCA1 and BRCA2, which occupy most of the genetic forms of breast and ovarian cancer It also depends, of course, on whether the "isolated" gene meets other statutory requirements for patentability, such as novelty and creativity The simple method of "comparing" or "analyzing" DNA sequence is not patentable, whether other legal requirements of patentability are met or not In broader legal terms, the case is considered a "victory" for the biotechnology industry and DNA based inventions The "merriard case" is also a "victory" for those who support the patent system as a means of encouraging invention Judge Laurie commented that the patent of the separated gene does not replace the natural law Composition is not a natural law Patents on life-saving materials and methods, involving a large number of venture capital, seem to be the subject type of obtaining exclusive rights "Mailiade case" is also a good news for Chinese herbal extracts, which is particularly important for China At present, many Chinese companies have asked the Federal Food and Drug Administration for approval of plant extracts These Chinese herbal extracts, like the DNA isolated in the case of maliade, do not occur naturally More precisely, the extract is a new composition with a different proportion of a marker with a substance already present in the plant before extraction They are different from natural plants in terms of name, characteristics and use, and should belong to the category of patentability subject.