Posts Tagged: "myriad"

The consequences of SCOTUS decisions are really severe. The U.S. is no longer a favorable jurisdiction for many biotech patents, medical devices and software. What that’s going to mean is companies are going to move. We’ve known this throughout history. Companies locate where the laws are the best for them. If you’re an innovator you’re going to go where the patent laws are the strongest. And that’s why the U.S. has dominated in these industries. We’re number one in biotech is because of Chakrabarty, which has basically been overruled. Prior to Myriad you would have said the ruling of Chakrabarty was this: if there’s human intervention it’s patent eligible, but now you can’t say that because there was human intervention in Myriad, which they acknowledged, and still the claims were patent ineligible. We know companies will move to jurisdictions with more favorable laws…

On the very same day that the U.S. jobs report shows unexpectedly weak growth, the Federal Court of Australia issued a ruling directly opposite to the ruling rendered by the United States Supreme Court relative to gene patents. In Yvonne D’Arcy v. Myriad Genetics, Inc., the Federal Court of Australia ruled that Myriad’s claims to isolated DNA are patentable under the laws of Australia. That is the correct ruling, and it is the ruling the U.S. Supreme Court should have reached in Association of Molecular Pathology v. Myriad Genetics. As the patent eligibility laws of the U.S. become increasingly inhospitable to high-tech innovative businesses we can expect more job losses and worse news for the U.S. economy on the horizon.

Written by David J. Kappos, former Director of the USPTO: “The language of the Myriad decision did not on its face mandate drastic, innovation-dampening action. The Supreme Court chose to narrowly decide the Myriad case, stating that a DNA segment merely “found” from nature without further human innovative intervention is not patentable subject matter… Indeed, the stakes are high – the decision and the USPTO’s interpretation may impact a number of industries that depend on patent protection to provide products, goods and services to the market and jobs to Americans, not to mention the future of life-saving medical discoveries. Of the over 300 drugs on the World Health Organization’s Essential Medicines List, fewer than a dozen were brought to market without having received patent protection. From the ibuprofen ubiquitous in the world’s medicine cabinets to breakthrough treatments for epidemics like the HIV-inhibitor AZT, the patent system has long played a pivotal role in global health.”

The U.S. Department of Commerce’s United States Patent and Trademark Office (USPTO) will host a public forum on May 9, 2014 at the USPTO headquarters in Alexandria, Virginia, to solicit feedback from organizations and individuals on its recent guidance memorandum for determining subject matter eligibility of claims reciting or involving laws of nature, natural phenomena, and natural products (Laws of Nature/Natural Products Guidance). The Laws of Nature/Natural Products Guidance implemented a new procedure to address changes in the law relating to subject matter eligibility in view of recent Supreme Court precedent.

The view of the USPTO now is that a claim to purified amazonic acid is not patent-eligible because there is no structural difference between the purified acid in the claim and the acid in the leaves, and the claim does not include features that demonstrate that the recited product is markedly different from what exists in nature. … It is, to say the least, unclear why the USPTO, without public consultation seeks to remove the patent-eligibility of isolated or purified natural products of new medical or other utility, which has been taken as a given in the US for 100 years and is consistent with practice in Europe and other major industrialised countries.

As the end of 2013 approaches and I look back on what has transpired I am saddened to see that through the year patent rights have continued to erode. Make no mistake about it, at every turn patent rights are eroding. You might think that there has been some collective, open-air discussion about whether this is a good idea. Nope! It seems government you get is the government you can afford, and those who have the ear of decision-makers on Capitol Hill are the extraordinarily well funding big tech companies that want to weaken patent rights or do away with them altogether. Indeed, there has been scant consideration paid to the effect of weakening patent rights. The erosion of patent rights is exceptionally alarming given the fact that the Founding Fathers thought it was self evident that a strong patent system was essential for America. The Founders believed the importance of patent rights to be so self evident that little debate was had on the topic. How the pendulum has swung!

Mark Lemley’s Firm Files DJ Against Myriad in Northern California —– Promise Not to Infringe Insufficient in ANDA Litigation —– Licensing Deals Stall in Pharmaceutical Sector in First Half of 2013 —– Mylan Settles with FTC over Agila Acquisition from Strides —– Amgen and ShanghaiTech University Announce China R&D Center —– Forest Laboratories sues over SAVELLA® generics —– Teva Pharmaceutical scores patent cictory over Mylan on AZILECT® —– Patent Awarded to New Hepatitis C Treatment —– Orphan drug designation for treatment of Acute Radiation Syndrome —– Avanir settles ANDA litigation with Actavis over NUEDEXTA

Senate Judiciary Committee Chairman Patrick Leahy (D-VT) asked NIH in a July 12 letter to force compulsory licensing of Myriad’s BRCA breast and ovarian cancer genetic test under the “march-in rights” provision of the Bayh-Dole Act. Myriad received an exclusive license to develop the test from universities operating under Bayh-Dole Act. The law allows nonprofit institutions receiving federal R&D funds to own and license resulting inventions so they can be commercialized for use by the public. Critics of Bayh-Dole have long sought to reinterpret its statutory standards under which the government can compel universities to issue compulsory licenses as a weapon to control prices. This was not the intent of the law.

Widely divergent views have formed in the wake of the Supreme Court’s decision in Association of Molecular Pathology v. Myriad Genetics, Inc., No. 12-398, slip. op. (U.S. Jun. 13, 2013). Some commentators have reacted with dire predictions for the biotech industry, suggesting that the Court’s holding has unduly narrowed patent protection traditionally granted to DNA technology and has disincentivized researchers in the field, particularly those from small start-ups. Other commentators suggest that the Supreme Court’s decision in Myriad will actually benefit genetic research, particularly researchers at the start-up level. The authors of this post tend to agree with this latter view.

By holding that Myriad’s claimed cDNA was patent-eligible, Thomas’ opinion reaffirms the major holding in Diamond v. Chakrabarty that claimed subject matter which truly only the “hand of man” can make (not simply snipped out of “mother nature”) will make it to the patent-eligibility zone. (Whether that same cDNA makes it to patentability zone under 35 U.S.C. § 102 and especially under 35 U.S.C. § 103 is another and far more important story.) I would also be careful in reading too much into Thomas’ statement (which is also dicta) about “very short series of DNA which may have no intervening introns to remove in creating the cDNA” might be patent-ineligible. By definition, cDNA (i.e., complementary DNA) is a DNA molecule which is created from mRNA (i.e., messenger RNA) and therefore lacking the introns in the DNA of the genome. Thomas (or his clerks) may not have realized that what they were talking about isn’t what would be defined (at least by a molecular biologist) as cDNA. So the impact of that statement should have minimal, if any impact.

The baffling aspect of the opinion is that the Court seems to agree that both the DNA of claim 1 and the DNA of claim 2 are man-made and do not occur in nature. Of claim 1, the Court states that “isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule”. Page 14 (emphasis added). Of claim 2, the Court states that “the lab technician unquestionably creates something new when cDNA is made.” Page 17 (emphasis added). According to the way many patent attorneys (and Judge Rader) think, that should be sufficient to comply with §101. But the Court does not see things this way.

USPTO to Examiners: “As of today, naturally occurring nucleic acids are not patent eligible merely because they have been isolated. Examiners should now reject product claims drawn solely to naturally occurring nucleic acids or fragments thereof, whether isolated or not, as being ineligible subject matter under 35 U.S.C. § 101.”

You can expect a near complete cessation in many areas of personalized medicine. If creating something in a lab, such as a composite cDNA, does not make the underlying claims patent eligible because what results is indistinguishable from what appears in nature that means that the fledgling and potentially promising technologies to grow organs for transplantation will shrivel up and die. The whole point is to create an organ that is indistinguishable from what appears in nature so that it can be transplanted into a human body to prolong life. Given the breadth of this opinion and the uncertainty it will cause funding will dry up in the U.S.