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This guest post is from the BiotechBlog Intern,  Fintan Burke. Fintan is a student at the School of Biotechnology at Dublin City University. Do you have a response to Fintan’s post? Respond in the comments section below.

While the dust has settled on the oral hearings of Association for Molecular Pathology (AMP) v Myriad (read our report here), the Supreme Court has yet to deliver its verdict in light of those hearings on April 15th. AMP’s argument against Myriad’s claim on the BRCA gene for its cancer diagnostic test was heavily reported, with amicus briefs by James Watson and the US Solicitor General  emphasising the gravity given by the US government and scientific communities alike. The case is notable by many in regards to both the fundamental question posed (“Are genes patentable?”) and its implications for the commercial future of personalised medicine.

The case comes in light of two previous cases that addressed diagnostic claims head on. In re Bilski was a US Federal Circuit Court of Appeals decision backed by the US Supreme Court which reiterated that if you need a machine to do some process, or doing that process changes one thing into another, then the process is patentable under Section 101 of the Patent Act (the “Machine or Transformation Test”). The second case, Mayo v Prometheus, gave the controversial decision that a newly discovered law of nature is unpatentable, with its application in a process also unpatentable if there is nothing new introduced into the art.

Dr Eli Loots, a partner in the San Francisco IP law firm Knobbe Martens, does not consider the Prometheus case beneficial to this one.

The court had a variety of reasons for disliking those claims. The claims defined a method but it didn’t require, necessarily, the invention itself in that particular scenario. You could definitely see many people struggling with the fairness of that issue. That can happen any time you have a litigation where one side is being very aggressive on their claim interpretation. This follow-on case is in my mind – and I think in many more practitioners’ minds – are much more telling of the future; of diagnostics in particular and biotech generally.

One source of difficulty for this case, says Loots, is the idea of defining invention in the science world.

At some level you just can’t see a lot of these inventions. You need years of training to understand what these building blocks are made out of. Are they actually there? You can get an expert up there and say ‘well these electrons are distributed on a probability function’ and everybody’s going to fall asleep! Because of that, what biotech has done in the past is to define things functionally… what ends up happening is it appears from the functional language that you have a new, non-obvious invention, but it also appears that you have some really broad claims that may encompass more than people originally envisioned.

From a legal point of view, the biggest cause of concern is the attack on the patent under Section 101, which sets out what is and is not patentable subject matter. During the oral hearing itself, Chief Justice Roberts was heard to ask whether the whole case would not be better off examined under the ‘previously non-obvious’ clause that makes up Section 103. One attorney of a high profile Californian firm (who did not wish to be named) agreed with this suggestion. “They were really just saying ‘you isolated the gene out of the body and you did some things to it but all those steps you did were not novel. They were obvious. They’ve been done before, so you shouldn’t get a patent.’ And a lot of the commentators said ‘well that’s a 103 argument, that’s not a 101 argument.’”

He also explains lifting the patent could damage investment and innovation in the field, though could also lower the price for consumers and offer second opinions. Friend-of-the-court briefs from both sides of the argument echo the ramifications of ruling whether or not genes are patentable. The Biotechnology Industry Organisation stated that “The PTO has been granting patents on isolated DNA molecules for thirty years” and that “modern biotechnology industry has developed and flourished under this regime of consistent protection.” A lift in genetic IP protection may see generic gene diagnostics flooding the market, making the field undesirable for investors. Meanwhile an amicus filed by The Nation Woman’s Health Network et al states “Because Myriad’s patents give them a monopoly on genetic testing for breast and ovarian cancer in the United States … physicians in our country cannot give second opinions regarding a diagnosis for the disease.”

The attorney also considers the previous Mayo v Prometheus case, which got several mentions in this case’s oral hearings, to have underperformed in clearing up patentability matters. “A lot of us in the field think that the Supreme Court sort of muddled the Prometheus opinion. If you read it you’ll see there’s an awful lot of references to obviousness and 103 and that’s probably how they really decided it. Under the guise of ‘you can’t patent mental operations’ is what Prometheus essentially said. But really they were saying ‘and everything else that was part of that was obvious.’”

“Every disinterested observer I talked to thought the Prometheus patent was really, really crappy—outrageous, and a huge mistake by the USPTO” says John Conley, Kenan Professor of law at the University of North Carolina when contacted. “In Myriad, I suppose it’s possible that the court will say, let obviousness handle it, but I think they’ll make a decision under 101.” Continuing his comment on his blog at genomicslawreport.com he notes “What difference will it make? If the Supreme Court invalidates genomic DNA patents, it will be seen as a win by the growing personalized medicine industry. Companies using isolated genomic DNA to screen patients at multiple gene loci will no longer have to worry about whether the genes they are testing are patented—though the industry hasn’t seemed terribly worried about that problem thus far.”

The court is expected to give its decision within the next month.

About the author:

Fintan Burke is a student at the School of Biotechnology at Dublin City University. His main fields of interest include biomedical therapies and recombinant organisms.  Fintan may be contacted at fintan.burke2@mail.dcu.ie .

Journal of Commercial Biotechnology This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

Strategies for improving communication between scientists and the public

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ABSTRACT: It is believed that a scientifically literate society benefits the national economy by improving the workforce and raising consumer awareness by helping people appreciate and support scientific advancement. Traditionally, communication between scientists and the public has been viewed as unidirectional, with an 'expert' scientist bestowing information on a recipient perceived to be largely passive and unquestioning...

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

Journal of Commercial Biotechnology This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

Singapore's biomedical science sector development strategy: Is it sustainable?

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ABSTRACT: This paper outlines the strategic efforts undertaken by Singapore to establish its national capability in the biomedical science sector, reviews the commercial base as a result of these efforts and compares Singapore's approach with the UK and US development models, discusses the challenges that Singapore faces and raises some questions on the long-term sustainability of the sector...

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

biologic-patent-watch_squarelogo_webAfter months of development, BiologicPatentWatch.com is live.

Building on the framework of DrugPatentWatch, BiologicPatentWatch provides comprehensive details on FDA approved biologic drugs, developers and patents. The integrated databases allow both freeform searching and dynamic browsing, making it easy to find information on drug patents both in the US and internationally, Orphan Drug Status, trends in patent expirations and more …

 BiologicPatentWatch concentrates deep knowledge on biologic drugs from more than 60 biotechnology companies, including more than 2,800 active and expired US patents and 41,000 international patents spanning 91 countries and regional patent offices.

BiologicPatentWatch complements DrugPatentWatch’s focus on small molecule drugs, and provides comprehensive information on:

  • monoclonal antibodies
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  • proteins intended for therapeutic use that are extracted from animals or microorganisms, including recombinant versions of these products (except clotting factors)
  • other non-vaccine therapeutic immunotherapies

Check out the free biotechnology industry infographics and database preview, or sign up for a free trial today!

This is a guest post from Susan K Finston, President of Finston Consulting. Do you have a response to Susan’s post? Respond in the comments section below.

Susan Kling FinstonIn an unanimous decision in Bowman v. Monsanto, argued February 19, 2013 and decided May 13, 2013, the U.S. Supreme Court explicitly confirms that the exhaustion doctrine does not extend to progeny of so-called self-replicating technologies.

We provided a summary of the oral argument here in the blog, and a longer  look at the case in a recent issue of the Journal for Commercial Biotechnology, here, anticipating that the primary point of interest in the case for the U.S. Supreme Court was the opportunity to address the intersection of the exhaustion doctrine and self-replicating inventions.

The idea that the case was all about a new asserted exception from patent rights for digital and GM technologies was signaled by statements of the Justices at Oral Argument and so was not particularly insightful.  Now this has been borne out by the Opinion of the U.S. Supreme Court, delivered this morning by Justin Kagan:

[T]he exhaustion doctrine does not enable Bowman to make additional patented soybeans without Monsanto’s permission (either express or implied). And that is precisely what Bowman did. He took the soybeans he purchased home; planted them in his fields at the time he thought best; applied glyphosate to kill weeds (as well as any soy plants lacking the Roundup Ready trait); and finally harvested more (many more) beans than he started with. That is how “to ‘make’ a new product,” to use Bowman’s words, when the original product is a seed. Brief for Petitioner 37; see Webster’s Third New International Dictionary 1363 (1961) (“make” means “cause to exist, occur, or appear,” or more specifically, “plant and raise (a crop)”). Because Bowman thus reproduced Monsanto’s pa tented invention, the exhaustion doctrine does not protect him. Were the matter otherwise, Monsanto’s patent would provide scant benefit.

In sum, Petitioner Vernon Hugh Bowman does not pass, go, collect $200 or otherwise avoid licensing fees by purchasing patented GM seeds outside of his ongoing Technology Agreement with the inventor and Respondent, Monsanto Company.

Just like death and taxes, Bowman has to pay for the advanced technologies and other agricultural inputs that he wants to use, including GM seeds that make his job easier, improve yields and contribute to the success of his farm.  And as noted previously, both Monsanto and U.S. Government attorneys have stated that this case does not affect farmers who do not intentionally plant GM seeds without payment of royalties.

Susan K. Finston is President of Finston Consulting LLC, and, together with biotechnology pioneer Ananda Chakrabarty, is co-founder of Amrita Therapeutics Ltd., an emerging biopharmaceutical company based in India with cancer peptide drugs entering in vivoresearch. She is currently preparing to launch her first Crowd Funding campaign for Amrita Therapeutics first-ever therapeutic oncology medical device. For more information see AmritaTherapeutics.com or FinstonConsulting.com.

Drug Patent Expirations for May 2013

TradenameApplicantGeneric NamePatent NumberPatent Expiration
HUMALOG PENLillyinsulin lispro recombinant5,514,646May 7, 2013
GEMZARLillygemcitabine hydrochloride5,464,826*PEDMay 7, 2013
HUMALOG MIX 50/50 KWIKPENLillyinsulin lispro protamine recombinant; insulin lispro recombinant5,514,646May 7, 2013
HUMALOG MIX 75/25 KWIKPENLillyinsulin lispro protamine recombinant; insulin lispro recombinant5,514,646May 7, 2013
HUMALOG KWIKPENLillyinsulin lispro recombinant5,514,646May 7, 2013
PREVACIDTakeda Pharms Usalansoprazole5,464,632*PEDMay 7, 2013
HUMALOG MIX 50/50Lillyinsulin lispro protamine recombinant; insulin lispro recombinant5,514,646May 7, 2013
HUMALOG MIX 75/25Lillyinsulin lispro protamine recombinant; insulin lispro recombinant5,514,646May 7, 2013
HUMALOGLillyinsulin lispro recombinant5,514,646May 7, 2013
ZAVESCAActelion Pharms Ltdmiglustat5,472,969May 13, 2013
DEPOCYTPacira Pharms Inccytarabine5,455,044May 14, 2013
ZOMIGIprzolmitriptan5,466,699*PEDMay 14, 2013
ZOMIG-ZMTAstrazenecazolmitriptan5,466,699*PEDMay 14, 2013
ZOMIGIprzolmitriptan5,863,935*PEDMay 14, 2013
ZOMIGAstrazenecazolmitriptan5,466,699*PEDMay 14, 2013
OSMOPREPSalix Pharmssodium phosphate, dibasic, anhydrous; sodium phosphate, monobasic, monohydrate5,616,346May 18, 2013
VISICOLSalix Pharmssodium phosphate, dibasic anhydrous; sodium phosphate, monobasic, monohydrate5,616,346May 18, 2013
ADRENACLICKAmedra Pharmsepinephrine5,665,071May 27, 2013
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.

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Journal of Commercial Biotechnology This paper is part of the free Open Access archive of the Journal of Commercial Biotechnology

Marketspace: Leading biotechnology players, 2002–08: Key products, indications and technologies

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ABSTRACT: For the full year 2002, the top ten biotechnology houses generated combined revenues (= royalties/licensing income + ethical or product sales; product sales includes both diagnostic and prescription drugs) of US$15.9bn, a 27 per cent increase over 2001. Using Datamonitor's proprietary forecasting methodology, the ethical sales of the ten leading biotechnology companies (Amgen, Genentech, Serono, Genzyme, Biogen, Chiron, MedImmune, Gilead, IDEC and Celltech) are forecast to grow from US$17...

The Journal of Commercial Biotechnology is a unique forum for all those involved in biotechnology commercialization to present, share, and explore new ideas, latest thinking and best practices, making it an indispensable guide for those developing projects and careers within this fast moving field.

Each issue publishes peer-reviewed, authoritative, cutting-edge articles written by the leading practitioners and researchers in the field, addressing topics such as:

  • Management
  • Policy
  • Finance
  • Law
  • Regulation
  • Bioethics

For more information, see the Journal of Commercial Biotechnology website

As I continue to investigate global biotechnology for Scientific American and international patenting trends for DrugPatentWatch.com, I came across a curious finding.

I was looking at the global spread of US drug patents — to obtain global patent protection for drugs companies must file for patents in each of the jurisdictions that they seek protection, within 12 months of the initial filing. Patents last for roughly 20 years, which means that current patent activity reflects a 20-year forward-looking sentiment on the attractiveness of a market.

global filings of us drug patentsWhen comparing India and China one sees an interesting trend. Before the 1980s there was little interest in obtaining patent protection in either country. In fact, it wasn’t possible in India because the country had not yet adopted the TRIPS accords which permit product patents. Over the course of the 1980s and 1990s interest in China increased, stabilizing at roughly 70% representation of US drug patents in that market.

In 2005 India adopted the TRIPS accords and (partially*) permitted product patents, so it would be very interesting to observe how global patenting trends were affected by the new ability to obtain pharmaceutical product patents there. Unfortunately, in 2005 Indian sources stopped sharing patent data with the European Patent Office, which serves as a global clearinghouse of patent globally-linked patents. This lack of transparency makes it impossible to determine global interest in the Indian market, and  robs India the opportunity to tell the story of the impact of taking steps towards harmonizing their patent system.

*An important exception in India’s patent law is that new drug products must offer substantial new efficacy relative to existing products. This has been at the center of Novartis’ patent disputes in India.