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Monthly Archives: April 2013

Which patents cover the most drugs?This infographic shows the pharmaceutical companies that listed the most patents last year.

The companies with the most drug patents listed last year are NovartisLillyMerck,AllerganSanofi Aventis UsAstrazenecaGlaxosmithklinePfizerVeroscience, andWatson Labss.

For more infographics, see the DrugPatentWatch Pharmaceutical Innovation Infographics.

Do you have a response to this infographic? Respond in the comments section below.

These infographics from DrugPatentWatch.com and BiologicPatentWatch.com track innovation and patent activity in the pharmaceutical and biotechnology industries:

Pharmaceutical Innovation Infographics

Upcoming drug patent expirations

Which Drugs Face Patent Expirations this Month?

Top selling drugs

What are the Top-selling Drugs?

Future drug patent expirations by month

How Many Drug Patents Will Expire in the Coming Months?

Upcoming drug patent expirations by year

How Many Drug Patents Will Expire in the Coming Years?

Which drugs have the most patents

Which Drugs Have the Most Patents?

Which pharmaceutical companies have the most drugs

Which Companies Have the Most Branded Drugs?

Which pharmaceutical companies listed the most drug patents last year

Which Companies Listed the Most Drug Patents Last Year?

Which pharma companies have the most drug patents

Which Companies Have the Most Active Drug Patents?

Which drug companies face the most patent expirations

Which Companies Face the Most Patent Expirations?

Which pharmaceutical companies recieved the most drug approvals last year

Which Companies had the Most Drug Approvals Last Year?

Which patents protect the most drugs

Which Patents Cover the Most Drugs?

Biotechnology Innovation Infographics

Upcoming biologic patent expirations by year

How Many Biologic Patents Will Expire in the Coming Years?

Which biologics have the most patents

Which Biologics Have the Most Patents?

Which biotechnolgy companies have the most approved biologics

Which Companies Have the Most Biologics?

Which biotech companies have the most biologic patents

Which Companies Have the Most Active Biologic Patents?

Which biologic companies face the most patent expirations

Which Companies Face the Most Patent Expirations?

Which biotechnology companies recieved the most biologic approvals last year

Which Companies had the Most Biologic Approvals Last Year?

Which patents protect the most biologics

Which Patents Cover the Most Biologics?

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

Cancer remains the dominant disease target for biotech through to 2010

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ABSTRACT: The two leading therapeutic areas for biological products, in terms of current sales and pipeline focus, are oncology and AIID (arthritis, immune and inflammatory disorders). Datamonitor's biotechnology strategic market analysis team recently analysed the AIID market, since this sector is currently powering biotechnology market growth, owing to high demand for biologicals to treat rheumatoid arthritis and psoriasis (Belsey, M...

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

This is a guest post by Morrison & Foerster‘s  Marc A. Hearron, James J. Mullen, III and Matthew I. Kreeger. Do you have a response to this post? Sound off  in the comments section below.

The Supreme Court of the United States recently heard oral argument in Association for Molecular Pathology v. Myriad Genetics, Inc. (No. 12-398) to decide the question, “Are human genes patentable?” The Court’s decision in Myriad could have broad implications for biotechnology companies. Morrison & Foerster was present at the argument.

Although one must be cautious about reading tea leaves from oral argument, a majority of Justices at the argument seemed skeptical that isolated human genes are patentable subject matter.

BACKGROUND
Myriad Genetics, Inc. is the patentee of several U.S. patents with claims directed to the human genes BRCA1 and BRCA2. The presence of mutations in these genes is highly correlated with the risk of developing breast or ovarian cancer. A coalition of groups and individuals brought a declaratory-judgment action over the patentability of the BRCA1 and BRCA2 claims.

A divided Federal Circuit panel held that claims covering isolated DNA sequences are patentable subject matter under 35 U.S.C. § 101. In March 2012, the Supreme Court sent the case back to the Federal Circuit for that court to reconsider its decision in light of the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012). In Mayo, the Supreme Court reaffirmed the principle that laws of nature are not patentable.

On remand, the Federal Circuit wholly reaffirmed its prior ruling. The challengers petitioned the Supreme Court for review. The Supreme Court granted certiorari to decide one question: “Are human genes patentable.”

THE BRIEFS BEFORE THE SUPREME COURT
The plaintiffs assert that Myriad “did not invent any genes or variants or cause their significance” and that Myriad’s patents “cover the BRCA genes of every person in the United States, even genes that Myriad has never seen.”

Because human genes and genetic variants of those genes are “products of nature,” they are not eligible for patenting. The fact that the BRCA genes have been isolated from the human body makes no difference because under that rationale, “a kidney ‘isolated’ from the body would be patentable, gold ‘isolated’ from a stream would be patentable, and leaves ‘isolated’ from trees would be patentable.” The challengers’ position is supported, in whole or in part, by 24 amicus briefs, including briefs by the American Medical Association, AARP, and the American Intellectual Property Association.

Myriad contends that the claimed isolated DNA molecules “fall on the inventive side of the line” drawn by Section 101 and Supreme Court precedent. According to Myriad, “(o)nly by human intervention have the claimed molecules come about.” “Where others failed, Myriad identified the BRCA genes, and then, using information it had collected and discerned from studying the genes, characterized, defined, and isolated these particular molecules. The creation of new molecules never before available to the public is invention.”

Myriad’s position is supported by 26 amicus briefs, including briefs by the American Bar Association, the Biotechnology Industry Organization (BIO), the Pharmaceutical Research and Manufacturers of America (PhRMA), and a number of pharmaceutical companies.

The Solicitor General filed an amicus brief on behalf of the United States, nominally supporting neither party, but which, in practical terms, is seen as supporting the challengers. In a departure from the position of the Patent Office, the Solicitor General argues that “isolated but otherwise unmodified DNA is not patent-eligible.” According to the Solicitor General, the “public’s ability to study and use native DNA would be unduly compromised if changes caused by the extraction of naturally-occurring substances from their native environments were sufficient to trigger patent-eligibility.” The Solicitor General departs from the challengers when it comes to “complementary DNA” (cDNA) molecules, which the government describes as “synthetic molecules built by scientists to include, in a single contiguous DNA segment, only the exons of a naturally occurring gene, without the introns and regulatory regions that are normally interspersed with exon sequences in genomic DNA.”

ORAL ARGUMENT
The Justices’ questioning at oral argument suggests that a majority of Justices seem inclined to agree with the challengers’ argument that isolated human genes are not patent-eligible. As to cDNA, however, several Justices suggested that it is the product of human invention and would be eligible for patenting under Section 101, although it may or may not be patentable under other doctrines such as obviousness.

The Challengers’ Argument
Counsel for the challengers began his argument by asserting that Myriad invented “nothing.” The decisions as to what the genes contained were “made by nature,” not by Myriad. Myriad merely “unlocked the secrets” of the genes; it did not invent them.

A number of Justices asked the challengers to clarify exactly what they contend is and is not patentable. Justice Sotomayor asked why the test for the presence of the BRCA genes had not been patented. Justice Scalia asked why the method of isolating the genes was not patented. Justice Kennedy asked whether the challengers were asserting that the process of “tagging” the isolated DNA was not patentable. Counsel answered that the method was patented but had been freely licensed for years, and he clarified that the challengers were not asserting that the process of tagging the DNA could not be patented.

Justice Alito was one of the only Justices to ask questions at oral argument suggesting outright agreement with Myriad that isolated genes can be patented. Justice Alito asked how the isolated DNA was different from a plant in the Amazon that is discovered to have therapeutic properties but which requires a chemical to be extracted and concentrated. Counsel agreed that the process of concentrating the substance might make it patentable. Justice Alito suggested that that was no different from isolating the gene because both the isolated gene and the concentrated plant substance have a different “function” and are in a new “form.”

Several Justices, including Justices Scalia, Kennedy, and Kagan, asked whether there would be sufficient incentives for biotechnology companies to perform the type of work that Myriad performed if the genes are not patentable. Justice Sotomayor stated that the isolated gene itself “has no value,” but rather it is “the use you put the isolation to” that has value.
As to cDNA, the Justices were far less receptive to the challengers’ argument. Justice Sotomayor stated that cDNA is “not a product of nature; it’s a product of human invention.” Justice Breyer stated that there is “no such thing in nature” as cDNA and that cDNA has properties that are not true of the isolated DNA. Justice Kennedy suggested that cDNA has features that regular DNA does not. Counsel repeatedly tried to assert that cDNA is found in nature, but he appeared to make little headway.

The Solicitor General’s Argument
Solicitor General Donald Verrilli himself argued as amicus on behalf of the United States, reflecting the importance of this case. The Solicitor General’s middle-ground position—that isolated genes are not patentable but that cDNA is—appeared to be carrying the day with several of the Justices.

The Chief Justice queried whether patentability under Section 101 was the proper way to consider these issues, suggesting that the doctrine of obviousness was the better course. He stated that taking a small part of something bigger is obvious, and thus it would be obvious to take an isolated gene from an entire chromosome.

“I don’t understand how a small part of something bigger isn’t obvious,” remarked the Chief Justice.

Nevertheless, the Solicitor General urged the Court to focus on patentability under Section 101 as it did in Mayo.
Justice Alito pointed out that the government has changed its position and that there are conflicting opinions within the Executive Branch. The Solicitor General acknowledged as much.

Justice Kagan brought up Justice Alito’s hypothetical about the Amazonian plant. The Solicitor General contended that the use of the substance in the plant would be patentable but that the substance itself would not.

Myriad’s Argument
Counsel for Myriad withstood a barrage of questioning about the patentability of merely isolated human genes, which several Justices stated are “found in nature.”

Justice Sotomayor, for example, likened the case to a new recipe for improved chocolate-chip cookies, stating that the cookie might be patentable because the inventor has done something new with the ingredients but that the basic ingredients themselves—salt, flour, eggs, and butter—could not be patented.

Myriad’s counsel argued that there was human invention in the decision where to begin the gene and where to end the gene—i.e., where to snip the gene from the rest of the chromosome. He likened isolating the gene to a baseball bat that has been isolated from the rest of a tree, stating that a baseball bat is found in nature but the decision where to start and end it is decided by humans. Justices Scalia and Breyer resisted the analogy, stating that this DNA is found in the human body. The Chief Justice also stated that the baseball-bat analogy is “quite different” because that is not just snipping. “Here,” he stated, “what’s involved is snipping. You’ve got the thing there and you snip—snip off the top and you snip off the bottom and there you’ve got it.”

Justice Kennedy remarked that isolated DNA is not useful until “tags” are added to it. He thus suggested that DNA that is isolated but not tagged is not different from how it exists in the body.

Justice Breyer stated that “the patent law is filled with uneasy compromises.” Returning to the hypothetical about the plant in the Amazon, Justice Breyer stated that the historically recognized compromise is that processes to extract the substance from the plant are patentable, that newly discovered uses of the substance are patentable, but that the substance itself is not. This “hornbook patent law,” he suggested, keeps substances themselves free of patent restrictions but encourages innovation to develop new uses for those substances.

Myriad’s counsel urged the Court to defer to the views of the Patent Office, which “sits at the intersection of law and science.” He pointed out that the Patent Office did not join the Solicitor General’s brief and has adopted the position that isolated genes are patentable. Justice Ginsburg responded that the federal government has disavowed the Patent Office’s position, and that “the strength of the presumption would be diluted” as a result.

Justice Kagan referred to the Patent Office as “very patent happy.”Justice Kagan asked whether the “first person who found a chromosome and isolated it” from the body could have patented chromosomes. She also asked whether “the first person who found a liver” could patent the liver.

Myriad’s counsel answered that these would be patentable under Section 101 but might not be under other provisions, such as 35 U.S.C. § 103. Justice Breyer responded that “that’s the problem” because it would mean “(a)nything from inside the body that you snip out and isolate” could satisfy Section 101. Justice Sotomayor added that “if you cut off a piece of the liver or a piece of the kidney,” that does not make it patentable, suggesting that the same should be true of a piece of a chromosome.

In the most explicit signs that the Court might accept the Solicitor General’s view, Justice Kennedy asked Myriad’s counsel whether, if the Court were to agree with the government, it would “give the industry sufficient protection for innovation and research.” And in the challengers’ rebuttal, Justice Sotomayor asked whether there would be “some value to us striking down isolated DNA and upholding the cDNA.”

Myriad had argued in its brief that the Federal Circuit erred in concluding that any of the challengers has standing. At oral argument, none of the Justices asked any questions about Myriad’s standing argument, suggesting that standing likely will not be a basis for the Court’s decision in this case.

CONCLUSION
One should not read too much into the Justices’ questions at oral argument because the Court does sometimes rule differently from how observers expect it to rule based on questioning. Many Justices, however, did seem to be searching for a middle ground in which isolated human genes could not be patented but syntheticDNA is patent-eligible under Section 101. A decision is expected by the end of June.

 About the authors:

Mr. Kreeger is San Francisco-based chair of Morrison & Foerster’s Patent Interferences practice, representing clients in technology, life sciences, and medical diagnostics. Mr. Mullen, managing partner of the firm’s San Diego office, represents IP clients across a range of cleantech and biotech industries, including medical therapeutics and diagnostics and nucleic and amino acid sequencing. The other co-author is MoFo associate Marc Hearron, a member of the firm’s Appellate and Supreme Court group in Washington.

bio_guestblogger_200I will be at BIO 2013, representing BiotechBlog, the Journal of Commercial Biotechnology, and Scientific American Worldview. I look forward to meeting new and existing readers.

If you have an interest in guest-posting on BiotechBlog, an interest in submitting a paper to the Journal of Commercial Biotechnology, or have perspectives on global biotechnlogy that may be of interest to Worldview, I’d be happy to meet up — drop me a line on the contact form.

If you would rather have an informal meeting, please stop by my book signing at on Tuesday April 23 from 2-3:30pm (I will be signing my books and demoing DrugPatentWatch.com and BiologicPatentWatch.com).

If your reader cannot render the information below, go to http://www.DrugPatentWatch.com/innovation to see the latest expirations

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Drug Patent Expirations for March 25 2013

TradenameApplicantGeneric Name Patent Expiration
XOPENEXSunovionlevalbuterol hydrochlorideMar 25, 2013
XOPENEX HFASunovionlevalbuterol tartrateMar 25, 2013

*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.


DrugPatentWatch Infographics

Which pharmaceutical companies recieved the most drug approvals last
year

Which Companies had the Most Drug Approvals Last Year?

More infographics »

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The above list does not discriminate between dominant and non-dominant patents. Drugs listed above may be protected by additional patents and other regulatory protections. See the DrugPatentWatch database for complete details

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Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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If your reader cannot render the information below, go to http://www.DrugPatentWatch.com/innovation to see the latest expirations

This newsletter is a free service of DrugPatentWatch
DrugPatentWatch offers comprehensive details on FDA approved drugs, developers, and their patents

Drug Patent Expirations for March 22 2013

TradenameApplicantGeneric Name Patent Expiration
RYBIX ODTShionogi Inctramadol hydrochlorideMar 22, 2013

*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.


DrugPatentWatch Infographics

Which pharmaceutical companies recieved the most drug approvals last
year

Which Companies had the Most Drug Approvals Last Year?

More infographics »

DrugPatentWatch Serves Your Competitive Intelligence Needs

Subscribers have access to valuable datasets, including:
  • Patent litigation
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  • International patent families
  • International patent priority and PCT information
  • Patent maintenance
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  • Tentative approvals
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See the Database Preview and Plan Comparison. Contact Us with any questions.

The above list does not discriminate between dominant and non-dominant patents. Drugs listed above may be protected by additional patents and other regulatory protections. See the DrugPatentWatch database for complete details

DISCLAIMER:
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
All trademarks and applicant names are the property of their respective owners or licensors.

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

The SEC's enforcement programme on biotechnology's communications with the investment community

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ABSTRACT: The proliferation of biotechnology start-up companies has led to increased scrutiny by the regulators of the securities markets. The author, a former head of a field office of the United States Securities and Exchange Commission, examines the growing cooperation among regulatory agencies in the U...

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

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 Finston
Even if you have never heard of Thomas Kuhn, your thinking about science has most likely been effected by his theory of what causes paradigm shifts.

Over 50 years ago, Thomas Kuhn published The Structure of Scientific Revolutions (1961), one of the most cited academic books of all time.  Kuhn’s theories about the fashion of research challenged the conventional wisdom of science as a logical, step-wise progression.

Kuhn demonstrated that rather than a step-by-step process, scientific research proceeds in fits and starts, with new, potentially important discoveries bumping up against established theories and prevailing fashions. He documented the empirical difficulties of establishing new science paradigms, where scientists may have a vested interest in preservation of the status quo.

Simply put, scientists with funding are loathe to discard research programs, regardless of whether they are breaking new ground – that is the human condition.  And grant-making organizations and corporate funders similarly prefer the familiar over the unknown.  This has the effect of pushing away new, possibly better ideas, even in the face of inconsistent data.

So until an overwhelming amount of these data points accumulate that cannot be reconciled with the existing paradigm, the science establishment resists change.  Then once the tipping point is reached, we come to Kuhn’s paradigm shift where continuing the status quo becomes unacceptable and change is unavoidable.

Now we can add Cancer R&D models to the long list of Kuhn’s illustrations where a science revolution is long overdue and blocked by over-commitment to the status quo.

Given the vast financial resources needed to bring new cancer drugs to market, the substantial time required to move from in vitro to in vivo research and through the regulatory process, and the professional stake of countless scientists and institutions to the status quo, the area of cancer research may be the least open to science revolution.

This is a research environment that rewards predictable R&D over truly ground-breaking research models, and where over $100 billion dollars is spent on research yielding few new effective therapies or cures:

“Jim Watson, the Nobel-winning discoverer of DNA’s double-helix structure, caused a minor sensation recently by arguing that curing most metastatic cancers — cancers that spread in the body — remains more daunting than ever, while researchers pursue scientific dead ends.  Lamenting a “conservative” research establishment that he suggested is reluctant to take scientific risks, he urged scientists to follow new, unexplored, yet more promising directions.”

Given recent high profile failures of late-stage cancer programs, even cancer research fast may be reaching the point where it is no longer possible to ignore the need for truly novel approaches.

Are you ready for the coming revolution in cancer R&D?

About the author:
President of Finston Consulting LLC since 2005, Susan works with innovative biotechnology and other clients ranging from start-up to Fortune-100, providing support for legal, transactional, policy and “doing business” issues. Susan has extensive background and special expertise relating to intellectual property and knowledge-economy issues in advanced developing countries including India and South Asia, Latin America and the Middle East North Africa (MENA) region. She also works with governments, s and NGOs on capacity building and related educational programs through BayhDole25. Together with biotechnology pioneer Ananda Chakrabarty, she also is co-founder of Amrita Therapeutics Ltd., an emerging biopharmaceutical company based in India with cancer peptide drugs entering in vivo research. Previous experience includes 11 years in the U.S Foreign Service with overseas tours in London, Tel Aviv, and Manila and at the Department of State in Washington DC. For more information on latest presentations and publications please visit finstonconsulting.com.

Drug Patent Expirations for April 2013

TradenameApplicantGeneric NamePatent NumberPatent Expiration
BROVANASunovionarformoterol tartrate6,589,508Apr 3, 2013
RAPLONOrganon Usa Incrapacuronium bromide5,418,226Apr 14, 2013
ACUTECTCis Bio Intl Satechnetium tc-99m apcitide5,508,020Apr 16, 2013
NICODERM CQSanofi Aventis Usnicotine5,508,038Apr 16, 2013
GENOTROPIN PRESERVATIVE FREEPharmacia And Upjohnsomatropin recombinant5,501,673Apr 16, 2013
OXYCONTINPurdue Pharma Lpoxycodone hydrochloride5,508,042Apr 16, 2013
CAVERJECT IMPULSEPharmacia And Upjohnalprostadil5,501,673Apr 16, 2013
GENOTROPIN PRESERVATIVE FREEPharmacia And Upjohnsomatropin recombinant5,435,076Apr 16, 2013
AZOPTAlcon Pharms Ltdbrinzolamide5,461,081*PEDApr 24, 2013
ZELNORMNovartistegaserod maleate5,510,353Apr 26, 2013
HYTRINAbbottterazosin hydrochloride5,412,095Apr 29, 2013
HYTRINAbbottterazosin hydrochloride5,294,615Apr 29, 2013
ALVESCOTakeda Gmbhciclesonide6,036,942Apr 30, 2013
CEDAXPernix Therapceftibuten dihydrate5,599,557Apr 30, 2013
ZETONNATakeda Gmbhciclesonide6,036,942Apr 30, 2013
*Drugs may be covered by multiple patents or regulatory protections. See the DrugPatentWatch database for complete details.

Subscribers have access to valuable datasets, including:

  • Clinical trial information
  • International patent families
  • International patent priority and PCT information
  • Patent maintenance
  • Full-text patent downloads
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  • Paragraph IV challenges
  • Tentative approvals
  • Dynamic search capabilities with data export
  • More…
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