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	<title>JOLT Digest &#187; Bioethics</title>
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	<description>JOLT Digest offers up-to-date information on current events in law and technology.</description>
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		<title>Assn. for Molecular Pathology v. USPTO</title>
		<link>http://jolt.law.harvard.edu/digest/patent/assn-for-molecular-pathology-v-uspto</link>
		<comments>http://jolt.law.harvard.edu/digest/patent/assn-for-molecular-pathology-v-uspto#comments</comments>
		<pubDate>Tue, 10 Nov 2009 18:26:54 +0000</pubDate>
		<dc:creator>DeeAccount</dc:creator>
				<category><![CDATA[2nd Circuit Decisions]]></category>
		<category><![CDATA[Bioethics]]></category>
		<category><![CDATA[District Courts]]></category>
		<category><![CDATA[First Amendment]]></category>
		<category><![CDATA[Patent]]></category>
		<category><![CDATA[Davis Doherty]]></category>
		<category><![CDATA[Jad Mills]]></category>

		<guid isPermaLink="false">http://jolt.law.harvard.edu/digest/?p=311</guid>
		<description><![CDATA[Constitutional Challenge to Gene Patents Survives Motion to Dismiss
By Davis Doherty &#8211; Edited by Jad Mills
Assn. for Molecular Pathology, et al. v. USPTO, et al., Case no. 09-CV-4514 (S.D.N.Y. Nov. 2, 2009)
Slip Opinion (hosted by Patent Baristas)
The United States District Court for the Southern District of New York denied defendants&#8217; motion to dismiss plaintiffs&#8217; claim [...]]]></description>
			<content:encoded><![CDATA[<p><strong>Constitutional Challenge to Gene Patents Survives Motion to Dismiss</strong></p>
<p>By Davis Doherty &#8211; Edited by Jad Mills<br />
Assn. for Molecular Pathology, et al. v. USPTO, et al., Case no. 09-CV-4514 (S.D.N.Y. Nov. 2, 2009)<br />
<a href="http://www.patentbaristas.com/wp/wp-content/uploads/2009/11/MTD_decision.pdf" target="_blank">Slip Opinion</a> (hosted by Patent Baristas)</p>
<p>The United States District Court for the Southern District of New York denied defendants&#8217; motion to dismiss plaintiffs&#8217; claim that patents on a human gene violate the First Amendment and Article I of the Constitution for jurisdictional issues, lack of standing, and failure to state a claim.</p>
<p>District Judge Sweet found that the plaintiffs’ constitutional claims challenging the validity of Myriad Genetics’ gene patents provided subject matter jurisdiction and standing to sue the United States Patent and Trademark Office because of the lack of available statutory remedies.  The plaintiffs claim that Myriad’s patents are inappropriate because they cover “products of nature”, and seek invalidation of the patents under the Constitution of the United States. Judge Sweet held that these claims met the stricter pleading standards recently announced in <a href="http://www.supremecourtus.gov/opinions/08pdf/07-1015.pdf" target="_blank">Ashcroft v. Iqbal</a>, 129 S.Ct. 1937 (2009).  In so holding, the court noted the “novel circumstances presented by this action against the USPTO”: The Patent and Trade Office is generally immune from suit due to the availability of statutory remedies for claims arising from patents. Such remedies do not provide for constitutional claims.</p>
<p><a href="http://arstechnica.com/science/news/2009/11/judges-refuses-to-block-lawsuit-over-patenting-genetic-tests.ars?utm_source=rss&amp;utm_medium=rss&amp;utm_campaign=rss" target="_blank">Ars Technica</a> provides a brief overview of the case.  The <a href="http://www.aclu.org/free-speech_womens-rights/court-upholds-right-scientists-and-patients-challenge-gene-patents" target="_blank">ACLU</a>, who represents the plaintiffs, writes in support of the decision.  <a href="http://www.patentbaristas.com/archives/2009/11/03/aclupubpat-gene-patent-challenge-moves-ahead/" target="_blank">Patent Baristas</a> put forward a more skeptical view of the plaintiffs’ prospects. <a href="http://www.patentdocs.org/2009/11/patent-suit-to-continue-in-southern-district-of-new-york.html" target="_blank">Patent Docs</a> features a longer analysis of the decision.<span id="more-311"></span></p>
<p>Defendant Myriad Genetics owns interests in several patents on the human genes <em>BRCA1</em> and <em>BRCA2</em>, both of which can indicate an increased risk of breast or ovarian cancer.  Myriad can thus control the availability of genetic testing for the <em>BRCA1</em> and <em>BRCA2</em> sequences, a process that can cost as much as $3000.  The patents also allow Myriad to restrict other laboratories’ research on the <em>BRCA</em> sequences.  The numerous plaintiffs include researchers, testing laboratories, medical societies, advocacy organizations, and cancer patients with various interests in seeing the invalidation of the patents-at-issue.</p>
<p>Arguing on behalf of the plaintiffs, the ACLU and the Public Patent Foundation claim that the patents violate the First Amendment’s protection of freedom of thought and Article I, section 8, clause 8’s instruction that Congress “promote the Progress of Science and useful Arts”.  In holding that the plaintiffs have standing to sue and that subject matter jurisdiction exists, the court relied on the fact that these constitutional claims fall outside the remedies provided by the Patent Act.  In holding the pleading sufficient, the court reasoned that the First Amendment claim is supported by the plaintiffs’ argument that the <em>BRCA</em> patents cover a product of nature, and the Article I claim is supported by the contention that the patent has inhibited research on the genes.</p>
<p>This suit is significant for both procedural and public policy reasons.  Using constitutional claims in an attempt to invalidate patents is a novel approach, and is probably the only approach that would allow the plaintiffs to include the USPTO as a defendant. A victory for the plaintiffs could result in an increased availability of genetic testing for breast cancer risks.  More broadly, if the plaintiffs present a successful challenge to the USPTO’s general policy of granting gene patents, the validity of patents on an estimated 20% of the human genome would be called into question.</p>
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		<title>Flash Digest: News in Brief</title>
		<link>http://jolt.law.harvard.edu/digest/9th-circuit/flash-digest-news-in-brief-7</link>
		<comments>http://jolt.law.harvard.edu/digest/9th-circuit/flash-digest-news-in-brief-7#comments</comments>
		<pubDate>Sat, 23 May 2009 18:38:40 +0000</pubDate>
		<dc:creator>DeeAccount</dc:creator>
				<category><![CDATA[2nd Circuit Decisions]]></category>
		<category><![CDATA[5th Circuit Decisions]]></category>
		<category><![CDATA[9th Circuit Decisions]]></category>
		<category><![CDATA[Bioethics]]></category>
		<category><![CDATA[Communications Decency Act]]></category>
		<category><![CDATA[District Courts]]></category>
		<category><![CDATA[First Amendment]]></category>
		<category><![CDATA[Flash Digest]]></category>
		<category><![CDATA[Internet]]></category>
		<category><![CDATA[Patent]]></category>
		<category><![CDATA[Trademark]]></category>
		<category><![CDATA[Vera Ranieri]]></category>

		<guid isPermaLink="false">http://jolt.law.harvard.edu/digest/?p=137</guid>
		<description><![CDATA[Content by Vera Ranieri
Google Sued for Use of Trademarked Terms in Adwords Program
A class action was filed against Google on May 11, 2009 in federal court in Texas challenging its use of trademarked terms in its adwords program. The New York Times covered the case and surrounding issues. Ars Technica analyzes Google&#8217;s new AdWords policy.
ACLU Challenges Constitutionality of [...]]]></description>
			<content:encoded><![CDATA[<p>Content by Vera Ranieri</p>
<p><strong>Google Sued for Use of Trademarked Terms in Adwords Program</strong></p>
<p><span style="font-weight: normal;">A <a>class action</a> was filed against Google on May 11, 2009 in federal court in Texas challenging its use of trademarked terms in its adwords program. The New York Times <a href="http://www.nytimes.com/2009/05/15/technology/internet/15google.html?_r=2&amp;hpw" target="_blank">covered</a> the case and surrounding issues. Ars Technica <a href="http://arstechnica.com/web/news/2009/05/google-may-relent-on-adwords-trademark-usage.ars" target="_blank">analyzes</a> Google&#8217;s new AdWords policy.</span></p>
<p><strong>ACLU Challenges Constitutionality of Gene Patents<br />
</strong><br />
The ACLU filed suit in the Southern District of New York challenging the patenting of genes and genetic tests as unconstitutional. The New York Times <a href="http://www.nytimes.com/2009/05/13/health/13patent.html?ref=health" target="_blank">reported</a> on the suit and the ACLU&#8217;s plaintiff. Patently-O provides further <a href="http://www.patentlyo.com/patent/2009/05/people-vs-the-brca-patents.html" target="_blank">analysis</a> and links to the ACLU blog and the complaint.</p>
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		</item>
		<item>
		<title>Dahl v. Angle</title>
		<link>http://jolt.law.harvard.edu/digest/bioethics/dahl-v-angle</link>
		<comments>http://jolt.law.harvard.edu/digest/bioethics/dahl-v-angle#comments</comments>
		<pubDate>Fri, 17 Oct 2008 04:45:32 +0000</pubDate>
		<dc:creator>Andrew Ungberg</dc:creator>
				<category><![CDATA[Bioethics]]></category>
		<category><![CDATA[State Courts]]></category>
		<category><![CDATA[Anna Lamut]]></category>
		<category><![CDATA[Stephanie Weiner]]></category>

		<guid isPermaLink="false">http://jolt.law.harvard.edu/digest/?p=72</guid>
		<description><![CDATA[
Oregon State Appeals Court Finds Frozen Embryos &#8221;Personal Property&#8221; in Divorce Proceeding 
By Anna Lamut &#8211; Edited by Stephanie Weiner 
Dahl v. Angle
Or. Ct. App., October 8, 2008, A133697
Slip Opinion
The Court of Appeals of the State of Oregon upheld the decision of the trial court to enforce a contract made between a now-divorced husband and wife regarding six frozen embryos resulting from [...]]]></description>
			<content:encoded><![CDATA[<p><!--StartFragment--></p>
<p class="MsoNormal"><strong>Oregon State Appeals Court Finds Frozen Embryos &#8221;Personal Property&#8221; in Divorce Proceeding <br />
<span style="font-weight: normal; ">By Anna Lamut &#8211; Edited by Stephanie Weiner</span> </strong></p>
<p class="MsoNormal">Dahl v. Angle<br />
Or. Ct. App., October 8, 2008, A133697<br />
<a href="http://www.publications.ojd.state.or.us/A133697.htm" target="_blank">Slip Opinion</a></p>
<p class="MsoNormal">The Court of Appeals of the State of Oregon upheld the decision of the trial court to enforce a contract made between a now-divorced husband and wife regarding six frozen embryos resulting from the couple&#8217;s attempt to conceive in vitro. The contract provided that, in the event of a disagreement, the wife would have the right to decide what would happen to the embryos. Necessary to the Court of Appeals’ decision was a finding that the contractual right to determine the fate of frozen embryos is personal property.</p>
<p class="MsoNormal">While married, the parties had unsuccessfully tried to conceive a child via in vitro fertilization, a process that left six frozen embryos at the Oregon Health and Science University (&#8221;OHSU&#8221;). The parties executed an &#8220;Embryology Laboratory Specimen Storage Agreement&#8221; at the time that they underwent the procedure, which gave the wife, Dr. Laura Dahl, the “sole and exclusive right” to instruct OHSU to transfer or dispose of the embryos in the event that the parties were not able to agree. Dr. Dahl chose to have the embryos destroyed, while her ex-husband, Dr. Darrell Angle, denied having initialed or read the agreement. He claimed that “embryos are life” and did not want the embryos destroyed because &#8220;there&#8217;s no pain greater than having participated in the demise of your own child.&#8221;</p>
<p class="MsoNormal">The <a href="http://hosted.ap.org/dynamic/stories/F/FROZEN_EMBRYOS?SITE=AP&amp;SECTION=HOME&amp;TEMPLATE=DEFAULT" target="_blank">Associated Press</a> and <a href="http://cbs2.com/health/embryos.divorce.rights.2.836198.html" target="_blank">CBS</a> provide overviews of the case. </p>
<p class="MsoNormal">Andy Dworkin of the Oregonian provides <a href="http://www.oregonlive.com/news/index.ssf/2008/10/oregon_court_sees_frozen_embry.html" target="_blank">commentary</a>. </p>
<p class="MsoNormal"><span id="more-72"></span><span id="_mce_tmp">Dr. Angle argued that the embryos are marital property, and that therefore a “just and equal distribution” of this property would mean giving him the embryos because he values them as &#8220;life.&#8221; Dr. Dahl argued that the embryos are not property and are therefore not within the purview of the court; she also argued that even if they are property, a court cannot not treat this property in a way that forces her to become a parent.</span></p>
<p class="MsoNormal">A three-judge panel of the Oregon State Court of Appeals, comprising judges Armstrong, Rosenblum, and Carson, held that the contractual right to possess or dispose of the frozen embryos was personal property subject to a “just and proper” distribution. The Court acknowledged the difficulty in defining such rights as “personal property,” and noted that this property right is fundamentally unique and distinct from most others, and cannot be measured by monetary value.<span> </span></p>
<p class="MsoNormal">Finding no controlling Oregon authority for such a case, the Court turned to two relevant decisions from Tennessee and New York, <em>Davis v. Davis</em><span>, 842 S.W.2d 588 (Tenn. Ct. App. 1992) and </span><em>Kass v. Kass</em><span>, 91 N.Y.2d 554 (N.Y. 1998).<span>  </span>Guided by these decisions, the court determined that the parties’ advance intent, as evidenced by the contract, should control, and thus awarded the decision-making authority to Dr. Dahl.<span> </span></span></p>
<p class="MsoNormal">This decision makes Oregon the eighth state to consider this situation and rule in favor of the party that did not want the embryos implanted. The Oregon decision is novel, however, in that it is the first of these decisions to hold that the contractual right to determine the fate of frozen embryos is property.</p>
<p class="MsoNormal"> </p>
<p><!--EndFragment--> </p>
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		<title>Monsanto v. Bayer Bioscience</title>
		<link>http://jolt.law.harvard.edu/digest/patent/monsanto-v-bayer-bioscience</link>
		<comments>http://jolt.law.harvard.edu/digest/patent/monsanto-v-bayer-bioscience#comments</comments>
		<pubDate>Wed, 30 Jan 2008 19:53:41 +0000</pubDate>
		<dc:creator>David Lawson</dc:creator>
				<category><![CDATA[Bioethics]]></category>
		<category><![CDATA[Federal Circuit Decisions]]></category>
		<category><![CDATA[Patent]]></category>
		<category><![CDATA[Michelle Yang]]></category>
		<category><![CDATA[Wen Bu]]></category>

		<guid isPermaLink="false">http://jolt.law.harvard.edu/digest/patent/monsanto-v-bayer-bioscience</guid>
		<description><![CDATA[Federal Circuit Holds Patent Unenforceable Following Patentee&#8217;s Failure to Disclose Material Notes
By Michelle Yang &#8212; Edited by Wen Bu
Monsanto Corp. v. Bayer Bioscience N.V.
Federal Circuit, January 25, 2008, No. 2007-1109
Slip Opinion
On January 25, the Federal Circuit affirmed the District Court for the Eastern District of Missouri’s holdings: 1) that Bayer’s patent for certain chimeric genes [...]]]></description>
			<content:encoded><![CDATA[<p><strong>Federal Circuit Holds Patent Unenforceable Following Patentee&#8217;s Failure to Disclose Material Notes</strong></p>
<p>By Michelle Yang &#8212; Edited by Wen Bu</p>
<p>Monsanto Corp. v. Bayer Bioscience N.V.<br />
Federal Circuit, January 25, 2008, No. 2007-1109<br />
<a href="http://www.cafc.uscourts.gov/opinions/07-1109.pdf">Slip Opinion</a></p>
<p>On January 25, the Federal Circuit affirmed the District Court for the Eastern District of Missouri’s holdings: 1) that Bayer’s patent for certain chimeric genes was unenforceable for inequitable conduct, and 2) that the district court had jurisdiction to declare three related patents unenforceable. </p>
<p>The Federal Circuit held that Bayer’s patent was unenforceable for inequitable conduct. Judge Gajarsa&#8217;s opinion held that Bayer breached its duty of candor and good faith to the United States Patent and Trademark Office in failing to disclose its employee’s notes on another researcher’s poster at a scientific conference. </p>
<p>The court also upheld the district court’s jurisdiction over three other patents relating to the chimeric genes, holding that the district court still retained jurisdiction because of Monsanto’s request for attorney fees, despite Bayer&#8217;s motion to dismiss the claims on the other patents and subsequent signing of a covenant not to sue Monsanto for infringement of those patents.</p>
<p><a href="http://www.patentlyo.com/patent/2008/01/bt-corn-patent.html">Dennis Crouch</a> of Patently-O summarizes the opinion.<br />
<a href="http://ipbiz.blogspot.com/2008/01/monsanto-v-bayer-bioscience.html">Lawrence B. Ebert</a> of IPBiz mentions some interesting aspects of the case&#8217;s procedural history.<br />
<a href="http://www.patentbaristas.com/archives/2008/01/26/bayer-learns-that-note-taking-can-come-back-to-bite-your-patent/">Stephen Albainy-Jenei</a> of Patent Baristas warns that “note-taking can come back to bite your patent.”</p>
<p><span id="more-24"></span></p>
<p>The case involved a patent for chimeric genes containing a Bt toxin-coding gene, intended to create insect-resistance in plants. At the time of prosecution, Bayer had disclosed Dr. Wayne Barnes’s abstract but distinguished its claims from this prior art to overcome an initial rejection by the patent examiner for obviousness. However, Bayer did not disclose its employee’s notes on Dr. Barnes’ poster, which contained more details about the extent of his research. The Federal Circuit did not decide whether, as the district court found, the notes “would establish a prima facie case of unpatentability.” It nonetheless held the notes were material because they directly contradicted Bayer’s arguments for patentability to the PTO, satisfying the standard of 37 C.F.R. § 1.56(2)(i). </p>
<p>The Federal Circuit did not find clear error in the district court’s finding of intent to deceive the PTO. It had previously held that “intent may be inferred where a patent applicant knew, or should have known that withheld information would be material.”  The district court had found Bayer’s explanations for withholding the notes to be unpersuasive. </p>
<p>Monsanto had originally sought a declaratory judgment in December 2000 that its MON810 genetically modified corn, which incorporated the Bt toxin gene, did not infringe any of Bayer’s four patents. Bayer sought dismissal of its infringement claims and filed a covenant not to sue Monsanto for infringement of those patents, but the district court still retained jurisdiction under 35 U.S.C. § 285 because of Monsanto’s request for attorney fees. Citing Nilssen v. Osram Sylvania, Inc., the Federal Circuit held that the district court’s § 285 jurisdiction to determine inequitable conduct conferred jurisdiction to hold all three patents unenforceable.  Though the patents were no longer in suit, the patents’ unenforceability automatically followed the determination of inequitable conduct.</p>
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