Publications – Oblon, McClelland, Maier & Neustadt, L.L.P. Intellectual Property Law Firm en-us 17 Sep 2019 00:00:00 -0800 firmwise Prosecution History Estoppel And Amendments Tangential To Patentability <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;The doctrine of equivalents is an equitable exception to the basic concept that the patent claims define the limit of claim protection. It is intended to prevent one from making an insubstantial change to a claimed invention to avoid infringement which is defined by the function-way-result test.&nbsp;The doctrine is limited by the prior art, dedication to the public, and prosecution history estoppel.&nbsp;The prior art limitation is straightforward, the doctrine cannot be applied to find infringement if it also results in the prior art infringing the claim, rendering to unpatentable.&nbsp;Dedication to the public is similarly straight forward, if the equivalent was disclosed but not claimed in the patent, the public is free to use the unclaimed but disclosed equivalent.&nbsp;Prosecution history estoppel while seemingly simple, a narrowing amendment to secure patentability surrenders the subject matter lying between the original claim and the amendment, has exceptions as explained in <i>Festo<a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/The%20Doctrine%20Equivalents%20and%20Prosecution%20History%20Estoppel%20v2.docx#_ftn1" name="_ftnref1" title=""><b>[1]</b></a></i>:</p> <p style="margin-left: 40px;">The equivalent may have been unforeseeable at the time of the application; the rationale underlying the amendment may bear no more than a tangential relation to the equivalent in question; or there may be some other reason suggesting that the patentee could not reasonably be expected to have described the insubstantial substitute in question. In those cases the patentee can overcome the presumption that prosecution history estoppel bars a finding of equivalence.</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;In <i>Eli Lilly &amp; Co. v. Hospira, Inc.</i>, appeal nos. 2018-2126, 2018-2127, and 2018-2128, the Federal Circuit applied the doctrine of equivalents where the original claims had been amended to avoid prior art.&nbsp;The original claim had been literally infringed but the amended claim was not.&nbsp;The claims were directed to reducing the toxicity associated with administering an antifolate agent by administering prior to the antifolate, folic acid and vitamin B<sub>12</sub>. As a result of prior art suggesting methatrexate, the antifolate was limited to pemetrexed disodium.&nbsp;Hospira&rsquo;s formulation used ditromethamine salt of pemetrexed instead of the disodium salt. The Lilly application only described either an antifolate broadly or pemetrexed disodium, no suggestion of other salts even though they were known.&nbsp;The Lilly application did cite to prior art for other antifolates but did not incorporate the disclosures by reference.&nbsp;It was not disputed that the active component was not the salt form but rather the pemetrexed which resulted from the dissociation of the salt in solution or in the body.<br /> <br /> Hospira&rsquo;s FDA application was not for an ANDA since the pemetrexed ditromethamine was not identical to Lilly&rsquo;s pemetrexed disodium.&nbsp;Instead, Hospira filed a 505(b)(2) application with the FDA.&nbsp;In its application it averred that its compound did not differ in the mode action from that of Lilly&rsquo;s since the active moiety was the same &ndash; pemetrexed - making success on its prosecution history estoppel essential to its non-infringement position.</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Since Lilly had only two choices for the antifolate, either the generic antifolate or the species pemetrexed disodium, to avoid the prior art it had no choice but to limit the claims to the specie.&nbsp;Lilly argued that the limitation to the disodium salt was tangential to patentability.&nbsp;On this point Lilly had evidence in the rejection of a dependent claim directed to pemetrexed disodium over prior art teaching the use of a pemetrexed disodium formulation which lacked the folic acid and vitamin B<sub>12</sub>.&nbsp;This rejection was overcome by the amendment requiring both vitamin B<sub>12</sub> and folic acid.&nbsp;This meant that the salt form was not a basis for patentability, i.e., it was tangential.</p> <p>&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;In this case Lilly was fortunate to have the dependent claim rejected as it provided objective evidence to support its argument that the specific salt was tangential to patentability, it was the pemetrexed that made it patentable over the methatrexate prior art not the salt form.&nbsp;In the absence of this evidence Lilly&rsquo;s tangential to patentability argument would have been weaker.</p> The lesson is simple, even when seeking to protect a species of a drug salt form, never limit the disclosure or all the claims to the specific salt.&nbsp;Always describe other salt forms including the generic term &ldquo;pharmaceutically acceptable salt.&rdquo; Here such an approach would have made Lilly&rsquo;s case much stronger and easier. <div><br clear="all" /> <hr align="left" size="1" width="33%" /> <div id="ftn1"> <p><a href="file:///C:/Users/ProfileDisk/ssejas-castro/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/RK8JVMEI/The%20Doctrine%20Equivalents%20and%20Prosecution%20History%20Estoppel%20v2.docx#_ftnref1" name="_ftn1" title="">[1]</a> <i>Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki</i> Co., 535 U.S. 722, 740, 741 (2002)</p> </div> </div> Article 17 Sep 2019 00:00:00 -0800 Dissent Exposes Flaws In Fed. Circ. ANDA Patent Holding - Dissent Exposes Flaws In Fed. Circ. ANDA Patent Holding_DPereira_092019.pdf&anc=995&format=xml <strong>Dan Pereira</strong> wrote an article entitled &quot;Dissent Exposes Flaws in Fed. Cir. ANDA Patent Holding&quot; featured in <em>Law360</em>&nbsp;as Expert Analysis, on September 16th, 2019.&nbsp; Article 17 Sep 2019 00:00:00 -0800 - Dissent Exposes Flaws In Fed. Circ. ANDA Patent Holding_DPereira_092019.pdf&anc=995&format=xml Method-of-Treatment Claims, Comprising Excluding Certain Patients from Treatment, Found to Be Patent-Ineligible Under 35 U.S.C. § 101 Therapeutics v Praxair 27Aug2019.pdf&anc=995&format=xml <p>On August 27, 2019, in <i>INO Therapeutics LLC v. Praxair Distribution Inc.</i>, in a 2-1 decision, the Federal Circuit upheld a district court decision that method-of-treatment claims, comprising excluding certain patients from treatment, were invalid under 35 U.S.C. &sect; 101.</p> <p>Claim 1 of U.S. Patent No. 8,795,741 is representative:</p> <p>1. A method of treating patients who are candidates for inhaled nitric oxide [&ldquo;iNO&rdquo;] treatment&hellip;comprising:</p> <p>(a) identifying a plurality of term or near-term neonatal patients who have hypoxic respiratory failure and are candidates for 20 ppm inhaled nitric oxide treatment;</p> <p>(b) determining that a first patient of the plurality does not have left ventricular dysfunction [&ldquo;LVD&rdquo;];</p> <p>(c) determining that a second patient of the plurality has left ventricular dysfunction, so is at particular risk of increased PCWP leading to pulmonary edema upon treatment with inhaled nitric oxide;</p> <p>(d) administering 20 ppm inhaled nitric oxide treatment to the first patient; and</p> <p>(e) excluding the second patient from treatment with inhaled nitric oxide, based on the determination that the second patient has left ventricular dysfunction, so is at particular risk of increased PCWP leading to pulmonary edema upon treatment with inhaled nitric oxide.</p> <p>The majority of the Federal Circuit panel noted that &ldquo;[i]t is undisputed that treatment of infants experiencing hypoxic respiratory failure with iNO gas has existed for decades&rdquo; (<i>slip op. </i>at page 8). The majority acknowledged that &ldquo;[t]he inventors observed an adverse event [pulmonary edema] that iNO gas causes for certain patients&rdquo; (<i>Id.</i> at pages 8-9).</p> <p>The majority focused on step (e) of the claim, reciting the exclusion of such patients from treatment with iNO. The majority characterized this step as &ldquo;simply an instruction <i>not</i> to act&rdquo; (<i>Id.</i> at page 10). The majority stated that &ldquo;[i]n effect, the claim is directed to detecting the presence of LVD in a patient and then doing nothing but leaving the natural processes taking place in the body alone for the group of LVD patients. Accordingly, the claim is directed to the natural phenomenon&rdquo; (<i>Id.</i>).</p> <p>The majority distinguished the claims in <i>INO</i> from method-of-treatment claims recently found to be patent-eligible in <i>Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals International Ltd.</i>, 887 F.3d 1117 (Fed. Cir. 2018). The majority in <i>INO</i> noted that in <i>Vanda</i>,</p> <p style="margin-left: 40px;">[a]fter the risk of QT prolongation was identified for certain metabolizers, the claims did not simply instruct doctors to stop treating those patients with iloperidone based on that information. Instead, the claims leveraged the natural phenomenon to improve treatment for schizophrenia. The claims required the doctor to <i>treat </i>a patient with a specific low-dose range if she had a &ldquo;poor metabolizer genotype&rdquo; or a specific high-dose range if she did not have the genotype. (<i>slip op. </i>at page 12).</p> <p>In contrast, the majority noted that in <i>INO</i>, &ldquo;the invention is not focused on changing the physiological state of the patient to treat the disease. The claimed invention is focused on screening for a natural law&rdquo; (<i>Id.</i> at pages 14-15). &ldquo;Claim 1 does not recite a set of dosages that offer some relief to LVD infants while minimizing the risk of an adverse event. It simply sets out an observation of the adverse event, and then instructs the physician to withhold iNO treatment&rdquo; (<i>Id.</i> at pages 15-16).</p> <p>Interestingly, the majority acknowledged that step (d) of claim 1 positively recites administering iNO to a patient who does not have LVD. That is, step (d) requires administering iNO to a certain patient, as opposed to step (e)&rsquo;s withholding of iNO treatment from a different patient (to let nature take its course). However, the majority found that step (d) &ldquo;is plainly not the focus of the claimed invention. [Plaintiff-Appellant] concedes this step is not innovative&rdquo; (<i>Id.</i> at page 11). This is similar to the district court&rsquo;s analysis, which found that steps (a), (b), (c) and (d) of claim 1 were &ldquo;routine and conventional in the art&rdquo; and therefore unable to &ldquo;transform a patient&rsquo;s natural risk of developing pulmonary edema, given preexisting LVD and treatment with iNO, into a patentable invention.&rdquo;</p> <p>Thus, the majority of the Federal Circuit panel continued the trend, from most cases in the <i>Mayo/Alice</i> line, of considering &ldquo;inventiveness&rdquo; in the &sect; 101 inquiry, rather than leaving inventiveness for an inquiry under &sect; 103.</p> <p>The majority expressed caution about the breadth of its holding, in particular about concerns that the holding could harm the nascent field of personalized medicine. The majority explained that &ldquo;[w]hile &sect; 101 precludes bare monopolies on natural phenomena, new and inventive methods of treatment in personalized medicine remain patent eligible. We conclude that the specific claims here are ineligible. But we emphasize the narrowness of our holding today, which is limited to the particular claims at issue and is driven by the particular circumstances here&rdquo; (<i>slip op.</i> at page 22).</p> <p>Judge Newman dissented from the majority&rsquo;s opinion on patent-eligibility under &sect; 101. She explained that &ldquo;[t]he claims are for a method of medical treatment&mdash;a class of subject matter whose eligibility under section 101 is established by precedent&rdquo; (<i>slip op.</i> at page 1). She criticized the majority&rsquo;s opinion for &ldquo;not acknowledg[ing] that the claimed multi-step method of treatment of hypoxic respiratory failure does not occur in nature. The majority improperly separates the claims into old and new steps, describes some claim steps as a &lsquo;natural phenomenon&rsquo; and some steps as &lsquo;well-understood, routine, and conventional steps,&rsquo; and avoids the requirement that a claimed invention is considered as a whole&rdquo; (<i>Id.</i> at page 2).</p> <p>Judge Newman acknowledged that the claimed &ldquo;method of treatment may or may not pass the tests of sections 102 or 103&rdquo; (<i>Id.</i> at page 2). However, she expressed concern that the majority&rsquo;s opinion &ldquo;adds to the inconsistency and unpredictability of this area of patent-supported innovation&rdquo; (<i>Id.</i> at page 3).</p> <p>The majority&rsquo;s opinion in <i>INO</i> suggests that method-of-treatment claims are not <i>per se</i> eligible under &sect; 101. That is, method-of-treatment claims still can face scrutiny under &sect; 101 as being &ldquo;directed to&rdquo; natural phenomena, especially when certain method steps are considered to be &ldquo;routine and conventional in the art.&rdquo; This contrasts with the clarity some hoped for after the decision in <i>Vanda</i>. As is usually the case with patent claims, the devil is in the details.</p> Article 13 Sep 2019 00:00:00 -0800 Therapeutics v Praxair 27Aug2019.pdf&anc=995&format=xml I burn, burn like a wicker chair; chalk white and oh-so frail… <p>The title above refers to a lyric from a 1998 song by Eve 6, although they used the word &ldquo;cabinet&rdquo; instead of &ldquo;chair.&rdquo; While this simple substitution of a word on my part is designed to evoke an image, the choice of words and the image evoked* can mean so much more in the world of design patents.&nbsp;</p> <p>Yesterday, in <i>Curver Luxembourg v. Home Expressions</i> (Fed. Cir. Appeal No. 18-2214), the U.S. Court of Appeals for the Federal Circuit affirmed a District Court of New Jersey decision against plaintiff-appellant Curver Luxembourg.&nbsp; Curver sued Home Expressions for infringement of U.S. Design Patent No. D677,946, asserting that Home &ldquo;makes and sells a basket that is identical to Curver&rsquo;s basket in every way, including incorporating the patented overlapping &ldquo;Y&rdquo; design.&rdquo;&nbsp; Home countered that its baskets could not possibly infringe Curver&rsquo;s design patent, because the patent claim was limited to a <i>chair</i>.&nbsp; The district court agreed and dismissed the case, reasoning that Curver&rsquo;s &ldquo;original application was for a design on furniture.&nbsp; And what Curver got, as opposed to what it asked for, was a patent that protects against infringement for a particular &ldquo;Y&rdquo; design on chairs only.&rdquo;&nbsp; Here, &ldquo;in a case of first impression,&rdquo; the Federal Circuit also agreed, holding that the scope of Curver&rsquo;s U.S. design patent was limited to &ldquo;an ornamental design for a pattern <i>for a chair</i>,&rdquo; such that it did not read on Home&rsquo;s <i>baskets</i>.&nbsp;</p> Curver&rsquo;s U.S. Design Patent No. D677,946 is entitled &ldquo;Pattern for a Chair,&rdquo; and depicts &ldquo;the ornamental design for a pattern for a chair, as shown&rdquo; in 5 Figures. &nbsp;But each of the 5 Figures in the patent only show portions of an overlapping Y-shaped pattern&mdash;nothing more.&nbsp; Representative Figs. 1 and 4 are shown below. &nbsp;The depicted pattern called to mind something I would expect to see incorporated into a wicker<b><sup>1</sup></b> object made by woven rattan.&nbsp; Maybe that object could be a chair, but it could also be a cabinet, a table, or even a basket.&nbsp; But it is not possible to understand what specific object (article of manufacture) was depicted by just viewing the Figures. &nbsp;One can understand that the pattern is &ldquo;for a chair&rdquo; only from reading the description of the Figures.&nbsp; The astute observer, or should I say the ordinary observer, will already see the problem this creates.&nbsp;<br /> <br /> <img src="" hspace="0" vspace="0" align="absmiddle" alt="" border="0" width="712" height="304" /><br /> <p>The Federal Circuit picked up on this point, noting that its cases did not &ldquo;confront the atypical situation we have here, where all of the drawings fail to depict <i>an article of manufacture</i> for the ornamental design&rdquo; (emphasis added). In this case, the Federal Circuit &ldquo;address[ed] for the first time whether claim language specifying an article of manufacture can limit the scope of a design patent, even if that article of manufacture is not actually illustrated in the figures.&rdquo;&nbsp;It explained &ldquo;that long-standing precedent, unchallenged regulation, and agency practice all consistently support the view that design patents are granted only for a design applied to an article of manufacture, and not a design <i>per se</i>.&rdquo;&nbsp;Thus, it held &ldquo;that claim language can limit the scope of a design patent <i>where the claim language supplies the only instance of an article of manufacture that appears nowhere in the figures</i>&rdquo; (emphasis added).</p> <p>Curver&rsquo;s original design patent application was directed to &ldquo;a design for a furniture part,&rdquo; and was entitled &ldquo;Furniture (Part of-).&rdquo;&nbsp;It included a foreign priority claim to an application entitled &ldquo;Furniture Part.&rdquo;&nbsp;Neither application mentioned any specific type of furniture, whether a chair, a cabinet, or a table.&nbsp;Nor was there any mention of other type of object, such as a basket.&nbsp;</p> <p>The Examiner at the U.S. Patent and Trademark Office indicated in a first action that Curver&rsquo;s application was in condition for allowance, but at the same time objected to the Title of the application and the descriptions of the Drawings in the Specification as being inconsistent.&nbsp;Here, the Title was &ldquo;Furniture (Part of-),&rdquo; the Drawings were described as &ldquo;Furniture Part,&rdquo; and the Claim recited a &ldquo;rattan design for a furniture part.&rdquo;&nbsp;The Examiner required that the Title be amended so as to designate the particular article that is the subject of the design, and &ldquo;suggest[ed] the title be amended to read:&nbsp;&ldquo;Pattern for a Chair&rdquo;.&rdquo;&nbsp;The Examiner also asserted that the Claim was &ldquo;too vague,&rdquo; because it was not &ldquo;directed to the design for an article.&rdquo;&nbsp;But the Examiner did not similarly suggest a specific amendment for the Claim.</p> <p>In response, Curver amended the Title to &ldquo;Pattern for a Chair,&rdquo; and similarly amended the descriptions of the Drawings.&nbsp;Curver also amended the Claim to replace the language &ldquo;rattan design for a furniture part, as shown and described&rdquo; with &ldquo;pattern for a chair, as shown and described.&rdquo;&nbsp;Curver remarked that &ldquo;the title and the specification have been amended as required&rdquo; by the Examiner, and that these &ldquo;amendments introduce no new matter.&rdquo;&nbsp;Curver did not provide any remarks regarding the amendment to the language of the Claim.&nbsp;</p> <p>We can only speculate as to why the Examiner suggested amending the Title to &ldquo;Pattern <i>for a Chair</i>.&rdquo;&nbsp;Granted, a chair is commonly understood as an example of a piece of furniture.&nbsp;And the originally claimed &ldquo;rattan design for a furniture part&rdquo; would probably call to mind a &ldquo;chair&rdquo; as a typical piece of furniture that could be a wicker object made by woven rattan.&nbsp;But there are other examples of furniture that the Examiner could have chosen as an article of manufacture:&nbsp;a cabinet, or a table, etc. &nbsp;The Examiner&rsquo;s search notes identified the terms &ldquo;Pattern, Rattan Pattern, Chair Pattern, Material Pattern, Fabric Pattern.&rdquo;&nbsp;And, the Examiner&rsquo;s search results did not point exclusively to &ldquo;chairs.&rdquo;&nbsp;In fact, other than the Examiner&rsquo;s search notes and the suggested amendment to the Title, there is nothing in the application file that singles out a &ldquo;chair&rdquo; from any other example of &ldquo;furniture.&rdquo;&nbsp;</p> <p>We can also only speculate as to why Curver accepted the Examiner&rsquo;s suggested amendment, and why it similarly amended the Claim.&nbsp;Granted, Curver&rsquo;s application referred to &ldquo;furniture&rdquo; and to a &ldquo;rattan design for a furniture part.&rdquo;&nbsp;But its Figures only depicted portions of the overlapping Y-shaped pattern, leaving one to guess what example of &ldquo;furniture&rdquo; may include the &ldquo;rattan design.&rdquo;&nbsp;</p> <p>Also unanswered is why, given the specificity of the claim amendment, Curver asserted that the claim was infringed by a <i>basket</i>.&nbsp;Curver&rsquo;s original complaint pointed out that &ldquo;Curver makes and sells <i>storage baskets incorporating the design in the &lsquo;946 Patent</i>, which it sells throughout the United States&rdquo; (emphasis added).&nbsp;Curver&rsquo;s complaint further pointed out that &ldquo;The &lsquo;946 Patent claims the ornamental overlapping &ldquo;Y&rdquo; design pictured&rdquo; by a rotated version of Figure 1 from the patent.&nbsp;But the Complaint did not paint the whole picture&mdash;it omitted any mention of a &ldquo;pattern <i>for a chair</i>.&rdquo;&nbsp;Instead, it asserted infringement of the Y-shaped pattern itself&mdash;which on the basis of the Complaint alone could theoretically have been asserted against <i>anything</i> having that pattern.</p> <p>According to the Federal Circuit, Curver first raised on appeal (and thus waived) an argument that the patent figures &ldquo;depict a &ldquo;three-dimensional <i>panel structure</i> that includes the ornamental Y pattern,&rdquo; and that under <i>Samsung Electronics Co. v. Apple Inc.</i>, 137 S. Ct. 429, 435 (2016), this &ldquo;panel&rdquo; provides the requisite &ldquo;article of manufacture&rdquo; because it is a &ldquo;component&rdquo; of a product&rdquo; (emphasis added).&nbsp;But the Federal Circuit distinguished <i>Samsung</i>, noting that any such panel does not &ldquo;constitute[] the type of &ldquo;component&rdquo; contemplated by <i>Samsung</i> as being an &ldquo;article of manufacture.&rdquo;&nbsp;In <i>Samsung</i>, the components covered by Apple&rsquo;s design patents were parts of a concrete &ldquo;multicomponent&rdquo; smartphone product, not a surface ornamentation disembodied from any identifiable product, as here.&rdquo;</p> <p>Importantly, the Federal Circuit noted that &ldquo;our law has never sanctioned granting a design patent for a surface ornamentation in the abstract such that the patent&rsquo;s scope encompasses every possible article of manufacture to which the surface ornamentation is applied.&rdquo;&nbsp;Thus, its holding &ldquo;decline[s] to construe the scope of a design patent so broadly here merely because the referenced article of manufacture appears in the claim language, rather than the figures.&rdquo;</p> <p>For practitioners and applicants alike, the takeaway message here is to be very careful about the choice of words in a patent application&mdash;whether it is a utility patent application or a design patent application.&nbsp;Particularly, in the case of design patents, be very careful about accepting an Examiner&rsquo;s suggested amendment to the Title, the descriptions of the Figures, and the Claim.&nbsp;Doing so on the assumption that only the Figures in a design patent dictate the scope of the Claim, <i>i.e.,</i> that the words themselves do not matter, might lead to quick grant of a design patent, but it also might lead to the problems exemplified in this case if that patent is later litigated.</p> <p>We are familiar with the expression that &ldquo;a picture is worth a thousand words,&rdquo; and have applied this in the context of design patents for years.&nbsp;Today, we see that an individual word can have the power to rein in the scope of that picture.&nbsp;</p> <p><b><sup>1</sup></b> Interestingly, the district court&rsquo;s opinion contains the only mention of the word &ldquo;wicker&rdquo; in the entire case&mdash;woven into a footnote in support of an argument that Curver&rsquo;s amendment resulted in the surrender of claim scope to anything that was not a chair, and that a &ldquo;basket would not reasonably be regarded as an item of &ldquo;furniture.&rdquo;&rdquo;&nbsp;Specifically, the district court distinguished the facts of this case from a 1959 case by the predecessor court to the Federal Circuit, noting that in &ldquo;<i>United States v. Quon Quon Co.</i>, the [predecessor court] disputed whether wicker tabletops intended for use as patio furniture and made of woven rattan should be classified as &ldquo;baskets&rdquo; or &ldquo;furniture.&rdquo;&nbsp;[citation omitted]&nbsp;The tabletops were classified as &ldquo;furniture&rdquo; because they were sold and used only as tops of coffee or cocktail tables; &ldquo;baskets&rdquo; were a separate, non-furniture category.&rdquo;&nbsp;[citation omitted]&nbsp;In the end, baskets were not considered furniture unless they were being used for a non-basket purpose.&nbsp;That would not apply in this case.&rdquo;</p> <p><i>* The photo at the top of this article is of a 130-year old chair that has been in my family for, I suppose, 130 years.&nbsp;We don&rsquo;t sit on it much anymore.&nbsp;Instead, it sits in my home.&nbsp;May it never burn.</i></p> Article 13 Sep 2019 00:00:00 -0800 Specification Must Adequately Disclose the Claimed Invention to Avoid Invalidation for Lack of Written Description <p>Drs. Stephen Quake and Christina Fan (&ldquo;Quake&rdquo;) appealed a decision of the U.S. Patent and Trademark Office Patent Trial and Appeal Board (&ldquo;the Board&rdquo;) finding the four claims of Quake&rsquo;s U.S. Patent 8,008,018 and Claim 25 of their U.S. Application No. 12/393,833 unpatentable for lack of written description.</p> <p>The claims at issue were directed to a method of determining the presence of a chromosomal abnormality (aneuploidy) in fetuses by using massively parallel sequencing (MPS) technology to sequence DNA fragments from a sample of the mother&rsquo;s blood that contains both maternal and fetal DNA. The claims recited a random MPS method for the detection step, meaning that all of the DNA in the sample is sequenced, as opposed to sequencing specific, targeted sequences. Quake&rsquo;s specification, however, only expressly described detection of <i>target </i>sequences and consistently focused on detection of <i>targeted</i> sequences, using the term &ldquo;target&rdquo; more than sixty times throughout the patent.</p> <p>Quake claimed a method of determining fetal aneuploidy by detecting target sequences in an application filed on February 2, 2007, and also filed a continuation application No. 12/393,803 in February 2009. The original claims of Quake&rsquo;s &rsquo;803 application explicitly recited methods that required the detection of &ldquo;target sequences.&rdquo; In 2011, Quake split the &rsquo;803 application into multiple applications. In the application which later issued as the &rsquo;018 patent, Quake canceled all pending claims and added new claims covering the use of random MPS to determine fetal aneuploidy.</p> <p>Representative issued claim 1 reads:</p> <p style="margin-left: 40px;">1. A method for determining presence or absence of fetal aneuploidy in a maternal tissue sample comprising fetal and maternal genomic DNA, wherein the method comprises:</p> <p style="margin-left: 80px;">a. obtaining a mixture of fetal and maternal genomic DNA from said maternal tis-sue sample:<br /> <br /> b. conducting massively parallel DNA sequencing of DNA fragments randomly selected from the mixture of fetal and maternal genomic DNA of step a) to determine the sequence of said DNA fragments;<br /> <br /> c. identifying chromosomes to which the sequences obtained in step b) belong;<br /> <br /> d. using the data of step c) to compare an amount of at least one first chromosome in said mixture of maternal and fetal genomic DNA to an amount of at least one second chromosome in said mixture of maternal and fetal genomic DNA, wherein said at least one first chromosome is presumed to be euploid in the fetus, wherein said at least one second chromosome is suspected to be aneuploid in the fetus, thereby deter-mining the presence or absence of said fetal aneuploidy.</p> <p>Claim 25 of Application No. 12/393,833, continued from the &rsquo;803 application, also recited using random MPS to determine fetal aneuploidy.</p> <p>In 2007, Yuk-Ming Dennis Lo, Rossa Wai Kwun Chu, and Kwan Chee Chan (&ldquo;Lo&rdquo;), filed a patent application that undisputedly described and claimed a method of using &ldquo;random&rdquo; MPS to determine fetal aneuploidy. Lo&rsquo;s application was directed to, and described in considerable detail, randomly sequencing the entire sample by MPS after fragmentation and division. Lo&rsquo;s application explained that a skilled artisan would need to adjust for chromosome size, i.e., normalize the data by the length of each chromosome, before being able to accurately determine the presence of fetal aneuploidy.</p> <p>Both Quake and Lo requested interferences to determine who first invented the random MPS method and when the method was invented. Lo attacked the claims of Quake&rsquo;s &rsquo;018 patent and &rsquo;833 application as unpatentable for lack of written description. Although the &rsquo;018 patent specification is over thirty columns, MPS was discussed in only two paragraphs. In Quake&rsquo;s view, these two paragraphs not only taught MPS as a sequencing tool, but also described a second detection methodology (random sequencing) different from targeted sequencing.</p> <p>In its first decision in 2015, the Board disagreed with Quake, found the random MPS claims invalid for lack of written description, and granted Lo&rsquo;s motions in all three interferences. Quake appealed. On appeal, in 2017, the Court of Appeals for the Federal Circuit (&ldquo;the Court&rdquo;) vacated the Board&rsquo;s 2015 decisions and remanded with instructions for the Board: (1) to consider whether the patent&rsquo;s written description at columns 19 to 20 discloses random MPS; (2) to explain the meaning of various phrases in that portion of the specification; and (3) to examine whether a skilled artisan would have known, as of the priority date, that the specification&rsquo;s reference to Illumina products meant random MPS sequencing based on record evidence describing Illumina products or any other random MPS products existing as of the filing date.</p> <p>On remand, the Board found that a citation to a reference and a single sentence in Quake&rsquo;s specification support random sequencing, but that the two, on their own, were insufficient to describe the claimed method of determining fetal aneuploidy through random MPS. The Board also found that the specification did not describe the final claimed comparison step in terms that would be applicable to random MPS, namely adjusting/normalizing for chromosome size before assessing the over- or under-representation of a chromosome. &nbsp;</p> <p>The Board looked in the two MPS paragraphs (A and B) of the &rsquo;018 patent specification for evidence of written description. The Board found that the citation to Balasubramanian (US 2003/0022207) in Passage A &ldquo;provides some[] disclosure of massively parallel sequencing of DNA fragments selected randomly&rdquo; based on the testimony of Lo&rsquo;s expert. The Board then found that Passage B &ldquo;expressly describe[s] random sequencing&rdquo; because it used the phrase &ldquo;random sequence information&rdquo; in the sentence &ldquo;about 30 bp of random sequence information are needed to identify a sequence as belonging to a specific human chromosome.&rdquo; But the Board subsequently found that Balasubramanian and the &ldquo;30 bp of random sequence information are needed to identify a sequence&rdquo; sentence were <i>not sufficient</i> to meet the requirements of &sect; 112. Passages A and B provided &ldquo;<i>some </i>express description of individual elements recited in Quake&rsquo;s claims,&rdquo; but these disclosures were insufficient to demonstrate that the inventors were in possession of a method of determining fetal aneuploidy with <i>random</i> massively parallel sequencing as claimed by Quake, because the &rsquo;018 patent (1) &ldquo;does not tie these elements together into a complete method&rdquo; and (2) &ldquo;does not explain how to use the data from random massively parallel sequencing of a mixture of genomic DNA to determine fetal aneuploidy.&rdquo;</p> <p>Quake appealed the Board&rsquo;s written description finding. The primary issue on appeal was whether the patent specification shared by the &rsquo;018 patent and the &rsquo;833 application sufficiently described using random MPS to determine fetal aneuploidy, such that it meets the requirements of &sect; 112. The Court found that substantial evidence supported the Board&rsquo;s findings on lack of adequate written description and affirmed the Board&rsquo;s findings.</p> <p>The Court addressed the Board&rsquo;s findings as to the Balasubramanian citation in Passage A and the single sentence in Passage B, and then its treatment of the chromosome size adjustment necessary for claimed step D. &nbsp;The Court agreed with the Board that the citation to Balasubramanian provided some disclosure of massively parallel sequencing of DNA fragments selected randomly, but noted that skilled artisans would have understood the specification to support <i>targeted</i> MPS.</p> <p>As for Passage B, first, the Board found that simply using the word &ldquo;random&rdquo; was not enough to indicate random MPS (&ldquo;finding that the phrase &ldquo;randomly fragmented genomic DNA&rdquo; from Passage A is &ldquo;not necessarily the same&rdquo; as the phrase referring to random MPS in the claims&rdquo;). Second, the 30 bp language covers identifying the chromosomes of origin for DNA fragments generated through <i>targeted </i>MPS. The Court agreed with the Board that the 30 bp sentence was more generally &ldquo;about the number of base pairs needed to identify the chromosomal origin of a sequence.&rdquo; There was no indication in the record that the length of a sequence needed to identify the chromosome of origin was any different for DNA fragments sequenced via random and targeted MPS. However, given the specification&rsquo;s repeated discussion of targeted sequencing, a bare citation to Balasubramanian and use of the phrase &ldquo;about 30 bp of random sequence information are needed to identify a sequence&rdquo; in the context of the patent &ldquo;would be a highly elliptical, cryptic way to communicate possession of a second method of sequencing to determine fetal aneuploidy. An alternative explanation consistent with the entire patent specification is that Quake invented using targeted MPS for determining fetal aneuploidy and wrote the &rsquo;018 patent specification to describe targeted MPS, among other ways of performing targeted detection such as digital PCR.&rdquo;</p> <p>The Court noted that in light of the limited disclosure value of the single Balasubramanian citation and the &ldquo;about 30 bp of random sequence information are needed to identify a sequence&rdquo; sentence, substantial evidence supported the Board&rsquo;s finding that those two items together were not adequate to convey using random MPS to determine fetal aneuploidy as claimed. &ldquo;In terms of <i>Ruschig</i>&rsquo;s analogy of the written description requirement being akin to creating a trail through the woods, the two are (at most) faint &ldquo;blaze marks&rdquo; for determining fetal aneuploidy by random MPS, while the rest of the specification marks a clear trail to targeted MPS. <i>In re Ruschig</i>, 379 F.2d 990, 994&ndash;95 (CCPA 1967).&rdquo;</p> <p>The Court agreed with the Board that if the &rsquo;018 patent had contained some description of adjusting for chromosome size when comparing the data resulting from the MPS step, then a skilled artisan might have had an indirect, but clear indication that the inventor contemplated a method of using random MPS to determine fetal aneuploidy. There was no discussion of adjusting for chromosome size before performing those statistical analyses. The Board was correct that &ldquo;[i]n the absence of a description of such analysis, [the] teachings in the specification about [the Balasubramanian] equipment <i>useful </i>for random massively parallel sequencing and techniques for determining sequences are not sufficient to demonstrate possession of the claimed method.&rdquo;</p> <p>The Court agreed that the claims in Quake&rsquo;s patent, directed to random MPS, were unpatentable and found that the patent's specification focused primarily on targeted MPS. While a limited number of references to non-targeted DNA sequences were made in the disclosure, there was no embodiment describing the specific statistical analysis needed to determine the presence of a chromosomal abnormality from data generated by random MPS. The Court concluded that substantial evidence supported the Board&rsquo;s finding that those two items together were not adequate to convey using random MPS to determine fetal aneuploidy as claimed.</p> <p align="center">***</p> <p>To satisfy the written description requirement, a patent application has to provide sufficient disclosure of what is claimed, i.e., provide trails by making blaze marks on trees to find one&rsquo;s way through the woods of a specification such that a skilled artisan would be able to follow that trail and understand what the inventors had invented. &nbsp;For example for method claims, to satisfy the written description requirement, the claimed method as a whole must be described by the specification. It is important to understand potential embodiments and desired scope of the claims when drafting an application and to describe the embodiments broadly and specifically so that if claims need to be amended during prosecution, e.g., to remove cited references, the description would support such amendments. A prior art search is recommended, while drafting, to help assess the extent of necessary disclosures. A more explicit disclosure, rather than obscure &ldquo;blaze marks,&rdquo; may be necessary to support a desired scope of the claims.</p> <p><i>Quake v. Lo</i>, Case Nos. 18-1779, -1780, -1782 (Fed. Cir. July 10, 2019)</p> <p><a href=""></a></p> Article 09 Sep 2019 00:00:00 -0800 Patently Obvious? Teddy Gron wrote an article entitled &ldquo;Patently Obvious?&rdquo; featured in the September issue of the <em>Illinois State Bar Association</em> magazine. Article 05 Sep 2019 00:00:00 -0800 Thinking Outside the (Utility Patent) Box – Don't Overlook Design Patent Protection in the Life Sciences <p>Design patents are very different from utility patents in that design patents only protect the ornamental features of an invention. In contrast to utility patents, the design is defined in scope by the content of the drawings rather than the words of a set of claims. Further, design patents have a 15 year term, as opposed to 20 years from filing for utility patents.</p> <p>The USPTO issues about 25,000 design patents each year, making them by far the minority of patents pursued and granted.&nbsp;Regardless, design patents have gained more recognition in recent years, in part based on the large damages awarded in the Apple-Samsung smartphone patent wars which included several design patents.&nbsp;Thus, stakeholders should not overlook whether or not their technology may be amendable to design patent protection.</p> <p>Notably, and contrary to instinct, an ornamental design that is worthy of design patent protection does not have to be aesthetically pleasing.&nbsp;Design patents can cover any design as long as it is not dictated by the product&rsquo;s function.</p> <p>Life sciences areas where design patent protection may be appropriate include, but of course are not limited to, bone or dental implants, diagnostic devices, laboratory consumables, prosthetics, cosmetic skin treatment devices, medical/laboratory protective clothing, and graphical user interfaces in software components.&nbsp;</p> <p>Some recent examples of design patents granted in the life sciences, illustrating a subset of the vast array of patentable subject matter, are shown in the below table:<br /> <br /> <img src=" 1.jpg" hspace="0" vspace="0" align="absmiddle" alt="" border="0" width="642" height="708" /><br /> <img src=" 1.2.jpg" hspace="0" vspace="0" align="absmiddle" alt="" border="0" width="643" height="837" /><br /> <img src=" 1.5.JPG" hspace="0" vspace="0" align="absmiddle" alt="" border="0" width="647" height="194" /></p> <p>Obtaining design patents tends to be cheaper, quicker, and easier than utility patents. That being said, careful consideration should be given to the scope of the design patent, and irrelevant details should not be included, because those provide loopholes for potential infringers in the future.</p> <p>Design patent coverage can complement utility patent coverage and strengthen a portfolio overall because competitors will have to consider the appearance of a particular product in addition to functionality that may be covered by a utility patent.&nbsp;In addition, a design patent can be filed to cover the latest iteration of a product, extending coverage past the life of a utility patent.</p> <p>Accordingly, medical device companies that have invested time and money in designing products should consider whether or not a design patent may be appropriate, particularly if the product has features that may be difficult to protect with a traditional utility patent.&nbsp;&nbsp;</p> <p><br /> <br /> <br /> <br /> <br /> <br /> &nbsp;</p> Article 30 Aug 2019 00:00:00 -0800 INSIGHT: Cannabis Patent Lawsuits Are Blazing – Why the Law is So Hazy <strong>Dan Pereira </strong>wrote an article featured in <em>Bloomberg Law</em>, entitled &ldquo;Cannabis Patent Lawsuits Are Blazing &ndash; Why the Law is So Hazy.&rdquo; Article 26 Aug 2019 00:00:00 -0800 Non-Limiting Clauses and Written Description Based on Substantially Equivalent Disclosure <p><i>Nalpropion Pharmaceuticals, Inc. v Actavis Laboratories FL, Inc</i> (Fed. Cir. Aug. 15, 2019) is a precedential opinion written by Judge Lourie with Judge Wallach and a dissent from Judge Prost in a case centered on an ANDA litigation in which Actavis sought approval for their generic version to Nalpropion&rsquo;s patents for the Contrave&reg; product. Footnote 1 in the opinion outlines the rather complex history of the ownership/license interests as they changed over time.</p> <p>The opinion address questions of written description and obviousness of certain claims of the patents-in-suit. For the purpose here, I found the dispute centered on Claim 11 of U.S. patent no. 8,916,195 (&lsquo;the &lsquo;195 patent) to be the most interesting. That claim is:</p> <p style="margin-left: 40px;"><i>A method of treating overweight or obesity having reduced adverse effects comprising orally administering daily about 32 mg of naltrexone and about 360 mg of bupropion, or pharmaceutically acceptable salts thereof, to a person in need thereof, wherein the bupropion or pharmaceutically acceptable salt thereof is administered as a sustained release formulation, wherein the naltrexone or pharmaceutically acceptable salt thereof is administered as a sustained release formulation, and wherein said sustained release formulation of naltrexone has an in vitro naltrexone dissolution profile in a dissolution test of USP Apparatus 2 Paddle Method at 100 rpm in a dissolution medium of water at 37&deg; C. of:</i></p> <p style="margin-left: 80px;"><i>a) between 39% and 70% of naltrexone released in one hour;</i></p> <p style="margin-left: 80px;"><i>b) between 62% and 90% of naltrexone released in two hours; and </i></p> <p style="margin-left: 80px;"><i>c) at least 99% in 8 hours; </i></p> <p style="margin-left: 40px;"><i>wherein about 16 mg of said sustained release formulation of naltrexone or a pharmaceutically acceptable salt thereof is administered twice daily, and about 180</i></p> <p style="margin-left: 40px;"><i>mg of said sustained release formulation of bupropion or a pharmaceutically acceptable salt thereof is administered twice daily.</i></p> <p>The center of the written description dispute is the <i>in vitro</i> dissolution profile:</p> <p style="margin-left: 40px;">Actavis argued that claim 11 of the &rsquo;195 patent lacked adequate written description support because its claimed dissolution profile was achieved using the USP Apparatus 2 Paddle Method (&ldquo;USP 2&rdquo;), but the specification discloses data obtained using the different USP Apparatus 1 Basket Method (&ldquo;USP 1&rdquo;). The court was not persuaded that the use of a different method from what is prescribed in the claim presented a written description problem, holding that &ldquo;whether the dissolution data reported in the specification was obtained using the basket method or the paddle method is not relevant to whether the inventors had possession of the invention.&rdquo;</p> <p>The majority and the dissent essentially disagreed as to what import to provide the dissolution profile</p> <p>Judge Lourie opined:</p> <p style="margin-left: 40px;">But that dissolution profile for naltrexone as measured by USP 2 relates only to the measurement of resultant in vitro parameters, not to the operative steps to treat overweight or obesity. And the district court concluded, on the facts, that USP 1 and USP 2 would be &ldquo;substantially equivalent,&rdquo; <i>Decision</i>, 282 F. Supp. 3d at 801 (citation omitted). Thus, it found that, irrespective of the method of measurement used, the specification shows that the inventors possessed the invention of treating overweight or obesity with naltrexone and bupropion in particular amounts and adequately described it. We conclude that this finding does not present clear error.</p> <p>Judge Prost had a different take:</p> <p style="margin-left: 40px;">I part ways with the majority, however, for at least three reasons. First, the USP 2 clause is limiting. Second, the majority&rsquo;s &ldquo;substantially equivalent&rdquo; rule is inconsistent with this court&rsquo;s precedent. Third, the district court clearly erred in finding that the &rsquo;195 patent&rsquo;s written description includes a disclosure &ldquo;substantially equivalent&rdquo; to USP 2.</p> <p>The issue of written description is one of fact and such questions of fact are reviewed for clear error. How the majority reviewed that question and to what they give most importance is interesting. The majority opinion giving more credence to the expert testimony, as did the district court while Judge Prost&rsquo;s view was that there was no evidence to support the notion that the two manners of determining the dissolution profiled were substantially equivalent and rather there was evidence that there were not.</p> <p>The majority opinion relied on the district court&rsquo;s analysis of the facts, while giving more credibility to Nalpropion&rsquo;s expert over Actavis&rsquo;s expert: &ldquo;[t]he district court performed precisely its fact-finding function, weighing credibility of testimony.&rdquo; Judge Prost was not so moved:</p> <p style="margin-left: 40px;">In finding that USP 1 and USP 2 are substantially equivalent, the majority overlooks the district court&rsquo;s clear error. Not a shred of record evidence supports this fact-finding. And other record evidence refutes it. The record contains no evidence showing that the two methods produce the same results.</p> <p style="margin-left: 40px;">Instead, the record includes evidence that the two methods do not produce the same results. First, Dr. Soltero, one of the inventors named on the &rsquo;195 patent, testified that USP 1 and USP 2 results are not comparable. He confirmed that &ldquo;just because you got a certain profile [using] a USP 1 method, you would not necessarily expect that you would get the same release profile [using] USP 2.&rdquo; <i>See </i>J.A. 11319:17&ndash;11321:12. The trial court&rsquo;s opinion does not even mention this testimony.</p> <p style="margin-left: 40px;">Second, Appellant&rsquo;s expert, Dr. Mayersohn, opined that a skilled artisan would not have understood the two methods to yield the same results. J.A. 11356:22&ndash;11357:3. The district court discounted Dr. Mayersohn&rsquo;s testimony, finding that his &ldquo;theoretical opinion that the methods would yield different results is at odds with his reliance on a prior art reference using [USP 1] to argue that claim 11, which specifies [USP 2], was obvious.&rdquo; <i>See </i>Majority Op. 11 (citing</p> <p style="margin-left: 40px;"><i>Orexigen</i>, 282 F. Supp. 3d at 801&ndash;02).</p> <p style="margin-left: 40px;">The standard for obviousness is not, however, the same as the standard for written description.</p> Article 16 Aug 2019 00:00:00 -0800 Argument with Emphasis on "Particular" Combination of Salts Invoked Prosecution History Estoppel <p> <p><span style="font-size:14.0pt;line-height:115%;&#10;font-family:&quot;MS Mincho&quot;,&quot;serif&quot;;MS Mincho&quot;;">「特定の」塩の組み合わせを強調して反論を行ったために包袋禁反言(審査経過に基づくエストッペル)が適用された事例</span></p> <p><span style="font-family:&quot;MS Mincho&quot;,&quot;serif&quot;;MS Mincho&quot;;">出願審査において拒絶理由に応答する際には、そのクレーム補正や反論内容が、後で特許権利行使に不利に働かないよう注意する必要があります。クレーム範囲を狭める補正を行ったり限定解釈につながるような反論を行ったりしたことが原因で、特許権利からある内容を放棄したとみなされてしまう場合があるからです。出願人が審査中に放棄したとみなされる内容に関して特許後に均等論侵害を主張することは出願人自身の先の言動に反し、禁反言が適用されて侵害主張が認められないことになります。</span></p> <p><i>Amgen Inc. v. Coherus Biosciences Inc.</i>, No. 2018-1993 (Fed. Cir. July 29, 2019)<span style="font-family:&quot;MS Mincho&quot;,&quot;serif&quot;;MS Mincho&quot;;">において、</span>Amgen<span style="font-family:&#10;&quot;MS Mincho&quot;,&quot;serif&quot;;MS Mincho&quot;;">のクレーム中の「特定の」塩の組み合わせについて何度も繰り返し強調して反論を行ったことで、他の塩の組み合わせを明確に間違いなく放棄(</span>clear and unmistakable surrender<span style="font-family:&quot;MS Mincho&quot;,&quot;serif&quot;;MS Mincho&quot;;">)したと言えるかが争点となりました。</span>Amgen<span style="font-family:&#10;&quot;MS Mincho&quot;,&quot;serif&quot;;MS Mincho&quot;;">は蛋白質をクロマトグラフィで精製する方法をクレームしており、バッファに使用する特定の塩の組み合わせをクレームに記載していましたが、地裁、</span>CAFC<span style="font-family:&#10;&quot;MS Mincho&quot;,&quot;serif&quot;;MS Mincho&quot;;">共に、審査中の反論により他の塩の組み合わせを放棄したと判断し、均等論侵害の主張を認めませんでした。</span></p> <p>CAFC<span style="font-family:&quot;MS Mincho&quot;,&quot;serif&quot;;MS Mincho&quot;;">判決は以下の点に言及しており、</span>Amgen<span style="font-family:&#10;&quot;MS Mincho&quot;,&quot;serif&quot;;MS Mincho&quot;;">にとって不利な事実となりました。</span></p> <p style="text-indent:-.25in;"><span>-<span style="font:7.0pt &quot;Times New Roman&quot;"> </span></span><span style="font-family:&quot;MS Mincho&quot;,&quot;serif&quot;;MS Mincho&quot;;">「特定の</span>(particular)<span style="font-family:&quot;MS Mincho&quot;,&quot;serif&quot;;MS Mincho&quot;;">」を強調して、その特定の塩に繰り返し(</span>2<span style="font-family:&#10;&quot;MS Mincho&quot;,&quot;serif&quot;;MS Mincho&quot;;">頁に渡って</span>3<span style="font-family:&quot;MS Mincho&quot;,&quot;serif&quot;;MS Mincho&quot;;">回)言及して引例との差異を主張した。</span></p> <p style="text-indent:-.25in;"><span>-<span style="font:7.0pt &quot;Times New Roman&quot;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span><span style="font-family:&quot;MS Mincho&quot;,&quot;serif&quot;;MS Mincho&quot;;">応答書と共に提出した宣誓書においてその特定の塩の組み合わせに言及し、その組み合わせに起因する効果を主張した。</span></p> <p style="text-indent:-.25in;"><span>-<span style="font:7.0pt &quot;Times New Roman&quot;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span><span style="font-family:&quot;MS Mincho&quot;,&quot;serif&quot;;MS Mincho&quot;;">応答書において宣誓書を引用し、</span>&rdquo;[u]se of this particular combination of salts greatly improves the cost-effectiveness of commercial manufacturing &hellip;&rdquo;<span style="font-family:&quot;MS Mincho&quot;,&quot;serif&quot;;MS Mincho&quot;;">と述べた。</span></p> <p>Amgen<span style="font-family:&quot;MS Mincho&quot;,&quot;serif&quot;;MS Mincho&quot;;">は下記主張を行いましたが、いずれも認められませんでした。</span></p> <p style="text-indent:-.25in;"><span>-<span style="font:7.0pt &quot;Times New Roman&quot;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span><span style="font-family:&quot;MS Mincho&quot;,&quot;serif&quot;;MS Mincho&quot;;">反論の際に引例と区別できる理由を複数挙げており、他の理由で差異を主張した。引例に「特定の」塩の組み合わせの開示が無いという事は事実として述べたにすぎないから、他の塩の組み合わせを明確に間違いなく放棄したとは言えない。</span></p> <p style="text-indent:-.25in;"><span>-<span style="font:7.0pt &quot;Times New Roman&quot;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span></span><span style="font-family:&quot;MS Mincho&quot;,&quot;serif&quot;;MS Mincho&quot;;">包袋禁反言が適用するか否か判断する際、許可通知を受ける前の最後の応答書に書かれた反論内容に焦点を絞って分析すべきである。本件の許可通知を受ける前に提出した応答書では、特定の塩の組み合わせが非開示であるという議論を再度行わなかったため、エストッペルは適用されない。</span></p> <p>CAFC<span style="font-family:&quot;MS Mincho&quot;,&quot;serif&quot;;MS Mincho&quot;;">は、反論として複数の主張を行った場合、各主張の内容に関してエストッペルが適用する可能性があるという判例を挙げて、</span>Amgen<span style="font-family:&#10;&quot;MS Mincho&quot;,&quot;serif&quot;;MS Mincho&quot;;">の上記の主張を退けました。</span><i>PODS, Inc. v. Porta Star, Inc.</i>, 484 F.3d 1359, 1367 (Fed. Cir. 2007).&nbsp;<span style="font-family:&quot;MS Mincho&quot;,&quot;serif&quot;;MS Mincho&quot;;">また、許可通知前に他の論点で反論していたとしてもその前の主張が消えるわけではないと述べ、許可を得るために必要な反論であったかどうかに関わらず、明確な主張にはエストッペル適用可であるとしました。</span><i>PODS, </i>484 F.3d at 1368.</p> <p><span style="font-family:&quot;MS Mincho&quot;,&quot;serif&quot;;MS Mincho&quot;;">本件事例に見られるように反論内容を繰り返し述べることは必ずしも良い結果をもたらすわけではなく、クレームで明確に差異を「見せる」ことに注力する方がより効果的と考えます。</span></p> </p> Article 16 Aug 2019 00:00:00 -0800