Publications – Oblon, McClelland, Maier & Neustadt, L.L.P. Intellectual Property Law Firm en-us 25 Jan 2022 00:00:00 -0800 firmwise Is There Any Hope For Antibody Patents in the United States? Opin Baxalta v Genentech 13Jan22.pdf&anc=995&format=xml <p><i>Conclusion<br /> </i><br /> Okay, let&rsquo;s get this out of the way up front. The answer is maybe&hellip; but only with a lot more work and with substantially reduced claim scope.&nbsp;</p> <p><i>The Story<br /> </i><br /> The United States Food and Drug Administration (US FDA) approved the first monoclonal antibody in 1986.&nbsp; Since that time, therapeutic antibodies have been on a meteoric rise becoming the predominant class of new drugs developed with the US FDA approving its 100<sup>th</sup> monoclonal antibody in mid-2021.&nbsp; Therapeutic antibodies dominate the global drug sales market for non-COVID treatments with Humira (AbbVie), Ketruda (Merck), Eylea (Regeneron), Opdivo (Bristol-Myers Squibb), and Stelara (Johnson &amp; Johnson) leading the way. The global therapeutic monoclonal antibody market was valued at approximately $115.2 billion (USD) in 2018, $150 billion by the end of 2019 and is expected to reach $300 billion by 2025. (<i>see</i> Lu et al. <i>Journal of Biomedical Science</i> volume 27, Article number: 1 (2020)).&nbsp;</p> <p>With such promise as an effective drug (and, let&rsquo;s face it, as a money maker), drug makers are quickly turning to mAb treatments for COVID-19.&nbsp; As of December 16, 2021, the US FDA granted Emergency Use Authorizations (EUAs) for three anti-SARS-CoV-2 mAb products.&nbsp; Although not yet approved by the US FDA, the EUAs permit the use of these anti-SARS-CoV-2 mAb products for treatment of mild to moderate COVID-19 in non-hospitalized patients with laboratory-confirmed SARS-CoV-2 infection who are at high risk for progressing to severe disease and/or hospitalization and also permits two of these anti-SARS-CoV-2 mAb products for post-exposure prophylaxis for certain individuals who are at high risk of acquiring SARS-CoV-2 infection and, if infected, are at high risk of progressing to serious illness.&nbsp; As with everything related to COVID-19, developments and evaluations of mAb treatment regimens are ongoing and rapidly developing.&nbsp;</p> <p>With so much capital investment in therapeutic antibodies, whether mAbs or bispecific antibodies, we would expect strong patent protection.&nbsp; Here is where the success story hits a brick wall.&nbsp; The stark reality that faces the drug industry is that many of the existing antibody patents are invalid and it has become harder and harder to obtain patents covering antibodies or treatment methods using antibodies.&nbsp; I discussed this issue back in October 2020 (<a href=""></a>), but since that time the dark clouds continue to accumulate for therapeutic antibody developers.&nbsp;</p> <p>Long gone are the days of the &ldquo;newly characterized antigen&rdquo; test which provided an exception to the general written description rules at the USPTO for antibody claims. &nbsp;This (admittedly flawed) test found sufficient written description support for a claim to a genus of antibodies through the disclosure of a newly characterized antigen if the production of such antibodies was conventional or routine.&nbsp; An example of a fairly typical claim granted prior to 2014 was at issue in <i>AbbVie Deutschland GMBH &amp; Co., KG, v. Janssen. Biotech, Inc.,</i> 759 F.3d 1285 (Fed. Cir. 2014):</p> <p>29. A neutralizing isolated human antibody, or antigen-binding portion thereof that binds to human IL-12 and disassociates from human IL-12 with a Koff rate constant of 1&times;10<sup>&minus;2</sup>s<sup>&minus;1</sup> or less, as determined by surface plasmon resonance.&nbsp; (US 6,914,128)</p> <p>In <i>AbbVie</i>, the CAFC did not address the enablement requirement but tossed aside the &ldquo;newly characterized antigen&rdquo; test for written description. &nbsp;Based on long-standing written description jurisprudence this outcome was not shocking as it is difficult to envision a scenario where it is possible to adequately convey that the inventors were in possession of the full scope of such a claim at the time of the invention as there are potentially millions of sequence variants embraced by this broad scope that may or may not meet the functional limitations.&nbsp;</p> <p>The CAFC also put a shot across the bow in <i>AbbVie</i> foretelling a very troubling future for therapeutic antibody developers:</p> <p>Functionally defined genus claims can be inherently vulnerable to invalidity challenge for lack of written description support, especially in technology fields that are <u>highly unpredictable</u>, where it is difficult to establish a <u>correlation between structure and function</u> for the whole genus or to predict what would be covered by the functionally claimed genus. <i>AbbVie </i>at 1301.</p> <p>What began as a trickle became a flood as therapeutic antibody claims have been frequently invalidated on both written description and enablement grounds by the District Courts and the CAFC.&nbsp; Take for example the following CAFC cases in 2021:<br /> <br /> <img src=" _AntibodyClaims 1.1.jpg" hspace="0" vspace="0" align="absmiddle" alt="" border="0" width="582" height="309" /><br /> <img src=" _AntibodyClaims 2.1.jpg" hspace="0" vspace="0" align="absmiddle" alt="" border="0" width="580" height="672" /></p> <p>2022 is also off to a similarly rocky start for therapeutic antibodies.</p> <p>On January 13, 2022, Circuit Judge Dyk sitting by designation in the United States District Court for the District of Delaware, granted Genentech&rsquo;s Summary Judgement motion in <i>Baxalta Inc. v. Genentech, Inc.,</i> No. 1:17-cv-00509-TBD (D. Del. Jan. 13, 2022) of invalidity for lack of enablement.&nbsp; Baxalta&rsquo;s patent (US 7,033,590) claims an antibody that binds to Factor IX, which is a protein that is important for blood clotting.&nbsp; Perhaps more (economically) important, US &lsquo;590 covers Genentech&rsquo;s infringing hemophilia drug Hemlibra which had global sales reported to be $1.5B in 2020.&nbsp;</p> <p>The claims at issue in <i>Baxalta</i> were illustrated by independent claim 1 and dependent claims 4 and 19:</p> <p>1. An isolated antibody or antibody fragment thereof that binds Factor IX or Factor IXa and increases the procoagulant activity of Factor IXa.</p> <p>4. The antibody or antibody fragment according to claim 1, wherein said antibody or antibody fragment is selected from the group consisting of a monoclonal antibody, a chimeric antibody, a humanized antibody, a single chain antibody, a bispecific antibody, a diabody, and di-, oligo- or multimers thereof.</p> <p>19. The antibody or antibody fragment according to claim 4, wherein the antibody is a humanized antibody.</p> <p>That Judge Dyk held these broad, functional claims to lack enablement is not at all surprising following <i>Amgen Inc. v. Sanofi</i>.&nbsp; Judge Dyk also echoed some of the themes from past CAFC decisions invalidating antibody claims calling the field of antibodies &ldquo;inherently unpredictable.&rdquo; &nbsp;As has become a common theme, Judge Dyk was critical of the guidance proffered by the specification as to how to identify antibodies that will satisfy the claim limitations and pointed out that the description does not provide &ldquo;what structural or other features of the disclosed antibodies cause them to bind to Factor IX/IXa or to increase the procoagulant activity of Factor IXa.&rdquo;&nbsp; Judge Dyk further expressed concern that the only way to practice the teachings of the patent is by &ldquo;trial-and-error; i.e., by screening tens of thousands, if not millions, of candidate antibodies to determine whether they satisfy the limitations of the asserted claims.&rdquo;</p> <p>Another common thread to <i>AbbVie</i>, <i>Amgen</i>, and <i>Baxalta</i> is the lack of or limited examples compared to the scope of the claimed genus.&nbsp; The <i>Amgen</i> Court framed the problem this creates under the <i>Wands</i> analysis noting that the scope of the claims encompasses millions of candidate antibodies, and it would be necessary to first generate and then screen each of these candidates to determine whether it meets the functional claim limitations.</p> <p><i>What does this all mean?</i></p> <p>First, it should be emphasized that most of the recent decisions invalidating therapeutic antibody claims on written description and enablement grounds were for patents granted before or shortly after the decision in <i>AbbVie</i>.&nbsp; This is likely to remain the case for several more years as the economic value of these patents are only now being realized in many cases.&nbsp; Further, although the decision in <i>AbbVie</i> should have steered applicants and practitioners in the right direction (i.e., away from claiming antibodies based solely on the target antigen, specific epitope, and/or function), many of the patents that were granted in the first two or three years after <i>AbbVie</i> were written before this decision and may very well lack the necessary components to satisfy a heightened requirements. &nbsp;Accordingly, it is very likely that the patentability story for therapeutic antibodies will get worse before it gets better.&nbsp;</p> <p>The challenge that faces applicants is to accept that far more details and examples are needed in the specification to support any claim breadth.&nbsp; Even then the scope of the antibody will be substantially limited compared to what was previously granted.&nbsp; Some have suggested that the scope of therapeutic antibodies that will survive is just those that have been explicitly described in the specification.&nbsp; But, should this be the case?&nbsp;</p> <p>Generally, the answer should be &ldquo;no&rdquo;.&nbsp; The literature is well developed with respect to the structure, function, and sequence of the constant regions for light and heavy chains of the various immunoglobulin types.&nbsp; So is it really fair to take the position that applicants cannot describe or enable variation of the framework structure without providing substantial examples or description?&nbsp; In fact, even humanization of the constant regions has become more and more trivial.&nbsp; Shouldn&rsquo;t we only really care about sequence and structure/function mapping at the antigen-binding interface of the variable region?&nbsp;</p> <p>Perhaps it pushes it too far to try to broadly claim the variable region based on the antigen or even the epitope to which the antibody binds, but once an applicant is able to map the variable region sequence and/or structure it should be able to obtain some scope of protection beyond the exemplified antibodies.&nbsp; Herein lies the challenge for the next generation of therapeutic antibody applications.&nbsp; What degree of description is necessary?&nbsp; How many representative examples are needed?&nbsp; Can applicants use theoretical models and/or artificial intelligence to generate and disclose candidate sequences?&nbsp;</p> <p>We shall see how this important area of patent law develops, but do not lose hope based on the recent therapeutic antibody decisions.&nbsp; After all, as Thomas Fuller once wrote &ldquo;It is always darkest just before the Day dawneth.&rdquo;</p> Article 25 Jan 2022 00:00:00 -0800 Opin Baxalta v Genentech 13Jan22.pdf&anc=995&format=xml UNITED STATES: THE EBONYS Decision Reveals TTAB's Claim Preclusion Limits <p><strong>Brian Darville</strong>&rsquo;s summary &ldquo;UNITED STATES: THE EBONYS Decision Reveals TTAB&rsquo;s Claim Preclusion Limits,&rdquo; is featured in the INTA Bulletin <i>Law &amp; Practice </i>Perspectives.&nbsp;</p> Article 24 Jan 2022 00:00:00 -0800 Supplementing Element 1 with Element 2 Lacking the Claimed Function is not Obvious <p>In <i>Ex parte&nbsp;</i>FRAN&Ccedil;OIS ROY, JONATHAN CLOUTIER, and VINCENT TANGUAY (Appeal 2021-000050; USSN 13/966,396), the Patent Trial and Appeals Board (PTAB) recently reversed an examiner&rsquo;s finding of obviousness in a rather involved rejection based upon four references, which hinged upon the presence of &ldquo;thermofusable glue droplets&nbsp;<i>providing a mechanical retention force&nbsp;</i>to retain the wood strips in an interconnected spaced-apart relationship.&rdquo;</p> <p style="margin-left: 40px;">Base claim 2 of the Roy Application recited (emphasis added)</p> <p style="margin-left: 40px;">[a] flexible sheet of wood strips, said wood strips being elongated wood strips of rectangular cross-section&nbsp;<b><i>held together in a side-by-side aligned spaced relationship by thermofusable glue droplets, the thermofusable glue droplets being spaced longitudinally apart from one another&nbsp;</i></b>along flat, opposed side edges of said wood strips, all having the same width between said opposed side edges and collectively interconnecting said wood strips to one another between said opposed side edges in a manner providing a constant spacing between the wood strips, the thermofusable glue droplets all having the same width between said opposed side edges collectively forming a flexible joint providing flexibility to said flexible sheet of wood strips,&nbsp;<b><i>the thermofusable glue droplets providing a mechanical retention force to retain the wood strips in an interconnected spaced-apart relationship</i></b>.</p> <p>The examiner relied upon a primary reference showing all elements of the claim except for&nbsp;<b><i>droplets</i></b>&nbsp;of glue and their spacing, and sought to remedy the deficiency with a secondary reference describing the use of beads for spacing wood planks or &ldquo;fillets.&rdquo; The secondary reference, however, did not indicate that the spacing beads were adhesive or otherwise &ldquo;providing a mechanical retention force to retain the wood strips.&rdquo;</p> <p>Although the Roy application provided no experimental examples showing an effect to the use of droplets, surprising or otherwise, relative to continuous lines of adhesive, the PTAB considered sufficient for the non-obviousness of the claims the statements of &ldquo;providing flexibility&rdquo; in the claim and description, and the mention in Roy&rsquo;s description of the use of adhesive tapes or adhesive fiber layers often encountering detachment during manipulation and transportation, and/or warping and consequent distortion of inter-board spacing and additional fabrication costs.</p> <p>The PTAB considered persuasive the appellant&rsquo;s arguments that the secondary reference&rsquo;s beads (analogized to droplets) would not perform the same function as the primary reference&rsquo;s adhesive because such beads did not adhere adjacent panels, but instead were for spacing.&nbsp; The PTAB therefore stated that the examiner&rsquo;s finding that one of ordinary skill in the art would have had a reason to replace the primary reference&rsquo;s adhesive with the secondary reference&rsquo;s spacer beads to achieve the same function was not supported by the evidence presented, and that even if one were to make such a substitution, the examiner&rsquo;s rejection did not identify evidence that the spacer beads would achieve the&nbsp;<b><i>recited</i></b>&nbsp;property of &ldquo;providing a mechanical retention force&rdquo; such that adjacent wood strips are &ldquo;held together.&rdquo;</p> <p>The appeal result in the Roy application is a reminder to applicants that reciting the function of a claim element may help to distinguish over a combination of cited art in which the substituted element from the secondary reference does not provide the&nbsp;<b><i>claimed</i></b>&nbsp;function, even though the function / effect is present in the primary reference from a different element.</p> Article 27 Dec 2021 00:00:00 -0800 PTAB Provides Another Example of Invalid Claims for Lack of Written Description and Enablement Litigator _ MMiller Dec 22.21.pdf&anc=995&format=xml <strong>Marina Miller'</strong>s article &quot;PTAB Provides Another Example of Invalid Claims for Lack of Written Description and Enablement,&quot; was featured in the November/December edition of <em>IP Litigator.</em> Article 22 Dec 2021 00:00:00 -0800 Litigator _ MMiller Dec 22.21.pdf&anc=995&format=xml Fed. Circ. Written Description Scrutiny Has Lessons For Attys Circ. Written Description Scrutiny Has Lessons For Attys _ 12.21.21.pdf&anc=995&format=xml <p><b>Jeffrey McIntyre</b> is quoted in the <i>Law 360</i> article &ldquo;<u><a href=";utm_source=newsletter&amp;utm_medium=email&amp;utm_campaign=ip"><u>Fed. Circ. Written Description Scrutiny Has Lessons For Attys</u></a></u>&rdquo; on December 20, 2021.</p> Article 21 Dec 2021 00:00:00 -0800 Circ. Written Description Scrutiny Has Lessons For Attys _ 12.21.21.pdf&anc=995&format=xml ModernaTx, Inc. v. Arbutus Biopharma Corp.: Sublicense Not Enough to Show Standing <p>On Dec. 1, 2021, the Federal Circuit held that Moderna lacked standing in an appeal from a Patent Trial and Appeal Board (&ldquo;PTAB&rdquo;) decision against rival Arbutus where the PTAB determined U.S. Patent No. 9,364,435 (&ldquo;the &rsquo;435 patent&rdquo;) was not unpatentable as obvious.<a href="file:///C:/Users/caske/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/9AO2BAFN/ES%20life%20sciences%20blog%2012-13-2021.docx#_ftn1" name="_ftnref1" title="">[1]</a> The &rsquo;435 patent concerns vaccine delivery technology, particularly a lipid nanoparticle delivery system used to protect nucleic acids delivered to cells as utilized in vaccines including Moderna&rsquo;s COVID-19 vaccine.</p> <p>Arbutus challenged Moderna&rsquo;s standing to sue, asserting that it had never initiated a patent infringement action against Moderna or otherwise accused Moderna of patent infringement, and therefore Moderna never established an injury in fact.&nbsp;Moderna argued that the risk of future infringement is not the only way an IPR petitioner can show an injury and instead relied on the argument that financial impacts based on licensing obligations can be another way to show injury for standing purposes.&nbsp;Moderna asserted that the rights granted to them through a sublicense to practice Arbutus&rsquo; patented technology in their development program created a sufficient injury.&nbsp;Specifically, Moderna asserted that the royalty and milestone obligations owed to the licensee, Acuitas Biotherapeutics (&ldquo;Acuitas&rdquo;), caused them harm by increasing their financial burden and further argued their financial obligations were impacted by the Board&rsquo;s validity determinations concerning the &rsquo;435 patent.</p> <p>Arbutus argued that the mere existence of a license is not sufficient to show standing as Moderna failed to identify any recent milestone payment or any other impending payment.&nbsp;Moderna supplemented the record with additional evidence, noting that the development program using the licensed patents had been terminated but argued that Moderna&rsquo;s ongoing development of the COVID-19 vaccine created a significant risk of being sued for accused infringement based on the assertion that Arbutus made &ldquo;aggressive public statements&rdquo; and refused to grant Moderna a covenant not to sue.</p> <p>At oral argument, Arbutus asserted that at the time of the filing of the appeal, Moderna&rsquo;s basis for standing lacked immediacy and the licensing obligations Moderna relied upon to show standing were too speculative.&nbsp;Arbutus further argued that Moderna had not shown how its sublicense payment obligations would change if the '435 patent were to be invalidated.&nbsp;The Federal Circuit agreed with Arbutus that Moderna lacked standing at the time the appeal was filed, stating that the evidence of financial burdens from the validity of the patent was too speculative.&nbsp;The court noted that the last milestone payment made under the sublicense was five years earlier, and therefore Moderna failed to show a concrete injury. The court also pointed out that the &rsquo;435 patent was not the only patent licensed under the Acuitas sublicenses, and further, Moderna had not shown evidence as to how its obligations under the Acuitas sublicenses would change if it was successful in its attempts to have the '435 patent declared invalid while the remaining licensed patents continue to exist.</p> <p>The court also highlighted Moderna&rsquo;s failure to show continuity of jurisdiction.&nbsp;Their proffered basis for standing shifted during the pendency of the appeal, from first alleging financial burdens of the sublicenses to then arguing there was a risk of a potential infringement suit regarding the COVID-19 vaccine.&nbsp;The evidence presented failed to show an approximate date when the development program was terminated and therefore, whether Moderna was already sufficiently underway with its development of a COVID-19 vaccine to create a substantial risk of future infringement.&nbsp;Accordingly, the court dismissed Moderna&rsquo;s appeal for lack of standing.&nbsp;This holding leaves Moderna&rsquo;s COVID-19 vaccine vulnerable to potential patent infringement lawsuits going forward.</p> <div><br clear="all" /> <hr align="left" size="1" width="33%" /> <div id="ftn1"> <p><a href="file:///C:/Users/caske/AppData/Local/Microsoft/Windows/INetCache/Content.Outlook/9AO2BAFN/ES%20life%20sciences%20blog%2012-13-2021.docx#_ftnref1" name="_ftn1" title="">[1]</a> <i>ModernaTx, Inc. v. Arbutus Biopharma Corp.,</i> 2021 U.S. App. LEXIS 35471 (Fed. Cir. 2021).</p> </div> </div> Article 13 Dec 2021 00:00:00 -0800 Federal Circuit Clarifies which Third Party Uses are Germane to Challenge a Registrant's Section 2(f) Claim of "Substantially Exclusive" Use <p>In <i><a href="/A11960/assets/files/Documents/Galperti_ Inc. v. Galperti S.r.L._ 2021 U.S. App. LEXIS 33616.pdf">Galperti, Inc. v. Galperti S.r.L.</a></i>, 2021 USPQ2d 1115, 2021 U.S. App. LEXIS 33616 (Fed. Cir. Nov. 12, 2021), the Federal Circuit addressed a challenge to Galperti S.r.L.&rsquo;s (&ldquo;Galperti-Italy&rdquo;) registration of the mark GALPERTI based on a claim of substantially continuous and exclusive use for five years under Section 2(f) of the Trademark Act. The Section 2(f) standard for acquired distinctiveness states:</p> <p style="margin-left: 40px;">The mark has become distinctive of the goods listed in the application through the Applicant&rsquo;s substantially exclusive <br /> and continuous use in commerce for at least the five years immediately before the date of the statement.</p> <p>15 U.S.C. &sect; 1052(f).</p> <p>Galperti, Inc. (&ldquo;Galperti-USA&rdquo;) had petitioned to cancel the registration on several grounds including that the registration was obtained by fraud because GAlperti-Italy&rsquo;s statement of &ldquo;substantially exclusive&rdquo; use was intentionally false.&nbsp;</p> <p>After an initial remand, the Trademark Trial and Appeal Board again dismissed Galperti-USA&rsquo;s fraud cancellation petition ruling that (a) Galperti-USA&rsquo;s use of GALPERTI had not acquired secondary meaning and therefore could not be the basis for showing that Galperti-Italy&rsquo;s use of the mark was not &ldquo;substantially exclusive;&rdquo; and (b) because Galperti-USA failed to demonstrate privity with other third party users of the GALPERTI mark during the relevant period, Galperti-USA could not rely on those other third party uses to show falsity of Galperti-Italy&rsquo;s claim of &ldquo;substantially exclusive&rdquo; use.</p> <p>In the second appeal, the Federal Circuit held that Galperti-USA was not required to establish secondary meaning of its own uses of GALPERTI in order for those uses to be counted in determining the falsity of Galperti-Italy&rsquo;s claim of substantially exclusive use; and &ldquo;[u]se by anyone, regardless of relation to the challenger, may undercut a claim of substantially exclusive use.&rdquo;&nbsp; Slip op. at *10. A relationship of privity was not required for those third party uses to be relevant. <i>Id</i>. &nbsp;Rather, &ldquo;when evaluating whether an applicant has had &lsquo;substantially exclusive&rsquo; use of a mark, we look to whether any use by a third party was &lsquo;significant,&rsquo; or whether it was merely &lsquo;inconsequential or infringing.&rsquo;&rdquo;&nbsp; <i>Galperti, Inc. v. Galperti S.r.L.</i>, 791 Fed. Appx. 905, 910 (Fed. Cir. 2019) (quoting <i>L.D. Kichler Co. v. Davoil, Inc.</i>, 192 F.3d 1349, 1352 (Fed. Cir. 1999)).</p> The Federal Circuit vacated the Board&rsquo;s decision and remanded for further proceedings. Article 13 Dec 2021 00:00:00 -0800 Biogen v. Mylan Written Description - What Does The Federal Circuit's Decision Really Mean? <p>Following up on my post last week (<u><a href="">Dec 1.</a></u>), I have read commentary about how the Federal Circuit&rsquo;s decision in <em>Biogen v. Mylan</em>&nbsp;was incorrect. Is it really the case that the decision was wrong and that the Federal Circuit needs to address it&nbsp;<em>en banc</em>&nbsp;(or that the Supreme Court needs to address it)?&nbsp;</p> <p>Let&rsquo;s look at the Mylan opinion and another recent Federal Circuit decision on written description,&nbsp;<em>Indivior v. Dr. Reddy&rsquo;s</em>&nbsp;(November 24, 2021).&nbsp;In both cases, the Federal Circuit noted the fact-specific nature of a written description analysis.&nbsp;In&nbsp;<em>Biogen</em>, the court stated that &ldquo;the written-description analysis is highly dependent on the facts of each case,&rdquo; while in&nbsp;<em>Indivior</em>&nbsp;it stated that &ldquo;written description cases are intensively fact-oriented.&rdquo;&nbsp;The Federal Circuit&rsquo;s focus on facts in a written description analysis is important and is affected by the context of each case when it reaches the court.</p> <p><em>Biogen</em>&nbsp;was an appeal of a district court decision, and the Federal Circuit employed a &ldquo;clear error&rdquo; standard of review, noting that appellate courts &ldquo;must take into account the &lsquo;unchallenged superiority&rsquo; of a district court&rsquo;s ability to make witness-credibility determinations and findings of fact.&rdquo;&nbsp;</p> <p><em>Indivior</em>&nbsp;was an appeal from a PTAB decision in which the Federal Circuit employed a &ldquo;substantial evidence&rdquo; standard of review (&ldquo;A finding is supported by substantial evidence if a reasonable mind might accept the evidence as adequate to support the finding&rdquo;).</p> <p>Both review standards substantially defer to the trier of fact, whether it is a district court or the PTAB.&nbsp;</p> <p>The Federal Circuit affirmed both the district court&rsquo;s decision in&nbsp;<em>Biogen</em>&nbsp;and the PTAB&rsquo;s decision in&nbsp;<em>Indivior</em>. Given that the Federal Circuit relied on the facts as determined by the district court or PTAB in these cases, it should not be surprising that the original decisions were affirmed owing to the &ldquo;intensively fact-oriented&rdquo; nature of the written description analysis.</p> <p>As for the&nbsp;<em>Biogen</em>&nbsp;decision, as noted in my earlier post, it is interesting that a new inventor (O&rsquo;Neill) was subsequently added to the patent application.&nbsp;If the original application actually demonstrated possession of the claimed invention by the inventor at the time of filing (per the written description analysis), would a new inventor have been added?</p> <p>So is it really the case that the&nbsp;<em>Biogen</em>&nbsp;decision was wrong and needs to be corrected?&nbsp;The discussion above explains why it is not necessarily the case.</p> Article 08 Dec 2021 00:00:00 -0800 Biogen v. Mylan: Make Sure Your Patent Applications Cover Your Current R&D <p>Yesterday, in Biogen v. Mylan, the Federal Circuit ruled that claims in Biogen&rsquo;s U.S. patent 8,399,514 (the &rsquo;514 patent) were invalid under 35 U.S.C. &sect;112 for failing to satisfy the written description requirement. The Federal Circuit upheld the district court&rsquo;s previous invalidity determination.</p> <p>The &rsquo;514 claims are directed to treating multiple sclerosis (MS) using Tecfidera&reg; (dimethyl fumarate -- DMF) in an amount of about 480 mg/day.&nbsp; The &rsquo;514 patent claims priority from a provisional application filed in 2007.</p> <p>The Federal Circuit noted that the &rsquo;514 patent contains only one paragraph related to treating diseases which mentions &ldquo;about 480 mg/day.&rdquo;&nbsp; Significantly, the Federal Circuit pointed out that this paragraph (1) is not linked to amounts for treating specific diseases, let alone linked to specific amounts for treating MS; and (2) only identifies about 480 mg/day &ldquo;at the bottom end of the spectrum of a DMF 480&ndash;720 mg/day range.&rdquo;&nbsp; Indeed, this paragraph cautions that &ldquo;[e]ffective doses will also vary, as recognized by those skilled in the art, dependent on route of administration, excipient usage, and the possibility of co-usage with other therapeutic treatments including use of other therapeutic agents.&rdquo;&nbsp;</p> <p>So could this paragraph really indicate that the inventor(s) had in mind, at the time the &rsquo;514 application was filed, a specific amount of DMF to treat MS?&nbsp; At minimum, it is understandable why the Federal Circuit agreed with the district court&rsquo;s analysis (or at least did not have sufficient reason to overturn the district court&rsquo;s decision) that the &nbsp;&rsquo;514 patent did not indicate the specific concentration of &ldquo;about 480 mg/day&rdquo; for treating MS.&nbsp; &nbsp;</p> <p>It is interesting that the Federal Circuit noted that the Biogen inventor initially named on the application in 2007 was Dr. Lukashev (a Biogen scientist who focused on more basic research related to pathways) &ndash; Dr. O&rsquo;Neill was not listed as a co-inventor at that time as he did not work on pathways.&nbsp; Rather, O&rsquo;Neill was added as an inventor in 2011 when the application was focused on methods of treating MS.</p> <p>The Federal Circuit noted:&nbsp; &ldquo;[w]hen asked during trial, Lukashev testified that he did not know why O&rsquo;Neill was added as an inventor. &nbsp;&nbsp;Lukashev also corroborated the original application&rsquo;s emphasis on drug discovery by noting that his work had encompassed &lsquo;a more exploratory nature. It[ was] to explore potential for follow-on compound discovery . . . .&rsquo; (alteration in original). And, more importantly, he &lsquo;denied that his research could be extrapolated to a clinical dose of DMF; it &lsquo;was never the focus of [his] work to inform the clinical dosing of [DMF].&rsquo;&rsquo;&rdquo;</p> <p>Here&rsquo;s the point regarding the inventorship discussion:&nbsp; was Biogen trying to fit a square peg into a round hole by adding MS treatment claims in 2011 to an application directed to pathway research filed in 2007?&nbsp; Is this why it was easier for the district court to find (and the Federal Circuit to agree) that the description in the &rsquo;514 patent did not correspond to the claims directed to treating MS?&nbsp; Would Biogen have been better off filing a new application directed to treating MS once it had determined to use 480 mg/day in phase III trials instead of trying to use the pending application as a vehicle for such claims?</p> <p>If the Federal Circuit&rsquo;s Biogen decision highlights one action point going forward for any company, not just pharma companies, it is this:&nbsp; make sure your patent applications keep up with your current R&amp;D efforts.&nbsp; You cannot always assume that previously-filed applications will be sufficient to protect current R&amp;D work.&nbsp; Sometimes it makes more sense to file new applications rather than trying to repurpose older, more general applications.</p> Article 01 Dec 2021 00:00:00 -0800 USPTO Grants Second Petition For Director Review <p>Following the Supreme Court&rsquo;s June decision in <i>U.S. v. Arthrex</i>, which reigned in the &ldquo;unreviewable authority wielded by the APJs during inter partes review[s],&rdquo; the USPTO quickly set up an interim Director review process by which &ldquo;[t]he Director [] may review final PTAB decisions and, upon review, may issue decisions himself on behalf of the Board.&rdquo; <i>See </i>my prior <u><a href="">June 21</a></u>, <u><a href=";an=117959&amp;anc=995&amp;format=xml">June 29</a></u>, and <u><a href="">July 21</a></u> posts on this topic. Since then acting Director Drew Hirshfeld has denied the vast majority of requests that he has received.&nbsp; But, recently, two such requests for Director review have been granted.</p> <p>In the first case between Ascend Performance and Samsung (order <u><a href="/A11960/assets/files/Documents/Ascend v. Samsung IPR2020-00349.pdf">here</a></u>), the Board found claims 1-5 and 13-17 of U.S. Patent No. 9,819,057 unpatentable; however, the panel failed to separately consider &ldquo;species claims 5 and 17 &hellip;, which [Samsung argued] are entitled to the provisional priority date and antedate the Shimura reference.&rdquo;&nbsp; Director Hirshfeld agreed that Director review should be granted because &ldquo;the Board&rsquo;s Decision did not specifically address claims 5 and 17&rdquo; and &ldquo;patent claims are awarded priority on a claim-by-claim basis based on the disclosure in the priority applications.&rdquo; The case was remanded to the Board to address the priority question surrounding claims 5 and 17.</p> <p>In the second case (<i>Proppant Express v. Oren Tech., </i>order <u><a href="/A11960/assets/files/Documents/Proppant Express v. Oren IPR2018-00733.pdf">here</a></u>), Director Hirshfeld granted review after finding that the Board&rsquo;s analysis of Oren&rsquo;s objective evidence of nonobviousness was &ldquo;substantially similar&rdquo; to the Board&rsquo;s analysis in a separate but related case between the parties (IPR2017-01918, Paper 83 (PTAB Feb. 14, 2019)) where, on appeal, the Federal Circuit remanded for further analysis of secondary considerations. Although the Federal Circuit agreed that Oren had established a presumption of nexus, the court ultimately faulted the Board for finding that Oren&rsquo;s commercial success and industry praise were largely a result of non-patented features because &ldquo;the Board did not contend with and weigh any of the evidence potentially showing that the [patented feature itself] is <i>also</i> an important contributor to the commercial success and praise of the system.&rdquo; <i>Oren Techs., LLC v. Proppant Express Invs. LLC</i>, No. 2019-1778, 2021 U.S. App. LEXIS 21859, at *18-20 (Fed. Cir. July 23, 2021).&nbsp; As in <i>Ascend v. Samsung, </i>the case was remanded to the Board &ldquo;to weigh any evidence of record showing that the patented invention itself, in addition to any unclaimed elements, contributes to the commercial success and praise of the Sandbox Product.&rdquo;</p> Based on the result in these two cases&mdash;juxtaposed with the many Director review petitions that have been denied&mdash;it appears that clear legal issues present the most likely chance of successfully obtaining Director review.&nbsp; But this also holds true for a &ldquo;routine&rdquo; request for panel rehearing. What remains to be seen and what I find the most interesting is whether the likelihood of success on these questions will be higher, lower, or the same when Director review is compared to panel rehearing requests. That is, if Samsung and Oren had requested panel rehearing rather than Director review, would they have obtained the same result or would the panel have been less inclined to find fault in their original work and deny rehearing? Going forward, I wouldn&rsquo;t be surprised if the stats support a strategy of seeking Director review for clear (legal) issues, whereas requests for rehearing may be leveraged for delay and/or arguments steeped in the factual record (which the Director, and original panel for that matter, are unlikely to have an appetite for).<br /> <br /> <br /> Article 22 Nov 2021 00:00:00 -0800