Patent Office Trials Blog
    • 8/15/2014
      Sughrue Partner, William Mandir, will join forces with an elite panel of General Counsel to discuss the best ways to streamline costs when working with outside counsel. This panel is part of IP Counsel Café’s conference in New York’s Crowne Plaza Hotel on November 13-14.

      IP Counsel Café has a long history of producing conferences that help practitioners stay at the forefront of IP law. IP Counsel Café’s New York conference will also cover topics such as: How to Develop an Effective and Sustainable Long-Term Patent Strategy; PTAB Strategies; Global Filing Strategies; ITC Litigation - Recent Trends and Best Practices; Open Source Compliance; Licensing and Structuring Joint IP Ownership Issues.
    • 7/30/2014
      The San Diego Daily Transcript recognized John B. Scherling, a well known intellectual property litigator in Sughrue's San Diego office, with the prestigious recognition of "Top Attorney" for Intellectual Property/Litigation. The Daily Transcript's Top Attorneys for 2014 pays tribute to San Diego County's legal cream of the crop. It is the culmination of a lengthy peer voting process that began in April, 2014. San Diego County lawyers were asked who among their peers -- with whom they had professional experience -- were worthy of this recognition. Out of the more than 6,000 attorneys listed in the 2014 San Diego County Attorney Directory, John Scherling was continually selected by his peers as worthy to be recognized as "Top Attorney" -- the best and the brightest.
    • 7/30/2014
      The San Diego Daily Transcript recognized Karen Dow, a well known biotech practitioner in Sughrue's San Diego office, with the prestigious recognition of "Top Attorney" for Intellectual Property/Transactional. The Daily Transcript's Top Attorneys for 2014 pays tribute to San Diego County's legal cream of the crop. It is the culmination of a lengthy peer voting process that began in April, 2014. San Diego County lawyers were asked who among their peers -- with whom they had professional experience -- were worthy of this recognition. Out of the more than 6,000 attorneys listed in the 2014 San Diego County Attorney Directory, Karen Dow was continually selected by her peers as worthy to be recognized as "Top Attorney" -- the best and the brightest
    • 7/8/2014
      A roundtable meeting to discuss the economic dangers posed by “patent trolls” was held recently by a group of San Diego County business executives and lawyers.
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    • 9/17/2014
      Over a year ago, the America Invents Act (AIA) (http://1.usa.gov/19AoMZ2) reshaped trials at the U.S. Patent Office (USPTO). The AIA established inter partes review (IPR) proceedings with the goal of having a new procedure that would provide a faster and cheaper alternative to district court litigation. Inter partes reviews allow for any person other than the patent owner to file a petition challenging the validity of a patent in view of prior art patents or printed publications. Under this new regime, a Petitioner may challenge the validity of a patent with an inter partes review at the USPTO prior to a district court dispute on non-infringement.
    • 8/29/2014
      The author reviews estoppel effects in post-grant opposition proceedings and argues that patent owner preliminary responses should be limited to attacking facial deficiencies in the petition, and that a separate reexamination or reissue proceeding is likely preferable to a motion to amend.
    • 8/15/2014

      Federal Circuit, August 15, 2014, 2013-1674

       

      When an applicant takes it upon himself to obtain a patent by intentionally duping the Examiner as to material issues, the applicant's conduct is inequitable and will result in a finding of unenforceability.  This is what the Federal Circuit found in upholding the District Court's decision in Apotex

      The technology of the patent on appeal, U.S. Patent No. 6,767,556 (“the ‘556 patent”) is a pharmaceutical composition comprising moexipril magnesium.  The '556 patent is owned by Apotex, Inc.  Dr. Bernard Charles Sherman, is the founder and chairman of Apotex, and is the sole inventor of the '556 patent.  Dr. Sherman also wrote the application for the '556 patent. 

      The '556 patent is generally directed to a process for manufacturing moexipril tablets.  Moexipril is an angiotensin-coverting-enzyme (ACE) inhibitor used to treat hypertension.  Stability of moexipril is improved by preparing moexipril magnesium by reacting moexipril or its acid salt with an alkaline magnesium compound.  The process claimed in the '556 patent is recited in the only independent claim, claim 1:

      Claim 1.       A process of making a solid pharmaceutical composition comprising moexipril magnesium, said process comprising the step of reacting moexipril or an acid addition salt thereof with an alkaline magnesium compound in a controlled manner in the presence of a sufficient amount of solvent for a predetermined amount of time so as to convert greater than 80% of the moexipril or moexipril acid addition salt to moexipril magnesium.

      In the preferred embodiment of the '556 patent, moexipril hydroxide is reacted with magnesium hydroxide or the magnesium salt of a weak acid (e.g., magnesium carbonate) to obtain moexipril magnesium.  '556 patent, col. 2, l. 66 to col. 4, l. 5.  The process used is "wet granulation," which has been known in the pharmaceutical industry since the 1980s. 

      During prosecution of the '556 patent, the claims were rejected over (1) U.S. Patent No. 4,743,450 ("the '450 patent"), which discloses an ACE inhibitor and magnesium carbonate as an alkaline stabilizer, (2) UNIVASC® and UNIRETIC®, which are made using the process described in U.S. Patent No. 4,743,450 to Warner-Lambert ("the 450 patent;" which is listed in the Orange Book for both products), and (3) an NPL reference ("the Gu article;" Gu et al., Drug-Excipient Incompatibility Studies of the Dipeptide Angiotensin-Converting Enzyme Inhibitor, Moexipril Hydrocholride: Dry Powder vs. Wet Granulation, 7. Pharm. Res. 379 (1990)), which describes the chemistry involved in stabilizing moexipril, including a wet process for converting moexipril to moexipril magnesium.  In addition, the background section of '556 patent includes a discussion of all of the above prior art.  In this discussion, Dr. Sherman characterized each of the prior art as including a combination of two individual compounds, i.e., Dr. Sherman describes the compositions of each of the prior art as including unreacted moexipril and a stabilizer.  In fact, during prosecution, at the direction of Dr. Sherman, counsel submitted the product monographs for UNIVASC® and characterized the same as including a moexipril composition that contains magnesium oxide that is "unreacted but combined and [functions] as a stabilizer."  Counsel also characterized the Gu article as teaching that the components of the moexipril composition disclosed therein as containing moeixipril hydrochloride and an alkaline stabilizing agent that are "merely combined and any reaction is insignificant to the desired end result," again at the direction of Dr. Sherman.  An expert Declaration by Dr. Michael Lipp was also submitted, in which Dr. Lipp reinforced the representations regarding the prior art that were included in the application as well as counsel's arguments submitted during prosecution.  In a subsequent Interview, the Examiner agreed to allow the application when Dr. Sherman's counsel agreed to amend claim 1 to recite that "greater than 80%" of the moexipril or moexipril acid salt is converted to moexipril magnesium.  The Examiner's basis for allowing the application was that "the prior art teaches that only a portion of the drug (if any) may be converted to the alkaline salt and that the stable product results entirely or primarily not from conversion to alkaline salts, but from stabilization of the moexipril hydrochloride by the presence of the alkaline stabilizing compound in the final product."  It should be noted that the Examiner's reasons above were in line with Dr. Sherman's characterization of the prior art. 

      Upon issuance of the '556 patent Apotex filed suit in the Southern District of Florida alleging infringement of the '556 patent by UCB (licensee of the '450 patent from Warner Lambert) based on their manufacture of UNIVASC® and UNIRETIC®, and generic versions of the same.  The District Court found the '556 patent to be unenforceable based on inequitable conduct.  On appeal, the Federal Circuit analyzed the Dr. Sherman's actions for both materiality and intent. 

      The Federal Circuit found clear and convincing evidence that Dr. Sherman engaged in material misconduct.  Primarily, the court found that Dr. Sherman directed the prosecution of the '556 patent application, both through his counsel and through Dr. Lipp.  Dr. Sherman directly instructed his counsel to continue to submit arguments that mischaracterized the prior art references, and also failed to inform Dr. Lipp of the true facts surrounding the composition of UNIVASC®.  In fact, at the District Court, Dr. Lipp testified that he was specifically asked to limit his discussions only to the documents provided by Apotex, which did not include any information on experiments conducted by Apotex on UNIVASC®.  The UNIVASC® product was tested by Apotex, and the results showed that the final product "mainly" contained moexipril magnesium.  At no time during prosecution of the '556 patent application was this data disclosed to the Patent Office.  In contrast, Dr. Sherman continued to mischaracterize UNIVASC® as containing unreacted moexipril and an alkaline stabilizing agent.  Moreover, as part of its infringement case, Apotex conducted NMR tests to show that UNIVASC® contains more than 80% moexipril magnesium, which contradicted all of Dr. Sherman's previous assertions about this product.  The Federal Court also determined that "but-for" Dr. Sherman's mischaracterization of the prior art, the Examiner would not have allowed the '556 patent to issue.  The Federal Circuit clarified that an applicant for a patent is entitled to advocating, in good faith, a reasonable interpretation of the teachings of the prior art.  See Rothman v. Target Corp., 556 F.3d 1310, 1328-29 (Fed. Cir. 2009).  However, Dr. Sherman "affirmatively and knowingly misrepresented material facts regarding prior art," and the Federal Circuit found "particularly significant and inexcusable that Dr. Sherman arranged for the preparation and submission of an expert declaration containing false statements instrumental to issuance of the patent." 

      With regard to Dr. Sherman's intent, the Federal Circuit found clear and convincing evidence to establish Dr. Sherman's intent to deceive the Patent Office, based on his blatant mischaracterization of prior art, submission of an expert declaration to bolster such mischaracterizations, and withholding of prior art.  In addition, Dr. Sherman admitted that he never performed any of the experiments described in the '556 patent, but nonetheless, drafted the examples in the specification in past tense.  The Federal Circuit agreed with the District Court that "Dr. Sherman's conduct evidences a pattern of lack of candor… deceptive intent is the single most reasonable inference that can be drawn from the evidence."

      The Federal Circuit affirmed the decision of the District Court of the Southern District of Florida, finding that the district court did not abuse its discretion in holding the '556 patent to be unenforceable due to inequitable conduct.

    • 8/15/2014
      Federal Circuit, August 15, 2014, 2013-1307-1313

      In a nonprecedential decision, the Federal Circuit invalidated as obvious claims directed to systems and methods of searching for information relevant to a user query using a combination of content-based filtering and user feedback. Concurring on separate grounds, and in describing Alice Corp. v. CLS Bank, 573 U.S. ___, No. 13-298, as providing a “technological arts” test, Judge Mayer opined that the claims were invalid under 35 U.S.C. § 101 as being directed to patent-ineligible subject matter even though the question of patentable subject matter was not raised on appeal.

      A central theme to Judge Mayer’s analysis, the use of science and technology provides a lynchpin in the subject-matter eligibility determination, without which Judge Mayer concludes that patent claims untethered to significant advance are subject-matter ineligible. Along similar lines, Judge Mayer argues that the inventive concept of the claims itself must be directed to a new technology that is a novel application of scientific principles to solve technological problems. Further narrowing the patent-eligibility filter, Judge Mayer offers that claims drawn to unscientific fields (business, law, sports, sociology, and psychology) are patent-ineligible, going to far as to state that no amount of specificity could render claims directed to such unscientific fields subject-matter eligible.

      Applying the “technological arts” test to the claims, Judge Mayer interprets the claims at issue as covering the abstract ideas of well-known and widely-used aspects of search and filtering. Without recitation of any application in the claims, the claim scope at issue is broadly viewed by Judge Mayer as covering a significant portion of all online advertising, and which if subject-matter eligible would provide broad and sweeping reach in return for minimal technological disclosure and improvement. In Judge Mayer’s view, therefore, the claims are clearly subject-matter ineligible.

      Accordingly, although nonprecedential, Judge Mayer’s perspective provides a useful example of the breath with which the subject matter eligibility paradigm post Alice Corp. might be applied.
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