MVS Filewrapper® Blog: Legitimate Advocacy and Genuine Misrepresentation of Material Facts

The Federal Circuit has issued a decision in Apotex Inc. v. UCB, Inc., upholding a district court's finding that Apotex's U.S. Patent No. 6,767,556 ("the '556 patent") is unenforceable due to inequitable conduct. 

 

Dr. Sherman, founder and chairman of Apotex, wrote the '556 patent application and is its sole inventor.  The '556 is based on Canadian application filed on April 5, 2000.  The ’556 patent is generally directed to a process for manufacturing tablets of moexipril tablets—an angiotensin-converting enzyme (“ACE”) inhibitor used to treat hypertension. The ’556 patent discloses a process of making moexipril tablets consisting mostly of moexipril magnesium obtained by reacting moexipril or its acid addition salts with an alkaline magnesium compound to improve stability and prevent degradation of the normally instable moexipril hydrochloride.

 

Two existing drugs— Univasc and Uniretic—were both cited as prior art in the prosecution of the '556 patent, and were also asserted to infringe the '556 patent after issuance.  During prosecution, Dr. Sherman, through his patent attorney, asserted that the prior drugs did not render the invention of the '556 patent obvious because the process for making them simply combined components, rather than reacting them.  However, evidence presented at trial indicated that Dr. Sherman suspected that the existing drugs were made by the process recited in his application at the time the application was filed, and later conducted experiments to confirm that the components in those existing drugs were reacted, rather than simply combined as he represented to the PTO.  The court also found that Dr. Sherman has misled or failed to inform a declarant, Dr. Lipp, regarding the true nature of the existing drugs in relation to the claimed invention, resulting in a declaration by Dr. Lipp that perpetuated Dr. Sherman's mischaracterizations of those existing drugs.  In addition, the court determined that Dr. Sherman withheld relevant prior art from the PTO.  The district court held the combined misrepresentations and withholdings were material to the prosecution of the '556 patent, and that Dr. Sherman intended to deceive the PTO based on his overall pattern of misconduct, and therefore the '556 patent was unenforceable due to inequitable misconduct. 

 

On appeal, Dr. Sherman argued that the conduct before the PTO was merely advocating a particular interpretation of the prior art.  However, the Federal Circuit determined that his statements were not mere advocacy for a preferred interpretation; his statements were factual in nature and contrary to the true information he had in his possession.  The court clarified that there is no duty to disclose suspicions or beliefs regarding the prior art, and that there is nothing wrong with advocating, in good faith, a reasonable interpretation of the teachings of the prior art.  However, affirmatively and knowingly misrepresenting material facts regarding the prior art goes beyond failing to disclose a personal belief or alternative interpretations of the prior art, and enters the realm of inequitable conduct, which may result in an unenforceable patent.

 

The full opinion is available here.  

 

MVS Filewrapper® Blog: Critical Versus Optional, but Desireable Claim Elements

On August 6, 2014, the Federal Circuit Court of Appeals issued its opinion in ScriptPro, LLC v. Innovation Associates, Inc. In 2006, the Petitioner ScriptPro, LLC sued Innovation Associates, Inc. for infringement of claims 1, 2, 4, and 8 of U.S. Patent No. 6,910,601 ("the '601 patent").  The '601 patent describes a "collating unit" that uses sensors to automatically dispense and organize prescriptions according to individual patients.  Shortly after the lawsuit was filed, Innovation Associates filed an Inter Partes Reexamination with the USPTO, and the district court stayed the proceedings pending the result of the re-exam.  In January of 2011, the USPTO concluded its reexamination of the claims of the '601 patent, confirming claims 1, 2, 4, and 8. 

 

The district court resumed proceedings and Innovation Associates moved for summary judgment, arguing that the claims were invalid under section 112 on the grounds that the patent's specification did not describe the subject matter of the asserted claims.  The claims at issue did not require the use of sensors.  However, the district court agreed with Innovation Associates that the specification of the '601 patent implied that the use of "sensors" is critical to the functionality of the machine. Specifically, the court held, "no reasonable jury could find that the inventors were in possession of a collating unit that operated without sensors." Accordingly, the district court granted Innovation Associate's motion for summary judgment of invalidity for failure to satisfy the written description requirements of § 112. 

 

On appeal, the Federal Circuit reviewed de novo the language of the specification and—after pointing to several places in the specification suggesting the sensor may or may not be used—found that the wording of the specifications made the sensors an "optional, though desirable," feature of the invention.  The Court also pointed to the original claims as filed and noted "[w]hen a specification is ambiguous about which of several features are stand-alone inventions, the original claims can help resolve the ambiguity, though even original claims may be insufficient as descriptions or be insufficiently supported by the rest of the specification."  The Federal Circuit reversed the grant of summary judgment holding that, ScriptPro could establish that a person of skill in the art would be able to tell from description of the specification that "the inventor[s] actually invented the invention claimed."  The Court concluded that, although the machine would be more efficient with the sensors, it could be fully functional without them and, therefore, the written description was sufficient.

MVS Filewrapper® Blog: Federal Circuit Invalidates Patent Claims As Non-Patentable Subject Matter

The U.S. Court of Appeals for the Federal Circuit's recent decision in Digitech Image Technologies v. Electronics for Imaging, Inc., upheld a decision that patent claims directed to a collection of numerical data that lacks a physical component or manifestation as well as an abstract idea of organizing data through mathematical correlations are invalid.

 The plaintiff, Digitech Image Technologies, filed infringement suits against 32 defendants in the U.S. District Court for the Central District of California, asserting claims of U.S. Patent No. 6,128,415 ("the '415 patent"). The '415 patent disclosed an "improved device profile" that describes spatial and color properties of a device within a digital image processing system and "includes both chromatic characteristic information and spatial characteristic information." The district court concluded that the "device profile" claims were directed to a collection of numerical data that lacks a physical component or physical manifestation and that a "device profile" is nothing more than information, thus not falling into one of the categories of eligible subject matter under 35 U.S.C § 101. Furthermore, the district court concluded that the asserted method claims for generating a device profile encompass the abstract idea of organizing data through mathematical correlations were also ineligible under § 101.

On appeal, Digitech asserted that the district court erred in its findings that both the "device profile" and method claims were invalid. With regard to the "device profile" claims, the Court of Appeals stated that for under § 101, for all categories except process claims, the eligible subject matter must exist in some physical or tangible form. Here the "device profile" is comprised of two sets of data that describe a device dependent transformation—one set of data for color information and the other set of data for spatial information. Though Digitech argued that the "device profile" is hardware or software within a digital image processing system, the Court of Appeals concluded that the claims' only description of the device profile relates to the two sets of data and that data in its non-physical form simply does not fall under § 101.

Additionally, the Federal Circuit concluded that the '415 patent's method claims were drawn to an abstract idea because it describes a process of organizing information through mathematical correlations and is not tied to a specific structure or machine. The Court reasoned that without additional limitations, the employment of a mathematical algorithm to manipulate existing information in order to generate additional information is not eligible for patent protection.  Specifically, the claim stated a process of combining two data sets into the "device profile" and was "so abstract and sweeping" as to cover any and all uses of a "device profile."

 The full opinion is available here: http://www.cafc.uscourts.gov/images/stories/opinions-orders/13-1600.Opinion.7-9-2014.1.PDF

MVS Filewrapper® Blog: Court of Federal Claims Confirms Payment of Maintenance Fees Still Required

A recent decision by the U.S. Court of Federal Claims ("CFC") has upheld the statutorily-mandated maintenance fees required by the USPTO in order to keep issued patents in force.   The owner of an issued patent must pay maintenance fees to the USPTO three times during the lives of their issued patents to keep them in force: at three years and 6 months after grant, at seven years and 6 months after grant, and at eleven years and 6 months after grant.  If a patent holder fails to pay maintenance fees within six months of the statutory deadlines, their pertinent patent expires.

 

The plaintiff, Teresa Lucree, failed to pay the third and final maintenance fee due on U.S. Patent No. 5,781,732.  As a result, the patent expired after only 12 years—8 years before the anticipated expiration date.  After the patent had expired due to non-payment, Lucree filed suit challenging the constitutionality of maintenance fees and Congress's ability to attach conditions to patents that have been issued, asserting that such conditions violate the property interests of patent holders in their patents by enabling the government to take their patents before their expiration date and place them in the public domain.  Lucree sought relief for the early expiration of her patent under the Fifth Amendment’s takings clause, which prohibits “private property [from] be[ing] taken for public use, without just compensation.”  The government in turn sought dismissal of the suit, arguing that post-issuance conditions, such as maintenance fees, are a constitutional exercise of Congress’s well-settled authority to legislate patent fee requirements.

 

In granting the motion to dismiss, the CFC noted the broad terms of Article 1, Section 8, Clause 8 of the U.S. Constitution (the "Intellectual Property Clause") granting Congress the authority to pass laws related to the promotion of progress in "science and the useful arts."  The CFC concluded that requiring the payment of maintenance fees is at least rationally related to the directives of the Intellectual Property Clause, and therefore constitutional. 

 

The CFC also concluded that the expiration of a patent for failure to pay maintenance fees does not constitute a taking under the Fifth Amendment.  The property interest in a patent is subject to the terms and conditions as set by Congress, and early expiration for failing to pay maintenance fees is merely a consequence of failure to meet those conditions. 

 

The full opinion is available here.  

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