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Posts Tagged: "inequitable conduct"

Federal Circuit Upholds Delaware Court’s Inequitable Conduct Analysis

In a precedential decision written by Judge Reyna, the U.S. Court of Appeals for the Federal Circuit (CAFC) on Wednesday upheld a Delaware district court’s ruling that Belcher Pharmaceuticals Inc.’s Chief Science Officer engaged in inequitable conduct, making its U.S. Patent No. 9,283,197 unenforceable. Belcher brought the suit against Hospira, Inc. for infringement of the ‘197 patent under the Hatch-Waxman Act, but the district court found that the Belcher Chief Science Officer withheld material information from the U.S. Patent and Trademark Office (USPTO) during patent prosecution, and the CAFC affirmed.

Federal Circuit Affirms Inequitable Conduct Holding Against GS CleanTech

The U.S. Court of Appeals for the Federal Circuit has affirmed a ruling by the United States District Court for the Southern District of Indiana finding CleanTech’s patents-in-suit unenforceable for inequitable conduct for making a pre-critical-date offer for sale.  The patents-in-suit, U.S. Patent Nos. 7,601,858 (“the ’858 patent”), 8,008,516 (“the ’516 patent”), 8,008,517 (“the ’517 patent”), and 8,283,484 (“the ’484 patent”), are directed to methods of recovering oil from a dry mill ethanol plant’s byproduct, i.e. “thin stillage.” 

Inequitable Conduct Lives: Patent Practitioners Beware

Inequitable conduct is practically the stuff of ghost stories among patent practitioners. You must satisfy your duty of candor to the U.S. Patent and Trademark Office (USPTO) or the patent – all the claims – will be worthless. Since Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011) (en banc) ushered in the “but-for” materiality standard, some patent practitioners may have become too complacent and willing to take a chance. Who will find out? A recent decision in Deep Fix, LLC v. Marine Well Containment Co. LLC (S.D.Tx. Feb. 18, 2020) may have patent prosecutors reviewing their files and even filing a request for supplemental examination or two.

Inequitable Conduct and Unclean Hands: Is There a Difference and Does it Matter?

Inequitable conduct remains the most powerful defense to patent infringement. In contrast to other defenses to patent infringement that require a claim-by-claim analysis, the defense of inequitable conduct is global. A finding of inequitable conduct renders the entire patent unenforceable. For this reason, the U.S. Court of Appeals for the Federal Circuit has referred to the defense of inequitable conduct as the “atom bomb of patent law” Aventis Pharma S.A. v. Amphastar Pharmaceutical, Inc., 525 F.3d 1334, 1349 (Fed.Cir.2008). Given the tremendous impact of the inequitable conduct defense, the Federal Circuit, in Therasense, Inc. v. Becton, Dickinson and Co., 649 F. 3d 1276 (Fed. Cir., 2011), has significantly increased the burden on patent infringers who assert this defense. Rather than needing to prove materiality in the context of 37 C.F.R. § 1.56 and intent to deceive, Therasense now requires an infringer prove “but for” materiality and a specific intent to deceive—a much higher burden than before. To the disappointment of those who believed that Therasense would spell the demise of inequitable conduct, this defense to patent infringement remains alive and well, although less prevalent than before. See Energy Heating, LLC v. Heat On-The-Fly LLC, 889. F.3d 1291 (Fed. Cir. 2018). Moreover, the Federal Circuit, in Gilead Sciences, Inc. v. Merck & Co. 890 F.3d 1231(Fed. Cir 2018), now seems to recognize an equitable defense (“business misconduct”) separate from inequitable conduct to penalize patentees for unethical behavior committed outside of the confines of patent prosecution before the United States Patent and Trademark Office (USPTO).

Inequitable Conduct Renders ’993 Patent Unenforceable

In Energy Heating v. Heat On-The-Fly, the court did not abuse its discretion in finding clear and convincing evidence that the inventor knew that the prior uses were material and specifically intended to deceive the PTO by not disclosing them. The court had sufficient evidence – including evidence of 61 commercial sales dating back to 2006 and no contemporaneous evidence of experimentation – to disbelieve Mr. Hefley’s testimony to the contrary.

Federal Circuit says inequitable conduct can be inferred from activities in a later patent litigation?

Although the patent prosecution process is adversarial in nature, patent practitioners must be keenly aware of their duty to maintain the integrity of any subsequently issued patent by supplying the patent examiner with all prior art that is believed to be relevant and also avoiding any misrepresentations of the prior art.  Patent litigators have long been aware of the potential pitfall of having a patent invalidated based on inequitable conduct due to activities of a patent prosecutor carried out months or years prior to the litigation proceedings.  In light of a recent decision by the Federal Circuit in Regeneron Pharmaceuticals v. Merus, however, it now appears that inequitable conduct by a patent prosecutor may be inferred due to activities of a patent litigator carried out month or years after patent prosecution has concluded.

Federal Circuit says Secondary Considerations Not Part of Prima Facie Obviousness Analysis

Objective indicia must be evaluated before drawing an ultimate conclusion on obviousness, but are not necessarily part of a prima facie “motivation-to-combine” analysis. To prove inequitable conduct based on failure to correct a misrepresentation, the moving party must show actual knowledge of a material misrepresentation and a deliberate failure to inform the PTO with an intent to deceive.

Federal Circuit declares Regeneron patent unenforceable due to inequitable conduct

The Federal Circuit issued a decision in Regeneron Pharmaceuticals, Inc. v. Merus N.V. upholding the determination that the patent owned by biotech firm Regeneron was unenforceable. The decision affirmed a lower court’s finding based on Regeneron’s inequitable conduct during prosecution of the patent at the U.S. Patent and Trademark Office (USPTO), which was the result of the withholding of references from the USPTO that had but-for materiality. The patent, which the Federal Circuit deemed unenforceable, is U.S. Patent No. 8502018, titled Methods of Modifying Eukaryotic Cells.

CAFC reverses Summary Judgment on inherent anticipation, affirms no Inequitable Conduct

It is inappropriate for a trial court to discount material expert testimony so as to weigh the evidence in favor of a party seeking summary judgment. The presence of a genuine dispute precludes summary judgment in such cases. … Failure to disclose arguments concerning claims of a different scope in a different patent application was not inequitable conduct when differences were apparent to the Examiner.

A Patent Drafting Checklist

Drafters need to think both outside and inside the claims. Outside thinking aims to make the court’s task easier by providing claim terms amenable to straightforward, simple claim construction. Preferably, at least, the key terms are expressly defined, or at least explained through demonstration. Inside thinking takes up the question whether the claim construction supports the patentee’s or owner’s intention, as manifested in the claims and specification. By the time a drafter is “experienced,” she has been exposed to considerable instruction on claim drafting. Claim construction rules, claim drafting principles, claim drafting strategy—the endless seminar. Yet, the Federal Circuit regularly lectures the patent bar on its drafting practices. The difficulty is that among all of our construction rules and strategic principles, we have lost sight of clarity and precision. We need to refocus on basic principles. Indeed, we’re going to need a bigger boat.

The Role of an Patent Procedure Expert in Patent Litigation

When you review file histories as a patent office practice expert it’s an eye-opening experience because sometimes it’s almost inexplicable as to what happened and how it could possibly have happened. And that’s what leads to some of the litigation because of the kinds of things that happen in these cases. It demonstrates why there’s still a place for a patent office practice expert in patent litigations due to the eccentricities of the practice and procedure that lead to peculiar results. An expert is needed to explain how and why these situations happen in the PTO… Sometimes you shake your head in terms of how one thing happened after another that led to a particular result that is defies how proper PTO practice and procedure is defined in the rules of practice and the MPEP.

Outside The Box Innovations v. Travel Caddy: Is a Misstatement of Small Entity Status Per Se Material to Patentability?*

In partially dissenting, Judge Newman’s beef with per curiam panel opinion on the small entity status issue was in “declin[ing] to correct the district court’s ruling that improper payment of the small entity fee is material to patentability.” Newman’s view that filing of an incorrect small entity statement doesn’t render it per se “material” is based on the 1928 Supreme Court case of Corona Cord Tire Co. v. Dovan Chemical Corp. which Newman said had made immaterial to patentability “an affidavit that was not the basis of the patent grant.” Put differently, Newman characterized Therasense as reiterating that the doctrine of inequitable conduct “should only be applied in instances where the patentee’s misconduct resulted in the unfair benefit of receiving an unwarranted claim.” In other words, Newman viewed a potentially incorrect assertion of small entity status as being “immaterial to the patent’s issuance.” But she found the per curiam panel’s opinion as being equivocal “on materiality and intent based on error in small entity status” and thus “simply add[ing] uncertainty when such is unwarranted.

Supplemental Examination at the USPTO

At the conclusion of the supplemental examination if the certificate issued indicates that a substantial new question of patentability is raised an ex parte reexamination will be ordered by the USPTO. The resulting ex parte reexamination, which will address each and every substantial new question identified, will substantially be conducted according to the rules and procedures associated with ex parte reexamination. Notwithstanding, there is one very notable exception — the ex parte reexamination is not limited to patents and printed publications. Additionally, a less consequential procedural distinction is that the patent owner will not have the right to file a statement pursuant to 35 U.S.C. 304.

Bob Stoll Part 3 – SCOTUS, the Future CAFC, Inequitable Conduct

In this final installment, Bob Stoll and I discuss the United States Supreme Court. We spend some time talking about the Supreme Court’s recent patent eligible subject matter decisions. We also discuss the problem of bad patent applications contributing to bad law and slower, more inefficient patent prosecution. We also discuss inequitable conduct after Therasense and who might make a good addition to the Federal Circuit. Stoll says the name he keeps hearing is Todd Dickinson.

US Patent Office Proposes Adopting Therasense Standard

In view of Therasense, the Patent Office is proposing to revise the materiality standard for the duty to disclose information to the Office in patent applications and reexamination proceedings. It is the belief of the Patent Office that the Therasense standard will reduce the frequency with which applicants and practitioners are being charged with inequitable conduct, thereby reducing the incentive for applicants to submit marginally relevant information to the Office. Thus, the Therasense standard should curtail the practice of filing Information Disclosure Statements that refer to boxes full of prior art that is of marginal significance, allowing patent examiners to focus on that prior art that is most relevant. The USPTO adopting the Therasense standard could, as a result, lead to improved patent quality and even a streamlining of prosecution in at least some cases.