Friday, August 11, 2017

Amgen v. Hospira

Federal Circuit:  [O]nce a patent is listed by the sponsor, the BPCIA’s (Biologics Price Competition and Innovation Act) information exchange further requires the applicant to “provide to the . . . sponsor, with respect to each patent listed . . . a detailed statement that describes, on a claim by claim basis, the factual and legal basis of the opinion of the subsection (k) applicant that such patent is invalid, unenforceable, or will not be infringed.” 42 U.S.C. § 262(l)(3)(B)(ii) In other words, once a sponsor lists a patent under paragraph (l)(3)(A), the applicant must once again come forward with additional disclosures under paragraph (l)(3)(B) that inform whether “a claim of patent infri http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/16-2179.Opinion.8-8-2017.1.PDFngement . . . could” or could not “reasonably be asserted.” If the applicant fails to comply with its obligation to respond under paragraph (l)(3)(B), the sponsor would have a reasonable basis for asserting a claim of patent infringement. . . Thus, if a sponsor forms a belief based on an inquiry limited by an applicant’s withholding of information, the sponsor has still satisfied Rule 11.

These considerations dispel the notion that Amgen would have needed to bring suit simply based on its own unsupported belief. Hospira, in fact, agrees that Amgen could have validly listed its cell-culture patents under paragraph (l)(3)(A) and that Hospira would have been obligated to respond with “detailed statement[s]” under paragraph (l)(3)(B). In this scenario, Amgen would have had an opportunity to assess the reasonableness of its litigation position long before filing suit and being exposed to Rule 11 sanctions or antitrust liability. Thus, the reasonableness requirement of paragraph (l)(3)(A) does not preclude a sponsor from listing a patent for which an applicant has not provided information under paragraph (l)(2)(A).5 The denial of discovery in this case does not undermine the purpose of the BPCIA.

The district court correctly denied Amgen’s motion to compel on the ground that the composition of Hospira’s cell-culture media was of “no relevance to the patents that are asserted.” J.A. 37. Amgen has not established a clear and indisputable right to discovery of the information it seeks. It therefore has not established the prerequisites for this court to issue a writ of mandamus. 

http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/16-2179.Opinion.8-8-2017.1.PDF

Wednesday, August 9, 2017

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Tuesday, August 8, 2017

Del. Mag. Judge: Claim Term “Molecular Weight” Is Indefinite

In Integra Lifesciences v. Hyperbranch Medical Technology, the Defendant took the position that the term "molecular weight" in the claims of U.S. Patent 6,566,406 was indefinite:

1. A method for preparing a biocompatible crosslinked polymer hydrogel, comprising: providing a biocompatible small molecule crosslinker with a molecular weight of 2000 or less, the crosslinker having n crosslinker functional groups, wherein n is two or more, and wherein the crosslinker functional groups are either electrophilic or nucleophilic; providing a synthetic biocompatible functional polymer with a molecular weight of at least about 7 times more than the crosslinker. . .

It was undisputed that, when determining the molecular weight of a polymer, different
statistical measures could be used and that these would yield different numerical values for a given polymer.  Defendant relied heavily on the decision of the United States Court of Appeals for the Federal Circuit in Teva Pharms. USA, Inc. v. Sandoz, Inc., 789 F.3d 1335 (Fed. Cir. 2015) in support of its argument, a case that analyzed indefiniteness with respect to the same term.  In Teva, the Federal Circuit held that:

[I]t is undisputed that "molecular weight" or average molecular weight can be ascertained by any of three possible measures: Mp, Mn, and Mw. The claims do not indicate which measure to use.  The specification never defines molecular weight or even mentions Mp, Mw, or Mn. And the term "average molecular weight" does not have a plain meaning to one of skill in the art .... During prosecution of the related patents, which with respect to molecular weight have identical specifications, examiners twice rejected the term "molecular weight" as indefinite for failing to disclose which measure of molecular weight to use (Mp, Mn, or Mw). And the patentee in one instance stated that it was Mw and in the other stated it was Mp . ... We hold that claim 1 is invalid for indefiniteness by clear and convincing evidence because read in light of the specification and the prosecution history, the patentee has failed to inform with reasonable certainty those skilled in the art about the scope of the invention. On this record, there is not reasonable certainty that molecular weight should be measured using Mp.

In this case, the magistrate judge also found that the claim term “molecular weight” was indefinite:

The claims and the specification of the '406 patent do not directly speak to this issue at all. Nor is the Court persuaded that the POSITA would follow [the patentee’s expert’s]  9-step pathway to "Mn" in order to fill in the gap. That pathway relies in significant part on a single citation in the later-issued '705 patent to the Aldrich Catalog. And that very citation, on its face, does not direct anyone to consult the Aldrich Catalog for purposes of assessing measurements of molecular weight. Even if one did turn to the Aldrich Catalog for this purpose, the catalog does nothing to clearly indicate what measurement should be used; instead, it makes reference to different types of molecular weight measurements, a fact that would only solidify a POSITA's uncertainty. All of this, along with Dr. Mays' tendency to cherry-pick (without explanation) which portions of the Aldrich Catalog a POSITA would look to in the first place, renders the outcome here clear. See Butamax Advanced Biofuels, LLC v. Gevo, Inc., 117 F. Supp. 3d 632, 641 (D. Del. 2015) (finding claim indefinite where various methods could have been used to make the calculation called for by the claim limitation at issue, and "[b]ased on the broad and ambiguous language of the specification, the court does not find commonsensible [the expert's] conclusory assertion that a [POSITA] would be directed by the specification to use the MegAlign program (and its online help manual not referred to in the specification)" to do so). The Court agrees with Defendant that this case is similar to Teva, and that the conclusion reached here should be the same as the conclusion the Federal Circuit reached in that case.



Tuesday, August 1, 2017

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Thursday, July 27, 2017

Federal Circuit: Regeneron’s Intent To Deceive the USPTO Is Inferred from Failure to Disclose Relevant Documents During Litigation

After being sued for patent infringement by Regeneron, Merus asserted a counterclaim of unenforceability due to inequitable conduct. Inequitable conduct is an equitable defense to patent infringement that, if proved, bars enforcement of a patent.  Inequitable conduct has two separate requirements: materiality and intent.

There was no question that Regeneron knew about several prior art references and did not disclose them to the Patent Office.  Regeneron, however, took the position that there was no inequitable content because there was no specific intent to withhold the prior art references and that the prior art references were not material. 

During litigation, Regeneron failed to disclose to Merus documents that were relevant to the issue of intent.  “The district court concluded that many documents on the log were directly relevant to the topics as to which privilege has been waived. In particular, these documents were directly relevant to Drs. Smeland and Murphy’s mental impressions of the Withheld References during prosecution of the ’018 patent. The documents would have been relevant to determining if Regeneron specifically intended to deceive the PTO by failing to disclose the Withheld References during prosecution of the ’018 patent.”

The Federal Circuit affirmed the district court’s decision that “it was appropriate to draw an adverse inference against Regeneron from the undisclosed documents. In particular, the district court concluded that Regeneron failed to disclose the Withheld References to the PTO during prosecution of the ’018 patent with the specific intent to deceive the PTO.”

The district court also found (the Federal Circuit did not address this issue) that Regeneron had engaged in affirmative egregious misconduct—an alternative to but-for materiality—based on certain misleading statements Regeneron made to the PTO during prosecution. 

Below is the relevant portion of the Federal Circuit’s decision:
---------------

The district court provided a lengthy list of Dr. Smeland’s problematic assertions to emphasize the seriousness of the issue. In particular, Dr. Smeland stated that:

I firmly believed—and still believe today— that Br├╝ggemann, Taki, Zou and Wood were not material to patentability because they were substantially different from the mice claimed in the ’176 application . . . and were cumulative of other information before the Patent Examiner.”
Dr. Smeland’s description of his understanding of what a materiality analysis for inequitable conduct involves: “Regardless of whether I satisfied the minimum requirements of being an ordinary skilled artisan, I felt comfortable evaluating the art from that perspective during the prosecution of the ’176 application. When I did have questions, however, I did not hesitate to reach out to those with more experience and knowledge.”
“I routinely made Regeneron inventors aware of the foregoing obligations when providing them with invention declarations.”
With regards to Br├╝ggemann and Zou, “I was generally familiar with the subject matter of those two references . . . [a]t no time did I consider these references to be material to patentability to the claims pending in the ’176 application.”
“Because of this experience [prosecuting the ’176 application as well as the ’287 Patent], I was readily familiar with both prior art that was before the Examiner in the ’176 application and the pending claims of the ’176 application.”
“I viewed the analysis [relating to the Withheld References] as straightforward.”
I concluded that [the Withheld References], alone or combined with other prior art of which I was aware, were cumulative of information already before the Examiner. Furthermore, it was my view that the skilled artisan would not have viewed them as teaching the reverse chimeric inventions that the Examiner had allowed in the ’176 application.” Id. at 590–93.

These statements and others implicated Dr. Smeland’s knowledge and state of mind regarding the Withheld References directly—both during prosecution and continuing through to trial. During litigation, Regeneron made a choice to maintain the attorney-client privilege as to Dr. Smeland’s knowledge and thoughts about the Withheld References during prosecution of the ’176 application. In maintaining its assertion of privilege, Regeneron shielded Dr. Smeland’s documents relating to his knowledge and thoughts about the Withheld References during prosecution from disclosure. As with any affirmative disclosure of information otherwise protected by the attorney-client privilege, however, once the disclosure of the trial affidavit was made, as it was not inadvertent, the waiver was complete. See In re von Bulow828 F.2d 94, 102–03 (2d Cir. 1987) (“‘[S]ubject matter waiver’ . . . allows the attacking party to reach all privileged conversations regarding a particular subject once one privileged conversation on that topic has been disclosed.”); see also Fort James Corp. v. Solo Cup Co., 412 F.3d 1340, 1349 (Fed. Cir. 2005) (“The widely applied standard for determining the scope of a waiver of attorney-client privilege is that the waiver applies to all other communications relating to the same subject matter.”). 

Thus, on the day that Regeneron disclosed Dr. Smeland’s trial affidavit, it waived the privilege as to the subject matter of each of the topics the affidavit addressed. In particular, Regeneron waived privilege as to Dr. Smeland’s views on the broadest reasonable construction of the claim language, understanding of the technology, and materiality (including cumulativeness) of each of the Withheld References.

Regeneron argued that it had fully complied with its disclosure requirements throughout litigation. Merus, on the other hand, pointed to entries on Regeneron’s privilege log that seemed inconsistent with Regeneron’s representations. To resolve this dispute, the district court conducted an in camera review of a subset of the “many thousands” of documents on Regeneron’s log. Regeneron I, 144 F. Supp. 3d at 594. According to the district court, the log turned out to be a “Pandora’s Box.” Id. The district court’s in camera review revealed that there were dozens of “Smeland documents” that were not disclosed during litigation but as to which privilege had now been waived. The district court’s in camera review revealed additional serious discovery issues including a number of relevant non privileged documents that had been withheld on the basis of privilege and documents that should have been produced pursuant to the Order regarding the Jones Memo issue that had not been disclosed.

In all, the district court concluded that there were three categories of documents that presented serious concerns of discovery misconduct:

1. Non-privileged documents that were not produced and instead resided throughout litigation
on the privilege log (e.g., numerous Excel spreadsheets with scientific test results, third party filings to the PTO, and fact statements by non-lawyers not seeking legal advice).
2. Previously privileged documents as to which Regeneron affirmatively waived the privilege by disclosing the “Jones Memo” and that the district court ordered be produced pursuant to its Order.
3. Documents on the privilege log relating to precisely those topics waived by Regeneron when Regeneron filed trial declarations of Drs. Smeland and Jones.

The district court determined that Regeneron’s failure to make full and adequate production of documents in the first two categories during the period of fact discovery independently of the trial misconduct warranted serious sanction. But the third category was the most egregious.  According to the district court, the production failure was undoubtedly larger than the few exemplars revealed by the court’s in camera review. Given the thousands of documents on Regeneron’s privilege log, the district court concluded that it could not possibly learn the full extent of the problem.

As to the first category, there were spreadsheets related to scientific tests, published articles, correspondence with third parties—all of which were relevant to issues in the case and should have been disclosed. Although the ultimate value of the documents in this category was unclear, it was clear that Merus should have received them well before trial.

In the second category, the district court concluded that there were a number of documents on the log involving Dr. Jones discussing his communication with the PTO during prosecution of the ’018 patent. These should have been produced as part of the “Jones Memo” waiver issue.

The third category was most troubling. In the third category, the district court concluded that many documents on the log were directly relevant to the topics as to which privilege has been waived. In particular, these documents were directly relevant to Drs. Smeland and Murphy’s mental impressions of the Withheld References during prosecution of the ’018 patent. The documents would therefore have been relevant to determining if Regeneron specifically intended to deceive the PTO by failing to disclose the Withheld References during prosecution of the ’018 patent.

Based on its review of the privilege log and its in camera review of some of the documents on the log, the district court concluded that Regeneron’s behavior warranted sanctioning. Before imposing its sanction, the district court considered several alternate options including allowing the trial declarations into evidence. To do so, however, the district court would have had to wholesale reopen discovery requiring “a top-to-bottom re-review of the Regeneron privilege log,” “additional document production, fact depositions, and revised expert reports and
depositions.” Regeneron I, 144 F. Supp. 3d at 594–95. Additionally, the district court noted that given its “concerns with Regeneron’s process to date, the [c]ourt would require that any such process only occur with the direct oversight of a special master.” Id. This would have significantly increased the time and cost for both Merus and the district court. As the district court noted, “[a]t this point in the litigation, this is not a fair burden for Merus or this [c]ourt.” Id.

The district court also considered whether striking the trial affidavits and precluding Drs. Smeland and Murphy from testifying at trial would be a sufficient remedy. The court concluded that it would not because doing so would not address the problems caused by the first two categories of undisclosed documents and would not address the delay and disruptions caused by Regeneron’s behavior throughout litigation.

The district court ultimately concluded that it would be unfair to Merus to reopen discovery on the eve of trial and inject further delay in the case entirely due to Regeneron’s behavior. The court also concluded that doing so would impose an unfair burden on the court and require expending substantial additional judicial resources. Further, because Regeneron’s behavior suggested “a pattern” of misconduct, simply reopening discovery, striking the problematic affidavits, and/or shifting costs would not ensure fairness. Id. at 595–96. Accordingly, the district court sought an alternative remedy and concluded that it was appropriate to draw an adverse inference against Regeneron from the undisclosed documents. In particular, the district court concluded that Regeneron failed to disclose the Withheld References to the PTO during prosecution of the ’018 patent with the specific intent to deceive the PTO.


http://www.cafc.uscourts.gov/sites/default/files/opinions-orders/16-1346.Opinion.7-24-2017.1.PDF

Monday, July 24, 2017

Sandoz Files IPR Petition Against Humira Formulation Patent

On July 20, 2017, Sandoz filed an IPR Petition (IPR2017-01824) against Abbvie’s U.S. Patent No. 8,802,100, which covers a stable liquid formulation of Humira.  The ‘100 Patent is similar to Abbvie’s U.S. Patent  8916157, for which the PTAB denied Amgen’s IPR petition:

8,802,100
8916157
(Amgen’s IPR Petition was not instituted)
9085619
(Coherus has filed multiple IPR petitions for this “bufferless patent”)
1. A stable liquid aqueous pharmaceutical formulation comprising
1. A stable liquid aqueous pharmaceutical formulation comprising
1. An aqueous pharmaceutical formulation consisting essentially of:

a) a human IgG1 anti-human Tumor Necrosis Factor alpha (TNF-alpha) antibody, or an antigen-binding portion thereof, at a concentration of 45 to 150 mg/ml,
a) a human IgG1 anti-human Tumor Necrosis Factor alpha (TNF-alpha) antibody, or an antigen-binding portion thereof, at a concentration of 20 to 150 mg/ml,
(a) an anti-tumor necrosis factor alpha antibody comprising a light chain variable region (LCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO:3, a CDR2 domain comprising the amino acid sequence of SEQ ID NO:5, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO: 7, and a heavy chain variable region (HCVR) having a CDR3 domain comprising the amino acid sequence of SEQ ID NO:4, a CDR2 domain comprising the amino acid sequence of SEQ ID NO: 6, and a CDR1 domain comprising the amino acid sequence of SEQ ID NO:8, wherein the concentration of the antibody is 50 to 200 mg/ml; and
(b) a polyol,
b) a tonicity agent,
(b) water.
(c) a polysorbate at a concentration of 0.1 to 10 mg/ml, and
(c) a surfactant, and

(d) a buffer system having a pH of 4.5 to 7.0, wherein the antibody comprises the light chain variable region and the heavy chain variable region of D2E
(d) a buffer system having a pH of 4.0 to 8.0, wherein the antibody comprises the light chain variable region and the heavy chain variable region of D2E7


Sandoz argues obviousness based on multiple references (over Salfeld in combination with van de Putte, Barrera, Remington and Lam).  According to Sandoz, “a POSA seeking to formulate D2E7 [Humira] would (1) determine the concentration of D2E7 to use based upon AbbVie’s own van de Putte disclosure of clinical data demonstrating the safety and efficacy of 20, 40 and 80 mg doses, which are readily converted to concentrations; (2) use Salfeld’s teaching that D2E7 should be combined with a tonicity agent like mannitol, a surfactant and a buffer; (3) determine the amount of mannitol based upon Remington’s teaching of how to use tonicity agents and AbbVie’s own Barrera disclosure of a D2E7 formulation having 12 mg/ml mannitol; and (4) identify the type and amount of surfactant based on Remington’s teaching that polysorbate is the most widely used surfactant and Lam’s teaching of a 0.01% to about 0.1% concentration of polysorbate, which is readily converted into mg/ml.” 

The PTAB’s denial of Amgen’s petition over a similar patent and Sandoz’s reliance on so many references does not bode well for Sandoz.  


Coherus Drops Two Out of Six IPR Petitions Against Humira Bufferless Patent

Coherus BioSciences, Inc. previously filed six IPR petitions against U.S. Patent No. 9,085,619, which covers a bufferless formulation of Humira.  Coherus has now dropped two of its IPR petitions. Below is the relevant portion of Coherus' motion.

------------------------

Pursuant to the Board’s instruction during the telephone conference held April 6, 2017, Petitioner hereby submits its unopposed motion to dismiss the petitions and terminate proceedings in IPR2017-00826 and IPR2017-00827,  without prejudice, in favor of IPR2017-01009 and IPR2017-01008, respectively.  The petitions in IPR2017-00826 and IPR2017-00827 were filed on January 31, 2017 and notices of accorded filing date were issued on February 24, 2017. 

The Patent Owner has not filed a preliminary response, and the Board has not made any rulings concerning the merits of the petitions.  The Patent Owner has indicated that it does not oppose termination of the IPR2017-00826 and IPR2017-00827 proceedings without prejudice. 

Therefore Petitioner respectfully requests that, pursuant to the Board’s authority under at least 37 C.F.R. §§ 42.5(a) and 42.71(a), Petitioner’s unopposed motion to dismiss and terminate proceeding numbers IPR2017-00826 and IPR2017-00827 without prejudice be granted.