by Dennis Crouch

Eli Lilly and Co. v. Hospira, Inc. (Fed. Cir. 2019)

On summary judgment, the district court found for the patentee Eli Lilly — holding that the ANDA filings by Hospira & Dr. Reddy infringed Lilly’s U.S. Patent 7,772,209.

On appeal, the Federal Circuit found error’s in claim construction and consequently reversed the judgment of literal infringement.  However, the court affirmed the alternative judgment of infringement under the doctrine of equivalents (DOE).

The drug at issue is pemetrexed (Lilly brand “Alimta”) approved for treatment of inoperable malignant pleural mesothelioma.  The drug operates as an anti-folate (blocking folic acid from binding and being harnessed for cancer cell growth).

The ‘209 patent does not cover the drug itself, but instead covers an “improved method for administering pemetrexed disodium to a patient in need of chemotherapeutic treatment.” I previously wrote about the patent being challenged in separate IPRs and explained that “the claimed invention calls for a pre-treatment of a patient with folic acid and vitamin B12 in order to reduce the risk skin rashes, fatigue, etc.”

Eligibility Cannot be Raised in IPR Appeal

In the litigation here, Hospira argues that its proposal does not infringe because it calls for intravenous administration of pemetrexed ditromethamine dissolved in saline and other compounds — that solution makes it different than the “pemetrexed disodium” as claimed.  Basically, a dissolved salt is not a salt.

The district court sided with the patentee writing that

Administration of pemetrexed disodium . . . refer[s] to a liquid administration of pemetrexed disodium. . . ., accomplished by dissolving the solid compound pemetrexed disodium into solution.

District Court Summary Judgment Decision. On appeal, the Federal Circuit reversed that decision — finding no literal infringement:

A solution of pemetrexed and chloride anions and tromethamine and sodium cations cannot be deemed pemetrexed disodium simply because some assortment of the ions in the solution consists of pemetrexed and two sodium cations. . . . Once diluted, the salt’s crystalline structure dissolves, and the individual ions dissociate. In other words, pemetrexed disodium no longer exists once dissolved in solution, and, as a corollary, a different salt of pemetrexed dissolved in saline is not pemetrexed disodium.

Thus, the appeallate panel found no literal infringement.

Doctrine of Equivalents. In yet another strong doctrine of equivalents decision, the Federal Circuit has held that the proposed generic solution of dissolved salts is the equivalent of the salt itself — and therefore infringes.

Few propositions of patent law have been so consistently sustained by the Supreme Court as the doctrine of equivalents. See Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushki Co., 535 U.S. 722, 733 (2002) (“Festo VIII”) (“[E]quivalents remain a firmly entrenched part of the settled rights protected by the patent.”); Warner-Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 40 (1997) (“[W]e adhere to the doctrine of equivalents.”); Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 608 (1950) (“Originating almost a century ago in the case of Winans v. Denmead, [56 U.S. 330 (1853)] . . . [the doctrine of equivalents] has been consistently applied by this Court and the lower federal courts, and continues today ready and available for utilization when the proper circumstances for its application arise.”). It is settled that a patentee is entitled “in all cases to invoke to some extent the doctrine of equivalents,” Seymour v. Osborne, 78 U.S. 516, 555 (1870), without a “judicial exploration of the equities of a case” beforehand.

Here, Lilly had narrowed its claims during prosecution, but the court found that the amendment was “tangential” to the equivalent in question — “touching lightly or in the most tenuous way.” Webster’s Third New International Dictionary (2002).

The reason for Lilly’s amendment, as the district court concluded, was to narrow original claim 2 to avoid Arsenyan, which only discloses treatments using methotrexate, a different antifolate.

The amendment was not intended to avoid dissolved pemetrexed disodium.

In summary, these cases are eminently suitable for application of the doctrine of equivalents, and we conclude that neither prosecution history estoppel nor the disclosure-dedication rule bars Lilly from asserting infringement through equivalence.

Thus, ultimately the judgment of infringement is affirmed despite the lack of literal infringement.

= = = = =

Prosecutors: It makes sense to consider the prosecution history of this case to consider how to limit prosecution history estoppel.

by Dennis Crouch

Ajinomoto Co., Inc. v. ITC; CJ CheilJedang Corp. v. ITC (Fed. Cir. 2019)

Some aspects of patent law are unduly complicated.  Here is one: Prosecution History Estoppel (PHE) as applied to the Doctrine of Equivalents (DOE).

The DOE finds infringement when someone is practicing something very similar (albeit different) than what is literally claimed.  Although the doctrine is court-created, courts are also wary of the potentially unmoored doctrine and thus have created a number of major limitations on the doctrine that have severely limited its scope.  Prosecution History Estoppel is one such limitation and arises when patent claims are narrowed during patent prosecution (something that happens in the vast majority of cases).

Under PHE, a narrowing limitation during prosecution is “presumed to be a general disclaimer of the territory between the original claim and the amended claim.” Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co., 535 U.S. 722 (2002).  In Festo though, the Supreme Court identified the disclaimer as rebuttable upon proof that “the amendment cannot reasonably be viewed as surrendering a particular equivalent.”  The high court particularly identified three mechanisms of such proof:

1. The equivalent was unforeseeable at the time;
2. The reasons for the amendment bear only a “tangential relation to the equivalent”; or
3. “some other reason.”

The Federal Circuit has noted in the past that these exceptions are “very narrow”  Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 480 F.3d
1335, 1342 (Fed. Cir. 2007)). Further, proof of the exceptions and the patent applicant’s intent must be “objectively apparent” and “discernible from the prosecution history record.”

Like I said, unduly complicated.  The easiest way to state this (recklessly ignoring the various burdens) is that PHE applies to cut-off DOE when there is a narrowing amendment reasonably related to the equivalent at issue.

I also have to say that this is a really poorly written opinion by Judge Taranto in that it muddles together various facts over many pages — often without spelling out which facts are relevant for what purposes.  The dissent by Judge Dyk is much more clear-headed as written.

= = = =

Ajinomoto’s patent claims E. coli bacteria genetically engineered with the yddG gene to increase L-amino acid production (including tryptophan) and also claims the method of making the amino acids by cultivating the aforementioned bacteria.  Ajinomoto filed a complaint against CJ CheilJedang in the USITC, and the Commission eventually sided with the patentee — finding infringement under the doctrine of equivalents.

The claim structure here is odd.   Claim 20 is the claim at issue and is couched as a multiple dependent method claim — the method of producing the L-amino acid by cultivating bacteria “according to any one of claims 9-12, 13, 14, 15-18, or 19.”  The appeal here focuses only on claim 20’s L-amino acid production according to claim 9.

The dissent explains why CJ does not literally infringe:

Claim 9 covers a recombinant bacteria having [sic] a “protein consist[ing] of the amino acid sequence of SEQ ID NO: 2.” Id. col. 22, ll. 56–57. This corresponds to the amino acid sequence of E. coli YddG protein (a membrane-bound protein involved in the cellular export of aromatic amino acids). [CJ’s] Strain B does not
literally infringe claim 9 because it produces a protein with an amino acid sequence that differs from SEQ ID NO: 2. Instead, Ajinomoto asserts infringement under the doctrine of equivalents, arguing that Strain B’s non-E. coli YddG protein is equivalent to the E. coli YddG protein (SEQ ID NO: 2) in claim 9.

Although not literally the same as what was claimed, the ITC found that it was the equivalent and therefore infringing.  On appeal, the Federal Circuit agreed — that DOE applies generally, but then focused on whether it was limited by PHE.

The original claim language covered SEQ ID NO: 2 along with modification such as “deletion, substitution, insertion or addition of one or several amino acids” of SEQ ID NO: 2. That claim was narrowed after an anticipation rejection to get around a different naturally occurring protein (YfiK).  By narrowing the claim, it also now excludes the particular YddG protein variation used by CJ.

On appeal, the Federal Circuit held that the purpose of the appeal was to get around the YfiK prior art, not the YddG prior art.  As such, the reasons for the amendment were merely tangential to the equivalent in question.

Judge Dyk writing in dissent argued the other side:

Originally, the claim covered proteins with amino acid sequence variations from SEQ ID NO: 2, which would have included the non-E. coli YddG protein at issue here. The examiner rejected the original claim based on anticipating prior art, and the patentee responded with a narrowing amendment. Instead of continuing to define the covered proteins in terms of amino acid sequence variations from SEQ ID NO: 2, the patentee deliberately chose to redefine the claimed proteins in terms of the ability of their encoding nucleotide sequences to hybridize with SEQ ID NO: 1 under the claimed conditions. The amended claim language excluded the prior art protein (Livshits) because it was made based on a nucleotide sequence that did not meet the newly added hybridization requirement. The accused equivalent is similarly not covered by the amended claims because it is produced based on an encoding nucleotide sequence that does not hybridize with SEQ ID NO: 1 under the claimed conditions. Thus, I do not see how the reason  for the narrowing amendment is tangential to the accused equivalent. . . .

In my view the tangential exception cannot apply. The equivalent is directly related to the reason for the amendment—to exclude those proteins made by an encoding nucleotide sequence that does not hybridize with SEQ ID NO: 1 under the specified conditions.

The majority disagreed with this analysis and affirmed the infringement holding.

by Dennis Crouch

VirnetX v. Cisco Systems (Fed. Cir. 2019)[Decision]

This one here stems from a set of longstanding inter partes reexamination proceedings that Apple and Cisco filed against VirnetX’s U.S. Patent Nos. 7,418,504 and 7,921,211 (establishing a secure internet connection). The examiner found the claims obvious/anticipated and the PTAB affirmed. (more…)

By Jason Rantanen

This past spring, Senators Tillis (R-NC) and Coons (D-DE), ranking members of the Senate Judiciary Committee, together with Representative Collins, Johnson and Stivers, released draft bill text for bipartisan patent legislation focusing especially on Section 101 (read here).  The Senate Judiciary Subcommittee on Intellectual Property conducted hearings on patent eligibility and disclosure requirements in June, and there was a sense that a proposed bill would drop before the August recess.  With the Senate recess beginning on Saturday, that is looking unlikely.  More likely we will see something in a few weeks, once Congress reconvenes.

There’s still a day and a half to go, however, and two recent letters to the Senate Judiciary Subcommittee on Intellectual Property have presented opposing viewpoints on the central issue being addressed by the proposed legislation: patent-eligible subject matter.

Letter from medical, health and civil rights organizations:

The first, signed by over 200 organizations, including the ACLU, Mayo Clinic Laboratories and Women’s March, begins:

We, the undersigned civil rights, medical, scientific, patient advocacy, and women’s health organizations, write to express our opposition to the recent proposal to amend Section 101 of the Patent Act. The draft legislation if enacted would authorize patenting products and laws of nature, abstract ideas, and other general fields of knowledge. Most troublingly, the legislation would permit patenting of human genes and naturally-occurring associations between genes and diseases. Allowing these patents will prevent the discovery of novel treatments for diseases including cancer, muscular dystrophy, Alzheimer’s disease, heart disease, and other rare and common diseases. It would also create barriers to patients’ access to potentially lifesaving genomic tests, eliminate access to confirmatory testing and dramatically increase the cost of tests that have benefited from innovation that led to reduced costs of DNA sequencing technology. Further, it will stymie competition for developing and improving diagnostic and medical tests, and increase the cost and hinder advancement of targeted therapeutics involving genomic markers. That means higher costs for patients, payers, and the healthcare system overall.

It further asserts that:

The draft legislation released by your offices not only rewrites Section 101 of the Patent Act, it states explicitly that any judicially created exception to patent-eligibility will be abrogated, thereby overturning the Mayo, Myriad, and Alice decisions. If enacted, this threatens to take us back to a time of greater uncertainty regarding patent eligibility. The draft goes further than that, as well. Beyond explicitly abrogating judicial precedent holding that genes, isolated from the genome, are not patentable, the legislation also would define the concept of what is useful to mean “any invention or discovery that provides specific and practical utility in any field of technology through human intervention.” This language essentially adopts the argument for patenting isolated genes that the Supreme Court rejected in Myriad. Myriad argued for, and the PTO granted,15 the patents on the BRCA1 and BRCA2 genes because the DNA was “isolated” from the cell through an act of human intervention. Isolation is required for scientific work with DNA, and permitting patents on isolated DNA resulted in the issuance of patents covering an estimated 20% of the human genome.16 Defining “useful” to include essentially any invention or discovery that was developed through human intervention reinvigorates the argument that human genes are patent-eligible.

Read the whole letter here: ACLU Letter

Law Professor Response Letter

A letter in response, signed by a group of 24 law professors, former government officials, and scholars (some of whom testified at the June hearings) opens with:

As law professors, former government officials, and scholars, we write to express our support for the congressional effort at reforming patent eligibility doctrine. As Congress considers legislation to bring balance back to the patent system in promoting the high-tech and biopharmaceutical inventions that drive the U.S. innovation economy, it is imperative that its deliberations are based on accurate statements of the law and of the real-world performance of the U.S. patent system.

The letter takes direct aim at the health and civil rights’ organizations’ letter:

We are deeply concerned about misapprehensions of law and misleading rhetoric in a recent letter to Congress submitted by the American Civil Liberties Union (ACLU) and other medical and policy organizations that oppose this legislative reform effort. Their claim, for instance, that the “draft legislation if enacted would authorize patenting products and laws of nature, abstract ideas, and other general fields of knowledge” is a profoundly mistaken and inaccurate statement. Rather, the proposed amendments preclude “implicit or judicially created exceptions to subject matter eligibility,” and do not eliminate constitutional and statutory bars to patenting laws of nature, abstract ideas, and general fields of knowledge.

Read the full letter here: Law professor response letter

Stay tuned for a third perspective, offered by Syracuse University  College of Law professor Shubha Ghosh.

By Jason Rantanen

Celgene Corp. v. Peter (Fed. Cir 2019)18-1167.Opinion.7-30-2019

Panel: Prost (author), Bryson, Reyna

While Oil States v. Greene’s Energy, 138 S.Ct. 1365 (2018), answered the question of whether inter partes review proceedings were unconstitutional generally, it left unanswered the question of whether application of inter partes review proceedings to patents granted prior to the America Invents Act constituted a taking under the 5th Amendment.  Here, the Federal Circuit directly addresses that question, concluding that it is not.

Constitutional challenges like this one can be challenging to raise effectively on appeal.  While usually, the issues are brought up in a footnote or single sentence, this was not one of those instances: Celgene devoted 8 pages of its principal brief to its takings argument, making a serious go at it.  Still, Celgene had not raised the argument before the Board and requests to address an argument for the first time on appeal are granted only in exceptional circumstances.  However, given the circumstances–Celgene’s raising of an issue not directly resolved by Oil States, the growing number of retroactivity challenges following Oil States, and the thoroughness of the briefing on the issue, among other considerations–the court concluded that “this is one of those exceptional circumstances in which our discretion is appropriately exercised to hear Celgene’s constitutional challenge even though it was not raised below.”  Slip Op. at 25.

Celgene’s argument on the merits rested on a regulatory takings theory.  It contended that “subjecting its pre-AIA patents to IPR, a procedure that did not exist at the time its patents issued, unfairly interferes with its reasonable investment-backed expectations without just compensations.”  Id. at 26.  In response, the PTO argued that (1) the patent owner never had a valid property right because the patent was erroneously issued in the first instance,” and (2) “patents have been subject to reconsideration and cancellation by the USPTO in administrative proceedings for nearly four decades, and Celgene’s own patent[s were] issued subject to this administrative revocation authority,” and that “the AIA did not alter patent holders’ substantive rights.”  Id. at 26, 27 (internal quotation marks omitted).

The Court’s analysis focused on the degree of the change: “specifically whether IPRs differ from the pre-AIA review mechanisms significantly enough, substantively or procedurally, to effectuate a taking.”  Id. at 27.  The court concluded that they were not, a conclusion that was also in line with its precedent rejecting “constitutional challenges to retroactive application of the pre-AIA ex parte reexamination mechanism.”  Id.  The money quote:

The validity of patents has always been subject to challenge in district court. And for the last forty years, patents have also been subject to reconsideration and possible cancellation by the PTO. As explained below, IPRs do not differ significantly enough from preexisting PTO mechanisms for reevaluating the validity of issued patents to constitute a Fifth Amendment taking.

The bulk of the court’s remaining discussion walks through the various administrative revocation procedures in place over the past few decades, comparing and contrasting them with IPRs.  While the court recognized differences between ex parte and inter partes reexaminations, on the one hand, and inter partes review proceedings on the other, it viewed the similarities as “far more significant.”  Id. at 30.  The substantive grounds for review are the same (anticipation and obviousness, based on the same categories of prior art, the same evidentiary standard applies (preponderance of the evidence), the same claim construction standard applies (broadest reasonable interpretation applied in this set of IPRs), in both cases the Director has discretion to initiate the proceeding, and serve essentially the same purpose.

In the end, “Although differences exist between IPRs and their reexamination predecessors, those differences do not outweigh the similarities of purpose and substance and, at least for that reason, do not effectuate a taking of Celgene’s patents.”  Slip. Op. at 36.

The court also affirmed the PTAB’s decisions finding the appealed claims obvious.

By Jason Rantanen

Solutran, Inc. v. Evalon, Inc., U.S. Bancorp (Fed. Cir. 2019) 19-1345.Opinion.7-30-2019

Panel: Chen (author), Hughes and Stoll

This opinion involves review of a district court opinion denying summary judgment that claims 1-5 of U.S. Patent NO. 8,311,945 are invalid for failure to recite patent-eligible subject matter.  (The district court also granted summary judgment that the claims were infringed.)

Claim 1 is below.  Without knowing more, can you predict how the court resolved the appeal?

1. A method for processing paper checks, comprising:

a) electronically receiving a data file containing data captured at a merchant’s point of purchase, said data including an amount of a transaction as-sociated with MICR information for each paper check, and said data file not including images of said checks;
b) after step a), crediting an account for the mer-chant;
c) after step b), receiving said paper checks and scanning said checks with a digital image scanner thereby creating digital images of said checks and, for each said check, associating said digital image with said check’s MICR information; and
d) comparing by a computer said digital images, with said data in the data file to find matches.

The answer is after the jump.

(more…)

By Jason Rantanen

Amgen Inc v. Coherus Biosciences Inc. (Fed. Cir. 2019)  18-1993.Opinion.7-29-2019

Judges Reyna, Hughes, Stoll (author)

The doctrine of equivalents (“DOE”) may be every patent law student’s favorite doctrine to hate.  (Edit: to clarify, I mean that it can be complicated not that it’s conceptually a “bad” doctrine.) I sometimes introduce it as “the rule against perpetuities – except more complicated and economically significant.”  Under the DOE, a patent can be infringed even when the accused product or process doesn’t literally meet all the limitations of the claim.

Central to the DOE is prosecution history estoppel: a doctrine that prevents “a patentee from using the doctrine of equivalents to recapture subject matter surrendered from the literal scope of a claim during prosecution.”  Slip Op. at 8, quoting Trading Techs. Int’l, Inc. v. Open E Cry, LLC, 728 F.3d 1309, 1322 (Fed. Cir. 2013).  Because prosecution history estoppel is a question of law, it often functions as threshold question that is resolved before moving to the fact-specific equivalents analysis.  Indeed, David Schwartz, Lee Petherbridge and others have argued that PHE is one of the key mechanisms that the Federal Circuit has used to limit the application of the doctrine of equivalents following Warner-Jenkinson.

Often when we think about prosecution-history estoppel, we think about amendment-based estoppel, which can arise when an applicant makes a narrowing amendment to a pending claim.  This case involves one of the trickier aspects of PHE: argument-based estoppel.

Background

Amgen sued Coherus for infringement of Patent No. 8,273,707, which relates to methods of purifying proteins using hydrophobic interaction chromatography (“HIC”).”  Slip Op. at 2.  This process uses a combination of a buffered salt solution containing the protein that is poured into a HIC column.  The proteins bind to column matrix and impurities are poured off.  The ‘707 patent claims a process that increases the maximum amount of protein in solution that can be loaded into the HIC column by using certain combinations of salts “chosen form one of three pairs: citrate and sulfate, citrate and acetate, or sulfate and acetate.”  Slip Op. at 4.

During prosecution (this gives rise to the PHE ruling), the examiner rejected the claims as obvious in view of a prior art patent that “disclosed several salts for improving hydrophobic interactions between a protein and the column matrix.” Slip Op. at 4.   Amgen responded by pointing out that “the pending claims recite a particular combination of salts.  No combinations of salts [are] taught nor suggested int eh Holtz et al. patent, nor [are] the particular combinations of salts recited in teh pending claims taught nor suggested in this reference.”  Id. at 4-5.  A supporting inventor declaration pointed out the three pairs above “reduced purification costs on a commercial scale as compared to using only a single salt.”  Id. at 5.  After another rejection, Amgen further pointed out that “choosing a working salt combinationw as a ‘lengthy development path’ and that ‘merely adding a second salt’ would not result in the invention” and the examiner allowed the claims.  Id. at 6.

In 2016, Coherus filed an abbreviated Biological License Application for an Amgen product.  Because Coherus’s protein purification method uses a chromatography buffer containing a salt combination, but not one of the specific combinations recited in Amgen’s claim, when Amgen sued for infringement in 2017, Amgen’s infringement theory rested on the doctrine of equivalents rather than literal infringement.  The district court subsequently granted Coherus’s motion to dismiss on the pleadings for failure to state a claim.

Federal Circuit: Argument-based prosecution history estoppel applies here

On appeal, the Federal Circuit affirmed the application of argument-based estoppel. “To invoke argument-based estoppel, ‘the prosecution history must evince a clear and unmistakable surrender of subject matter.'” Slip Op. at 9, quoting Conoco, Inc. v. Energy & Envtl. Int’l, L.C., 460 F.3d 1349, 1363 (Fed. Cir. 2006).  Here, the court held, argument-based estoppel applies “because Amgen clearly and unmistakably surrendered unclaimed salt combinations during prosecution.”  Id. at 9.  Amgen repeatedly pointed to the particular combinations of salts as important in distinguishing the prior art references.  As a result, “a competitor would reasonably believe that Amgen surrendered unclaimed salt combinations.”  Id. at 10 (internal quotation marks omitted).

Amgen’s primary argument, that it asserted other reasons for distinguishing the prior art reference, was not persuasive as “our precedent instructs that estoppel can attach to each argument.”  Id. at 11.  Nor was the court persuaded by Amgen’s argument that it’s last response before the claims were allowed did not contain the particular-salt-combination argument.  But “[t]here is no requirement that argument-based estoppel apply only to arguments made in the most recent submission before allowance.”  Id. at 11.  For those seeking to avoid this outcome, note the court’s final words on the subject: “We see nothing in Amgen’s final submission that disavows the clear and unmistakable surrender of unclaimed salt combinations made in Amgen’s January 6, 2011 response.”  (I’m curious: has any applicant ever disavowed an argument made earlier in prosecution?  This seems like a risky strategy for getting claims allowed.)

Overview: A recent bill proposed by Russian officials would require companies whose technology devices are shipped to Russia to contain locally developed software.

Recent Articles: 

• Tom Balmforth: Russian Lawmakers Propose Making Local Software Mandatory On Smartphones ( REUTERS )
• PYMNTS: Bill Proposes Requirement Of Russian Software On Tech Devices ( PYMNTS )

Please send all recent software law-related topics to grant@patentlyo.com

by Dennis Crouch

My law school Dean, Lyrissa Lidsky recently published a new op-ed entitled Patent reform is needed to protect patients’ access to lifesaving drugs.  Dean Lidsky is in the midst of breast cancer treatment that includes $150,000 for the biologic drug Herceptin.  Genentech (Roche) has aggressively protected this multi-billion-dollar marketplace by asserting its patent rights against potential competitors.

Dean Lidsky is receiving the treatment and insurance is paying price, but argues that the cost is simply too high:

I’m grateful that pharmaceutical companies continue to make discoveries like the one that saved my life. But Congress should pursue patent reform that puts patients first. Our lives are worth it.

The Op-Ed does not present a solution, but does cite to efforts by former Mizzou Law School professor Senator Josh Hawley (R-MO) and others.

Hawley and Sen. Rick Scott (R-FL) proposed the Transparent Drug Pricing Act of 2019 (S.977) includes a fairly weak transparency proposal requiring each state to adopt policies requiring pharmacists to disclose the price of prescription drugs.

The Bill would also limit the “retail list price” of U.S. drugs to “the lowest retail list price for the drug among Canada, France, the United Kingdom, Japan, or Germany.” Sen. Hawley explains in his press release: “There is no reason why U.S. pharmaceutical companies sell drugs to people in foreign countries far cheaper than what they charge Americans.”  As it stands, the Bill this provision could be easily skirted by manufacturers and retailers.  Notably, the Bill does not (1) define “retail list price;” (2) offer any enforcement mechanism; or (3) indicate if any agency would have authority to enforce the pricing provision.  Unless those elements are tightened-up, the provision will be mere lip service.

Prior to becoming Senator, Josh Hawley helped lead the charge against the Affordable Care Act (Obamacare) both as Missouri AG and privately in the Hobby Lobby case.

Imperium IP Holdings (Cayman), Ltd.., v.  Samsung Electronics Co., Ltd., et al. (Supreme Court 2019)

QUESTION PRESENTED

This case implicates fundamental questions about the proper roles of the jury and the court. After a six-day trial, a jury found that Respondent Samsung willfully infringed Petitioner Imperium’s patent rights. In reaching that verdict, the jury found that Samsung had failed to carry its burden of proving by clear and convincing evidence that the relevant patent claims were invalid. Following post-trial proceedings, including an award of treble damages plus attorney’s fees in light of Samsung’s willful infringement and litigation misconduct, the district court entered judgment for over $22 million on the patent claims at issue.

The Federal Circuit reversed, however, holding that Samsung was entitled to judgment as a matter of law on invalidity because the jury was required to accept the purportedly credible, “unrebutted,” and “uncontradicted” testimony of Samsung’s paid expert. The court of appeals reached that holding only after performing its own assessment of Samsung’s expert’s credibility and ignoring numerous other facts that could have led a reasonable jury to discount the value of this witness’s testimony.

The question presented is

whether an appellate court may reverse a jury verdict based on its own view that expert testimony was credible, “unrebutted,” and “uncontradicted,” or instead whether the Seventh Amendment requires the jury to make determinations about credibility and the weight of the evidence in determining whether a party has properly carried its burden of proof.

Docs:

• Supreme Court Docket.
• Federal Circuit Non-precedential Decision (“We agree with Samsung [and disagree with the Jury and lower court Judge] that the only reasonable finding on this record is that the ’884 patent claims at issue here are invalid for anticipation.”)

In his petition for writ of certiorari, Gilbert Hyatt asks:

Whether MPEP § 1207.04 violates patent applicants’ statutory right of appeal following a second rejection.

This section of the MPEP allows a patent examiner to “reopen prosecution to enter a new ground of rejection” in response to a patentee filing an appellate brief.  Hyatt argues that this approach violates the right to appeal under 35 U.S.C. § 134 and § 6(b).  When I previously wrote about the case, I noted a “remarkably parallel” case from 1904 where the Supreme Court authorized mandamus action where the examiner refused to forward cases to the Board. U.S. ex rel. Steinmetz v. Allen, 192 U.S. 543 (1904).  The Supreme Court in that case also wryly spells-out the justification for restriction practice — “to obtain more revenue” for the Patent Office.

In its newly filed responsive brief, the USPTO agrees that after having its claims “twice rejected . . . the applicant is entitled to appeal that rejection. . . [However], contrary to petitioners’ assertion, that procedure does not deprive any patent applicant of his right to review by the Board.”

[Supreme Court Docket Page]

The PTO draws a distinction with Steinmetz because it was related to a refusal to allow an appeal with regard to restriction practice — rather than repeated reopening of prosecution.

= = = =

My take here is that the PTO should be able to reopen prosecution when it acts reasonably.  A mandamus action or APA lawsuit should be available if the agency acts otherwise.