Novartis Pharm. v. West-Ward Pharm.

Novartis Pharmaceuticals sued West-Ward Pharmaceuticals for patent infringement on  U.S. Patent 8,410,131 after Novartis filed its Abbreviated New Drug Application (ANDA), because West-Ward is seeking to make and sell a generic version of Novartis chemotherapy drug everolimus (a treatment method for solid tumors).

Novartis Pharm., Corp. V. West-Ward Pharm., Intl., Ltd. (Fed. Cir. 2019). Both the district court and the Federal Circuit found in favor of the patentee and adopted the “obviousness” test in this case.

The district court agreed that a person having ordinary skill in the art (PHOSITA) would have been motivated to pursue everolimus as a potential treatment for advanced solid tumors; however, this statement contradicted another district court statement “there was no motivation to combine the prior art.”

The Federal Circuit rejected the district court’s contradicted holding and agreed with the lack of “reasonable expectation of success” factor in the “obviousness” test.

Using the “obviousness” test, patent claims shall be invalid “if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made” to a person of ordinary skill in the art to which said subject matter pertains. 35 U.S.C. § 103(a).

Specifically, there are two factors to be considered: “Motivation to Combine” and “Reasonable Expectation of Success.” The Federal Circuit held that “Motivation to Combine” is not required for the obviousness test, and the district court erred in requiring the patentee to prove that a PHOSITA would have selected everolimus over any other prior art treatments.

In addition, the district court and the Federal Circuit both held that the claimed treatment method in this case would not have been obvious because the prior art did not appear to have sufficiently high “reasonable expectation of success,”; because these courts found that there was no clinical data on everolimus as an anti-cancer treatment and no completed trial for similar compounds.

Moreover, the district court found that there has been some promising attempts of finding a compound that may work as an anti-cancer treatment. Therefore, the Federal Circuit affirmed the district court’s decision for non-obviousness in this case.

Marks for Cannabis and Cannabis-derived Goods and Services after Enactment on the 2018 Farm Bill

On December 20, 2018, the 2018 Farm Bill was signed into law and hemp-derived cannabidiol (CBD) was removed from the Controlled Substance Act (CSA). To comply with the enactment of the 2018 Farm Bill, on May 2, 2019, the United States Patent and Trademark Office (USPTO) published Examination Guide 1-19 to elaborate the procedure for examining marks for cannabis and cannabis-derived goods in regard to trademark registration.

Specifically in the Examination Guide, the USPTO clarifies that trademark applicants must specify that their goods are derived from “hemp, or cannabis with no more than 0.3% concertation of a delta-9 terahydrocannabinol (THC) on a dry-weight basis,” because the 2018 Farm Bill removed hemp from the CSA’s definition of marijuana and cannabis plants and its derivatives such as CBD that contain less than 0.3% THC on a dry-weight basis are no longer considered as controlled substances under CSA.

The USPTO also states that trademark applications that involve CBD or cannabis filed before the 2018 Farm Bill (December 20, 2018) will be refused due to the unlawful use or lack of bona fide intent to use in lawful commerce under the CSA. However, trademark applications that involved CBS or cannabis filed on or after December 20, 2018 may be accepted as long as the USPTO examined the goods that are derived from hemp or Cannabis/CBD that contain less than 0.3% THC on a dry-weight basis.

However, registration of marks for foods, beverages, dietary supplements, or pet treatments containing CBD or cannabis will still be refused for trademark registration, even if the goods are derived from hemp or Cannabis/CBD less than 0.3% THC on a dry-weight basis, because the Federal Food Drug and Cosmetic Act (FDCA) stated that goods that are currently undergoing clinical trials cannot be lawfully introduced into interstate commerce.

Inter Partes Review: Challenging Amended Claims

By Michael Ginsberg

An Inter Partes Review (IPR) is a procedure for challenging the validity of a United States patent and is conducted by the Patent Trial and Appeal Board (PTAB).

Under Section 311(b) of the Patent Act, someone may only challenge a patent using an IPR only under the grounds that could be raised under 35 U.S.C. Section 102 (which generally relates to when an invention is already public) or Section 103 (which provides that a patentable invention must not have been obvious to a “person having ordinary skill in the art”).

Additionally, the challenge can be made only based on the existence of a prior art. A patent owner can amend their patent claims for reexamination if their patent is found to be ineligible under an IPR and the reexamination would once again be an IPR conducted by the PTAB.

In the case, Amazon.com Inc. v. Uniloc Luxembourg SA, Amazon challenged and filed for an IPR for claims 1-25 for one of Uniloc’s patents. Uniloc then filed a Contingent Motion to Amend, which meant that if claims 1, 22 and 25 were found to be unpatentable, Uniloc would be able to replace those claims with claims 26, 27 and 28.

In response to the Contingent Motion to Amend, Amazon filed an Opposition to the Motion to Amend on the grounds that the amended claims (claims 26, 27 and 28) were not an eligible subject matter under Section 101.

However, under Section 311(b) of the Patent Act it states that, you can petition for an IPR, “only on a ground that could be raised under Section 102 or 103”.  Knowing this Uniloc, instead of arguing how its patent was indeed an eligible subject matter under Section 101, argued that Amazon was not permitted to challenge a Section 101 issue in an IPR.

Despite Uniloc’s argument, the PTAB made a determination on both the original and amended claims. Not only did it rule the original claims 1, 22 and 25 patent ineligible but it additionally ruled the amended claims 26, 27 and 28 patent ineligible under the grounds of Section 101.

The PTAB justified its decision to rule on the substituted claims even though it was not a Section 102 or 103 issue. It pointed out how while the law in Section 311(b) prevents it from considering the patentability of a claim under other grounds, it did not extend that same restriction to the PTAB for considering the patentability of an amended claim under other grounds.

The PTAB emphasized that there is a difference between a claim and an amended claim to justify why the PTAB was able to consider different grounds when determining the patent eligibility of an amended claim. The main difference between a claim and an amended claim is that the amended claim can only be added in after “a final written decision and action of the Director” had already taken place.

In conclusion, the consequence of this case is that the PTAB can deny a substituted or amended claim based on grounds other than those found in Sections 102 and 103.  

Building on Abstract Ideas: Alice v CLS Bank

By Evan Jensen

In its much-anticipated Alice v CLS Bank decision the Supreme Court held that Alice’s software patent was patent-ineligible subject matter under §101. But in its decision the Supreme Court seems to have blended a §101 analysis with a §103 analysis. The Court seems to infer that well-known ideas, such as methods that are fundamental to modern economy, are abstract and therefore patent-ineligible under §101.

There is no debate that abstract ideas are not patentable subject matter. No one may claim exclusive rights to the idea of addition, or of binary-decimal conversion, or any other generic abstract mathematical or conceptual idea. To allow a patent on an abstract idea would preempt everyone else from using that idea, greatly discouraging innovation, which is contrary to the primary goals of the patent system. The issue is which software claims, or whether software claims in general, are made patent-ineligible by the Alice decision.

Continue reading Building on Abstract Ideas: Alice v CLS Bank

In re Hyon: Substantial Evidence Standard Helps Preserve Finding of Obviousness

By Chris Reaves

A recent appeal of a lengthy prosecution ended last week, when the Federal Circuit in In re Hyon, 102 USPQ2d 1889 (Fed. Cir. 2012) upheld the Board of Patent Appeals and Interferences (BPAI) findings that a person of ordinary skill would have reason to combine two references to create the invention at issue.  The Board’s decision, though possibly “flawed,” could not be found unreasonable under the applicable standard of review, emphasizing the challenge that patent prosecutors face in overcoming a factual finding.

Background

The applicants, Suong-Hyu Hyon and Masanori Oka, were granted U.S. Patent No. 6,168,626 on a specific type of “Ultra High Molecular Weight Polyethylene” (abbreviated throughout the patent and the opinion as “UHMWPE”), and on the method for creating these material.  The inventors intended the material to be used for artificial joints although the claims were not limited to this embodiment.  The patent had only eleven claims, with limitations such as thickness of the UHMWPE and orientation of the crystal planes within.

Deciding these limitations were unnecessary, the applicants filed a reissue application (No. 10/643,674) within the two-year window, cancelling the original claims and adding several dozen new claims.  These new claims generally consisted of a method of four steps:

(a) crosslinking an ultra high molecular weight polyethylene block having a molecular weight not less than 5 million by irradiating the block with a high energy radiation at a level of at least 1 MR;

(b) heating said crosslinked block up to a compression deformable temperature below the melting point of the UHMWPE;

(c) subjecting said heated block to pressure; and then

(d) cooling said block.

(All claims to the UHMWPE material itself were eventually cancelled voluntarily.)

The examiner rejected all the reissue claims as obvious over two prior art patents, “Zachariades” and “Kitamaru” (Patent Nos. 5,030,402 and 3,886,056, respectively).  As the applicants acknowledged, Zachariades contained all the steps of the applicants’ claims, but in a different order – irradiation occurred after cooling.  (The exact radiation levels and molecular weights also varied, but not to a degree that the examiner thought relevant, and the applicants did not address this difference before either the Board or the Federal Circuit.)  Kitamaru, meanwhile, used a somewhat different method to prepare UHMWPE for use in films and sheets, but it began the process with an irradiation step.  The examiner found that it would be obvious to take the teaching of Kitamaru, to begin with the irradiation crosslinking, and apply it to Zachariades.

The applicants appealed to the Board of Patent Appeals and Interferences, arguing that there was no motivation to combine the references.  The Board, however, affirmed the rejection, and the applicants appealed again to the Federal Circuit.

Ruling: Board Had Substantial Evidence to Support Finding

The majority opinion, written by Judge Bryson and joined by District Judge Jeremy Fogel (N.D. Cal., sitting by designation), opened by recalling that “existence of a reason for a person of ordinary skill to combine references” is a factual finding, reviewed under the “substantial evidence” standard.

Examining the applicants’ arguments, the majority first rejected the suggestion that the prior art came from “fundamentally different material technologies.”  Both patents spoke to the preparation of UHMWPE products, and although each focused on different embodiments, “[n]either reference limits the structure of the UHMWPE product that can be made”.

The majority also found arguments that Zachariades taught against irradiating before molding, or that the examiner and Board had cherry-picked one aspect of Kitamaru to combine with Zachariades, unconvincing.  Although its claims were limited to irradiating after molding, nowhere had Zachariades stated that the opposite was unfeasible or inadvisable.  More importantly, Kitamaru had emphasized that irradiation before molding was the key to creating desired improvements in UHMWPE, namely “a higher melting or softening point, improved transparency, and excellent dimensional stability.”  Therefore, the suggestion to select that element from the reference was in the reference itself.

Judge Newman, in dissent, found it telling that Kitamaru predated Zachariades (indeed, the former issued over a decade before the latter was filed).  It was therefore “noteworthy that Zachariades, seeking mechanical strength and dimensional stability, did not follow the known Kitamaru processing sequence, but instead crosslinked the polyethylene after deformation”.  Newman found this sufficient to show that a person of ordinary skill would not find the results of the combination predictable; had it been obvious to combine, Zachariades would have already done it in his own patent.  The Board, she concluded, had engaged in impermissible hindsight analysis, “reasoning backward from” the patent at issue to see what Zachariades himself had not.

Analysis: Don’t Directly Challenge a “Reason to Combine” Finding

The majority emphasizes the standard of review in its decision.  “Substantial evidence,” a standard used in review of factual findings by both juries and quasi-judicial agency decisions, requires deference to the Board’s decision unless it was without “such relevant evidence as a reasonable mind might accept as adequate to support [the] conclusion” (Universal Camera Corp. v. NLRB, 340 U.S. 474).  In other words, unless no reasonable fact-finder could come to the same conclusion given the same evidence, the appellate court will affirm.

Given this emphasis, the standard was likely what tipped the court.  The applicants may have presented a sufficiently convincing case under a preponderance standard, but could not show that the Board’s decision was “unreasonable.”  (Notably, the dissent did not mention the standard of review once, merely calling the Board’s reasoning “flawed”.)

The substantial evidence standard reminds prosecutors that the Board hearing is the stage to win questions of obviousness.  A Circuit panel with a clear focus on this standard is highly unlikely to overturn such a finding, so prosecutors should treat the Board as their only chance.  Should that fail, however, a prosecutor can also focus more energy on the meaning of claims, both prior art and present, which are reviewed de novo.  Finally, although expensive, a § 145 civil action can reset the entire record and remove all deference (see the recent Kappos v. Hyatt, 132 S.Ct. 1690), should the applicant be in true need of a do-over.

The opinion is available at: http://www.cafc.uscourts.gov/images/stories/opinions-orders/11-1239.pdf

Oral arguments may be heard at: http://oralarguments.cafc.uscourts.gov/default.aspx?fl=2011-1239.mp3 (NOTE: the Federal Circuit’s oral argument database has been inconsistently accessible as of this article’s posting)

Federal Circuit Reaffirmed Lead Compound Analysis for Evaluating Obviousness of a New Chemical Compound

James Jang

In Otsuka Pharmaceutical Co. v. Sandoz, Inc., 678 F.3d 1280 (Fed. Cir. 2012), the Federal Circuit affirmed the decision of the district court that the patent was not obvious based on prior art evidence, nor the asserted claims were invalid for nonstatutory double patenting.

The Defendants are drug manufacturers who submitted ADNA filings to the Food and Drug Administration (FDA) for an approval to manufacture, use, or sale of generic aripiprazole products. Otsuka Pharmaceutical Corporation brought action against the drug manufacturers for infringement of patent on the compound claimed in Patent No. 5,006,528, aripiprazole, an atypical antipsychotic compound approved by the FDA for the treatment of schizophrenia. The Defendants counterclaimed that the patent was invalid for obviousness and nonstatutory double patenting. The Federal Circuit analyzed three ‘lead compounds’ asserted by the Defendants, unsubstituted butoxy compound, 2,3-dichloro propoxy compound, and OPC-4392 compound. A ‘lead compound’ means “a compound in the prior art that would be most promising to modify in order to improve upon its … activity and obtain a compound with better activity.” Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.d 1350, 1357 (Fed. Cir. 2007). The patents which disclosed the lead compounds, unsubstituted butoxy and 2,3-dichloro propoxy, also disclosed numerous examples of agents useful for the central nervous system, including an antischizophrenia agent.

In its ruling, the Federal Circuit reaffirmed the lead compound analysis, employed in Takeda Chemical Industries and Eisai Co. v. Dr. Reddy’s Labs, 533 F.3d 1354 (Fed. Cir. 2008) for evaluating obviousness of a new chemical compound, which were the first two lead compound cases decided post-KSR. The Federal Circuit explained that the lead compound analysis consists of a two-part inquiry:

First, the court determines whether a chemist of ordinary skill would have selected the asserted prior art compounds as lead compounds, or starting points, for further development efforts . . . . The second inquiry in the analysis is whether the prior art would have supplied one of ordinary skill in the art with a reason or motivation to modify a lead compound to make the claimed compound with a reasonable expectation of success.

The Federal Circuit also noted that for the lead compound selection, mere structural similarity between a prior art compound and the claimed compound is not enough, but it should be guided by the compound’s “pertinent properties.”

Applying this approach, the Federal Circuit rejected the Defendant’s argument that the lead compound analysis applied by the district court was a “rigid” obviousness analysis precluded by KSR because the court assumed that only the most obvious choice could serve as a lead. The Federal Circuit found that after evaluating all of the potential choices available to one of ordinary skill the district court correctly determined that the compounds asserted by the Defendants, unsubstituted butoxy, 2,3-dichloro propoxy, and OPC-4392, would not have been selected as lead compounds. Furthermore, focusing on the pertinent property of the new compound, rather than the structural similarity, Federal Circuit found that two other compounds — clozapine and risperidone — were viable lead compounds because these were the only capable antipsychotic compounds at the time of the invention. The Federal Circuit concluded that the Defendants failed to prove that the patent would have been obvious under 35 U.S.C. § 103.

The ruling in Otsuka Pharmaceutical Co. might be seen as the Federal Circuit’s return to the “rigid” motivation rules precluded by KSR.1 However, It appears that the Federal Circuit attempted to avoid this concern by addressing that to keep with the “flexible” nature of the obviousness inquiry, “the reason or motivation for modifying a lead compound may come from any number of sources and need not necessarily be explicit in the prior art.” This is consistent with the rulings in the previous chemical compound cases after KSR, such as Eisai Co. v. Dr. Reddy’s Labs, where Judge Rader found that the decision in KSR for flexibility would not preclude the Federal Circuit from assessing motivation in the case. Thus, the post-KSR chemical compound cases may imply that the flexible motivation test is still viable.2

“Laundry List” of potential effects is not sufficient to prove the obviousness

The Federal Circuit also rejected the Defendants’ argument that the three lead compounds asserted by the Defendants were known to have antipsychotic activity so that the claimed compound, aripiprazole, would have been obvious to one of ordinary skill. The Federal Circuit found that the patents’ “laundry list” of the potential central nervous system controlling effects, would not have informed one of ordinary skill in the art that the three compounds would have antipsychotic activity.

Nonstatutory Double Patenting

The double patenting doctrine is a judicially created doctrine “precluding one person from obtaining more than one valid patent for either (a) the ‘same invention,’ or (b) an ‘obvious’ modification of the same invention.” In re Longi, 759 F.2d 887, 892. The latter is referred to as the obviousness-type double patenting. The Federal Circuit differentiated obviousness-type double patenting from obviousness under § 103 by addressing that when examining the obviousness-type double patenting in chemical compound cases, the earlier-filed application need not qualify as prior art and “the issue is not whether a skilled artisan would have selected the earlier compound as a lead compound.” However, the Federal circuit rejected the Defendants’ argument that the double patenting never requires identifying the motivation to modify the earlier claimed compound. The Federal Circuit noted that the identification of the reason for modification is an essential part of the question whether the two claimed compounds are “patentably distinct” in the obviousness-type double patenting analysis.

In concluding that the asserted claims were not invalid for obviousness-type double patenting, the Federal Circuit also noted that predictability is an important element to consider in the obviousness analysis. The Federal Circuit held that given the high degree of unpredictability in antipsychotic drug discovery at the time of the invention, “the prior art would not have provided a skilled artisan with a reason to make the necessary structural changes.”


1. Mark D. Janisal, Tuning the Obviousness Inquiry After KSR, 7 Wash. J. L. Tech. & Arts 335 at 344-45 (2012), available at http://digital.law.washington.edu/dspace-law/bitstream/handle/1773.1/1125/7WJLTA335.pdf?sequence=4.

2. Id. at 342-44.

Board of Patent Appeals and Interferences Rules on Indefiniteness of the Term “Substantially Filled,” Prima Facie Obviousness in an Engine Cooling Method

By Charles Pierce

In Ex Parte Evans et al. (Appeal 2011-004119; Application serial no. 11/823,993), the Board of Patent Appeals and Interferences reversed examiner rejections under 35 U.S.C. § 112 for indefiniteness, and 35 U.S.C. § 103(a) for obviousness.

Claim 1 of the patent states:

A method for cooling an internal combustion engine using a reduced toxicity, ethylene glycol and water based heat transfer fluid, said method comprising the steps of:

(a) formulating a heat transfer fluid comprising (1) a glycol component consisting of ethylene glycol and propylene glycol, wherein the weight of the propylene glycol is between 5% less to less than 30% of the total weight of the glycol component and wherein the glycol component is less toxic than 10,000 mg/kg on an acute LD50(rat) oral toxicity basis, and (2) water, wherein the water comprises between 40% and 70% by weight of the total weight of the heat transfer fluid; and

(b) substantially filling the cooling system of the internal combustion engine with the heat transfer fluid such that the heat transfer fluid absorbs heat that is produced by the internal combustion engine and releases the absorbed heat to the atmosphere. (emphasis added).

The examiner rejected this claim reasoning that because the term “substantially” is not defined, the specification does not sufficiently describe the invention such that a person of ordinary skill in the art would be reasonably apprised of its scope.  The board disagreed.  They noted that “substantially” was used to describe how much a cooling system should be filled, and any person skilled in the art would know what can be considered substantially filled.  The term “substantially” was used to avoid a strict measurement,  because slight variations in the amount of fluid may still be considered to have filled a cooling system.  The board decided that the claim was sufficiently definite.

The board also disagreed with the examiner’s obviousness rejections.  The examiner’s rejection was that the claims were prima facie obvious.  The board noted that no reference disclosed the weight range of the propylene glycol in the glycerol component, or the weight range of the glycerol in the polyhydric alcohol component.  Because the references also disclosed only the components of the invention, the board ruled that they were not enough for a person of ordinary skill in the art to create the claimed cooling method.