Monthly Archives: April 2024

April 22, 2024, The 55th Earth Day

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The first Earth Day was April 22, 1970, it was not until 20 years later, that the impact of Earth Day was recorded in the U.S. Patent collection. In U.S. Patent No. 5090559, issued in 1992 on Reusable Garment Bags for Dry Cleaning, acknowledged that ” ‘Earth day,’ citizen activist groups, scientists and a large number of television documentaries and public information and service programs have all increased public awareness of [issues with disposable bags.”

In 1997, U.S. Patent No. 5601204 on a Tank Vault With Sealed Liner, noted:

Since the 1970s, the world, and in particular, the United States, has been concerned with the environment and the contamination of that environment, including the earth’s soil, its atmosphere and its water. The first Earth Day in 1970 resulted in the eventual creation of the Environmental Protection Agency by the United States Congress.

Since the 1970s, the world, and in particular, the United States, has been concerned with the environment and the contamination of that environment, including the earth’s soil, its atmosphere and its water. The first Earth Day in 1970 resulted in the eventual creation of the Environmental Protection Agency by the United States Congress.

U.S. Patent No. 5595114 issued in 1996 on a Simulated Musical Rainmaker, which it described as “a perfect toy to celebrate Earth Day, which is slowly becoming an important holiday in the calendar year.”

U.S Patent No. D407127 issued on a baseball with an Earth Day logo:

U.S. Patent No. 7560822 issued in 2009 on an Educational Electrical Generation Kit that is “sturdily and durably configured, particularly since it may be used in crowded environments with children present (e.g., in schools, science fairs, Earth Day events, open houses at utility companies, museums, etc.).”

U.S. Patent Nos. 8870061 issued in 2014 and 9302818 issued in 2016 disclose a Reusable Envelope, which the patents indicate is particularly adapted for Earth Day mailings.

U.S. Patent No. 10107029, issued in 2018, commented that “forty years after capturing the imagination of many people during the first observance of Earth Day, America’s recycling revolution is getting mixed reviews.” While the patent noted that “140 million Americans recycle—more than vote in national elections,” we can certainly do better, and as the 55th Earth Day approaches, hopefully, we will.  

Reasonable Expectation of Success Made Claims Obvious

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In Salix Pharmaceuticals. Ltd v. Norwich Pharmaceuticals Inc., [2022-2153, 2023-1952] (April 11, 2024), the Federal Circuit affirmed the district court determination that Norwich infringed claim 8 of U.S. Patent 8,624,573, claim 6 of U.S. Patent 9,421,195, and claims 11
and 12 of U.S. Patent 10,335,397 and had failed to prove that those claims were invalid.

Rifaximin, the active ingredient in Salix’s commercial product Xifaxan®, has been widely used as an antibiotic for decades, having been first synthesized in the early 1980s
in Italy and approved there as an antibiotic in 1985. The FDA approved Xifaxan nearly 20
years later, in 2004, as 200 mg tablets for the treatment of travelers’ diarrhea. The FDA subsequently approved 550 mg tablets for hepatic encephalopathy in 2010 and for irritable bowel syndrome with diarrhea (“IBS-D”) in 2015.

Norwich sought to market a generic version of rifaximin and, in 2019, filed an ANDA for 550 mg tablets with the same indications as Xifaxan, certifying pursuant to 21 U.S.C. § 355(j)(2)(vii)(IV) that Salix’s rifaximin patents were invalid. Salix timely sued, asserting that Norwich’s
ANDA infringed dozens of valid, Orange Book-listed patents. By the time of trial, the case had been streamlined to three groups of patents:

  1. the ’573, ’195, and ’397 patents, directed to treating hepatic encephalopathy
  2. the ’569 and ’667 patents, directed to treating irritable bowel syndrome with diarrhea with 550 mg rifaximin three times a day (1,650 mg/day) for 14 days; and,
  3. the ’199 and ’206 patents, directed to rifaximin form β

Following a bench trial, the district court held that Norwich infringed the hepatic encephalopathy patents’ claims and had failed to establish their invalidity. Norwich did not appeal those holdings. The court also held that Norwich’s ANDA infringed the irritable bowel syndrome and polymorph patents, but that those patents’ claims would have been obvious
over the prior art. Salix appealed those invalidity holdings.

Norwich then amended its ANDA in an attempt to remove the infringing hepatic encephalopathy indication and moved to modify the judgment under Federal Rule of Civil Procedure 60(b), asserting that the amendment negated any possible infringement. The court denied Norwich’s motion, and Norwich cross-appealed.

Validity of the Irritable Bowel Syndrome Claims

The key limitation on appeal is the dosage amount that appears in the claims: 550 mg, three times per day (“TID”), for a total of 1,650 mg/day. Norwich challenged the IBS-D claims’ validity by asserting as prior art references a clinical trial protocol that had been published and a 2006 journal article by Pimentel. The Protocol described a Phase II study evaluating
twice-daily doses of 550 mg (1,100 mg/day) and 1,100 mg (2,200 mg/day) for 14 and 28 days for the treatment of irritable bowel syndrome. Pimentel taught administering 400 mg, TID (1,200 mg/day), for the treatment of irritable bowel syndrome but further opines that the “optimal dosage of rifaximin may, in fact, be higher than that used in our study.” The district court found that those two references disclose each and every limitation of the challenged irritable bowel syndrome claims, and further found that a skilled artisan would have been motivated to combine those two references to arrive at what is claimed with a reasonable expectation of success.

Salix appealed, asserting that the court erred in finding that a skilled artisan would have had a reasonable expectation of success in using the claimed 1,650 mg/day dosage to treat irritable bowel syndrome. According to Salix, the highest prior art dosage amount
that could have been supported with a reasonable expectation of success was the 1,200 mg/day dose evaluated by Pimentel. The Federal Circuit disagreed, noting that while the Protocol alone might not support the reasonable expectation of success, in combination with Pimentel, which taught that “[r]ecent data suggest that the optimal dosage of rifaximin may, in fact, be higher than that used in our study,” it was not error for the district court to conclude that there was a reasonable expectation of success as to the efficacy of 550 mg TID dosing.

Validity of the rifaximin form β Claims

Norwich challenged the polymorph claims’ validity by asserting, inter alia, Cannata, which discloses that rifaximin exists in crystalline form with “outstanding antibacterial properties.”

The district court held that expert testimony supported a conclusion that, in view of the prior art, (1) a skilled artisan would have had good reason to characterize the crystalline
rifaximin obtained by following the Cannata protocols, (2) that such characterization was routine and could have been performed “in one day,” and (3) that doing so would have led the skilled artisan to have “detected rifaximin β.”

The Federal Circuit noted that the scope and content of the prior art here includes preparations of crystalline rifaximin, which expert testimony supports would have yielded the β form of rifaximin. The difference between the prior art and the claims is thus effectively nothing more than the performance of routine characterization to identify the polymorphic forms that result from the known Cannata processes.

Salix argued that the rifaximin’s β form nonetheless constituted a non-obvious invention because, although skilled artisans actually succeeded in producing and characterizing it, they would not have expected to succeed because, as of the critical date, the polymorphic nature of rifaximin had not yet been reported and the identity of the β form remained undisclosed. Salix further argues that there could have been no expectation of success because the skilled artisan would not have been able to predict what polymorphic forms might result from following the preparation protocols disclosed in the prior art. The Federal Circuit disagreed, noting that Salix has done no more than combine known elements of the prior art to verify readily accessible information concerning a compound already in the hands of those of ordinary skill in the art, and such routine efforts do not justify removing this polymorph from the public domain.

The Federal Circuit noted that it was not holding that there is always a reasonable expectation of success in accessing or characterizing polymorphs. It was simply reviewing the district court’s decision before it as to its factual finding of a reasonable expectation of success, and in so doing, have not been left with a definite and firm conviction that a mistake was made in reaching that finding.

Norwich’s Cross Appeal

On cross-appeal, Norwich raises two related but distinct arguments that arose after the district court held that Norwich infringed the HE patents and failed to establish invalidity. Norwich first argues that the district court misinterpreted 35 U.S.C. § 271(e)(4)(A), which directs a court, following a finding of infringement, to order the FDA to defer final approval of an ANDA until the expiration of the infringed patent. According to Norwich, that statute precludes delaying final approval of an entire ANDA, and instead requires delaying only the approval of the infringing use.

The Federal Circuit said Section 271(e)(4)(A) instructs that, following a finding of infringement, “the court shall order the effective date of any approval of the drug or veterinary biological product involved in the infringement to be a date which is not earlier than the date of the expiration of the patent which has been infringed.” Norwich argued that the language of § 271(e)(4) requires courts to tie the restriction on FDA approval to the
indication for which the ANDA seeks approval when that indication was the source of infringement. The district court order concerned only the specific ANDA in question that included an infringing use, referred to the ANDA by its number, and enjoined the approval
of that ANDA.

Since the FDA does not approve drugs in the abstract, but rather approves drugs for particular uses (indications) of that drug, the statute is appropriately construed as directed to approval of particular infringing uses of the drug, not all uses of the drug including non-infringing uses. The statutory scheme makes clear that the relevant infringement is the submission of the ANDA that included an infringing use. That the ANDA further recited a non-patent-protected indication does not negate the infringement resulting from the ANDA’s submission. The order thus appropriately delayed the effective final approval date of “this
infringing ANDA” submission.

Norwich’s second argument arises from its decision to amend its ANDA to carve out the infringing HE use after final judgment. Following that amendment, Norwich filed a motion to modify the final judgment to allow for prompt approval of the amended ANDA that purportedly no longer sought approval for the infringing HE use. The district court denied that motion, holding that Norwich “fully litigated the merits of its non-infringement and invalidity case, lost, and now seeks a way around the final judgment through Rule 60(b).

The Federal Circuit said that a district court may reconsider its own finding of infringement
in light of an amended ANDA, but the court need not do so, and the Federal Circuit said that the court reasonably held that consideration of the amended ANDA would be inequitable
and inappropriate. The court noted that it is not a simple matter to determine whether an
ANDA applicant has successfully carved out language from a label to turn infringement into non-infringement” and that what Norwich sought in its Rule 60(b) motion would essentially be a second litigation” following final judgment.

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Total Eclipse of the Sun on April 8

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Several inventors have addressed the problem of safely watching a total eclipse of the sun. One of the earliest is U.S. Patent No. 548868, which issued October 29, 1895, on an Apparatus for Observing Eclipses:

This patent is long ago expired, so feel free to adapt for your use on April 8, A more modern device is disclosed in U.S. Patent No. 9123285, which provides a Transparent Display Device and Transparency Adjustment Method Thereof, which explains:

U.S. Patent No. 11438494 on a Device for Viewing and Imaging the Sune and Solar Phenomena, the augments a user’s smartphone:

U.S. Patent No. 10103768 provides a Mobile Device Casing that includes a filter 304 for photographing solar eclipses:

U.S. Patent No. 11536947 on a Tunable Window System for a Vehicle, that can adapt to “local conditions (e.g., solar eclipse). 

Solar eclipses have inspired some to make games, like U.S. Patent No. 5678823 on a Total Solar Eclipse Game of Skill:

Others have named plants after solar eclipses, as in U.S. Patent No. PP23647:

The technology is there to have a safe viewing experience. Enjoy the April 8 solar eclipse.

Reading Limitations into the Claims and Failure to Follow Proper Obviousness Inquiry Required Non-obviousness Determination to be Vacated

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In Jannsen Pharmaceuticals, Inc., v. Teva Pharmaceuticals USA, Inc., [2022-1258, 2022-1307] (April 1, 2024), the Federal Circuit affirmed the district court’s determination that the claims of U.S. Patent NO. 9,439,906 were not indefinite, and vacated and remanded the determination that the claims were not obvious.

The patent, which generally relates to dosing regimens of paliperidone palmitate, is the last remaining Orange Book patent for Invega Sustenna. Teva First argued that the district court’s analysis of obviousness required Teva to show that it would have been obvious to use the recited dosing regimens for the general population of patients—i.e., a generalized dosing regimen. The court found that the prior art did not demonstrate population-wide safety and efficacy and thus did not teach a generalized dosing regimen. Teva contended that the claims were not directed to a generalized dosing regimen and therefore the district court asked for a showing of obvious-ness that went beyond what was claimed, and the Federal Circuit agreed, saying nothing in the claims requires that the regimen be used for—let alone be ideal for—the patient population generally or a certain percentage of the patient population.

Teva argued that the court also read a “mild” limitation into the renal-impairment claims, whereas the claims do not specify a level of renal impairment. Janssen countered that Teva presented an obviousness theory that was pred-icated on dosing a patient with mild renal impairment. The Federal Circuit agreed that many of the district court’s statements suggest that it understood the claims themselves to require administration to a patient with mild renal impairment, yet there was no such requirement in the claims.

Teva also argue that the court’s analysis was impermissibly rigid and did not comport with KSR or otherwise reflect the Federal Circuit’s obviousness jurisprudence. The Federal CIrcuit agree, noting that Instead of considering the prior art in context or in combination, the district court’s analysis seems to tackle the ex-press statements of each reference one-by-one—identifying each difference or dissimilarity between an individual ref-erence and the claims, but not fully assessing the teachings in toto. This seemingly siloed and inflexible approach left insufficient room for consideration of how background knowledge in the art would have impacted a POSA’s un-derstanding of, or motivation to modify, the primary refer-ences at issue, thereby inflating the significance of minor variations between the prior art and the claims.

Among other things, the Federal Circuit criticized the district court for concluding that in the pharma-ceutical context, if a prior art reference does not contain safety and efficacy data, there is no reason to combine it with other prior art references. The Federal Circuit also criticized the court for looking for Teva to demonstrate an explicit problem to provide motivation, notning among other things that the motivation analysis is not limited by the problem or need recognized by the inventors. The Federal Circuit said that:

A motivation “may be found explicitly or implicitly in market forces; de-sign incentives; the interrelated teachings of multiple patents; any need or problem known in the field of endeavor at the time of invention and addressed by the patent; and the background knowledge, creativity, and common sense of the person of ordinary skill.”

Overall, the district court’s analysis ran afoul of KSR’s basic mandate in a number of ways. It failed to consider the “interrelated teachings of multiple” references, “the back-ground knowledge possessed by a person having ordinary skill in the art,” or “the inferences and creative steps that a person of ordinary skill in the art would employ.” Instead, the court sought an explicit indication in the prior art that an improvement was re-quired—at times also suggesting that it was searching for an indication that the claims captured the singular way the protocol would be modified.

Finally, Teva argued and the Federal Circuit agreed, that the district court did not apply the correct test for teaching away. A teaching that a particular value is optimal is not a criticism of all other values, nor is the fact that a reference does not disclose the claimed value a teaching away. The Federal Circuit instructed that the district court should have analyzed whether the claimed value was “criticize[d], discredit[ed], or otherwise discourage[d].”

Indefiniteness

To satisfy the definiteness requirement, a patent’s claims, viewed in light of the specification and prosecution history, must inform those skilled in the art about the scope of the invention with reasonable certainty. The Federal Circuit has held that claim scope is not reasonably certain where a claimed characteristic can be measured in multiple ways, those different measurements “would typically yield a different result” when applied to the same sample, and the intrinsic record fails to provide reasonable certainty about which measurement was intended by the claims.

The claims contain a particle-size limitation, but do not specify what measurement technique should be used to determine whether the particle-size limitation is met. The specification states that the particle size can be measured by art-known conventional techniques, such as sedimentation field flow fractionation, photon correlation spectroscopy or disk centrifugation. Teva argued that the different particle-size measure-ment techniques, which were all allowed by the claims, would yield meaningfully different results. However, the district court found that the actual discrepancy in particle-size measurement that Teva relied on was “an outlier measurement taken with a defective device,” i.e., was not based on a discrepancy typical of the measurement technique used. Teva has not shown that the court’s outlier finding was clearly erroneous. As a result, the district court correctly determined that, on this record, Teva did not meet its burden to show that the challenged claims were invalid as indefinite.

April Showers

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April is known for spring rains, and fortunately for us, inventors have our backs with umbrellas of all kinds. An all-time favorite is the combination umbrella/lightning rod in U.S. Patent No. 4,447,847, which only issued after the inventor, Drulard, successfully appealed the Examiner rejection that the invention lacked utility:

Inventors have provided protection for infants, U.S. Patent No. 849055 provides an umbrella mount for a stroller:

and the aged, U.S. Patent No. 10285893 provides an umbrella mount for a walker:

Even pets are covred (literally). U.S. Patent No. 6871616 provides a pet umbrella:

Inventors have protected us during all of our daily activities. U.S. Patent No. 8556141 provides a backpack with an umbrella:

U.S. Patent No. 639634 provides a bike with an umbrella:

U.S. Patent No. 5609321 provides a golf cart with an umbrella:

U.S. Patent No. 10952487 provides an umbrella for hands-free drinking:

U.S. Patent No. 7967274 provides an umbrella for getting in and out of a car:

U,S, Patent No. D664761 provides an umbrella for watching sports:

Inventors have provided us umbrellas that protect our phones. U.S. Patent No. D822370 protects a cell phone mount for an umbrella::

So, when April showers may come your way, remember that they bring the patents that issue in May (and the rest of the year).