Guest Post by Professor Jorge L. Contreras

The Patent Eligibility Restoration Act should be modified to prevent the reintroduction of patents on naturally-occurring genomic sequences that are isolated and purified in the lab, a change that will enable international pathogen research to continue while interfering little with private incentives to develop new biomedical technologies.

The Patent Eligibility Restoration Act of 2022 (PERA), introduced by Senator Thom Tillis (R-NC) in August 2022, is designed, among other things, to abrogate the Supreme Court’s patent eligibility decisions in Bilski, Mayo, Myriad and Alice. While Congressional action may be useful to clarify the confusing landscape of patent eligibility that has followed from these decisions, particularly in areas such as medical diagnostics, software and business methods, one piece of the eligibility puzzle that the Supreme Court got right, and which should not be changed, is Myriad’s holding that naturally occurring genomic sequences are ineligible for patent protection, even when “isolated and purified.”

In my book, The Genome Defense: Inside the Epic Legal Battle Over Who Owns Your DNA (New York: Algonquin, 2021), I discuss the Myriad case at length, focusing on its implications for human health and access to care.  Like many others, I am concerned that PERA would make newly identified human genetic variants with significant health implications (e.g., this and this) patentable again, potentially removing them from the broad competitive market and placing them in the hands of the first research team that chances to identify them (a task that is, today, largely serendipitous and requires little innovative skill). I have previously discussed these concerns here. In this post, however, I focus on a different and less-discussed issue: the risk that non-human pathogenic genomic sequences (i.e., from viruses and bacteria) will be patented by non-U.S. institutions and used to delay the development of lifesaving diagnostics, vaccines and therapeutics.

When Patents Held Up Pathogen Research

Prior to the Myriad decision, research groups around the world were able to obtain patents on newly identified pathogen genomic sequences, including those of the H5N1 influenza strain and the SARS and MERS coronaviruses. As I discuss in this new article, these patents led to disputes and delays in research on the diseases and effective countermeasures. After Myriad, however, research groups appear to have stopped seeking patents on new pathogenic agents, as shown by the global experience with the Ebola and Zika outbreaks, leading to greater global cooperation and rapid responses by public health agencies and private developers of diagnostics, vaccines and therapeutics.

SARS-CoV-2:  the Benefits of Patent-Free Pathogens

The genomic sequence of SARS-CoV-2 (the virus responsible for COVID-19) was first identified in early January 2020 by a team of researchers in China. On January 5, they uploaded the sequence to the publicly accessible GenBank database. Within days, diagnostic tests for the virus had been developed and a few months later, new vaccines against COVID-19 were being tested. As I have written previously, the unavailability of patents on genomic sequences, and the rapid uploading of the SARS-CoV-2 sequence to public databases, enabled researchers around the world to study the viral genome without fear of patent infringement and without the need to negotiate complex patent licensing agreements and pay royalties to the first researchers to determine its sequence. This open and unencumbered global research environment enabled scientists to identify and trace the spread of multiple pathogenic variants around the world, to understand the biological mechanisms of the virus, and to develop vaccines, diagnostics and therapeutics, all in record time.

PERA and U.S. Competitiveness

Senator Tillis, when introducing PERA, explained that a major goal of the bill is to enhance “the economic and global competitiveness of the United States”. He faults judicial decisions like that in Myriad for “undermining American innovation and allowing foreign adversaries like China to overtake us in key technology innovations.” Likewise, supporters of the draft legislation have enthusiastically proclaimed that it will “rev the US innovation engine once again”, warning that “[e]conomic growth, job creation, global competitiveness, public health and national security are all at risk until Congress repairs the law of patent eligibility that the Supreme Court has distorted.”

Yet, ironically, at least in the case of pathogenic sequences, PERA would work largely to benefit institutions in China and elsewhere, and could have adverse consequences for U.S. businesses and global public health.

Pathogens Usually Emerge, and are Sequenced, Outside the United States

Most serious pathogenic outbreaks result from the transmission of disease agents from animals to humans. These outbreaks originate in regions characterized by extensive animal husbandry, live animal markets, hunting or habitat loss. Within these parameters, the particular locale of a future outbreak is unpredictable. Recent infectious disease outbreaks have been traced, respectively, to China (SARS and H5N1), Saudi Arabia (MERS), Zaire and Congo (Ebola), Uganda and Brazil (Zika).

Likewise, once a pathogenic outbreak has entered human populations, the locations where its variants will emerge is also unpredictable. For example, the major variants of SARS-CoV-2  were first documented in China (original strain), the United Kingdom (alpha), South Africa (beta, omicron), Brazil (gamma), India (delta), Peru (lambda) and Botswana (omicron).

Today, genomic sequencing equipment is widely available at a modest cost. Researchers in 2021 estimated that the cost of sequencing a SARS-CoV-2 genome (only 1/100,000 the size of the human genome) is approximately $120, bringing it well within the reach of researchers in countries such as Gambia, which had, by mid-2021, sequenced more SARS-CoV-2 genomes than Germany.

It is also worth noting that countries, including the United States, that are parties to the World Trade Organization (WTO) Agreement on Trade Related Aspects of Intellectual Property (TRIPS) must give “national treatment” to applicants from all other member states. Thus, researchers from any TRIPS member country may apply for a U.S. patent and will be afforded the same rights as applicants from the United States. Indeed, for the past several years, most U.S. patents have been issued to non-U.S. applicants. In 2021, for example, of approximately 374,000 issued U.S. patents, nearly 200,000 (roughly 53%) were issued to foreign entities. This situation is not unique to the United States and is simply indicative of today’s global technology markets.

The combination of unpredictable sites of pathogenic emergence, inexpensive genome sequencing and national treatment under TRIPS suggests that if U.S. patents become available for pathogenic sequences, the parties most likely to obtain these patents will originate outside of the United States in countries that are likely sites of disease emergence. It is doubtful that allowing pathogen patenting would result in more patents being issued to U.S. applicants. Rather, U.S. and other companies that wished to develop diagnostics, vaccines and other technologies dependent on those sequences would either be excluded from the market or required to pay unpredictable prices for a license to operate under those patents.

Countries That Are Willing to Hold-Up Research

In recent years, certain foreign governments have shown themselves willing to hold-up international disease research and response efforts in order to gain concessions and advantages for themselves under the banner of “access and benefit sharing” (ABS). The most prominent example of this tactic occurred in 2006-07, when the government of Indonesia refused to share samples of the H5N1 influenza virus strain with the World Health Organization until it obtained commitments regarding access to any resulting biomedical products. Similar tactics were adopted by other countries during the MERS, Ebola and Zika outbreaks, as documented here.

If countries are willing to hold-up international research and disease response in order to secure ABS benefits for themselves, then they are also likely to use patents to extract further concessions from the international community. Demands for ABS concessions are not necessarily unjustified in view of past exploitation of local resources by foreign firms in developing countries. Yet even if justified, these barriers to the international response to emergent disease outbreaks can negatively impact global health. Reintroducing pathogen patenting will give countries where diseases emerge yet another tool to hold-up critical international research and development to the detriment of all.

Patents are not Necessary to Incentivize Pathogen Sequencing

One of the principal functions of the patent system is to provide financial incentives for innovators to develop new technologies. Yet, this rationale does not support the issuance of patents claiming pathogen sequences. The identification of new pathogens during emergent disease outbreaks is rarely undertaken by private industry. Rather, this function is usually carried out by public health agencies and academic laboratories, typically in the locale of the outbreak, and which are supported by public funds. Thus, unlike the development of vaccines and therapeutics, the financial incentives offered by patent exclusivity are not necessary to incentivize these early stage research efforts.

There Are Ample Patentable Innovations Relating to Disease Response and Containment Beyond Pathogen Sequences

It is also unnecessary to patent underlying pathogenic sequences in order to protect novel and innovative technologies such as diagnostics, vaccines and therapeutics. A 2012 WIPO study identified more than 50,000 patents and published patent applications across 57 countries that claimed the active ingredients of pneumonia, typhoid and influenza vaccines, most without claiming the underlying pathogen. Even more opportunities for innovation exist with respect to therapeutics, which can adopt a broad range of approaches to combating infection. For example, Regeneron filed more than 100 patent applications around the world on its Ebola drug Inmazeb, though the viral sequence was freely available on GenBank.

The broad availability of patents for innovation around pathogenic disease outbreaks is amply demonstrated by the COVID-19 pandemic. Despite the absence of patents claiming the SARS-CoV-2 sequence or its many variants, the research institutions and private firms that developed COVID-19 diagnostics and vaccines obtained numerous patents on the innovative aspects of their products. For example, one 2020 study found that, with respect to mRNA vaccine technology alone, 56 different entities ranging from large pharmaceutical companies to small and medium-sized entities held a total of 119 different patent families. Perhaps the most convincing evidence that sizeable numbers of patents have issued in this space is the expanding universe of patent litigation among mRNA vaccine manufacturers, now dubbed the “COVID-19 Patent Wars”. All of these examples demonstrate that COVID-19 technology innovations, vaccines in particular, have been amply protected without the need for patents on naturally occurring pathogenic sequences.

But is this Threat Real?

An argument that may be made against the need to limit further pathogen patents is that the ability of patent holders to enforce their patents, especially during global health crises, is limited by law.  For example, in the United States, a patent holder cannot obtain a permanent injunction preventing an infringer from practicing a patented invention unless it demonstrates that the public interest would not be disserved by the entry of the injunction.  Likewise, the International Trade Commission, when assessing the appropriateness of an exclusion order barring the importation of infringing goods into the United States, must take into account “the effect of such exclusion upon the public health and welfare.”  These limitations have greatly reduced (but not entirely eliminated) the number of injunctions and exclusion orders issued with respect to medical and health-related technologies.

These limitations suggest that, at least in the United States, the existence of patents claiming pathogenic sequences might not represent a significant threat to pathogen research or biomedical product development. However, the existence of patents on these basic research tools, no matter what the likelihood of eventual litigation outcomes, can chill research, impose delays and prompt the payment of unwarranted fees. Moreover, even meritless claims are costly to fend off in court and impose some level of risk on defendants, particularly in the U.S. where fee shifting is rare.  Thus, while various litigation doctrines may tend to lessen the threat of pathogen patents in the U.S., that threat is not eliminated entirely and may still represent a significant cost and deterrent to firms engaged in research and development of pathogen-based biomedical products.

Don’t Let PERA Potentially Hold Up Research Efforts

For the reasons outlined above, PERA should be modified to ensure that naturally occurring genomic sequences – even once isolated – remain ineligible subject matter for patent protection. Preventing the reintroduction of pathogen patents will enable international pathogen research to advance rapidly while interfering little with private incentives to develop innovative new biomedical technologies. In contrast, opening the door to pathogen patents arguably will provide opportunities for individual countries where outbreaks emerge to hold up international research efforts for their own benefit, causing delays and barriers to the development of lifesaving diagnostics, vaccines and drugs.

by Dennis Crouch

I just gave a short (45 min) talk about the past year in patent law. See the slides here: Patent Year in Review.  Key points:

1. Director Review and Ex Parte Lobbying: Exercising the constitutional right to petition the government via shadow request for director review.
2. Full Scope Enablement and Written Description: Increased focus by both the USPTO and the Federal Circuit.  Pending SCOTUS cases of Amgen v. Sanofi and Juno v. Kite.
3. Patents as Commodity: Many folks are treating it as such.
4. Broad IPR Estoppel: CalTech v. Broadcom/Apple.  Pending before the Supreme Court.
5. Who is the Inventor: AI and Corporation as the inventor.  Thaler v. Vidal cert petition likely in January 2023.
6. Eligibility: Tropp and Interactive Wearables are not great vehicles for Supreme Court review.  Hopefully IBM petitions its case from IBM v. Zillow.
7. Patent Venue: Lots still happening in W.D.Tex.  IMO, parties arguing inconvenient venue don’t really care about convenience. Their basic concern is that they want to escape from Judge Albright’s courtroom and raise costs on the patentee.

Janke v. Vidal (Supreme Court 2023)

Some of you may know Oregon patent attorney Garth Janke.  Janke’s new petition for certiorari offers a philosophical inquiry into the scope of patent eligibility.  It all started with Janke’s invention of an improved leaf rake, which the USPTO found patentable. But, Janke also invented a method of manufacture and hit an eligibility roadblock in his attempt to patent aspects of that process.  The following three claims are representative:

• 1. A leafrake head product, as described above.
• 21. Installing a mathematical model of the same leaf rake head product defined in Claim 1 on a computer.
• 26. Applying the mathematical model of Claim 21 on a conventional 3D printer to result in making the same leaf rake head product defined in Claim 1.

The USPTO found claims 21 and 26 directed to abstract ideas and that judgment was affirmed on appeal. Now, Janke has petitioned the US Supreme Court for certiorari with the following two questions:

• Can a known patentable product become ineligible for patenting when it is claimed to be made by applying a mathematical model of the product on a 3D
  printer?
• Can it be too much patent “monopoly” to preempt (in practical effect) a mathematical model of a product, as no one is disputing follows from Gottschalk v. Benson, when it is known that it is not too much patent monopoly to pre-empt the real product itself?

Petition.

by Dennis Crouch

In the USA, civil litigation typically involves substantial discovery — with each party demanding to see the other side’s secrets.  In patent law, these secrets are often at the core of the business process: product development and manufacturing processes, key product details, detailed market and sales data, etc.  That information may be needed to resolve the infringement litigation, but you could imagine a competitor also using the information for a competitive advantage in the marketplace.

Protective Order: The common solution is a protective order with varying levels of confidentiality.  A number of districts have adopted an automatic protective order that basically fits this scheme.  As one example, the District of Utah Federal Courts automaticaly apply a Standard Protective Order in every case that allows parties to designate materials as CONFIDENTIAL INFORMATION – ATTORNEYS’ EYES ONLY.  The result of that designation is that the information can only be reviewed by attorneys (and perhaps their staff), and cannot be provided to any “competitive decisionmaker.”   In addition to avoiding improper competitive use of litigation, limiting the scope of access also reduces the likelihood that trade secret information will be inadvertently disclosed.

In this situation, parties regularly argue about whether certain in-house counsel can review the material. The recent interlocutory appeal in Modern Font Applications LLC v. Alaska Airlines, Inc., — F.4th — (Fed. Cir. 2022), highlights some of these issues; although the appellate court ultimately determined that it lacked jurisdiction to hear the appeal.

Unlike the competitor-litigation situation I highlighted above, Modern Font and Alaska are not competitors.  Rather, Modern Font is a patent assertion entity that makes its money through licensing IP rights.  Still, Alaksa balked at allowing Modern Font’s in-house counsel to review the source code it disclosed in discovery.  The Utah magistrate judge and district court agreed with Alaska that the Modern Font in-house counsel was a competitive decisionmaker and refused to modify the standard protective order to allow access.  On this point, the court concluded that Modern Font’s key business activity is IP licensing, and the in-house counsel is intimately involved with that activity.  In my view, the court’s interpretation of “competitive decisionmaker” does not seem to fit the limitation’s purpose because there was no sense that the in-house counsel would have any use for Alaska’s source code beyond the context of the litigation at hand.  Certainly, Modern Font is not about to begin competing with Alaska Airlines in any marketplace.  It looks to me that the Utah court used the “competitive decisionmaker” designation as a hook to limit code distribution to outside counsel in order to avoid inadvertent disclosure.  “The risk of inadvertent disclosure outweighs the risk of prejudice to Plaintiff.”

This is a pretty big deal in this case since the content of the code is going to determine whether or not Alaska infringes.  And now in-house counsel will be unable to inspect the accused specimin.  In this case, in house counsel is an experienced and skilled patent attorney who (1) was doing lots of the work in order to reduce litigation costs; (2) is intementely involved with parallel litigation and so has a very good understanding of whether a particular process is infringing; (3) is a key settlement negotiator; and (4) is the key monitor of outside counsel and their handling of the lawsuit.  Those activties will all be significantly hobbled by the protective order, especially considering that Modern Font’s outside counsel trial & appellate team consists of one person – Perry Clegg.

Modern Font appealed the order, but had a major procedural problem: the Final Judgement Rule generally bars appeals of interlocutory orders, such as a discovery order.  There are a number of important exceptions to the Final Judgment Rule:

1. Partial Final Judgment: This comes up most often when a court issues a partial summary judgment, and the losing party is able to peal-off that portion for immediate appeal.
2. Rulings on Injunctions: Under 28 U.S.C. 1292(a), a district court’s ruling regarding injunctive relief can be automatically appealed, even if the case is not yet final as a whole. In patent cases, these appeals typically involve preliminary injunctions.
3. Appeal of Certified Question: Under 28 U.S.C. 1292(b), a district court can certify a question of law for immediate appeal. The appellate then has the discretion to decide whether or not to hear the appeal.
4. Mandamus: The appellate court can issue an interlocutory writ of mandamus in situations where a district court has clearly abused its discretion causing a major injustice.  For historical reasons, this is not called an appeal but today is effectively treated as an appeal.
5. Appeal under the Collateral Order Doctrine: This doctrine permits immediate appeal in a small subset of cases where the district court (1) conclusively decides an issue that (2) “resolve[s] important questions separate from the merits” and (3) the decision would be “effectively unreviewable on appeal from the final judgment in the underlying action.” Quoting Swint v. Chambers Cnty. Comm’n, 514 U.S. 35 (1995).

The collateral order doctrine is the only one of these five that fit the situation, and Modern Font appealed under the doctrine.

The Federal Circuit never reached the merits. In a split decision, the appellate court held that it lacked appellate jurisdiction.  In particular, the court concluded that the case failed to meet prong #3 of the Collateral Order Doctrine. I.e., the court concluded that the question (of whether in-house counsel should have access to the code) can wait until after final judgment.  On this point, the appellate decision is extremely weak since an abuse of discretion at the discovery stage will likely be seen as a non-appealable harmless error by the time of final judgment because it does not rise to a due process violation.  Still, the decision fits within the typical approach that appellate courts almost always refuse to hear collateral order appeals of discovery issues.

The majority opinion here was penned by Judge Cunningham and joined by Judge Reyna. Judge Newman wrote in dissent.  Her particular argument focused on the issue of appellate jurisdiction.

Judge Cunningham had concluded that the court lacked jurisdiction since Modern Font’s issue could wait until final judgment.  Judge Newman argued that the court generally has discretionary jurisdiction in situations like this, and the proper question is whether the court should exercise its discretion. “[O]ur authority to review this ruling is not a matter of appellate jurisdiction, but of appellate discretion. . . . [T]he question concerning this particular protective order is within our jurisdiction and subject to our discretion to review and resolve.” Newman in Dissent.

The US GAO (Gov’t Accountability Office) has released its report on the Patent Trial & Appeal Board — providing evidence to support the open secret that (1) political appointees have power to influence PTAB judicial decisions; and (2) most PTAB Judges feel their independence has been impacted by oversight practices. The report calls for increased transparency in PTAB Judicial oversight.

Read the report here:

• Website with Overview: Patent Trial and Appeal Board: Increased Transparency Needed in Oversight of Judicial Decision-Making | U.S. GAO
• Full Report: GAO-23-105336, PATENT TRIAL AND APPEAL BOARD: Increased Transparency Needed in Oversight of Judicial Decision-Making

The next report may need to move one level up and focus on outside lobbying of political appointees and its impact on USPTO decisionmaking.

by Chris Holman

A branded drug manufacturer can sometimes extend its exclusive right to market a drug by patenting a method of using the drug and successfully suing a potential generic competitor for infringement based on the premise that an instruction or warning appearing on the generic product’s label will induce doctors and/or patients to infringe the patent. In some cases, a generic company can skirt infringement by means of a “skinny label” that carves out the patented method, a practice that is the subject of a pending petition for certiorari in Teva v. GSK, as discussed by Dennis in a recent post (see an earlier post for a more detailed discussion of Teva and skinny labels).

In Teva, the drug is approved for the treatment of multiple indications, two of which are unpatented, and the generic company attempted to avoid infringement by carving out (unsuccessfully, absent Supreme Court intervention) an indication covered by the patent.  In a case in which a patent covers a method of using the drug safely, as opposed to a new indication, the skinny label option is generally not available, and the generic product label will be required to closely track the label of the branded product. A remaining option for a generic company facing such a patent is to challenge it in a Hatch-Waxman proceeding and successfully argue that the patent claims are invalid and/or not infringed. An example of this appears in the Federal Circuit’s recent decision in Genentech v. Sandoz.

The active ingredient at issue in Genentech is pirfenidone, marketed by Genentech under the tradename ESBRIET.  Pirfenidone was first studied as an investigational new drug in 1973.   In 2004, the United States Food and Drug Administration (“FDA”) granted pirfenidone orphan drug status for treatment of patients with idiopathic pulmonary fibrosis (“IPF”), a chronic, irreversible lung disease.  In 2008 it was approved for the treatment of IPF in Japan under the trade name of PIRESPA.  Approvals in the European Union and Canada followed in 2011 and 2012, respectively.

When Genentech obtained approval to market pirfenidone (ESBRIET) in the U.S. in 2014, it was granted seven years of orphan drug exclusivity, which expired in 2021.  However, Genentech still holds 19 Orange Book-listed patents purportedly covering ESBRIET. The patents were issued between 2009 and 2014, and expire between 2026 and 2033.

Sandoz submitted Abbreviated New Drug Applications (“ANDAs”) seeking approval from the FDA to market a generic version of pirfenidone, to which Genentech responded by bringing a Hatch-Waxman suit, asserting that Sandoz’s generic product would induce the infringement of five of the Orange Book-listed patents.  The asserted patents do not claim pirfenidone itself, or the use of pirfenidone to treat IPF. Instead, the patents claim methods for managing certain side effects that can occur when using pirfenidone to treat IPF. The patents fall into two categories: the Liver Function Test (“LFT”) patents and the Drug-Drug Interaction (“DDI”) patents.

The LFT patents are directed to methods for administering pirfenidone to a patient who has exhibited abnormal biomarkers of liver function in response to pirfenidone administration. The asserted claims in these patents recite various options, including: (1) temporarily reducing the dose of pirfenidone and then returning to the full dose, (2) maintaining the full dose of pirfenidone, (3) reducing the dose of pirfenidone, (4) discontinuing pirfenidone for a week and then returning to the full dose, and (5) discontinuing pirfenidone for a week and then returning to a reduced dose.

The DDI patents are directed to methods for avoiding adverse interactions between pirfenidone and fluvoxamine, a drug that can interfere with drug metabolism. The three asserted DDI claims involve methods for administering pirfenidone to a patient taking fluvoxamine by either discontinuing fluvoxamine or modifying the dose of pirfenidone and continuing fluvoxamine.

The district court found the LFT patents invalid for obviousness over a 2005 publication reporting the results of clinicals trials involving the use of pirfenidone in patients with IPF (the “Azuma” reference), combined with the PIRESPA label and “known, standard medical practices.”  Prior to reviewing the district court’s analysis, the Federal Circuit noted its:

initial perception that, as the district court noted, varying doses in response to the occurrence of side effects would seem to be a well-established, hence obvious, practice. Thus, claiming it as an invention would appear to be at best a long shot. The district court gave it careful scrutiny, however, as do we.

The Federal Circuit then proceeded to affirm the district court’s obviousness determination, stating that:

The asserted claims in the LFT patents do not represent the invention of a new drug, nor do they recite a novel application of an existing drug. Instead, these claims recite adjusting doses in the presence of side effects, which clinicians routinely do, and which would have been obvious in view of the prior art.

As to the DDI patents, the district court found that although warnings appearing on Sandoz’s proposed label appeared to encourage, recommend, and/or promotes infringement of the patents, there was insufficient evidence of direct infringement. The district court stated that:

Genentech had not shown that any patient would be prescribed both pirfenidone and fluvoxamine such that the methods of the DDI patents would even be relevant. [E]ven if an IPF patient were prescribed fluvoxamine, a physician would likely choose a non-infringing treatment adjustment over any of the claimed methods.

The Federal Circuit affirmed, noting that the evidence of record included testimony from physicians that, in their decades of treating IPF patients, they had never prescribed pirfenidone to an IPF patient taking fluvoxamine; and were they to find themselves in that position, they would choose a noninfringing response—i.e., prescribing nintedanib instead (nintedanib is another drug approved by FDA for the treatment of IPF).

Genentech argued that if an IPF patient needed fluvoxamine, instead of a doctor prescribing nintedanib to treat their IPF, the doctor could prescribe pirfenidone and an alternative to fluvoxamine. However, the court credited Sandoz’s expert testimony to the effect that:

a pulmonologist prescribing pirfenidone would not be able to alter another physician’s prescription of fluvoxamine or take over that aspect of the patient’s treatment. Therefore, the pulmonologist would prescribe nintedanib to be taken in conjunction with the patient’s preexisting prescription of fluvoxamine.

This was a split decision, with Judge Newman dissenting without offering an opinion.

by Dennis Crouch

Although somewhat slow thus far, there is some potential that 2023 will turn out to be a major year for Supreme Court patent law jurisprudence.

Full Scope Enabling Written Description: The court has granted only one petition, Amgen Inc., v. Sanofi, No. 21-757, with merits briefs due beginning December 27, 2022. Although Amgen presented two questions in its petition, the Supreme Court indicated its interest only in hearing the second:

Whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. § 112, or whether it must instead enable those skilled in the art “to reach the full scope of claimed  embodiments” without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “ ‘time and effort,’ ”

Amgen Petition.  Enablement rejections continue to primarily be found in chem and biotech areas.  This case, for instance, focuses on a functionally claimed monoclonal antibody.  Still, the Federal Circuit has been clear in recent years that the “full scope” requirement applies to all tech areas and both to enablement and written description requirements.   The parallel full-scope written description issue is raised in the parallel case of Juno Therapeutics, Inc., v. Kite Pharma, Inc., No. 21-1566.  Juno’s petition argues that the Federal Circuit’s test goes too far by requiring the original patent filing “demonstrate the inventor’s possession of ‘the full scope of the claimed invention,’ including all ‘known and unknown.'”  Juno Petition.  The Court is holding conference on January 6, 2023 to consider the fate of Juno.  Although petition-stage briefing is complete in Juno, questions raised by Amgen and its amici will hopefully influence the court to simultaneously pick-up this Juno case.  USPTO written description rejections most often occur based upon late-stage claim amendments, and those can happen in any area of technology.  (Note here that often the result is refusal to permit a priority claim resulting in intervening prior art rather than a straight written description rejection.)

Six additional petitions remain pending. Of these, the Court has indicated at least some interest in five (three CVSGs and two additional requests for responsive briefing).  The sixth petition was only recently filed and so the court has not had the opportunity to indicate interest.

Eligibility: Similar to the enablement/WD cases, the eligibility petitions all come from patent holders who argue that their claims were wrongly invalidated.

• Interactive Wearables, LLC v. Polar Electro Oy, No. 21-1281 (System for displaying media information while simultaneously experiencing the media content).
• Tropp v. Travel Sentry, Inc., No. 22-22 (method of using a luggage lock with a master key held by TSA for airport security).

Both of these cases argue that the Federal Circuit has taken Alice Corp., too literally and in a way that is limiting the patentability of traditionally eligible subject matter.  Also in both, the Supreme Court has asked for views of the Solicitor General (CVSG) and will very likely await that filing before deciding whether to grant or deny certiorari. In my view, the Interactive Wearables claims are much stronger because they recite an arguably novel device. See, US9668016.  It will be interesting to see whether the SG splits hairs or simply refiles a version of its American Axle brief supporting certiorari.

Skinny Label: Although it involves a fairly narrow issue, the pending case of Teva Pharms. v. GlaxoSmithKline LLC, No. 22-37, has a good chance of being heard by the Court, although it may be better for Congress to work to resolve the pending questions.  The basic issue here involves a generic drug with several medical treatments.  Some of the treatments are covered by method-of-use-patents while other treatments are no longer patented.  Teva has been selling the drug for the non-patented uses, and the question is whether the FDA-approved drug label that purported to carve-out the patented actually encourages infringement.  Question presented:

If a generic drug’s FDA-approved label carves out all of the language that the brand manufacturer has identified as covering its patented uses, can the generic manufacturer be held liable on a theory that its label still intentionally encourages infringement of those carved-out uses?

Teva petition.  The Federal Circuit held that the drug label could induce infringement, even though FDA approved it.  In my view, the generic manufacturer here has a very strong estoppel defense because the patentee itself proposed the language used on the generic label.  That defense has not yet been considered at the district court.  As with the eligibility cases, the Supreme Court has asked for the views of the Biden Administration in this case as well.  Although the SG’s views have often been important in guiding certiorari grant/denial, it is unclear to me what influence Solicitor General Prelogar’s statements will have on the strongly conservative court.

Estoppel and Procedure: The remaining three pending petitions all relate to some form of estoppel or procedure.

• Apple Inc., et al. v. California Institute of Technology, No. 22-203.  Following  an inter partes review, the petitioner is estopped from re-raising validity arguments that “reasonably could have been raised during that inter partes review.”  Apple lost the IPR against CalTech’s patent and wants to raise additional defenses in the district court litigation.  Apple has argued for a very narrow interpretation of the 315(e) estoppel while the Federal Circuit broadly interpreted the statute.
• Jump Rope Systems, LLC v. Coulter Ventures, LLC, dba Rogue Fitness, No. 22-298. This case focuses on the doctrine of collateral estoppel and asks whether the Federal Circuit is correct that “a determination of unpatentability by the Patent Trial and Appeal Board in an inter partes review proceeding, affirmed by the Federal Circuit, has a collateral estoppel effect on patent validity in a patent infringement lawsuit in federal district court.”  In other parallel scenarios, there would be no collateral estoppel because the first decision (invalidity at PTAB) is judged with a lower preponderance-of-the-evidence standard as compared with the later district court case that requires clear-and-convincing-evidence.
• Innovation Sciences, LLC v. Amazon.com, Inc., No. 22-554.  This final asks the Supreme Court to reinvigorate its old precedent requiring contemporary corroboratory evidence in order to invalidate a patent based upon prior art.

These final three cases are all in the petition briefing stage.  They could still be heard and decided by June if the Court quickly grants certiorari.  However, it is increasingly more likely that the briefing would extend over the summer.

Three more petitions likely coming soon:

• Thaler v. Vidal (patentability of AI-created inventions)
• Novartis v. HEC. (Written description and changed panel composition)
• Wakefield v. Blackboard (pro se; indefiniteness of means-plus-function claim for failure to disclose corresponding algorithm in the specification)

by Dennis Crouch

I posted yesterday about changes in W.D.Tex. distribution of patent cases under the lead “Waco may be Heating Up Again this Winter.”  I noted a new order from Judge Garcia that seemed to implicitly distribute Waco patent cases back to Judge Alan Albright.  I also noted initial statistics for December 2022 showing the vast majority of Waco cases being assigned to Judge Albright.  The only exception so-far in December is a pair of related cases assigned to Judge Yeakel.

This post pulls-back a bit. I dug into the data a bit further, with the following results:

• 18 cases filed in the Waco Division of W.D.Tex.
• 13 of these have been assigned to Judge Albright. BUT, all 13 are directly related to a case either currently before Judge Albright or one that was dismissed within the past year.
• 2 of the cases were assigned to Judge Yeakel; and 3 of the cases are unassigned.  None of these appear related to a case currently before Judge Albright.

What all this means: (1) there is still some amount of distribution ongoing; and (2) we don’t know what is really happening from any official position. The key takeaway then is that we’ll need to wait and see what actions new Chief Judge Moses takes.

In case numbers overall, For December 2022 WDTex remains the most popular district but is closely followed by NDIll and NDCal.

One interesting case to watch is Apple Inc. v. AliveCor, Inc., Docket No. 5:22-cv-07608 (N.D. Cal. Dec 02, 2022).  AliveCor appears to be winning its case in the ITC showing that the the Apple Watch is infringing. Now, Apple has sued AliveCor, alleging that the startup’s wearable heart monitors infringe Apple patents. [APPLE ALIVECOR complaint].