Tag: patent law

COVID-19 Update: Patent Rights in the COVID-19 Pandemic: How will Industries and Governments Respond?

As the world scrambles to address an ever-expanding wave of COVID-19 infections, new and urgent needs for medical supplies, diagnostics and treatments arise.  Shortages of such supplies are plaguing hospitals and care-givers, while doctors and nurses put their lives at risk in their desperate efforts to save COVID-19 patients.  Many of these vital supplies, however, are protected by valuable patent rights.  The essence behind patents rights is to exclude others from making, using, or selling a patented invention, except by authorization of the patent holder in carefully negotiated license agreements to ensure proper compensation for the efforts and costs invested in developing the patented invention.1  On the other hand, the U.S. government has rights to forcibly license a patented invention during times of need, in particular when there is a threat to public safety.2  Will the government resort to use of these available, yet rarely used, compulsory licensing provisions?  How patent owners are responding to the current COVID-19 pandemic is revealing that benevolence may, in some cases, have a place in commercial business without the government needing to exercise its compulsory licensing rights.

In the face of the COVID-19 pandemic, several large companies have come forward with offers to manufacture medical supplies such as masks and respirators.  Manufacturers, such as the auto makers General Motors, Ford and Tesla, are offering to repurpose production lines to help manufacture and increase the supply of ventilators and other much needed medical equipment.3  Fashion and cosmetic companies, such as Louis Vuitton, L’Oréal and Coty, are also pitching in and offering to re-allocate their resources to produce hand sanitizers, while fashion designers, like Christian Siriano and Brandon Maxwell, are offering to mobilize their teams to produce masks and hospital gowns.4  Even the beer company giant, ABInBev will use its facilities to manufacture and distribute hand sanitizer.5

On the patent front, the drug manufacturer AbbVie has taken a bold public health stance by suspending enforcement of its global patent rights on all formulations of the HIV medication, Kaletra (Aluvia) while the drug is being evaluated as a candidate to treat COVID-19 in several clinical trials.  AbbVie’s bold stance would allow generic versions of Kaletra to be made by others without fear of repercussion based on patent infringement.  This would allow countries to purchase generic versions of Kaletra, if it is found effective in treating COVID-19, and would help alleviate possible drug supply shortages.  AbbVie is the first drug-maker to take such a strong public health stance amid the COVID-19 pandemic.  However, whether AbbVie’s decision to suspend its patent rights to Kaletra is an act of pure benevolence, mounting public pressures, or because at least one clinical trial  already suggested Kaletra may not be effective in treating COVID-19, AbbVie’s strong public health stance is at the very least a comforting thought and may hopefully sway other drug-makers, like Gilead Sciences Inc. (“Gilead”), to do the same.

On the other end is the drug-maker Gilead who recently halted emergency access to its COVID-19 candidate drug, Remdesivir, except for pregnant women and children with severe symptoms.6  In suspending access to Remdesivir, Gilead issued a company statement7 on March 22, 2020 citing “overwhelming demand” and “exponential increase” in requests which “flooded [its] emergency treatment access system.”  However, Gilead’s restrictions to Remdesivir come on the heels of it being granted “orphan” drug status8 by the U.S. Food and Drug Administration (“FDA”) on February 23, 2020 and on the heels of a Chinese drug-maker, BrightGene Bio-Medical Technology (“BrightGene”),9 filing for patent protection in China for a combination drug therapy to treat COVID-19 using the active ingredients of Remdesivir.  The 1983 Orphan Drug Act10 allows a seven-year market exclusivity period for pharmaceutical companies developing treatments for a “rare disease” and also provides tax credits.  Gilead’s strategic move to obtain orphan drug status for Remdesivir blocks generic drug manufacturers from supplying the drug and thus further limiting access.

Remdesivir has been previously used to treat the Ebola virus, Middle Eastern Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS), but these infections did not cause a sustained global crisis to earn Gilead a sizable or continued financial revenue stream and other more successful experimental therapies existed.11  If Remdesivir is found to be effective for combating COVID-19, a patent protecting such a use may stand to earn a high and continued stream of global revenue for the patent owner.  As new combination drug patents or method patents for new uses of known drugs may be separately patentable, repurposing Remdesivir as a combination drug patent or for treating COVID-19 may prove to be a blockbuster hit for its patent owner.  Thus, while Gilead has cited overwhelming demand as the reason to restrict access to Remdesivir, one can’t help but wonder whether patent rights and the associated commercial revenue are Gilead’s underlying concern.

Gilead is not the only patent holder invoking a protectionist stance and seemingly attempting to profit from the global pandemic through the patent system’s exclusionary principle.  Labrador Diagnostics LLC (“Labrador”)—a company backed by its major investor SoftBank and who bought patents from a failed blood-testing start-up called Theranos—recently filed a patent infringement lawsuit against BioFire Diagnostics (“BioFire”), a health start-up who launched three COVID-19 tests.12  Labrador also requested an injunction demanding BioFire to stop using the technology covered by the Theranos patents.13  However, since filing the lawsuit and seemingly after public backlash, Labrador issued a press release14 stating it would allow third parties to use its Theranos patents to develop COVID-19 tests with a royalty-free license, but that it is continuing its lawsuit against BioFire for activities over the past six years not related to COVID-19 testing.

Similarly, in Italy, a patent holder of a special respirator valve used in respiratory machines allegedly threatened a patent infringement lawsuit against two engineers who volunteered to use their 3-D printing technology to manufacture the patented valves for a hospital in Brescia, Italy without obtaining permission or a license from the patent holder.15  However, in a follow-up statement, both the patent holder and the two engineers stopped short of calling the communications a threat, and instead characterized them as merely a refusal of the patent holder to assist or collaborate with the engineers.16

While some patent owners are choosing to suspend their global patent rights and others are taking a more protectionist stance, the U.S. government also has the right to take action by forcing patent owners to grant compulsory licenses when there is a threat to public safety.  A compulsory license refers to the government’s authority to grant permission to a party seeking use of another’s patented invention without the consent of the patent owner, and is provided broadly by 28 U.S.C. § 1498.  Several multilateral international agreements also address compulsory patent licenses.17  Other U.S. laws also allow for compulsory licenses in certain circumstances.  For example, march-in rights is a provision of the Bayh-Dole Act of 1980 and is codified in 35 U.S.C. § 203.  March-in rights allow the federal government the right to grant patent licenses to other parties or take licenses for themselves if the patented invention was researched and developed with the help of federally funded dollars.18

March-in rights may be a perfectly poised vehicle for increasing access to COVID-19 related therapeutic drugs and vaccines.  To fight the global pandemic, the Biomedical Advanced Research and Development Authority (“BARDA”), a division of the U.S. Department of Health and Human Services (“HHS”), has partnered with several drug manufacturers, including Johnson & Johnson, Sanofi and Regeneron Pharmaceuticals, to fund the development of treatments and vaccines for COVID-19.19  However, some members of Congress have expressed concern as to the affordability and access should such drugs be found safe and effective, especially since federal funds are being provided.

No U.S. federal agency has ever exercised its power to march-in and license patent rights to others.  For example, advocacy groups have long petitioned the National Institute of Health (“NIH”) to exercise march-in rights for HIV/AIDS related drugs, but have been rejected by the NIH contending that high drug prices are an insufficient reason to break a patent.  However, in the face of a global pandemic, “health or safety needs” may provide a strong basis for the exercise of march-in rights and grant of a compulsory license if more patent owners, like Gilead, take a protectionist patent stance.  On the other hand, if more companies like AbbVie take a more socially conscious approach, there may not be need for government intervention in terms of compulsory patent licenses.  Nevertheless, the availability of this measure may at least provide some comfort and may motivate companies to voluntary suspend their patent rights during this global public health emergency in order to avoid government march-in, or maybe as a pure act of benevolence showing that social responsibility has a place in commercial business.

1   See 35 U.S.C. § § 154, 271.

2   See, e.g., 28 U.S.C. § 1498(a), 35 U.S.C. § 203.

3   See https://www.usatoday.com/story/money/cars/2020/03/22/coronavirus-ventilator-shortage-gm-tesla-covid-19/2895190001/.

4   See https://wwd.com/fashion-news/fashion-scoops/fashion-designers-make-masks-hospital-gown-hand-sanitizer-to-fight-coronavirus-1203545006/.

5   See http://longisland.news12.com/story/41926769/anheuserbusch-to-make-hand-sanitizer-in-response-to-coronavirus-pandemic.

6   See Id.

7  https://www.gilead.com/purpose/advancing-global-health/covid-19/emergency-access-to-remdesivir-outside-of-clinical-trials.

8   See https://www.ibtimes.com/coronavirus-treatment-gileads-potential-covid-19-treatment-labeled-orphan-drug-could-2945353.

9   See https://time.com/5782633/covid-19-drug-remdesivir-china/.

10 Orphan Drug Act of 1983. Pub L. No. 97–414, 96 Stat. 2049.

11 See https://www.statnews.com/2020/03/16/remdesivir-surges-ahead-against-coronavirus/.

12 See https://www.theverge.com/2020/3/18/21185006/softbank-theranos-coronavirus-covid-lawsuit-patent-testing; see also, https://www.businessinsider.com/theranos-patents-fortress-labrador-diagnostics-lawsuit-biofire-coronavirus-tests-2020-3.

13 See Id.

14 See https://www.businesswire.com/news/home/20200316005955/en/.

15 See https://www.law360.com/articles/1255547/3d-printing-as-indirect-patent-infringement-amid-covid-19.

16 See https://www.theverge.com/2020/3/17/21184308/coronavirus-italy-medical-3d-print-valves-treatments.

17 See Convention of Paris for the Protection of Industrial Property, 13 I.S.T. 25 (1962), Art. 5(A)(2) (“Paris Convention”); See Agreement on Trade-Related Aspects of Intellectual Property Rights, April 15, 1994, Art. 31. (“TRIPS Agreement”).

18 See 35 U.S.C. § 203.

19 See https://crsreports.congress.gov/product/pdf/LSB/LSB10422.

© Copyright 2020 Cadwalader, Wickersham & Taft LLP

Virtual Marking: Guidance on Doing It Right

Despite the fact that virtual patent marking was introduced nearly a decade ago, jurisprudence addressing virtual marking issues has been quite limited. Recent guidance from U.S. district courts, however, paints a clearer picture of the patent marking statute’s requirements to (a) associate the patented article with the number of the patent; (b) place either “patent” or “pat.” together with a website address on the product; and (c) ensure the marking is “substantially consistent and continuous.”

Since 1952, the patent marking statute (“Marking Statute”) has encouraged patentees to give public notice of a patented article through physical application of the patent number to the article, which assists the public and helps mitigate innocent infringement. 35 U.S.C. § 287; Nike, Inc. v. Wal-Mart Stores, Inc., 138 F.3d 1437, 1443 (Fed. Cir. 1998). Giving effect to this goal, the marking statute provides a financial disincentive for patent owners who do not mark their products (i.e., a patentee is precluded from recovering damages for infringement of unmarked articles prior to notice of infringement). Once marked, a patent owner’s marking must be “substantially consistent and continuous.” Id. at 1446.

Since the AIA’s passage in 2011, however, patentees have been able to inform the public that an article is patented through “virtual marking” (i.e., use of the word “patent” or the abbreviation “pat.” together with the URL of a website address where the actual patent number may be found). 35 U.S.C. § 287. As opposed to physically marking a patent number on a product, virtual marking allows a patent owner to quickly update its patent data website page without the costs of modifying product tooling or packaging (e.g., for newly issued, expired, or invalidated patents). In relevant part, the Marking Statute provides:

“Patentees . . . may give notice to the public that the same is patented . . . by fixing thereon the word ‘patent’ or the abbreviation ‘pat’ together with an address of a posting on the Internet, . . . that associates the patented article with the number of the patent.” 35 U.S.C. § 287(a) (emphasis added).

The Delaware District Court recently clarified what does, and does not, constitute adequate association, concluding that a “website itself must do more than simply list the patentee’s patents.” Mfg. Res. Int’l v. Civiq Smartscapes, LLC, Case No. 17-269, 2019 U.S. Dist. LEXIS 146060, at *3 (D. Del. Aug. 28, 2019)(emphasis added). Citing the statute’s “plain language,” the court reasoned that “[s]imply listing all patents that could possibly apply to a product or all patents owned by the patentee” “merely creates a research project for the public,” as opposed to giving public notice. Id. at *30-31. The court described why this would be the case by pointing to two examples lacking the association necessary “as a matter of law to meet the requirements of virtual marking”:


View larger image

Id.

The Court concluded that Plaintiff’s examples did “nothing to ‘associate’ any specific product it has marked with the patents which cover it.” Id. at 31. The Court was not persuaded by Plaintiff’s arguments that proper association was met in view of (1) Plaintiff’s statement that “[o]ne or more of the above listed MRI patents may be used by LG-MRI products under license from MRI, Inc.”, and (2) Plaintiff’s clarification of “the patent category (LCD Display Patents)”. Id. Accordingly, Plaintiff’s website failed to “provide ‘a ready means of discerning the status of the intellectual property embodied in an article of manufacture or design,” and no damages were awarded for infringement that occurred prior to the notice that was provided by the filing of the suit. Id., citing Bonito Boats, Inc. v. Thunder Craft Boats, Inc., 489 U.S. 141, 162 (1989).

Beyond the association requirement, courts also have found that a website address lacking the words “patent” or “pat.” does not provide constructive notice, A to Z Machining Serv., LLC v. Nat’l Storm Shelter, LLC, 2011 U.S. Dist. LEXIS 149387 (W.D. Okla. 2011), and that evidence supporting consistent marking of substantially all products may include (a) documentary evidence concerning the timeframe in which the website has operated; (b) engineering and assembly drawings or the actual product depicting virtual mark placement; and (c) testamentary evidence concerning the frequency of the virtual mark’s use on products. See Asia Vital Components Co. v. Asetek Danmark A/S, 377 F. Supp. 3d 990, 1024-25 (N.D. Cal. 2019), citing SEB S.A. v. Montgomery Ward & Co., 594 F.3d 1360, 1378 (Fed. Cir. 2010).

Notably, the burden remains on the patentee to demonstrate that its patent marking practices are effective and appropriate. In view of recent court guidance, consider the following points for creating an effective virtual marking strategy:

  • Include either “pat.” or “patent” together with the website address where the actual patent number may be found.
  • Place the patent owner’s website address on all patented products and clearly correlate each product that is covered by at least one claim of a specific patent on that website address for a patented product.
  • Periodically review the patent website page to ensure that it is current, accurate, and complete (e.g. reflecting new products; updating issued, expired, or invalidated patents).
  • Create and preserve records that demonstrate that the virtual marking was consistent and continuous. This may entail keeping a written log of updates to the patent website address, and preserving evidence that it was continually maintained

© 2019 Brinks Gilson Lione. All Rights Reserved.

California Tackles Big Pharma’s Anticompetitive ‘Pay for Delay’ Practices That Slow Down Lower-Cost Generic Drug Development

California Gov. Gavin Newsom has signed AB 824, known as the “Pay-for-Delay” bill, blocking pharmaceutical companies from paying generic drug makers to not develop and bring lower-cost medicines to market. The law makes these so-called “reverse payment” settlements of patent disputes – which the Federal Trade Commission says cost consumers $3.5 billion a year – “presumptively anticompetitive.”

The new law provides that an agreement resolving a patent infringement claim is anticompetitive if the generic drug or biosimilar drug makers receive anything of value from the brand name company that’s claiming infringement, and if the generic maker agrees to slow-walk or stop research, development, manufacture, marketing, or sales of a generic product for any period of time. Exceptions are made in cases in which an agreement promotes competition.

The state Attorney General is authorized to seek civil penalties within four years of any violations of the law. Other remedies would be available under California’s Cartwright Act, Unfair Practices Act, or unfair competition laws.

Sidestepping Competition

The FTC has prosecuted brand name and generic drug companies and has sued to stop these reverse payment agreements which allow drug companies to “sidestep competition.” Earlier this year, for example, the FTC announced a global settlement of three separate federal antitrust lawsuits involving subsidiaries of pharmaceutical manufacturer Teva Pharmaceuticals Industries Ltd.

There is no legitimate pro-competitive justification for pay-for-delay of generic drugs by brand name pharma companies. It's the consumer who pays the price. In one of the cases, Teva’s Cephalon company paid four generic drug manufacturers $200 million to back off on their plans to sell a generic version of Cephalon’s Provigil, a medication used to treat excessive sleepiness caused by sleep apnea, narcolepsy, or shift-work sleep disorder. Teva, which was able to delay the generic version for six years, agreed in its settlement to create a $25 million consumer fund and pay $69 million plus another $200,000 to cover the state’s legal fees. Teva was also barred from engaging in reverse-payment patent settlement agreements for 10 years.

In another instance, the FTC announced the settlement of its case against Endo Pharmaceuticals Inc., which paid Impax Laboratories $112 million not to go to market with a competing generic version of Endo’s Opana ER – a pain reliever in the opioid family.

Collusive Arrangements

Attorney General Xavier Becerra, AB 824’s sponsor, wrote that these kinds of pay-for-delay agreements are “collusive arrangements between brand-name drug companies and rival drug manufacturers” that allow the companies to charge monopolistic prices. “Pay-for-delay agreements hurt consumers twice – once by delaying the introduction of an equivalent generic drug that is almost always cheaper than the brand name and second by stifling additional competition because we know that when multiple manufacturers of generic drugs compete with each other, prices can be up to 90% less than what the brand name drug cost originally,” Becerra wrote.

Supporters of the bill included Health Access of California, the California Labor Federation, and the Small Business Majority. Another supporter, the California Public Interest Research Group, said brand-name drugs cost an average of 10 times and sometimes 33 times more than generics, adding that brand-name companies make billions in sales while generics are delayed.

All Those Opposed

The Association for Accessible Medicines (AAM) opposed the bill, saying it “penalizes procompetitive patent settlements that significantly expedite generic and biosimilar access.” Besides, the group argued, a federal framework already exists to review patent settlements, citing FTC v. Actavis, the 2013 decision in which the Supreme Court held that a brand drug manufacturer’s reverse payment to a generic competitor to settle patent litigation can violate the antitrust laws. The Supreme Court refused to call these agreements presumptively unlawful, instead saying the FTC had to prove its case as it would in any other “rule of reason” cases. The likelihood that a pay-to-delay settlement would have anticompetitive effects “depend[s] on its size, its scale in relation to the payor’s anticipated future litigation costs, its independence from other services for which it might represent payment, and the lack of any other convincing justification,” the Supreme Court ruled.

The pro-industry pro-tort reform Civil Justice Association of California called the bill “an enhanced, steroid infused codification” of the California Supreme Court’s 2015 decision in In re Cipro, which followed the U.S. Supreme Court’s FTC v. Actavis ruling.

Biopharmaceutical company Biocon opposed the bill for, it said, replacing the FTC with the State of California in the commission’s role as prosecutor of anticompetitive conduct.

The FTC’s Competition Bureau has been keeping track of the effectiveness of the Supreme Court’s FTC v. Actavis decision. In May 2019, FTC Chairman Joe Simons announced: “The data are clear: the Supreme Court’s Actavis decision has significantly reduced the kinds of reverse payment agreements that are most likely to impede generic entry and harm consumers.”

Commentary

There is simply no legitimate procompetitive justification for pay-for-delay settlements. There is simply no legitimate procompetitive justification for pay-for-delay settlements. They are explicit agreements between competitors to restrain competition and serve only to keep pharmaceutical prices unnecessarily high in this country. According to FTC data, pay-for-delay settlements cost consumers billions of dollars per year.

AB 824 simply aligns the law with the reality of this burden on the consumer, creating a presumption that such settlements are anticompetitive and requiring the settling parties to demonstrate why this is not the case. In fact, AB 824 essentially codifies the rule the FTC argued should govern pay-for-delay settlements in Actavis.

Critics of the law will challenge its legality, including its constitutionality under the dormant commerce clause. And while it may not withstand these legal challenges, AB 824 is an encouraging sign that lawmakers are beginning to understand the negative impact that pay-for-delay settlements have on competition in the pharmaceutical industry. We hope more states follow suit.

© MoginRubin LLP

ARTICLE BY Jennifer M. Oliver and Timothy Z. LaComb of MoginRubin. Edited by Tom Hagy for MoginRubin LLP. Photo of “worried man” by Nik Shuliahin via Upsplash.
For more on pharmaceutical regulation, see the National Law Review Biotech, Food & Drug law page.

Claim Construction Disputes Must Be Decided Before Applying Alice

On August 16, 2019, the Federal Circuit issued a 2-1 decision holding that a lower court erred by adjudicating patent eligibility without resolving the parties’ claim construction dispute. See MyMail, Ltd. v. ooVoo, LLC et al., Nos. 2018-1758, 2018-1759 (Fed. Cir. Aug. 16, 2019).

The patents at issue in MyMail cover methods for modifying toolbars displayed on Internet-connected devices. In response to defendants’ motion for judgment on the pleadings that the patents claim ineligible subject matter, MyMail raised a legal dispute over the proper construction of “toolbar.” The district court granted defendants’ motions without addressing the parties’ claim construction dispute, and without construing “toolbar.” The Court found in a split decision that the district court erred.

The majority held that “[d]etermining patent eligibility requires a full understanding of the basic character of the claimed subject matter.”  Accordingly, “if the parties raise a claim construction dispute at the Rule 12(c) stage, the district court must either adopt the non-moving party’s constructions or resolve the dispute to whatever extent is needed to conduct the § 101 analysis.”  Because the district court never addressed the parties’ claim construction dispute, or otherwise construed “toolbar,” the Federal Circuit vacated and remanded for further proceedings.

In his dissent, Judge Lourie argued that the facts of the case demonstrate that the parties’ claim construction dispute is “little more than a mirage,” and the claims at issue are “clearly abstract, regardless of claim construction.”

Implications

This decision provides patentees with another tool to help delay early patent eligibility decisions by raising legal issues over the proper scope of the claims. It is important to note, however, that this decision does not mean that judges must always construe the claims before ruling on patent eligibility—only when the parties raise a dispute. Further, patentees should weigh the relative pros and cons of raising claim construction issues early in a case, as this may come with some risks including putting a stake in the ground without sufficient discovery concerning the accused products.

© 2019 Brinks Gilson Lione. All Rights Reserved.

For more on patent law see the National Law Review Intellectual Property law page.

How to Get a PTAB Decision Designated Precedential

This past year, we have seen the Patent Trial and Appeal Board (PTAB) designate a number of decisions as precedential and informative more so than in past years. This is directly a result of the USPTO’s revised Standard Operating Procedure 2 (SOP2). On September 20, 2018, the USPTO announced that Board decisions can now be designated as precedential or informative through either one of two tracks: (1) POP Review or (2) a “ratification” process.

Under both tracks, a newly formed Precedential Opinion Panel (POP) comprising of at least three members will decide whether the decision should be designated as precedential or informative. Members of the POP will be selected by the Director and, by default, will comprise the Director, the Commissioner of Patents and the Chief Judge. The three members of the POP may each decide to delegate their authority in certain circumstances.

POP Review

POP Review under the first track is a rehearing of an issue in a pending trial. A party to a proceeding or any other member of the Board may recommend POP review—or a rehearing—of a particular Board decision. The request for POP review should be limited to situations where the Board decides issues of exceptional importance involving policy or procedure. A screening committee will review the recommendations and forward its recommendations to the Director. The Director will then convene with the POP to decide whether to grant rehearing, and if rehearing is granted, to render a decision on rehearing of the case.

If POP review is ordered, the Order will identify the issues the POP intends to resolve, may request additional briefing from the parties and, in some cases, may authorize amicus briefs. The POP may also order, at its discretion, an oral hearing. The decision resulting from POP Review will then be designated precedential, informative, or “routine.”

At this time, only two decisions have been issued by the newly formed POP:

  • Proppant Express Investments, LLC v. Oren Techs., LLC, Case IPR2018-00914, Paper 38 (Mar. 13, 2019) (designated: Mar. 13, 2019)

  • GoPro, Inc. v. 360Heros, Inc., Case IPR2018-01754, Paper 38 (Aug. 23, 2019) (designated: Aug. 23, 2019)

Please see my latest blog post on the GoPro decision regarding the one-year time bar under 35 U.S.C. § 315(b).

To request POP review, a party to the proceeding must submit a request by email to Precedential_Opinion_Panel_Request@uspto.gov. The email must identify with particularity the reasons for recommending POP review along with a request for rehearing filed with the Board under 37 C.F.R. § 41.52(a) or 42.71(d). In addition, counsel must also include a statement that the Board’s decision for which rehearing is requested was contrary to law or is a question of exceptional importance.

“Ratification” process

Under the second track, the public may nominate already issued decisions to be designated precedential or informative. Under this track, the Board is relying on the public to recognize which decisions are valuable to post-grant practice. This is the more traditional path for which a decision may be designated as precedential or informative. In this past year, there have been more than a dozen decisions that have been designated as precedential or informative through this ratification process. As above, a screening committee will review the recommendations and the Director will then convene with the POP to decide whether to designate the decision as precedential or informative.

Nominations should be submitted by email to PTAB_Decision_Nomination@uspto.gov and must set forth with particularity the reasons for the requested designation.

To learn more about the process under either track described above, I recommend reviewing the revised Standard Operating Procedure 2 (SOP2) online which provides the detailed procedural requirements for nominating a decision as precedential or informative.

© Polsinelli PC, Polsinelli LLP in California
ARTICLE BY Margaux A. Savee of Polsinelli PC.

Genotyping Patent Claims Do Not Escape The Reach of s. 101

In Genetic Veterinary Sciences, Inc. v. Laboklin GMBH & Co., the University of Berlin, App. No. 2018-1565 (Fed. Cir., Aug. 9, 2019), a Fed. Cir. panel affirmed the district court’s JMOL ruling that the claims of the University’s U.S. Pat. No. 9,157,114 were patent-ineligible because they merely involved the discovery of a natural phenomenon. Interestingly, the Judges on the panel were Wallach, Hughes and Stoll, all of whom dissented from the refusal of the Fed. Cir. to rehear the Athena decision en banc. However, Athena was a straightforward “If A, then B” diagnostic test, while the claims of the ‘114 patent were not written as diagnostic claims, but as “method of genotyping” claims:

An in vivo method for genotyping a Labrador Retriever comprising:

  1. obtaining a biological sample from the Labrador Retriever,
  2. genotyping a SUV39H2 gene encoding the polypeptide of SEQ ID NO:1[;] and
  3. detecting the presence of a replacement of a nucleotide T with a nucleotide G at position 972 of SEQ ID NO:2.

This “genotyping method” detected a single point mutation in the gene that confirms the presence of a skin condition, HNPK, in the dog, that is heritable if both parents possess the mutation. It can also be used to confirm whether or not a skin condition present in the dog is HNPK.  However, the absence in the claim of a step directed to drawing a diagnostic conclusion from the presence of the mutation, while in accord with the PTO’s 2014 101 Guidance, did not save this claim from the judicial exception prohibiting claiming a law of nature. Rather, the claim jumped from a legal frying pan of Athena into the legal fire of Ariosa, that bars patenting the mere discovery or observation of a natural phenomenon:

“Similarly [to Ariosa], In re BRCA1 – & BRCA2-Based Hereditary Cancer Test Patent Litigation, we concluded that the claims were directed to a patent ineligible law of nature because the claims’ “methods, directed to identification of alterations of the gene, require[d] merely comparing the patient’s gene with the wild–type gene and identifying any differences that ar[o]se”. 774 Fed.. Cir.755, 763 (Fed. Cir. 2014). In each of these cases, the end result of the process, the essence of the whole, [Ed. note: Is this some new poetic legal standard?] was a patent-ineligible concept”. [Ed. note: “concept” seems to be veering into abstract idea-land.]…Taken together, the plain language of claim 1 demonstrates that it is directed to nothing more than ‘observing or identifying’ the natural phenomenon of a mutation in the SUV39H2 gene….Thus the asserted claims are directed to a natural phenomenon at Alice step 1.”

Since the next section of the opinion is entitled “The Asserted Claims Do Not Recite an Inventive Concept”, you know this opinion is going to end badly for Labokin, the exclusive licensee of the university patent. Given that this opinion was written by the dissenters in the Athena petition for rehearing in banc, might this case turned out differently? Could the existence of the mutation in some of the SUV39H2 genes have been part of a public data base but its significance be unknown until the inventor discovered that the mutation could be correlated to the presence of HPNK? In other words, could the panel have begun by giving weight to the fact that one could observe the mutation without knowing what it means?

To get “credit” for the discovery of the utility of the mutation, claim 1, at the least, would need a mental process step that draws a diagnostic conclusion, a la Athena. Now the Athena dissenters would argue that the discovery of the utility of the correlation should provide the “inventive step” required by Alice step 2. But the Fed. Cir.’s Meriel decision precludes that outcome, since that panel ruled that the discovery of the utility of a correlation cannot meet the “inventive step” requirement. (Genetics Techs. v. Meriel is cited at page 25 of the slip opinion, but only as supporting a finding a lack of inventive step when the laboratory techniques employed to carry out the diagnostic procedure are routine, conventional, etc.)

So to get this claim past the “inventive concept” gatekeepers, it would also need to recite a positive action step of some sort. Here, the panel cites and distinguishes Vanda because it taught “a specific method of treatment for specific patients, using a specific compound at specific doses to achieve a specific outcome.” Remember, the claims of Vanda recited a first genotyping step, and then drawing a conclusion from that step, but didn’t stop there. This case did not give the dissenters much to work with, so they wrote a decision that Siri could have come up with. This case could at least have taken a swing at the failure of the Alice test to consider the claim elements in ordered combination. Judge Newman may yet get to write for a panel that has the nerve to distinguish Mayo and to find that an “If A, then B” diagnostic claim based on the discovery if the utility of a natural correlation is patent eligible because the steps, considered as a whole, are not conventional or well-known to the art.

© 2019 Schwegman, Lundberg & Woessner, P.A. All Rights Reserved.

For more on patent eligibility see the National Law Review Intellectual Property law page.

Wide-Ranging Senate Bill Aims to Streamline Post-Grant Proceedings and Block Trolls

On Wednesday, Senator Coon—of 101 hearings fame—and five co-sponsors introduced the Stronger Patents Act in the Senate (“Support Technology & Research for Our Nation’s Growth and Economic Resilience”). About 22 of the bill’s 40 pages involve amendments to IPR, PGR and ex parte reexamination that limit appeals and clarify overlapping court and PTO actions. These provisions have been ably summarized by Joshua Rich in a post at PatentDocs, but there are other interesting amendments to 35 U.S.C. so I thought I would start toward the last half of the bill.

Section 106 of the bill, entitled “Restoration of Patents as Property Rights,” amends section 283 to require that a court that finds infringement to presume that further infringement would cause irreparable injury and that remedies available at law are inadequate to compensate for that injury. These are the circumstances that encourage the court to issue an injunction against the infringer.

Section 42 of 35 U.S.C. would be amended to end USPTO fee diversion into the general fund by providing that any fees collectable by the Director shall be “available to the Director” and used to operate the PTO. Remaining unobligated funds are to be maintained in the “USPTO Innovation Promotion Account.”

Section 123(d) would be amended to clarify that a mircoentity includes an applicant who receives the majority of his income for a institution of higher education, or applicant has, or is under an obligation to assign, grant or convey a license or other ownership interest to said institution or the applicant is the institution or the applicant is a 501(c)(3) “nonprofit organization” that holds title to the institution’s patents “for the purpose of facilitating commercialization of the technologies” of the IP.

The bill establishes a pilot program whereby no fewer than six district courts will receive one additional law clerk or secretary who is tasked, with the assistance of the Federal Judicial Center, with helping  the court “develop expertise in patent and PVPA cases”…”for the purpose of expanding the [patent cases pilot program] to address special issues raised in patent infringement suits against individuals or small business concerns.”

The bill introduces Title II—”Targeting Rouge and Opaque Letters” and defines “Unfair or Deceptive Acts or Practices in Connection with the Assertion of a United States Patent” (section 202). The bill makes it an “unfair or deceptive act or practice,” as defined by the ITC, to send written communications that the recipient is or was an infringer of “the patent” and bear liability or owe compensation to another, if the sender, in bad faith (high probability of deceit and intentional avoidance of the truth—defined in more detail in the bill—sends communications regarding 15 specific assertions regarding infringement, licensing and prior suits, or failure to identify the sender.

These bad acts or failures to act are a laundry list of the approaches patent trolls use to intimidate recipient targets or to mask their identities. Bad acts include falsely representing that sender has the right to enforce the patent, that a civil action has been filed against the recipient or other parties, that recipient will be sued, that third parties have taken licenses, including failure to disclose that the other licenses are not to the allegedly infringing acts, that recipient’s alleged infringement has been investigated by sender or that sender has filed an action that sender knew had failed.

A sender cannot seek compensation for infringement of a claim that has been held unenforceable or invalid, acts by recipient after the patent has expired or recipient’s acts that the sender knew were properly licensed.

A sender in bad faith, cannot fail to include the identity of the person asserting the right to license or to enforce the patent, including ultimate parent entities. The patent asserted to be infringed upon must be identified, as must the product or activity of the recipient alleged to be infringing. The name of a contact person must be given to the recipient.

While the sender can argue that any of these acts or failures to act was due to an honest mistake, enforcement is by the FTC and the fines can be as high as $5 million.

Section 204 preempts State laws regarding “transmission or contents of communication relating to the assertion of patent rights,” but does not preempt other State laws relating to state trespass, contract or tort law. The FTC can intervene in suits brought by States and, if the FTC has instituted a civil suit, the State cannot begin an action under section 202.

While I am sure that there are freedom of speech and commerce clause arguments to be made, this bill elevates its prohibitions to the level of shouting “fire!” in a crowded theater. Combined with the proposed traffic laws meant to limit the use of multiple IPR filings, and their associated appeals at every turn in the litigation road, this seems to be a reasonable attempt to untangle the tortuous relationship between district court litigation and post-grant PTO proceedings.

Senator Coons played an important role in the recent Senate subcommittee hearings on the misguided expansion of patent ineligibility under Section 101. He may have found this part of the Patent Statute to be easier to untangle than defining a “natural phenomenon” or an “abstract idea” but I hope that this issue remains on his IP to-do list.

© 2019 Schwegman, Lundberg & Woessner, P.A. All Rights Reserved.
For more on patent laws & legislation see the National Law Review Intellectual Property page.

Last Week Tonight’ Host John Oliver Ignores the Last Three Years of Patent Reform

Have you seen John Oliver’s piece about abuses in the patent system? The ‘Last Week Tonight’ host has quite a bit of fun at the expense of the patent system.  He tossed out three primary complaints:

(A) patent owners that don’t practice their patents shouldn’t be able to assert them;

(B) patent owners enforcing their patents are extorting parties, including small businesses and end users, that lack the funds or capability to litigate; and

(C) patents, especially software patents, are too vague, resulting in uncertainty as to what products or actions are encompassed.

John Oliver is witty, dry, and often downright silly – and it is for those reasons that millions of people are drawn to his humor and his show.  For those of us inclined to think that America’s tradition of strong patent protection has led us to be the most innovative country in the world, this particular story drew our attention for different reasons. His reporting posited the idea that the Innovation Act, H.R. 9, working its way through the House of Representatives, would solve most of the problems he identified in our patent system.  Far from providing the solutions its proponents claim, that legislation would do little or nothing to limit the sending of bogus demand letters to unsophisticated targets in hopes of extracting nuisance value settlements – a practice that many decry as the most egregious example of patent abuse.  Further, Mr. Oliver seems unaware that the last several years have seen judicial action and legislation that address the costs of patent litigation and the vagueness of software patents.  Whether these measures are sufficient without additional legislation is up for debate, but John Oliver’s hypothesis is weakened by his reliance on outdated and largely irrelevant facts and data.

In the interest of making sure truth isn’t sacrificed for the sake of a few good laughs, there are several points we would like to raise.

  • Not every patent owner that licenses its patents rather than practicing them is a “patent troll” deserving of punishment or deterrence.

  • Patent litigation is decreasing, and its costs are overstated.

  • With the America Invents Act of 2011, Congress has already taken steps to reduce the cost of patent litigation.

  • The Supreme Court has also recently addressed the costs of litigation.

  • The Supreme Court addressed vague software patents as well.

Authored by: Michael T. Renaud, Robert J. Moore and Jack C. Schecter of Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.

©1994-2015 Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. All Rights Reserved.

U.S. International Trade Commission Grants Injunctive Relief on Standard Essential Patent

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The U.S. International Trade Commission has issued an exclusion order barring importation of certain older model Apple products for infringing a Samsung patent.  The case is significant because the infringed patent was standard essential and encumbered by a commitment to license on fair, reasonable and non-discriminatory terms.  Patent holders and potential defendants should carefully monitor further developments regarding the availability of injunctive relief for infringement of standard essential patents.

On June 4, 2013, the U.S. International Trade Commission (ITC) issued an exclusion order barring the importation and sale of several older model Apple iPhones and iPads for infringing a Samsung patent.  This in itself is unremarkable, as the patent laws permit patent holders to seek monetary and injunctive relief against anyone who infringes their patents, and injunctive relief is commonly granted to prevailing patent holders.  The ITC ruling is noteworthy, however, because the infringed patent was essential to the 3G standard and was subject to a fair, reasonable and non-discriminatory (FRAND) licensing commitment.  The ruling therefore runs counter to views expressed by the U.S. antitrust enforcement agencies to the effect that injunctive relief should be disfavored when dealing with FRAND-encumbered standard essential patents (SEPs), underscoring the growing debate as to the appropriate balance between the rights of SEP holders under the patent laws and antitrust policy.

In September 2012, the presiding administrative law judge (ALJ) ruled that Apple had not infringed any of the patents-in-suit, and that one of those patents was invalid.  Samsung and the staff attorney from the ITC’s Office of Unfair Import Investigations petitioned for review of the ALJ’s decision.  The ITC then requested public comment on its authority to issue an import ban (which is in essence injunctive-type relief) on products that infringe SEPs.  (Monetary damages are not awarded in ITC cases.)  After receiving a number of comments, the ITC issued its decision modifying the ALJ’s construction of certain terms in one of the patents and holding that, as modified, Apple had infringed the patent.  The ITC determined that two of the three remaining patents were not invalid, but also not infringed, and the final of those patents was both invalid and not infringed.  Based on the infringement of one of Samsung’s patents, the ITC issued an import ban with one commissioner dissenting on public interest grounds.

The case arose as part of the broader ongoing intellectual property disputes between Apple and Samsung over popular consumer electronics devices.  The matter has been submitted to the White House and U.S. Trade Representative for a 60-day presidential review period, but it has been decades since an administration overruled an ITC exclusion order.  If the administration does not reverse the decision, Apple can appeal the decision to the U.S. Court of Appeals for the Federal Circuit.

In a recent policy paper entitled “Policy Statement on Remedies for Standards-Essential Patents Subject to Voluntary F/RAND Commitments,” the U.S. Department of Justice Antitrust Division and the U.S. Patent and Trademark Office argued that the ITC and the courts generally should not grant injunctive relief for infringement of SEPs.  The Federal Trade Commission argued the point even more forcefully in a statement submitted last year in ITC investigation 337-TA-752, In re Certain Gaming and Entertainment Consoles, Related Software, and Components Thereof, asserting that on the basis of its mandate to consider the public interest, the ITC should not issue exclusion orders related to FRAND-encumbered SEPs.  In support of their position, these agencies have advanced two principal arguments.  First, they assert that the fact that the patentee voluntarily agreed to license the patent on FRAND terms implies that money damages are a sufficient form of relief.  They therefore argue that if the patentee’s first priority was excluding others from using the patent, it would not have bound itself to FRAND terms or tried to secure the patent’s incorporation into a standard.

Second, the agencies argue that injunctive relief may enable patent “hold-ups” by SEP holders.  At the time a standard setting organization is deciding what technology to adopt, patentees often compete with one another as to whose technology will be adopted.  But once a standard is adopted and large investments are made based on that standard, sunk costs often make switching to a different technology or innovating around the patent prohibitively expensive.  Thus, a company wishing to have its patent incorporated into the standard typically must agree to license that patent on FRAND terms.  The antitrust agencies fear that SEP owners can use the threat of injunctive relief to extract above-FRAND royalties from rivals, and that these additional costs are likely to be passed on to consumers.  The agencies therefore argue that the public interest, which the ITC is charged with taking into account, counsels against exclusion orders in these circumstances.

On the other side of the ledger, SEP holders point out that when a patent holder agrees to license its patent on FRAND terms, it is only making a commitment about the terms on which it will grant a license, not surrendering any remedy afforded by the patent laws.  They go on to argue that the position staked out by the agencies places them in an untenable position because prospective licensees may not accept a proposed license on FRAND terms or may disagree with the SEP holder about whether the terms are, in fact, FRAND.  When a dispute arises over the terms on which a SEP will be licensed, patent holders have a legitimate interest in wanting to ensure their ability to pursue all remedies authorized under the patent laws.  These remedies afford patent holders the ability to protect their intellectual property rights and thereby promote innovation.  Making it more difficult to obtain injunctive relief on SEPs would diminish their incentive to invest in innovation, which is one of the fundamental objectives of the patent laws.

The recent ITC decision represents a clear win for SEP holders, but as noted above, it is subject to further review and possible appeal.  And in all events, the underlying policy debate will most assuredly continue.  As a consequence, it is incumbent both upon patent holders and potential defendants to continue to carefully monitor developments in evaluating the availability of injunctive relief in the context of SEPs.

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“Imitation Two-Year Provisional” Option Extended Through 2012

The National Law Reviewrecently published an article by Jeffrey S. Whittle, Ryan B. McBeth, James E. Bradley, and Michael R. Samardzija, Ph.D. of Bracewell & Giuliani LLP regarding Provisional Patents:

As technology developers make New Year’s resolutions regarding patent filings for 2012, the “Imitation Two-Year Provisional Patent Application” may be a tool worthy of consideration. The U.S. Patent Office (“Patent Office”) has extended, until the end of 2012, what it calls the “Extended Missing Parts Pilot Program.”1 In essence, this program attempts to imitate what a true two-year provisional application would provide, but it sidesteps international priority risks and patent term issues and necessitates a few extra steps to achieve the “imitation.” Another caveat is that applicants must still file a non-provisional patent application and must still file internationally, if that protection is so desired, both within 12 months of filing a provisional application. The good news under this program, and what makes the program worthy of consideration, is that applicants now have an additional 12 months after filing the non-provisional from which to file any “missing parts,” including perhaps the most beneficial portion of the program—postponement of payment of search, examination, and any excess claims fees. For many entities, the postponement of these fees could be significant.

Traditional Provisional and Missing Parts Practice

Under traditional practice, the filing of a provisional patent application serves as a priority date place holder for an invention while inventors and practitioners have an opportunity to work out finer details of language for the claims. Important to this end is that in order to assert benefits to the priority filing date, a provisional application does not require a single claim, an oath or declaration, formally compliant drawings, or search and examination fees. As such it is also not subject to examination. After filing a provisional application, the more formal non-provisional patent application must be filed within 12 months to take advantage of the provisional application’s earlier priority date.

When filing a non-provisional application under traditional practice, if either a proper oath/declaration by an inventor, sufficient government filing fees, or compliant formal drawings are missing from the application, the Patent Office issues a Notice to File Missing Parts. An Applicant then has to respond to the Notice to File Missing Parts which, in effect, allows an update to a filed non-provisional application to append the “missing parts” not originally included. The Applicant has two months to respond and the option to respond later by paying time increasing, one-month extension fees for up to five months after the initial two month period.2 The accumulation of progressively more expensive extension fees limits the use of traditional missing parts practice.

Achieving the “Imitation Two-Year Provisional”

Under the “Extended Missing Parts Pilot Program,” the traditional fee extendable two months turns into a non-extendable 12 months with a requirement to pay a rather minimal surcharge for the late submission of fees.3 Other requirements to file a non-provisional under the “Extended Missing Parts Pilot Program” include: (i) Applicant must submit a formal request4 with its non-provisional application to participate in the pilot program; (ii) the application must be an original non-provisional filed before December 31, 2012; (iii) the application must directly claim the benefit of the prior provisional application;5 and (iv) Applicant must not have filed a non-publication request. The non-provisional application must also contain at least one claim, at least one drawing, and be ready for publication. By allowing an Applicant to submit a non-provisional application in this manner, while still preserving the beneficial priority filing date of the provisional application, the “Extended Missing Parts Pilot Program” is effectively extending the useful life of a provisional patent application to two years from the filing date, thereby achieving the Patent Office desire of an “Imitation Two-Year Provisional Application.”

The time extension and fee deferral aspects of this program can be utilized from a business standpoint to postpone strategic decisions regarding the further pursuit of an application. For example, an entity may file a number of provisional patent applications in a specific technology space and later change strategic direction or select only one of the areas within the specific technology space to pursue. Under this program an Applicant may defer the search and examination fees, which total almost $900 and are typically due upon filing a non-provisional.6 This translates to a deferral of almost 70% of the fees for up to an additional 12 months. For large entities with large patent portfolios, these savings could be quite significant.

Risks and Limitations Associated with Using the “Imitation Two-Year Provisional”

Patent developers should be aware that entities utilizing the “Imitation Two-Year Provisional” may suffer diminishing patent term adjustments. Under this program, when the non-provisional application is filed, the Patent Office will still send a “Missing Parts Notice” to the Applicant. After three months of no response, any additional time taken by the Applicant may be subtracted from any patent term adjustment the Applicant may be eligible for at the end of the application process. Applicants should also keep in mind that the 18-month publication period will still be in effect from the earliest date to which priority benefit is sought,7 and this new program does nothing to defer international filing costs or requirements. For a filing outside the U.S. that claims priority to a U.S. provisional application, the Applicant has only 12 months from which to file a foreign or PCT application.8 For these reasons, patent developers interested in foreign filings should be aware of these risks and limitations of the “Imitation Two-Year Provisional Program.”

Summary

By providing more time for technology developing entities to make strategic decisions on which patent applications to pursue, and by keeping money in the entities pockets all the while, the “Imitation Two-Year Provisional Application” should provide reason to celebrate for many patent applicants as the New Year begins. Pending further evaluation by the Patent Office this temporary program may see permanent adoption. Should it be made permanent, the “Imitation Two-Year Provisional Application” also strategically could be significant as the Patent Office moves to a modified first-to-file system on March 16, 2013, shortly after this extended option period expires.9 For now though, this tool is available for use at least until the end of 2012.

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1 Extension of the Extended Missing Parts Pilot Program, 76 Fed. Reg. 78,246 (Dec. 16, 2011), available here.
2 37 CFR § 1.136.
3 37 CFR § 1.16(f).
4 See PTO/SB/421, available here.
5 See, e.g., 35 U.S.C. § 119(e); 37 CFR § 1.78.
6 See USPTO Fee Schedule, available here. (Search and examination fees are deferrable under this program. Minimum fees due at filing: filing $380, search $620, examination $250. Note that small entities pay one-half this amount.)
7 35 U.S.C. § 122(b)(1)(A).
8 See, e.g., Paris Convention for the Protection of Industrial Property art. 4, as last revised at the Stockholm Revision Conference, July 14, 1967, 21 U.S.T. 1583, 828 U.N.T.S. 303 (under the Paris Convention, adopted by 174 countries worldwide, a twelve-month priority period is mandated); Patent Cooperation Treaty art. 8, 28 UST 7645; TIAS 8733 (under the PCT the same period is mandated as that provided by the Paris Convention).
9  Leahy Smith America Invents Act, Public Law 112-29, Sec. 3, 125 Stat. 284 (2011).

© 2012 Bracewell & Giuliani LLP