A newly released study shows that generic drug companies win nearly half the time when challenging patents on United States government-approved pharmaceutical products through the Patent Trial and Appeal Board (PTAB) process.
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PORTAL’s new study demonstrates that generic drug manufacturers have embraced the new process, challenging 198 patents covering 134 different drug products over the last 5 years. In 43% of the inter partes review cases since 2011, the challengers succeeded in overturning all challenged patent claims. In addition, inter partes review for drug patents has consistently been completed within 12 months, as required by statute—much faster than litigation. According to Dr. Darrow, “In the pharmaceutical market, the inter partes review process can meaningfully contribute to competition and lower drug prices by ensuring that invalid patents do not block timely availability of generic drugs and by resolving many patent disputes in a more efficient manner than was previously possible.”
Bhagat v. Iancu is a newly filed petition for writ of certiorari now pending before the United States Supreme Court. (Case No. 18-277). Bhagat is the founder and CEO of Asha Nutrition and is seeking to patent a lipid-formulation – that contains a mixture of omega-6 and omega-3 faty acids at a ratio of 4:1 or greater.
The USPTO refused to issue the patent finding the claims barred both by on eligibility (101) and anticipation (102) grounds. On appeal, the Federal Circuit affirmed. The 101 denial is most interesting. The PTAB found that that claimed fatty-acid mixtures already occur naturally in walnut oil and olive oil. And, although the claims require (via disclaimer) that the mixture of oils come from different sources, the Board found them to be directed to a natural phenomenon. On appeal, the Federal Circuit agreed — finding that the original ingredients of walnut oil and olive oil are natural products and the mixtures were not shown to be a “transformation of the natural products, or that the claimed mixtures have properties not possessed by these products in nature.”
The appeal here stems from three Inter Partes Review (IPR) proceedings — each cancelling the claims of aseparate Worlds’ patent. U.S. Patent Nos. 7,945,856; 8,082,501; and 8,145,998. The Worlds’ patents involve methods and systems for displaying avatars within a virtual environment and claim priority back to a 1995 provisional patent application.
The appeal here does not focus on the merits of the case but rather whether the IPR proceedings were time barred. I.e., whether the patentee’s still-pending lawsuit against Bungie’s contracting partner Activision will block Bungie from pursuing its IPR.
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In the IPR, the patentee Worlds requested discovery on the connection between Bungie and Activision in order to determine whether Activision could be considered a “real party in interest” or “privy.” However, that request was summarily denied and the PTAB concluded that the patentee “has not demonstrated that Activision is an unnamed real party in interest in this proceeding.”
On appeal, the Federal Circuit has vacated and remanded — holding that the PTAB should have investigated the relationship between the IPR petitioner (Bungie) and the prior litigant (Activision) and that the PTAB should have explained its reasoning.
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On remand, the Board will reconsider its the real-party-in-interest decision — placing the ultimate burden of persuasion on the IPR petitioner.
As was the case with Justice Neil Gorsuch, Kavanaugh has a history of being skeptical toward the growth of the Administrative State, which means the growth of agency power is not something he has shown a predisposition to being in favor of in his decisions. Given the outsized importance of the Patent Trial and Appeal Board (PTAB) within the patent industry, and the fact that the Supreme Court has already twice mentioned "shenanigans" in PTAB procedures...
Andrei Iancu: Chief Judge Ruschke, he hasn’t left the PTO, obviously. He will be in a new role at the PTO addressing an important issue for the office, which is the coordination between the PTAB and the overall patents organization. Sometimes there is a gap between the two organizations that we would like to bridge, or at least minimize. He will take on that role and study that issue and try to make suggestions on how to improve it. I do think it’s an important function to address. And at the PTAB, we will have new leadership. For now, come September 2nd, the acting chief will be Scott Boalick, and the acting deputy chief will be Jackie Bonilla.
The Intellectual Property Owners Association (IPO) will offer a one-hour webinar entitled "The Revised PTAB Trial Practice Guide and Its Impact on Your Practice" on September 13, 2018 from 2:00 to 3:00 pm (ET). Hon. Michael Tierney, Lead Administrative Patent Judge, Patent Trial and Appeal Board, U.S. Patent and Trademark Office; Tarek Fahmi of Ascenda Law Group; and Eliot Williams of Baker Botts LLP will discuss the reasoning behind recent changes to the PTAB Trial Practice Guide and explain how these revisions will impact PTAB practice.
Comments
Asha Admin
2018-09-15 21:23:20
65. A lipid-containing formulation, comprising a dosage of omega-6 and omega-3 fatty acids at an omega-6 to omega-3 ratio of 4: 1 or greater, contained in one or more complementing casings providing controlled delivery of the formulation to a subject, wherein at least one casing comprises an intermixture of lipids from different sources, and wherein (1) omega-6 fatty acids are 4-75% by weight of total lipids and omega-3 fatty acids are 0.1-30% by weight of total lipids; or (2) omega-6 fatty acids are not more than 40 grams.
Better and fair publications on this case are available. See following:
Where is the line between patentable subject matter and non-patentable products of nature? http://www.ipwatchdog.com/2018/09/07/patentable-subject-matter-non-patentable-products-of-nature/id=101134/
"Bhagat v. Iancu – Did the Myriad Decision Overrule Funk Bros.?” by Warren Woessner http://www.patents4life.com/2018/09/bhagat-v-iancu-myriad-decision-overrule-funk-bros/
"In re Urvashi Bhagat – The Slippery Slope of Natural Product Claims” by Warren Woessner http://www.patents4life.com/2018/03/re-urvashi-bhagat-slippery-slope-natural-product-claims/
Asha Admin
2018-09-16 22:24:09
NUMBER ONE:
We pointed out above in our comment dated September 15, 2018, that Dr. Roy Schestowitz repeated some of the discrepancies from Dennis Crouch's article word for word. For example, the Bhagat patent does not just claim, "a mixture of omega-6 and omega-3 faty acids at a ratio of 4:1 or greater."
There are numerous additional limitations in Bhagat's claims. For example, one of the independent claims, Claim 65 recites,
"65. A lipid-containing formulation, comprising a dosage of omega-6 and omega-3 fatty acids at an omega-6 to omega-3 ratio of 4: 1 or greater, contained in one or more complementing casings providing controlled delivery of the formulation to a subject, wherein at least one casing comprises an intermixture of lipids from different sources, and wherein (1) omega-6 fatty acids are 4-75% by weight of total lipids and omega-3 fatty acids are 0.1-30% by weight of total lipids; or (2) omega-6 fatty acids are not more than 40 grams."
There are over 30 claims in the Bhagat patent that were also mutilated by USPTO and alleged as patent ineligible.
NUMBER TWO:
Dr. Schestowitz's "It [Bhagat patent] has just been ‘intercepted’ by PTAB." This is also incorrect. Bhagat patent was alleged as patent ineligible by PTAB in April 2016. Bhagat appealed to US Court of Appeals for the Federal Circuit (CAFC) in August 2016, and CAFC reaffirmed without proper review in March 2018. See Open letter to USPTO and CAFC. http://asha-nutrition.com/wp-content/uploads/2018/04/Open-letter-to-USPTO-CAFC.pdf. The Petition For A Writ Of Certiorari with Supreme Court of United States was filed on September 29, 2018. See http://asha-nutrition.com/wp-content/uploads/2018/09/180829-US2009-Cert-Petition-.pdf
EPO and USPTO have been copying each other in impropriety. Hearing before EPO Appeal Board took place in July 2017. The EPO improprieties were reported on this cite in March 2018. See http://techrights.org/2018/03/07/guest-post-epo-defrauds-small-patent-applicant-company-asha-nutrition-sciences-in-collusion-with-applicants-own-lawyer/
NUMBER THREE - AND MOST IMPORTANT PART OF THIS COMMENT
Dr. Roy Schestowitz states, "PTAB is sometimes saving lives (almost literally) by battling unjust patent monopolies which do not advance science but actively prevent or impede scientific progress while killing those in need of it." This is the million dollar question, "Which patents save lives, and which patents impede scientific progress?"
The US Supreme Court has held that Congress has provided a patent system to “have a positive effect on society through the introduction of new products and processes of manufacture into the economy, and the emanations by way of increased employment and better lives for our citizens.” Chakrabarty, 447 U.S. at 307 (quoting Kewanee Oil Co. v. Bicron Corp., 416 U.S. 470, 480 (1974)).
The US Supreme Court has also held that the scope of patentability must be limited to avoid the “considerable danger that the grant of patents would ‘tie up’ the use of” “basic tools of scientific and technological work” and thereby ‘inhibit future innovation premised upon them.’” Myriad, 569 U.S. at 589. The formulations of the present claims do not pose a danger of such tying up.
So there are two principles to be balanced, (1) patents must better lives for our citizens, and (2) they must not tie up basic tools.
Bhagat claims neither preclude basic research on, or use of, any of the individual components of the claimed formulations, nor would they preclude anyone from making, using, selling, offering for sale, or importing any oil. Thus, the reasons to exclude basic tools from patent eligibility do not apply to the present claims.
Bhagat patent is directed to solving a critical public health problem. Inventor realized confusion around lipids is a massive public health hazard continuing for centuries, and wanted to remove the problem once and for all.
Lipids were considered important for health 6000 years ago when oils were invented, but since then lipid delivery fundamental to health has not materially advanced. Periodically, certain fatty acids (e.g., omega-3) or oils or low-fat teachings have been hailed, only to reverse a few years later. To date random oils are randomly added to foods; no guidance is given that different batches of the oils can have significantly different lipid composition and that minor lipids components present in oils can be potent. Oil making has advanced but delivery of oil for ingestion by subjects is still archaic.
This problem is there partly because of refusal to nurture innovation via proper patent grant. Severely restricted nutrition patents are ineffective and create more confusion and chaos. These mini-patents give rise to millions of products, conflicting marketing, and competition smearing each other with “our formulation is the best and everybody else is making snake oil.” Consequently, clear teaching is lost and public stops believing everything.
The scale of the problem is very large. According to WHO statistics, 33% of Europeans above the age of 15 have a chronic disease (e.g., heart disease, diabetes, cancer, asthma, ADHD), a large part of which is associated with mismanaged lipid consumption including omega-6 and omega-3. Premature deaths of 550,000 working age people across European Union countries from chronic diseases cost EU economies EUR 115 billion or 0.8% of GDP annually. This figure does not include the additional loss in terms of lower employment rates and productivity of people living with chronic health problems. (See http://www.oecd.org/health/europe-paying-a-heavy-price-for-chronic-diseases-finds-new-oecd-ec-report.htm).
Furthermore, even after the disclosure of Bhagat Application, although a skilled person can practice the solutions based on the disclosure of the application, but there is little chance that public by and large can practice the solutions because less than 1% of public can understand (even name) or measure lipids in lipid sources and the problem pertains to daily life. Therefore, the solutions have to be implemented at public level, rather than skilled person level. From public health perspective, solutions have to be pre-formulated for them and they have to be taught how to adapt the solutions in daily life, a very challenging and expensive feat.
The above backdrop lead the Inventor and the Applicant to pursue the subject patent application because in order to effectively solve the problem significant clear public teaching—overcoming the noise in the art—is required, which requires capital and a protected environment to nurture the solutions.
The innovation would also set humanity on a course for long-term solution to several downstream problems. Not granting appealed claims is tantamount to taking the position public should be kept confused, ill, and on drugs, and this 1000s of years old problem should continue into perpetuity. Ultimate purpose of research is to enhance human condition. If the solutions devised cannot be fully applied for public benefit then the patent policy is obstructing the very purpose of research.