The Thorny Problem of Patentable Eligible Subject Matter: Part 1 of a 10-Part Series: U.S

This is Part 1 of a 10-part series examining patent eligible subject matter in the U.S., BRIC and several non-BRIC countries.

Statutory Classes of Patentable Subject Matter

In the U.S., patentable subject matter is defined by Section 101 of the Patent Act which states: Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title. 35 U.S.C. §101 (Section 101).

The Patent Act of 1793, authored by Thomas Jefferson, contained the original statute defining patentable subject matter which ultimately evolved into modern day Section 101. At that time, the statute defined patentable subject matter as any new and useful: art, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.

In 1952, when the patent laws were recodified, Congress replaced the word “art” with the word “process” but otherwise Jefferson’s original wording remained unchanged. Although the term “process” was not added until 1952, “processes” historically enjoyed patent protection because they were considered a form of “art” as used in the 1793 Act. Interestingly, according to the Committee Reports accompanying the 1952 Act, Congress intended statutory subject matter to “include anything under the sun that is made by man.”

Thus, under Section 101, all patents issued in the U.S. must be classified into at least one of the following four statutory classes:

  1. Machines – A concrete thing consisting of parts or devices;
  1. Manufacture – An article produced from raw or prepared materials;
  1. Composition of Matter – A composition of substances or composite articles; and
  1. Processes -An act or a series of acts.

Inventions that do not fall within any of above described statutory classes are not eligible for patenting.

The U.S. Supreme Court (Supreme Court) has long held that Section 101 contains a number of important “implicit” exceptions. Specifically, laws of nature, natural phenomena and abstract ideas are not patentable. For example, the Supreme Court has written that a new mineral discovered in the earth, a new plant found in the wild, Einstein’s law E=mc2 or Newton’s law of gravity are not patentable subject matter. As the Supreme Court stated in Gottschalk v. Benson, 409 U.S. 63, 67 (1972), “[P]henomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable as they are the basic tools of scientific and technological work.” Additionally, Section 33(a) of the Leahy-Smith American Invents Act provides that human organisms (such as claims to a human embryo) are not patent eligible subject matter.

U.S. Patent and Trademark Office Guidelines

In view of recent Supreme Court decisions including Association for Molecular Pathology v. Myriad Genetics, Inc. (Myriad) and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Mayo), the U.S. Patent and Trademark Office (USPTO) on March 4, 2014, issued a guidance for evaluating subject matter eligibility under Section 101 (Guidance). The Guidance superseded the June 13, 2013 memorandum issued on the day of the Myriad decision. While the Guidance was issued without public notice or opportunity for the public to comment, the USPTO is holding a forum on May 9, 2014 to receive feedback from organizations and individuals regarding the Guidance.

The Guidance is divided into four sections. Part I discusses the three-part test for determining subject matter eligibility. Part II explains how to determine whether a claim (as a whole) is “significantly different.” This portion of the Guidance provides a list of 12 factors – six that weigh toward eligibility (namely, finding a significant difference) and six that weigh toward ineligibility (namely, a finding of no significant difference).  Part III provides seven examples explaining the application of the factors. Part IV provides a new form paragraph for Examiners to use when rejecting claims in accordance with the guidance.

The USPTO has made it clear that the Guidance is to be used for making subject matter eligibility determinations for all four statutory categories of subject matter (namely, a machine, composition, manufacture or process) that recite or involve laws of nature, natural principles, natural phenomena and/or natural products. The Guidance is not to be used if the subject matter recites or involves an abstract idea {alone or in combination with other judicial exceptions (namely, laws of nature, natural principles, natural phenomena and/or natural products)}.

In addition to the Guidance, the USPTO has prepared detailed training materials (containing 93 PowerPoint slides) for Examiners. During the Biotechnology/Chemical/Pharmaceutical Customer Partnership meeting on April 16, 2014 (BCP meeting), June Cohan and Ali Salimi from the Office of Patent Legal administration, and Daniel Sullivan, a supervisor patent Examiner from Art Unit 1611, provided insight on how the Guidance was developed, including its basis in Supreme Court precedent. As discussed during the presentation, the first round of training for Examiners on the Guidelines is in progress and a second round of training is currently in development. Plans for this second round of training include providing additional training materials containing more examples from the seven provided in the current Guidelines. Moreover, the USPTO plans to update the MPEP. It will be interesting to see the content of the next round of training materials, particularly after the USPTO receives feed-back from the public during the forum on May 9th.

Three-Part Analysis

The Guidance provides a three-step analysis for determining the subject matter eligibility of a claim. The analysis involves determining the broadest reasonable interpretation for a claim and asking the following questions:

  1. Does the claim recite one of the four statutory categories of patent eligible subject matter (namely, a machine, a composition, a manufacture or a process)? If the answer to this question is no, then the analysis is complete and the claim is rejected under Section 101 as drawn to ineligible subject matter. If the answer to this question is yes, proceed to question 2.
  1. Does the claim recite or involve one or more judicial exceptions (namely, an abstract idea*, law of nature or natural principle, natural phenomena or natural product)? If the answer to this question is no, then the analysis is complete and the claim qualifies as eligible subject matter. If the answer to this question is yes, proceed to question 3.

*If an abstract idea, however, is recited or involved, then the Guidance should not be used to determine if the claim qualifies as eligible subject matter.

  1. Does the claim as a whole recite something significantly different from the judicial exception? If the answer to this no, then the analysis is complete and the claim is rejected under Section 101 as drawn to ineligible subject matter. If the answer to this question is yes, then the analysis is complete and the claim qualifies as eligible subject matter.

According to the Guidance, it is not enough that a claim is directed to a product or composition that is non-naturally occurring. Rather, the claimed product or composition must also be significantly different in structure from a naturally occurring product.

What does “significantly different” mean?

According to the Guidance, if a claim recites or involves a judicial exception (a law of nature/natural principle or natural phenomenon and/or something that appears to be natural product), the claim only qualifies as eligible subject matter if the claim as a whole recites something significantly different than the judicial exception itself. This raises the question of the meaning of “significantly different.” According to the USPTO, the Supreme Court has articulated two pathways to eligibility for claims reciting judicial exceptions (such as natural products):

  1. Marked difference from what exists in nature; or
  1. Addition of significantly more to the judicial exception.

The “marked difference” inquiry focuses on the structural differences of a claimed product or composition and whether these structural differences impart one or more unique functions to the product when compared to a naturally occurring product. Applicants must be cognizant that including limitations in a claim such as “synthetic,” “isolated,” “recombinant,” “cDNA,” “composition,” “primer,” “purified,” and “vector” are not likely to be found to constitute a “marked difference” from what exists in nature. In fact, in the Examiner training materials, the USPTO made it clear that “[T]hese words may reflect ‘hand of man’ but are not necessarily determinative of eligibility.”

Additionally, a claim reciting a method that involves or recites a judicial exception must recite meaningful limitations that add significantly more (namely, practically apply) to the judicial exception. A claim that recites limitations that are insignificant or tangentially related and/or are well known or understood and purely conventional or routine steps or features are not likely to be found to have added “significantly more” to a judicial exception.

The Guidance and training materials provide a list of 12 factors (six that weigh toward eligibility (namely, finding a significant difference) and six that weigh toward ineligibility (namely, a finding of no significant difference)) to be evaluated for determining if a claim as a whole is “significantly different.” The Guidance makes it clear that not every factor will be relevant to every claim and does not need to be considered in every analysis. The 12 factors are provided in the table below.

ImageFile_20140430_124208

*These factors are only relevant to product claims. The remaining 10 factors (b-f and h-l) are applicable to all claims.

The initial burden is on an Examiner to establish a prima facie case of ineligibility. Specifically, when rejecting a claim, the Examiner is required to provide a rationale or evidence to reasonably support a determination that a product is not markedly different from what exists in nature. The evidence that can be used by an Examiner is not limited to that available as of the filing date of the application. Moreover, as discussed in detail in the Guidance and training materials, an Examiner’s analysis “should carefully consider every relevant factor and related evidence before making a conclusion.” In fact, the materials make clear that a determination of eligibility is not “a single, simple determination but is a conclusion reached by weighing the relevant factors, keeping in mind that the weight accorded each factor will vary based upon the facts of the application.”

Examples

The Guidance and the training materials provide a number of examples demonstrating how the factors are to be weighed when conducting a subject matter eligibility analysis. However, several of the examples have resulted in significant discussion and consternation by practitioners. Some of these examples include:

  1. Examples directed to compositions containing purified natural products and methods of using these purified natural products for various purposes (See, Example B in the Guidance and the examples on pages 41 and 67-85 of the training materials). Specific examples include: a composition containing purified amazonic acid or 2-methyl-2-pentenoic acid, a beverage composition comprising pomelo juice and a preservative or vitamin E and a method of treating colon cancer using purified amazonic acid.
  2. Examples directed to compositions containing a mixture or aggregation of natural products (See, Example D in the Guidance and the example on page 44 of the training materials). Specific examples include: an inoculant for plants comprising a plurality of selected mutually non-inhibitive strains of different species of bacteria and a composition comprising 90% copper and 10% tin.
  3. Examples directed to articles of manufacture containing a natural product (See, Example C in the Guidance). A specific example includes a fountain-style firework comprising calcium chloride and gunpowder.

But Wait…Didn’t Myriad Just Involve DNA?

During the BCP meeting, the USPTO addressed the question of why the Guidance extends the Myriad decision beyond just nucleic acids. According to the USPTO, the Guidance was not intended to be limited to just Myriad, but addresses Myriad in the context of at least 10 other Supreme Court decisions addressing subject matter eligibility. The USPTO justifies this approach arguing that Myriad “explicitly” relied on earlier Supreme Court precedent such as Chakrabarty and Mayo, all of which are interrelated.

Moreover, the USPTO further argues that despite the fact that for over 30 years Office practice was that “isolation” or “purification” of an otherwise unchanged naturally occurring product was sufficient for eligibility, the Supreme Court has given no deference to this past practice. Specifically, the USPTO states that the:

Supreme Court made it clear in Myriad that isolating a natural product such as a gene, even though it ‘creates a nonnaturally occurring molecule’, is not enough for eligibility. Instead, eligibility requires the creation of something not naturally occurring, which is markedly different from what exists in nature.

So, what now??

Applicants prosecuting applications that have one or more claims rejected under Section 101 should consider amending their claims to include limitations that impose meaningful limits on the scope of the claims. Applicants should avoid adding limitations that are well-understood, purely conventional or routine and consider explaining why a step or the claim as a whole is not routine or conventional. Other possible suggestions include adding a particular machine or particular transformation (such as a method of treatment) to the claims.

Applicants should consider amending product claims to recite the structural differences between the claimed product and the naturally occurring product. Applicants should also explain how these structural differences impart unique functions to the product when compared to a naturally occurring product. Although such claims would be relatively narrow in scope, Applicants should consider filing one or more continuation applications to await further judicial clarification on the subject matter eligibility in view of the Guidance.

When drafting applications, Applicants should make sure to include multiple claim sets with progressively narrower scope. Additionally, Applicants should make sure that the specification includes sufficient detail to provide the description necessary to provide any support that may be needed to demonstrate “a marked difference” between a claimed product or composition and a naturally occurring product(s) and/or to impart “meaningful limits” to the scope of the claims.

This post was written by Julia Cox, Ph.D., Paul Jenny, Laura Opperman, Ph.D. and Lisa Mueller of Michael Best & Friedrich LLP.

The Copaxone Story in the U.S. and India: To Stay or Not to Stay is the Question

As an update to our March 5th, April 4th and April 9th postings, The Copaxone Story in the U.S. and India,  The Copaxone Story in the U.S. and India: An Update and The Copaxone Story in the U.S. and India: A Further Update, on April 18th, the U.S. Supreme Court (Supreme Court) denied Teva Pharmaceutical Industries Ltd.’s (Teva) application to recall and stay the Federal Circuit’s mandate pending the Supreme Court’s decision. This denial paves the way for Sandoz and Mylan to launch their generic versions of Copaxone® at risk in approximately one month.

Background

On December 27, 2007, Sandoz  filed the first abbreviated new drug application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to manufacture and sell its proposed generic version of Copaxone®, before the expiration of the Orange Book patents. On June 29, 2009, Mylan filed its own ANDA. In view of the ANDA submissions, Teva (and Yeda Research and Development Co., Ltd.) separately sued Sandoz (in August 2008) and Mylan and Natco (in October 2009) in the U.S. District Court, Southern District of New York (District Court) for infringement of the Orange Book patents as well as U.S. Patent Numbers 5,800,808 (‘808 patent) and 6,048,898 (‘898 patent). The District Court issued an injunction barring Sandoz and Mylan from marketing their generic versions of Copaxone® until September 1, 2015 (the expiration date of the ‘808 patent).

The lawsuits were consolidated and on June 29, 2012, the Judge found all nine patents valid, enforceable and infringed. Specifically, the Judge found Mylan had infringed seven of the patents and Sandoz infringed four patents. On July 26, 2013, the Federal Circuit ruled that four of the patents were valid but found five invalid for indefiniteness. Specifically, the Federal Circuit ruled that the claims of the five patents were indefinite because a person skilled in the art could not discern the boundaries of the claims. The patents declared invalid were U.S. Patent Numbers 5,800,808, 5,981,589, 6,048,898, 6,620,847 and 6,939,539. The patents held valid were U.S. Patent Numbers 6,054,430, 6,342,476, 6,362,161 and 7,199,098. The invalidation of the ‘808 patent was significant because of all the Orange Book listed patents, it had the longest expiration date {namely, September 1, 2015 (all of the remaining patents expire on the same date – May 24, 2014)}. The Federal Circuit remanded the case to the District Court to determine whether to modify its injunction.

On November 13, 2013, the Supreme Court denied Teva’s request to stay the Federal Circuit’s decision during appeal. As a result of this denial, the District Court was compelled to follow the Federal Circuit’s mandate and modified its injunction. As a result, Sandoz and Mylan are permitted launch their respective generic versions of Copaxone® beginning May 24, 2014 (rather than September 1, 2015).

On March 31, 2014, the Supreme Court granted Teva’s writ of certiorari to review the Federal Circuit’s decision. Specifically, Teva petitioned for writ of certiorari to clarify the correct standard of review used by Federal appellate courts when reviewing factual findings made by a district court. Most Federal appellate courts review a district court’s factual findings to see if they are “clearly erroneous.” However, the Federal Circuit has had a practice of reviewing a district court’s factual findings in support of claim construction using de novo review.

Application to Recall and Stay Federal Circuit’s Mandate

On April 4th, Teva filed an application with Chief Justice John G. Roberts (Chief Justice) asking the Supreme Court to recall the Federal Circuit’s mandate which modified the District Court’s injunction. In its application, Teva stated that it would “likely face irreparable harm if the mandate is not recalled.” Specifically, Teva argued:

Absent a recall of the mandate, respondents will be free to launch products that infringe the ’808 patent fifteen months before that patent expires. In analyzing whether that premature launch will cause Teva irreparable harm, the Court assumes that Teva’s legal position is correct, Barnes, 501 U.S. at 1302—an assumption that carries greater weight now that the Court has chosen to grant the petition. Applying that standard, the Federal Circuit’s insistence on lifting the District Court’s injunction while this Court’s review proceeds will leave Teva unprotected and likely cause Teva serious, irreparable harm.

The Chief Justice gave Sandoz and Mylan until April 14th to respond to Teva’s application.

Opposition of Sandoz and Mylan to Teva’s Application

On April 14th, Sandoz and Mylan filed a joint opposition to Teva’s application. The parties argued that the stay should be denied because:

1.  The relief sought by Teva would require the issuance of a new injunction (the original injunction no longer existed because that injunction had been modified by the District Court) and Teva could not justify such extraordinary relief; and

2.  Even if a recall and stay of the mandate could provide the relief sought, Teva failed to satisfy its burden demonstrating that such relief was warranted. Specifically, Teva had failed to show a “fair prospect” that the Supreme Court would reverse the Federal Circuit’s decision.

Interestingly, Sandoz and Mylan argued that an injunction or stay could ultimately cause each of them immense harm. Specifically, the parties argued:

What is more, the harm to Sandoz and Mylan from an injunction or stay is likely to extend well beyond the duration of any such order as a result of Teva’s ongoing efforts to undercut the present Copaxone® market before the introduction of a generic alternative. Until a few months ago, Copaxone® had been administered only in daily 20-milligram injections – the version of the drug that Sandoz and Mylan intend to produce. But on January 28, 2014, Teva obtained FDA approval to market a version of the drug that is administered in 40-milligram injections three times a week.  Glatiramer Acetate, Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations, U.S. Food & Drug Admin. The 40-milligram version purportedly is covered by separate patents, not at issue in this litigation, that will not expire until 2030. Ibid. 

Because the 40-milligram version is shielded from imminent generic competition, Teva has made efforts to move the Copaxone® market to that version, because ‘the more patients it converts ahead of generic approvals, the higher the probability insurers won’t force those customers to switch back to daily shots once generics become available.’ David Wainer, Teva’s Early Copaxone® Conversion Effort Convincing Analysts, Wash. Post, Mar. 11, 2014. Indeed, Teva even has created financial incentives for patients to use the new 40-milligram version by pricing it thousands of dollars per year lower than the 20-milligram formulation.

…Simply put, Teva is aggressively moving to cannibalize the 20-milligram market that Sandoz and Mylan are seeking to enter: by February 28, 2014 – after only one month on the market – Teva already had switched 8.7% of Copaxone® users to the 40-milligram formulation.

Teva’s Reply in Support of its Application to Recall and Stay Federal Circuit’s Mandate 

On April 17th, Teva filed a reply in support of its application. In its brief, Teva reiterated that its application was for a stay of a mandate and not an injunction. Specifically, Teva argued that “The District Court in this case enjoined respondents from such infringement, and the requested stay would prevent the Federal Circuit’s incorrect decision from disrupting the injunction while this Court decides whether (as is likely) the Federal Circuit must be reversed.” Additionally, Teva argued that there was far more than a “fair prospect” that the Supreme Court would reverse the Federal Circuit. Teva argued that “…the briefs of the United States and a host of other amici, the closely divided en banc court (6-4), and two decades of vigorous dissents from Federal Circuit judges seeking to overturn the no-deference rule all demonstrate not just a fair prospect, but a probability of reversal.”

In response to the arguments made by Sandoz and Mylan regarding the harm each would suffer as a result of an injunction or stay, Teva argued:

Respondents’ argument seems to be that if they could launch before this Court decides the case, they could lock up more customers who have not yet tried Teva’s new three-times-per-week Copaxone® product. That product is now FDA-approved, is as efficacious as the daily injection, and allows patients to substantially reduce the number of injections they must undergo. Respondents hope that insurance companies will decide to reimburse patients only for the less expensive (but still expensive) generic daily injection product. Respondents’ desire to lock up customers before they try Teva’s three-times-a-week product rests on speculation about voluntary choices between products that patients and doctors will make. Such speculative fear of competition is not cognizable harm in any event.

If anything, the existence of three-times-a-week Copaxone® undermines respondents’ position.  Respondents oppose reinstating the District Court’s injunction precisely so that they can undermine Teva’s ability to sell the new product – one that offers real advantages to patients – and permanently erode the price of that product as well. What respondents seek to preserve is their chance to increase the irreparable harm that the launch of their generic products before the expiration of the ‘808 patent would cause Teva. Such changes in the market would make the damages from the launch of an infringing generic product even more difficult to calculate here than in other cases in which courts have routinely found that launching a generic product would create irreparable harm (emphasis in original).

Additionally, Teva stated that it was prepared to post a bond of up to $500 million at the “earliest practicable time, but in no event later than May 24, 2014.” According to Teva, the “bond would fully protect both respondents for many months of sales even under their most wildly optimistic projections”.

Denial of the Application by the Supreme Court 

On April 18th, the Chief Justice denied Teva’s application. Specifically, the Chief Justice acknowledged that while the Supreme Court had granted certiorari and Teva had demonstrated a fair prospect of success on the merits, he was not convinced that Teva had demonstrated a likelihood that irreparable harm would result as a result of the denial of the stay. More specifically, the Chief Justice stated:

[R]espondents acknowledge that, should Teva prevail in this Court and its patent be held valid, Teva will be able to recover damages from respondents for past patent infringement.

…Given the availability of that remedy, the extraordinary relief that Teva seeks is unwarranted.

At Risk Launch?

With approximately one month to go, it will be interesting to see whether or not Sandoz and Mylan launch their generic versions of Copaxone®.

Continue to watch the BRIC Wall Blog for further updates on this case.

This post was written by Lisa Mueller.

The BRIC Wall Turns 1!

Happy birthday BRIC Wall! April 18 marks the 1st anniversary of our blog’s initial post and we want to take this moment to thank our readers, contributors and supporters during this past year. When we started, we did not know where the blog would take us and it has been an incredible journey so far – over 18,500 views from 106 countries.

We have written on a wide range of globe-spanning topics including:

  • Understanding biosimilars in Brazil, Turkey and Nigeria;
  • Data protection and patent term extension in Russia;
  • Protecting and enforcing trade secrets in China;
  • Section 3(d) of the Indian Patents Act;
  • A global perspective of patent trolls;
  • The ongoing Copaxone® story in the U.S. and India;
  • The basics of patent protection in Nigeria;
  • The time period and burden of proof requirements when requesting revocation of a patent in Kenya;
  • Obviousness in Pakistan;
  • Supplementary protection certificates and pediatric extension in Croatia;
  • Genetic heritage and traditional knowledge in Brazil;
  • Mailbox patents and the scope of prior consent by ANVISA in Brazil; and
  • A 9-part series on divisional practice in the BRIC and various other countries.

In fact, our 10 most popular posts to date have been:

1.  Section 8 of the Indian Patents Act and a Comparison with the Disclosure Requirements in Canada, Israel and the U.S.

2.  Understanding Compulsory Licenses in India – Part 1 of a 2-Part Series

3.  Section 3(d) of the Indian Patents Act – Part I

4.  The Problem of Mailbox Patents and Patent Term in Brazil

5.  Understanding Compulsory Licenses in India – Part 2 of a 2-Part Series

6.  Understanding Biologics and Biosimilars in Turkey

7. Understanding Biologics and Biosimilars in Brazil

8. Availability of Biosimilar Pathways and Data Exclusivity in Asian, Latin American and Eastern European Countries

9. Patent Trolls: A Global Perspective

10. Recent Decisions Involving Section 3(d) of the Indian Patents Act

The success of the BRIC Wall would not have been possible without the very kind and helpful assistance of our colleagues from around the world. We would particularly like to thank the following individuals and firms for giving so graciously of their time answering our questions and providing input on the various posts for the blog:

  • Gustavo de Freitas Morais and other attorneys of Danneman Siemsen
  • Ivan Shen of Shen IP
  • Nidhi Anand and Tarun Gandhi of Chadha & Chadha
  • Vladislav Ugryumov and Tatiana Lyu of Gowlings (Russia)
  • Trevor Newton and other attorneys of Gowlings (Canada)
  • Martin O’Brien, Soo Ee Lin and Kristian Robinson of Spruson & Ferguson
  • Micaela Modiano and other attorneys of Modiano & Partners
  • Katsumasa Osaki and other attorneys of Kawaguti & Partners
  • Nicky Garnett, Dario Tanziani and other attorneys of Adams & Adams
  • Canan Ozturker and Aydin Deris of Deris Patents & Trademarks Agency A.S.
  • Ufuoma Akpotaire of Nigerian Law Intellectual Property Watch
  • Igor Simoes of Clarke, Modet & Co.
  • the attorneys of Olivares & CIA, S.C.
  • the attorneys of Lee & Li
  • the attorneys of Central Intellectual Property & Law
  • the attorneys of AGIP KSA
  • the attorneys of Barreda Moller
  • the attorneys of Castellanos & CO
  • the attorneys of DePenning & DePenning
  • the attorneys of Dr. Shlomo Cohen & Co.
  • the attorneys of Ferrere
  • the attorneys of Invenco
  • the attorneys of Katzarov
  • the attorneys of Noetinger & Armando
  • the attorneys of Quevedo & Ponce
  • the attorneys of Tilleke & Gibbins

From Michael Best, I would like to thank my colleagues Lauren Falk, Laura Opperman, Julia Cox, Sansun Yeh, Paul Jenny and Wei Yan.

What does the future hold for the BRIC Wall? In our very first post, we said that our mission was to provide unique insights on patent law developments in at least the BRIC countries. We used the phrase “at least” because it was our intent to expand our discussions to other emerging market countries such as South Africa, Vietnam, South Korea, Singapore, Philippines, etc.  In the upcoming year, we will continue to cover patent law developments in the BRIC countries and expand our discussions to other emerging countries in Asia, Africa and Latin America.

However, what this means is that the BRIC Wall needs you! If you have a blog post idea or would like to write a blog post, email us at llmueller@michaelbest.com (all posts are reviewed and edited). We are interested in any intellectual property and regulatory issues in the life sciences area. Any suggestions to improve this blog are always appreciated. If you liked a particular posting and wish to see more or if you did not like a posting, please let us know.

Happy birthday and thank you again to everyone who has helped make this blog a success!

This post was written by Lisa Mueller.

 

The Thorny Problem of Patentable Eligible Subject Matter: An Introduction

In view of recent U.S. Supreme Court (Supreme Court) decisions including Association for Molecular Pathology v. Myriad Genetics, Inc. (Myriad) and Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Mayo), the U.S. Patent and Trademark Office (U.S. PTO) on March 4, 2014, issued a guidance for evaluating subject matter eligibility under 35 U.S.C. § 101 (Guidance). The Guidance superseded the June 13, 2013, memorandum issued on the day the Myriad decision was issued. Interestingly, the Guidance was issued without public notice or opportunity for the public to comment.

The Guidance is divided into four sections. Part I discusses the three-part test for determining subject matter eligibility. Part II explains how to determine whether a claim as a whole is “significantly different.” This portion of the Guidance provides a list of 12 factors – six that weigh toward eligibility (namely, finding a significant difference) and six that weigh toward ineligibility (namely, a finding of no significant difference). Part III provides seven examples explaining the factors. Part IV provides a new form paragraph for Examiners to use when rejecting claims in accordance with the guidance.

Many in the patent community have expressed concern regarding the Guidance. Comments have ranged from practitioners being “horrified” by the Guidance to others suggesting that perhaps the Guidance violates international trade agreements. Kevin Noonan, in a March 18, 2014 post on Patent Docs, nicely summed up what I think many in the patent community are thinking when he stated:

It is perhaps not a surprise that the Office issued these Guidelines in view of the hostility to patents evinced almost weekly by the Obama administration. Whether the result of undue influence from companies themselves hostile to patenting due to the impact patents can have on their industries, or from academics having their own reasons for taking an anti-patent stance, or simply because administration officials believe that patents make drugs and other products more expensive, it has consistently been the case that in its public statements and policy initiatives the Executive Branch has acted in ways not supportive of patenting and frequently seemingly naïve about the issues and the effects of the positions that have been taken (recall the “magic microscope,” for example). Former Director Kappos seemed to be a buffer between the Office and the rest of the administration in this regard, consistent with his broad experience. His absence (and the consequences of not naming a permanent Director since Mr. Kappos left) is evident in the substance of these Guidelines.

It is important to remember that the Guidance does not have the force of law and is simply a tool that the U.S. PTO will use to administer the law based on it current understanding (correct or incorrect) of Supreme Court case law. The Federal Circuit has stated that such guidance/guidelines are not binding on the Court. For example, readers will recall that in 2001 the U.S. PTO issued guidelines for reviewing patent applications for compliance with the written description requirement {Guidelines for Examination of Patent Applications under the 35 U.S.C. 112, ¶1 “Written Description” Requirement (Guidelines)}. The Federal Circuit specifically mentioned these Guidelines in Enzo Biochem, Inc. v. Gen-Probe Inc. stating that “The PTO has issued Guidelines governing its internal practice for addressing that issue. The Guidelines, like the Manual of Patent Examining Procedure (MPEP), are not binding on this court, but may be given judicial notice to the extent they do not conflict with the statute.”

In view of the significance of the Guidance, we at the BRIC Wall thought it would be informative to compare the requirements for evaluating patent eligible subject matter in the U.S. with that of the BRIC and other countries. Specifically, in an upcoming series of posts, we will review subject matter eligibility not only in the U.S., but also in Australia, Brazil, Canada, China, Europe, Japan, India, Russia and South Africa. In addition, we will examine the subject matter eligibility in each of these countries of four of the seven examples provided in the Guidance. Finally, we will also analyze claim one of U.S. Patent Nos. 6,573,103 (Antenatal Screening for Down’s Syndrome) and 6,355,623 (the claim discussed in Mayo).

We are excited about these upcoming posts and look forward to comments from our readers.

This post was written by Lisa Mueller.

The Copaxone Story in the U.S. and India: A Further Update

As an update to our March 5th and April 4th postings, The Copaxone Story in the U.S. and India and The Copaxone Story in the U.S. and India: An Update, the U.S. Supreme Court (Supreme Court) yesterday asked Sandoz Inc. (Sandoz) and Mylan Inc. (Mylan) to respond to Teva Pharmaceutical Industries Ltd.’s (Teva) application to recall and stay the Federal Circuit’s mandate pending the Supreme Court’s decision.

Background

On December 27, 2007, Sandoz filed the first abbreviated new drug application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to manufacture and sell its proposed generic version of Copaxone®, before the expiration of the Orange Book patents. On June 29, 2009, Mylan filed its own ANDA. In view of the ANDA submissions, Teva (and Yeda Research and Development Co., Ltd.) separately sued Sandoz (in August 2008) and Mylan and Natco (in October 2009) in the U.S. District Court, Southern District of New York (District Court) for infringement of the Orange Book patents as well as U.S. Patent Numbers 5,800,808 (‘808 patent) and 6,048,898 (‘898 patent). The District Court issued an injunction barring Sandoz and Mylan from marketing their generic versions of Copaxone® until September 1, 2015 (the expiration date of the ‘808 patent).

The lawsuits were consolidated and on June 29, 2012, the Judge found all nine patents valid, enforceable and infringed. Specifically, the Judge found Mylan had infringed seven of the patents and Sandoz infringed four patents. On July 26, 2013, the Federal Circuit ruled that four of the patents were valid but found five invalid for indefiniteness. Specifically, the Federal Circuit ruled that the claims of the five patents were indefinite because a person skilled in the art could not discern the boundaries of the claims. The patents declared invalid were U.S. Patent Numbers 5,800,808, 5,981,589, 6,048,898, 6,620,847 and 6,939,539. The patents held valid were U.S. Patent Numbers 6,054,430, 6,342,476, 6,362,161 and 7,199,098. The invalidation of the ‘808 patent was significant because of all the Orange Book listed patents, it had the longest expiration date {namely, September 1, 2015 (all of the remaining patents expire on the same date – May 24, 2014)}. The Federal Circuit remanded the case to the District Court to determine whether to modify its injunction.

On November 13, 2013, the Supreme Court denied Teva’s request to stay the Federal Circuit’s decision during appeal. As a result of this denial, the District Court was compelled to follow the Federal Circuit’s mandate and modified its injunction. As a result, Sandoz and Mylan were permitted to launch their respective generic versions of Copaxone® starting May 24, 2014 (rather than on September 1, 2015).

On March 31, 2014, the Supreme Court granted Teva’s writ of certiorari to review the Federal Circuit’s decision. Specifically, Teva petitioned to clarify the correct standard of review used by Federal appellate courts when reviewing factual findings made by a district court. Most Federal appellate courts review a district court’s factual findings to see if they are “clearly erroneous.” However, the Federal Circuit has had a practice of reviewing a district court’s factual findings in support of claim construction using de novo review.

Application to Recall and Stay Federal Circuit’s Mandate

On April 4th, Teva filed an application {a copy of which is available here (Teva_App)} with Chief Justice John G. Roberts (Chief Justice) asking the Supreme Court to recall the Federal Circuit’s mandate which modified the District Court’s injunction. In its application, Teva stated that it will “likely face irreparable harm if the mandate is not recalled.” Specifically, Teva argues:

Absent a recall of the mandate, respondents will be free to launch products that infringe the ’808 patent fifteen months before that patent expires. In analyzing whether that premature launch will cause Teva irreparable harm, the Court assumes that Teva’s legal position is correct, Barnes, 501 U.S. at 1302—an assumption that carries greater weight now that the Court has chosen to grant the petition. Applying that standard, the Federal Circuit’s insistence on lifting the District Court’s injunction while this Court’s review proceeds will leave Teva unprotected and likely cause Teva serious, irreparable harm.

Yesterday, the Chief Justice gave Sandoz and Mylan until April 14th to respond to Teva’s application.

Continue to watch the BRIC Wall Blog for further updates on developments regarding Copaxone® in both the U.S. and India.

This post was written by Lisa Mueller.

The Copaxone Story in the U.S. and India: An Update

As an update to our March 5th posting, The Copaxone Story in the U.S. and India, the U.S. Supreme Court (Supreme Court) this week granted Teva Pharmaceutical Industries Ltd.’s (Teva) writ of certiorari to review the Federal Circuit’s decision invalidating several of Teva’s patents covering its multiple sclerosis drug, Copaxone®.

Background

On December 27, 2007, Sandoz Inc. (Sandoz) filed the first abbreviated new drug application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to manufacture and sell its proposed generic version of Copaxone®, before the expiration of the Orange Book patents. On June 29, 2009, Mylan filed its own ANDA. In view of the ANDA submissions, Teva (and Yeda Research and Development Co., Ltd.) separately sued Sandoz (in August 2008) and Mylan and Natco (in October 2009) in the U.S. District Court, Southern District of New York for infringement of the Orange Book patents as well as U.S. Patent Numbers 5,800,808 (‘808 patent) and 6,048,898 (‘898 patent).

The lawsuits were consolidated and on June 29, 2012, the Judge found all nine patents valid, enforceable and infringed. Specifically, the Judge found Mylan had infringed seven of the patents and Sandoz infringed four patents. On July 26, 2013, the Federal Circuit ruled that four of the patents were valid but found five invalid for indefiniteness. Specifically, the Federal Circuit ruled that the claims of the five patents were indefinite because a person skilled in the art could not discern the boundaries of the claims. The patents declared invalid were U.S. Patent Numbers 5,800,808, 5,981,589, 6,048,898, 6,620,847 and 6,939,539. The patents held valid were U.S. Patent Numbers 6,054,430, 6,342,476, 6,362,161 and 7,199,098. The invalidation of the ‘808 patent was significant because of all the Orange Book patents, it had the longest expiration date (September 1, 2015).

On November 13, 2013, the U.S. Supreme Court denied Teva’s request to stay the Federal Circuit’s decision during appeal. As a result of the Supreme Court’s denial, Sandoz and Mylan can launch their respective generic versions of Copaxone® in May 2014 (rather than in September 2015).

Significance of the Case before the Supreme Court

Teva petitioned for writ of certiorari to clarify the correct standard of review used by Federal appellate courts when reviewing factual findings made by a district court. The only issue on appeal is encompassed by the question presented:

QUESTION PRESENTED:

Rule 52(a) of the Federal Rules of Civil Procedure provides that in matters tried to district court, the court’s “[f]indings of fact . . . must not be set aside unless clearly erroneous.”

 The question presented is as follows:

Whether a district court’s factual finding in support of its construction of a patent claim term may be reviewed de novo, as the Federal Circuit requires (and as the panel explicitly did in this case) or only for clear error, as Rule 52(a) requires.

Most Federal appellate courts review a district court’s factual findings to see if they are “clearly erroneous.” However, the Federal Circuit has had a practice of reviewing a district court’s factual findings in support of claim construction using de novo review.

The Supreme Court is no longer adding cases to the docket for this term. Therefore, this case will be decided in the October 2014 term. A finding by the Supreme Court for Teva will restore its patent protection for Copaxone® until September 2015. It will be interesting to see whether Sandoz and Mylan proceed with launching their generic versions of Copaxone® “at risk” in May 2014 or will wait a few more months for the decision of the Supreme Court.

This post was written by Lisa Mueller.

Divisional Practice in the BRICs and Other Countries – Part 9 of a 9-Part Series: A Comprehensive Summary

This is Part 9 of a nine-part series examining divisional practice in the BRIC as well as several non-BRIC countries. To view Part 1 (Divisional Practice in Mexico), click here. To view Part 2 (Divisional Practice in Brazil), click here. To view Part 3 (Divisional Practice in the United States), click here. To view Part 4 (Divisional Practice in India), click here. To view Part 5 (Divisional Practice in Russia), click here. To view Part 6 (Divisional Practice in China), click here. To view Part 7 (Divisional Practice in Canada), click here. To view Part 8 (Divisional Practice in Europe), click here.

In this last post in the series, we at the BRIC Wall are pleased to provide a table summarizing the key aspects of divisional practice in the eight countries surveyed. We hope our readers have found this series to be education and informative.

Divisional Summary Table:  FINALDIVISONALTABLE 2