Third Party Submissions in the U.S. – Part 4 of an 8 Part Series

This is Part 4 of an 8-part series examining post-grant review proceedings, oppositions, and third party observations in the U.S., BRIC and several non-BRIC countries. To see Part 1, Post-Grant Oppositions in Japan, click here. To see Part 2, Third Party Submissions in Russia, click here. To see Part 3, Pre- and Post-Grant Oppositions in India, click here.

Third Party Submissions

The Leahy-Smith America Invents Act (AIA), enacted on September 16, 2011, modified the rules concerning third party submission of certain documents during the pendency of a patent application. Specifically, the new rules (1) expanded the time period during which a third party can submit documents; and (2) allows a third party to comment on each document submitted. The main objective of the third party or pre-issuance submissions program is to provide relevant information to Examiners early in the examination process and, as a result, improve the quality of granted patents.

The new rules became effective on September 16, 2012 and apply to any patent application filed before, on or after this date. Any third party (who can remain anonymous) who is not the patent owner, can submit patents, published patent applications or other printed publications of potential relevance during examination along with a concise description of the relevance of each document to the U.S. Patent and Trademark Office (USPTO). Potentially relevant documents submitted may be those raising questions of novelty, inventive step, written description enablement, indefiniteness, improper propriety claim, prior use, etc.

The time period for making such submissions is prior to the earlier of:

  1. The mailing date of a Notice of Allowance; or
  2. The later of:
    1. Six months after the date of first publication of the application by the USPTO (publication of a PCT application or re-publication of a U.S. patent application does not count); or
    2. The mailing date of a first Office Action on the merits rejecting the claims (a restriction requirement does not constitute a first Office Action on the merits).

The documents submitted must be filed prior to, not on, any of the above dates. Also, the filing a request for continued examination (RCE), does not reset the time period for making any such submissions.

There is no limit on the number of submissions that can be made, provided that each submission is made prior to the above dates. However, each submission must contain the following:

  1. A document list identifying the patents, published patent applications or other printed publication being submitted;
  2. A legible copy of all publications or portions of publications submitted (other than U.S. patents and patent applications);
  3. A concise description of the asserted relevance of each document;
  4. An English language translation of any non-English language documents;
  5. A statement by the submitting party stating that it is not an individual having a duty to disclose information to the USPTO and that the submission complies with the requirements of 35 U.S.C. §122(e) and 37 C.F.R. §1.290; and
  6. The required fee, if necessary (A $180.00 fee is required for every ten items or a fraction thereof submitted. However, if the submission is the first submission by a third party and three or fewer documents are being submitted, then no fee is required. Additionally, a small entity discount is available).

There is no requirement that the documents submitted be prior art. In fact, a third party can submit patents, published applications or other printed publications that are already of record (in other words, cumulative submissions are permitted). However, such documents cannot be submitted in provisional applications, issued patents or in a post-issuance proceeding (such as a reissue application or reexamination proceeding).

The description of relevance is a statement of facts regarding the patents, published patent applications or publications submitted. The description can be submitted as a narrative or as a claim chart and must explain how each item listed is of potential relevance to the examination of the application. The description must be more than a bare statement that one or more documents are “relevant”. Specifically, the description should draw the Examiner’s attention to the potential relevant pages or lines of the each document submitted and how it relates to the claims.  While there are no page limits, no arguments or conclusions regarding patentability are permitted. For example, statements such as the below should be avoided:

It would have been obvious to one of ordinary skill in the art to combine the teachings of publication X and publication Y to obtain Z as recited in claim 1; or

The composition of claim 1 is unpatentable in view of publication X and publication Y.

How useful are these third-party submissions in influencing Examiners at the USPTO?  Apparently, not very useful so far.  As shown below, the number of applications at the USPTO that received Office Actions after receipt of a proper third-party submission as of September 2014 was approximately 13%.

PIECHART

Source: USPTO – September 26, 2014 data available at: http://www.uspto.gov/sites/default/files/patents/init_events/preissuance_submission_statistics1.pdf)

It will be interesting to see whether over time third-party submissions become more effective in influencing Examiners during the examination process.

This post was written by Lisa Mueller.

 

 

 

The Copaxone Story in the U.S. and India: U.S. Supreme Court Decision

As an update to our earlier 2014 postings, The Copaxone Story in the U.S. and India, The Copaxone Story in the U.S. and India: An Update, The Copaxone Story in the U.S. and India: A Further Update and The Copaxone Story in the U.S. and India: To Stay or Not to Stay is the Question, the U.S. Supreme Court (Supreme Court), on January 20, 2015, held 6-2 that questions of fact resolved by a district court prior to claim construction must be given deference by the Court of Appeals of the Federal Circuit (Federal Circuit) and can only be reversed if clearly erroneous.

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 Pharmaceutical Industries Ltd.’s (and Yeda Research and Development Co., Ltd.) (Teva) 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.

U.S. Supreme Court Decision

The Supreme Court reversed the Federal Circuit and established a new split standard of review of district courts’ claim construction rulings. Since Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996) (Markman), the Federal Circuit has applied a de novo standard of review to all portions of district courts’ claim construction rulings, meaning the Federal Circuit reviewed “anew” the district court’s entire ruling, including the lower courts’ factual findings. The Supreme Court ruled that the de novo standard alone is improper and instead, the Federal Circuit must apply a “clear error” standard of review on “subsidiary factual disputes” resolved by district courts in construing a patent’s claims.

The Supreme Court agreed with Teva that the Federal Circuit applied the wrong standard of review in not giving deference to the District Court’s factual determinations. Specifically, the Supreme Court concluded that while Markman determined that the issue of claim construction is a question of law, Markman also recognized that “subsidiary factfinding is sometimes necessary” during this construction. Id. at 6, 574 U.S. ____. Federal Rule of Civil Procedure 52(a)(6) (Rule 52) required that courts of appeal not set aside a district court’s findings of fact unless “clearly erroneous.” Based upon Rule 52, as well as additional precedent, the clearly erroneous standard applied to district courts’ factual findings used in the proper construction of a patent claim. The Supreme Court also relied on the fact that “practical considerations favor clear error review.” In particular, patent law frequently requires knowledge of specific scientific problems and principles that are “not usually contained in the general storehouse of knowledge and experience.” Id. at 7, 574 U.S. ____, (citing Graver Tank & Mfg. Co. v. Linde Air Products Co., 339 U.S. 605, 610 (1950)). The Court noted that a district court judge who has presided over a proceeding has a “comparatively greater opportunity to gain” more familiarity with the specific scientific problems and principles than an appeals court judge.

Additionally, the Supreme Court held that while the ultimate issue of the proper construction of a claim remains a question of law that the Federal Circuit reviews de novo, any subsidiary factual disputes resolved by a district court, including those that may be dispositive to the proper construction of a claim, must be reviewed under Rule 52’s “clearly erroneous” standard.

The Supreme Court also provided an explanation to ensure that the federal courts properly applied this change in the standard of review. The Court explained that when a district court’s claim construction required it to review only evidence intrinsic to a patent, that is, only the patent claims and the specification, along with the prosecution history, the district court’s determination would be solely a question of law, and thus, subject to de novo review. Conversely, where a district court is forced to look beyond the patent’s intrinsic evidence and consider extrinsic evidence in constructing a patent’s claims the clear error standard must apply. Thus, for example, where a district court considers opposing testimony of experts and makes a factual finding, that determination is subject to clear error review, but the ultimate construction based upon that factual underpinning remains subject to de novo review.

Application of the new split standard to the facts required reversal of the Federal Circuit’s determination. The Supreme Court found that the Federal Circuit erred in not accepting the District Court’s determination that Teva’s expert’s explanation was correct in analyzing how to determine molecular weight. The Supreme Court reversed and remanded to the Federal Circuit to consider the appeal in light of the new standard.

Finally, Justices Thomas and Alito dissented from the majority decision. Writing for the dissent, Justice Thomas argued that the District Court’s “subsidiary findings” made in the course of constructing the patent’s claims were not “factual findings” that fall within the purview of Rule 52. Instead, according to the dissent, the subsidiary findings associated with construing claim language is more closely related to the findings associated with construing a statute and thus, according to the dissent, de novo review should be applied.

This post was written by John C. Scheller, Albert Bianchi, Jr. and Lisa Mueller.

Inching Closer to the First Biosimilar Approval in the U.S.

Last week we saw some significant biosimilar activity in the U.S. Specifically, on January 7, 2015, a U.S. Food and Drug Administration (FDA) Advisory Committee (Advisory Committee) voted 14-0 to approve Sandoz Inc.’s (Sandoz) filgrastim biosimilar (referred to as “EP2006”) for all five indications of Neupogen® (the reference product manufactured by Amgen Inc. (Amgen)).  Specifically, the Advisory Committee found EP2006 to be “highly similar” to filgrastim, “notwithstanding minor differences in clinically inactive components,” and that “there are no clinically meaningful differences between EP2006 and filgrastim in terms of [purity], safety, and effectiveness.”  Typically, the FDA follows an Advisory Committee’s recommendation, although it is not required to do so.  Assuming the FDA follows the Advisory Committee’s recommendation, EP2006 would be the first biosimilar approved under the FDA’s 351(k) biosimilar pathway.  Sandoz manufactures a biosimilar version of filgrastim under the brand name Zarzio® in more than 40 countries. For example, Zarzio® was first approved in the European Union in 2009.

As mentioned above, EP2006 received a recommendation for approval in five indications (all of which are somewhat related):  (1) cancer patients receiving myelosuppressive chemotherapy; (2) patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; (3) cancer patients receiving bone marrow transplant; (4) patients undergoing peripheral blood progenitor cell collection and therapy; and (5) patients with severe chronic neutropenia.  Interestingly, because Sandoz provided Phase III data for only one of the five indications, the remaining four indications were awarded by extrapolation.

Extrapolation is highly controversial but viewed as crucial in keeping the research and development costs down for biosimilars.  It will be interesting to see how the FDA handles extrapolation with more complex molecules (such as antibodies), which have been approved for very distinct applications (such as, for example, infliximab and adalimumab, which are approved for such distinct indications such as rheumatoid arthritis, ulcerative colitis and Crohn’s disease).  For example, in Europe, Celltrion Inc. (Celltrion) was able to fully extrapolate to six indications (including psoriasis and digestive disorders) for its biosimilar version of infliximab.  However,  extrapolation was not permitted in Canada where regulators found that differences between Celltrion’s biosimilar and the reference product raised questions about whether the biosimilar infliximab would be suitable for every condition.

Sandoz’ requested approval for EP2006 as a biosimilar to Neupogen® and not as an interchangeable product.  However, switching studies are in process that could support a future interchangeability application.  Publication of the FDA’s guidance document on interchangeability is expected in 2015.

One significant issue not discussed by the Advisory Committee or in its briefing document released prior the meeting was naming.  Will Sandoz’ product have the generic name filgrastim or some variant?  Novartis proposed the brand name, Zarxio for EP2006.  However, this brand name has not yet been approved by the FDA.  Industry is still waiting publication of the FDA’s guidance document on naming.

Despite the good news, significant challenges still remain for Sandoz and its biosimilar product.  On January 6, 2015, the day before the Advisory Board’s vote, Amgen filed a motion for partial summary judgment in its lawsuit filed against Sandoz on October 24, 2014.  Specifically, Amgen urged a California federal judge to find that pursuant to the Biologics Price Competition and Innovation Act (BPCIA) Sandoz was required to provide Amgen with a copy of its 351(k) application for its biosimilar product as well as its manufacturing information no later than 20 days after the FDA notified Sandoz of acceptance of its 351(k) application.  Additionally, Amgen requested that the judge find that Sandoz could not have provided notice of commercial marketing as required under the BPCIA because the FDA had not yet approved Sandoz’ 351(k) application.  Thus, according to Amgen, Sandoz’s conduct violated the BPCIA and this violation represented unfair competition under California law.  Unfortunately, this litigation will likely need to be resolved before EP2006 can enter the marketplace.  Resolution could be years away thus  further delaying entry of the first biosimilar product into the U.S. marketplace.

This post was written by Lisa Mueller.

2014 Year in Review of U.S. Biosimilar Activity

Lisa Mueller, partner and Chair of the Life Sciences and Chemical Practice Groups, and Laura Opperman, Patent Scientist and member of the Intellectual Property Practice group at Michael Best & Friedrich LLP, published an article on Law360 highlighting activity taking place in respect to biosimilars in 2014.

Here is a short excerpt: “This year witnessed significant activity in the U.S. with respect to biosimilars. Highlights include issuance by the U.S. Food and Drug Administration of two new guidances, further debate over the naming of biosimilars, acceptance by the FDA of the first biosimilar application, publication of the “Purple Book” and continued legal wrangling over the so-called patent dance patent resolution provisions added to the Public Health Service Act by the Biologics Price Competition and Innovation Act of 2009…” Click here to read more of Lisa and Laura’s article.

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

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

In Re Roslin Institute (Edinburgh)

In part 1 of this series (which can be found here), the statutory classes of patentable subject matter in the U.S. as well as the guidance issued by the United States Patent and Trademark Office (USPTO) for evaluating subject matter eligibility (Guidance) were discussed. As an update to that discussion, provided below is a brief overview of a recent decision by the United States Court of Appeals for the Federal Circuit (CAFC) regarding patentable subject matter. In the U.S. court system, the CAFC hears appeals relating to patent law and any appeals to CAFC decisions are to the U.S. Supreme Court (Supreme Court). Specifically, the CAFC decided on May 8, 2014 in In Re Roslin Institute (Edinburgh) (Roslin) that Roslin’s clone (i.e., Dolly the Sheep) was unpatentable subject matter under Section 101.

In Roslin, the application at issue was U.S. Patent Application No. 09/225,233 (the ‘233 Application), which contained product claims to clones resulting from somatic cell nuclear transfer (i.e., a clone from an adult or differentiated cell). A representative claim is claim 155, which stated:

A live-born clone of a pre-existing, non-embryonic, donor mammal, wherein the mammal is selected from cattle, sheep, pigs, and goats.

In its opinion, the CAFC stated that “Roslin’s claimed clones are exact copies of patent ineligible subject matter [i.e., the donor mammal].” These exact copies (e.g., Dolly the Sheep), according to the CAFC, did not possess markedly different characteristics from any farm animals found in nature. The genetic information and genetic structure of the DNA used to make the clones was not created or altered by the inventors.

Additionally, while the Appellant argued that Dolly possessed distinguishable characteristics from the donor mammal (i.e., phenotype and mitochondrial DNA), the CAFC pointed out that these differences were not indicated in the claims directed to the clone. The CAFC further stated that the phenotypic differences arose independent of the inventors’ efforts and the specification of the ‘233 Application did not identify how differences in mitochondrial DNA would have influenced characteristics of the cloned mammals.

Accordingly, the CAFC concluded that the claimed clones were defined in terms of the identity of their nuclear DNA relative to the nuclear DNA of the donor mammals. The CAFC thus decided that Dolly’s genetic identity to her donor parent rendered her unpatentable subject matter, and as the claims did not describe clones that had markedly different characteristics from the donor animals of which they were copies, the claims were directed to patent ineligible subject matter under Section 101.

It should be noted that the CAFC did not comment upon what may or may not constitute a markedly different characteristic. While the characteristic considered by the CAFC here in Roslin was genetic identity (i.e., genetic information and nuclear DNA structure), does a markedly different characteristic always have to be a marked difference in structure as stated in factors a and g of the Guidance or can a markedly different characteristic be, in certain instances, differences in function, use, and the like, where no change in structure occurs? It will be interesting to see how the U.S. courts interpret the term “markedly different characteristic” in future cases in relation to the patent eligibility of product claims.

Please continue to watch the BRIC Wall for further updates on patentable eligible subject matter.

This post was written by Laura Opperman and Lisa Mueller.

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 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.